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INDEX

INTERNATIONAL

1. IPR 1

2. Regulatory 2

3. New Products 3

4. R&D / Clinical Trials 4

5. Mergers & Acquisitions / Collaborations 5

6. Pricing 6

7. Trade & Others 7

8. Biotechnology 10

9. Medical Diagnostics / Devices 10

10. New Appointments 10

DOMESTIC

1. IPR 10

2. Regulatory 11

3. New Products 14

4. R&D / Clinical Trials 14

5. Mergers & Acquisitions / Collaborations 16

6. Pricing 18

7. Trade & Others 19

8. Biotechnology 22

9 Medical Diagnostics / Devices 23

10. New Appointments 24

11. OPPI Related News 24

Volume 5 Issue 7 July 2012

Organisation of Pharmaceutical Producers of India

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International IPR

As Compulsory Licensing Spreads, Drugmakers Adapt June 22, 2012, Fierce Pharma There is the concept associated with evolution that you must adapt or die. Now some experts are suggesting the same thing for drugmakers when it comes to the growing threat of compulsory licensing. Now that China is following India into this realm, which allows countries to essentially strip companies of patents if they deem it in the public interest, the tension among big drug developers is rising. LiveMint quotes a research company in the U.K. saying the research-oriented companies "will have to restructure their business plans in emerging markets," to compete. Strategies will include making their drugs cheaper themselves in the countries where the threat of compulsory licensing exists and making sure they are available to more poor patients to cut off the incentive to invoke the maneuver.

Big Pharma Firms May Learn To Live With Compulsory Licensing June 22, 2012, Livemint With China amending its patent law on compulsory licensing soon after India granted the first such permit in the country, innovator pharmaceutical firms that bank on patent protection for growth are under pressure to revamp sourcing, distribution and pricing strategies, industry experts said. “The research-oriented companies, which mostly focus on the patented technologies that give them an edge, will have to restructure their business plans in emerging markets now as local governments are taking all possible measures to lower the healthcare cost,” said a London-based life sciences partner at a global consultant.

Beware: Patent Losses To Climb Back To $56B By 2015 June 20, 2012, Fierce Pharma For years we've been anticipating 2012 as the steepest patent cliff, the year when the world's biggest drugs would be slammed with generic competition. No doubt about it, $67 billion in drug sales at risk from patent expirations is a whopping big figure.

But as EvaluatePharma reminds us in its latest World Preview report, released at this week's BIO conference, 2012 is far from the end of pharma's patent woes. Next year provides something of a respite, with only $29 billion's worth of drugs losing exclusivity.

Merck Loses A Patent Ruling On Blockbuster Nasonex June 18, 2012, Fierce Pharma Even as the clock is ticking down on the patent for its super blockbuster Singulair, Merck got smacked Friday with a negative decision in its battle with genericmaker Apotex over Merck's blockbuster Nasonex spray. A federal judge in New Jersey ruled against Merck, saying Apotex's generic did not step on Merck's patent, then separately ruled against Apotex, throwing out its claim that Merck's patent on the nasal spray is invalid. Merck's general counsel Bruce Kuhlik tells Reuters it may appeal the decision, while Merck spokesman Ron Rogers tells Bloomberg, "As far as we know, the FDA has not approved Apotex's application. We do not expect generic competition near-term." Apotex declined comment.

China Now Carries A Big Compulsory-Licensing Stick June 11, 2012, Fierce Pharma Drugmakers can count compulsory licensing among the new pitfalls of China's huge-and-growing drug market. Thanks to amended intellectual property laws, the Chinese government can now force generic drugs onto the market before branded meds lose patent protection. China isn't alone in this, of course; India recently caused a dust-up by compelling Bayer to license its cancer drug Nexavar to Natco Pharma, which promised to sell its copycat version for $176 per month, compared with Bayer's $5,600 monthly price.

US Firm Sues Zydus Cadila Subsidary For Infringement Of Patents June 12, 2012, Business Standard A complaint for infringement of patents with regard to drug for treatment of acne has been filed against Zydus Pharmaceuticals USA, Inc, a fully owned subsidiary of Ahmedabad-based pharma major Cadila Healthcare Ltd (Zydus Cadila) in a district court of US. This complaint petition has been filed by one Arizona-based Medicis Pharmaceutical Corporation (MPC). Zydus USA has been accused of seeking approval from the United States Food and Drug Administration (FDA) to commercially manufacture, use, and selling of a generic

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version of Solodyn minocycline hydrochloride and extended release tablets, before the drug’s patents which is with MPC, expires.

China Amends Patent Law In Fight For Cheaper Drugs June 8, 2012, Moneycontrol.com China has overhauled parts of its intellectual property laws to allow its drugmakers to make cheap copies of medicines still under patent protection in a move likely to unnerve foreign pharmaceutical companies. The Chinese move comes within months of a similar move by India to effectively end the monopoly on an expensive cancer drug made by Bayer AG by issuing its first so-called "compulsory licence". Similar action by China will ring alarm bells in Big Pharma, since the country is a vital growth market at a time when sales in Western countries are flagging. The amended Chinese patent law allows Beijing to issue compulsory licences to eligible companies to produce generic versions of patented drugs during state emergencies, or unusual circumstances, or in the interests of the public.

Cipla Losses Appeal In US Court For Animal Healthcare Product June 8, 2012, The Economic Times Drug firm Cipla today said it has lost an appeal in a US court over a patent case against Merial Ltd regarding an animal healthcare product. The company had moved the US Court of Appeals in Washington against a ruling by District Court Georgia that held that the company's sales of animal healthcare product, PetArmor Plus infringed a patent held by Merial Ltd, a subsidiary of Sanofi-Aventis, and suspended sales of the product in the US. "Company has now received an order from the Federal Circuit wherein it has affirmed the order of the District Court with two judges ruling against the company and one judge in favour of the company," Cipla said in a filing to BSE.

Regulatory

EMA Investigating Deficiencies In Roche's Drug Safety Reporting June 22, 2012, Pharma Letter The European Medicines Agency revealed yesterday that it is working with national medicines agencies to investigate deficiencies in the medicine safety reporting

system of Swiss drug major Roche (ROG: SIX), the world’s biggest producer of cancer drugs. The EMA says this includes looking at whether the deficiencies have an impact on the overall benefit-risk profile for any of the products involved. However, it points out that there is at present no evidence of a negative impact for patients and, while the investigations are being conducted, there is no need for patients or health care professionals to take any action.

US To Charge Fee On Generic Drug Sale Application June 21, 2012, Business Standard All generic pharmaceutical companies, including Ranbaxy Laboratories, Cipla, Dr Reddy’s Laboratories, Lupin, Glenmark and Torrent Pharma, might soon have to pay a fee to the US drug regulator when they seek its permission to sell their products there. America is the world’s largest drug market. A Generic Drug User Fee Act is on the way, to enable the US Food and Drugs Administration (FDA) to levy a user fee of around $100,000 on each generic drug application filed for approval, it is learnt. The new norms are likely to be introduced from October.

FDA Panel Turns Thumbs Down On Sanofi's Anti-Clotting Drug June 20, 2012, Fierce Biotech Sanofi's attempt to gain its first new drug approval in two years experienced another setback today as a committee of external experts decisively voted against an OK for semuloparin, a treatment designed to prevent blood clots among patients receiving chemotherapy. The advisers concluded that Sanofi didn't proffer a clear picture of who would benefit from the treatment, particularly worrying given their risk of bleeding. The 14 to 1 landslide likely buried any remaining chance of a near-term approval for the treatment.

AstraZeneca’s Obesity Drug Study Stopped After Adverse Event June 20, 2012, Fierce Biotech Score one against AstraZeneca in the obesity drug game. Safety reviewers called a stop to the London-based drug giant's Phase I study of an experimental obesity treatment after a man on the injected drug became sick. The drug, code named AZD2820, is a peptide melanocortin-4 receptor partial agonist from AZ's collaboration with the Cranbury, NJ-based biotech Palatin Technologies. The potential bad reaction hit one

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of the 72 obese men that AZ had planned to enroll in the trial, and the man might have suffered from an allergic reaction to his first shot of the drug.

US FDA Calls For More Efficacy Data On Pfizer's Tafamidis NDA June 19, 2012, Pharma Letter The US Food and Drug Administration yesterday issued a complete response letter regarding drugs behemoth Pfizer’s New Drug Application for tafamidis meglumine, requesting the completion of a second efficacy study to establish substantial evidence of effectiveness prior to an approval. The Agency has also asked for additional information on the data within the current tafamidis NDA. Tafamidis is a novel, investigational medication for the treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP) in adult patients with symptomatic polyneuropathy to delay neurologic impairment.

FDA Approves Glaxosmithkline's New Combo Vaccine MenHibrix June 18, 2012, Pharma Letter The US Food and Drug Administration has approved US pharma giant GlaxoSmithKline’s MenHibrix (meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine), a combination vaccine for infants and children aged six weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b. The basis for FDA approval of MenHibrix included data GSK submitted from clinical trials conducted in the USA, Mexico, Australia, Belgium and Germany over seven years in which 7,521 infants and toddlers received at least one dose of MenHibrix.

German Model For Assessment Of New Medicines Slammed By EU Pharma Leaders June 11, 2012, Pharma Letter Leading pharmaceutical companies in Europe, represented in the European Federation of Pharmaceutical Industries and Associations (EFPIA), meeting in Berlin last Friday, called on the German government for urgent action to protect patient access to new medicines and ensure that Germany remains a home for pharmaceutical innovation. “Recent years have seen the introduction of a series of punitive measures in Germany. A 16% rebate; an

international reference pricing system that links the price of medicines in Germany to those in countries like Greece; and a medicines assessment system that links the price of new medicines to generics.

Following US Senate And House Pass Of FDA Reforms, Now Comes The Detail June 5, 2012, Pharma Letter Now that the US House of Representatives and the Senate have passed HR 5651 and S 3187 (the FDA Safety and Innovation Act), respectively, focus will move to a conference committee, which will iron out differences between the bills and reach a compromise, comments Karl Karst on law firm Hyman, Phelps & McNamara’s FDA Law Blog. Both bills reauthorize and amend old (PDUFA and MDUFA) and establish new (GDUFA and BsUFA) user fee statutes, permanently reauthorize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, and create several new provisions of law, among other things, he notes.

New Products

Dr Reddy’s Laboratories Launches Parkinson’s Drug In US May 8, 2012, The Economic Times Dr Reddy's Laboratories has launched in the US market ropinirole hydrochloride XR (extended release) tablets used to treat the signs and symptoms of Parkinson's disease. Ropinirole hydrochloride XR tablets are the bioequivalent generic version of Requip XL tablets, a registered trademark of pharma giant SmithKline Beecham. The Indian company has obtained the approval of the United States Food and Drug Administration for its abbreviated new drug application for ropinirole hydrochloride XR tablets to launch a generic product. Requip XL had reported sales of around $58 million for the 12 months period ended March 2012 in the US market according to IMS Health.

Ranbaxy To Relaunch Bessling Brand May 29, 2012, The Economic Times Ranbaxy Laboratories has received US drug regulator's approval to relaunch one of its best selling brand in the US after being banned for nearly four years. US Food and Drug Administration (FDA) has approved Absorica, a novel, patented brand formulation of isotretinoin that is used to treat acne.

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The drug has been developed by its Canadian partner Cipher Pharmaceuticals to whom Ranbaxy will pay royalties on net sales of the drug, Ranbaxy said in a release. "Absorica will be the flagship brand for Ranbaxy's specialized dermatology sales force," said Ranbaxy's Americas senior VP and regional director Venkat Krishnan said.

R&D/Clinical Trials

Global R&D Spending Rises 8.2% In FY11 June 22, 2012, Hindu Business Line Global R&D spending, after witnessing a decline in fiscal 2010, has grown by 8.2 per cent in FY2011, according to a Zinnov study. India’s prominence as an R&D hub is growing with the likes of IBM, SAP, Oracle and others setting up R&D centres and currently, 30 per cent of the top 1000 R&D spenders across verticals have a presence here. This growth has been primarily driven by organisations in the semiconductor, industrial and consumer hardware and electrical and electronic sectors.

Researchers At CCMB Make Breakthrough Discovery To Contain Diabetes By Deactivating A Gene June 21, 2012, Pharmabiz, A Raju A team of researchers at the Centre for Cellular and Molecular Biology (CCMD) in Hyderabad have come out with a major breakthrough discovery to contain diabetes by successfully deactivating a gene to regulate the functioning of beta cells in pancreas. The malfunction of these beta cells leads to non-production of insulin or production of ineffective insulin. The research team conducted the experiments on the mouse model. In this model, the researchers could successfully regulate the mass of beta cells in pancreas of the mouse.

India And US Sign Agreement On Collaboration In Diabetes Research June 19, 2012, The Economic Times Indian and US have signed an agreement on collaboration in Diabetes Research. The agreement was signed between Ghulam Nabi Azad, Union Minister for Health and Family Welfare and Kathleen Sebelius, US Secretary,

Health and Human Services during the bilateral meeting between India and the US. The primary aim of this collaboration is to initiate a health research relationship between the two countries to generate a better understanding of the molecular and biological mechanisms underlying diabetes, to characterize the genetic, social and environmental determinants, and to identify innovative approaches for improving prevention and treatment of diabetes.

Hit By Red Tape, Clinical Trial Companies Eye South-East Asia For Expansion June 13, 2012, The Economic Times Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities. Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials conducted on Indian patients .

Alzheimer’s Vaccine Trial Proves Successful June 8, 2012, Zee News Scientists have found a new vaccine to be effective against Alzheimer’s disease. The vaccine, CAD106, can prove a breakthrough in the search for a cure for this seriously debilitating dementia disease. Alzheimer’s disease is a complex neurological dementia disease that is the cause of much human suffering and a great cost to society. According to the World Health Organisation, dementia is the fastest growing global health epidemic of our age. The prevailing hypothesis about its cause involves APP (amyloid precursor protein), a protein that resides in the outer membrane of nerve cells and that, instead of being broken down, form a harmful substance called beta-amyloid, which accumulates as plaques and kills brain cells.

India, US To Begin Collaborative Research On Tuberculosis Soon June 5, 2012, PharmaBiz Even as tuberculosis (TB) continues to threaten the lives and wellbeing of thousands of people each year in India and several other countries, India and the US will soon

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begin collaborative research on TB under the Indo-US vaccine action programme (VAP). The main aim of this initiative is to build and enhance biomedical and clinical research capacity in India by establishing long term longitudinal cohorts of TB patients and their contacts (or other high TB risk patients) for studies using state of the art research tools.

Zerhouni Trumpets New R&D Mindset At Sanofi June 1, 2012, Fierce Biotech Sanofi has reorganized its research and development over the past couple of years, and R&D chief Elias Zerhouni offered up some insights about the new mindset at the French drug giant. For example, the company has emphasized a focus on results of clinical programs over the scientific bureaucracy that has been implicated in the industry's lack of R&D productivity. "The project is what matters, not people's titles," Zerhouni said, as quoted by Bloomberg. "The least hierarchical the model is, the better."

Eli Lilly Opens Diabetes R&D Center In China June 1, 2012, BioSpectrum Asia Eli Lilly officially opened the Lilly China Research and Development Center (LCRDC) on May 30, keeping with its commitment towards China. The center will focus on discovering innovative diabetes medicines with novel mechanisms that can be tailored for the Chinese population to delay the progression of the disease. Affecting nearly 90 million Chinese people, diabetes is a significant national public health problem, due in part to longer life expectancies, dietary changes and a sedentary lifestyle emerging in China. Differences in the genetic makeup of Asian patients may also play a role in diabetes development and progression, and exploring these differences is a priority for the LCRDC.

GSK Unit Stiefel Snags Rights To Skin Drug For CAD$35M May 31, 2012, Fierce Biotech Stiefel Laboratories has injected a new drug in mid-stage development into its dermatology pipeline. The company, a unit of GlaxoSmithKline, has ponied up CAD$35 million ($33.9 million) in an upfront payment to Welichem Biotech for rights to an experimental anti-inflammatory compound dubbed WBI-1001 for markets outside of China, Taiwan, Macao and Hong Kong.

The topical drug is a non-steroidal treatment in Phase II development for psoriasis and atopic dermatitis, Research Triangle Park, NC-based Stiefel said in a statement. Welichem ($WBI.TSX), headquartered in Burnaby, British Columbia, has gathered safety and efficacy evidence on the drug...........

Mergers & Acquisitions / Collaborations

India, Norway To Extend Partnership In Healthcare Sector June 21, 2012, The Economic Times India and Norway have decided to extend by five years its partnership in healthcare sector after the success of their joint efforts in delivering child and maternal health services. At a meeting in Oslo on Monday between Health Secretary P K Pradhan and Norway's Secretary General from the Ministry of Foreign Affairs Bente Angell-Hansen signed a letter of intent to initiate Phase II of the Norway India Partnership Initiative (NIPI) on reducing child and maternal mortality. NIPI is a partnership between India and Norway to improve delivery of child and maternal health services in select states under the National Rural Health Mission (NRHM). The partnership was initiated in 2006 by the Prime Ministers of India and Norway Manmohan Singh and Jens Stoltenberg.

Piramal In Talk To Buy US Contract Drug Maker Cambridge For $200 M June 16, 2012, Financial Express Piramal Healthcare (PHL) is in talks to buy US contract drug manufacturer Cambridge Major Laboratories (CML) for around $200 million, a person with direct knowledge of the development said. “Early stage negotiations are on and it will take a while to conclude the deal,” he said. PHL is the flagship company of the Ajay Piramal-owned Piramal Group while the Wisconsin-based unlisted CML makes pharmaceutical intermediates and active pharmaceutical ingredients (APIs) used in drugs.

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GSK Unit To Buy Basilea Eczema Drug For $227m June 13, 2012, Financial Express (epaper page 10) GlaxoSmithK.ine is to buy Basilea’s new eczema drug Toctino for an initial 146 million pounds ($227 million) to boost its Stiefel dermatology business, the two companies said on Thursday. The Swiss biotech company is also entitled to further payments of up to 50 million pounds if the drug is approved in the United States, as well as double-digit percentage payments o US sales begning three years after launch.

Pricing

Roche Slashes MabThera Price In S. Africa To Drive Sales June 20, 2012, Fierce Pharma Drugmakers are chafing under European price cuts. But more and more, they're cutting prices on their own in the developing world. It's part of the strategy to increase emerging markets sales, a recognition of the fact that developing countries, a., can't afford drugs at the prices charged in U.S. and Europe, and b., present very different tactical challenges. Roche is the latest mover: The Swiss drugmaker has cut the price on its MabThera cancer treatment by one-half in South Africa. The move will immediately increase volume, Business Day says. The government hasn't been able to afford routine use of the pricey drug, which treats lymphoma, leukemia and rheumatoid arthritis. Now, more patients can get it.

Pharma Herd Faces Hurdles With Pricey New Drugs June 20, 2012, Fierce Pharma There was a time when specialty care drugs for diseases such as multiple sclerosis, cancer and rare genetic disorders flew under the radar of payers, as the treatments gobbled up a modest piece of the overall prescription-drug spending pie. That time is over. With drugmakers flocking to these lucrative drug markets, the bar has risen to get reimbursement and physician uptake of the expensive products. But there are ways to hedge bets in the specialty care game.

India Firm Shakes Up Cancer Drug Market With Price Cuts June 16, 2012, The Economic Times Indian pharmaceutical tycoon Yusuf Hamied revolutionised AIDS treatment more than a decade ago by supplying cut-price drugs to the world's poor -- and now he wants to do the same for cancer. Hamied, chairman of generic drugs giant Cipla, last month slashed the cost of three medicines to fight brain, kidney and lung cancer in India, making the drugs up to more than four times cheaper. "I hope we'll cut prices of many more cancer drugs," he told AFP, adding that he wants to supply the cheaper drugs to Africa and elsewhere.

Drugmakers Warn German Pricing Is Killing Innovation June 14, 2012, Fierce Pharma As economies have wilted in Europe, Germany has been all about austerity and how that is the only way to cure the E.U.'s financial woes. But the backlash from drugmakers to German drug pricing has become so significant that, for its own consumers, drugmakers warn the cure may be becoming worse than the disease. Novartis pulled its blood pressure medication Rasilamlo from the German market three months after introducing it to Germany. Eli Lilly simply bypassed Germany with its launch of Trajenta, the diabetes drug it's launching in Europe with Boehringer Ingelheim.

MNCs Get Flexibility In Transfer Pricing; Move Will Dispel Fear Among Foreign Companies June 11, 2012, The Economic Times The government has allowed multinationals flexibility in valuing their transfer of intangibles such as brand to their Indian subsidiaries without any fear of the tax department. The government hopes it will dispel the fears that India was gunning for foreign companies after it changed income tax law retrospectively and announced tough tax avoidance rules. The new rule will allow multinationals to use any arms-length methodology to value intangibles such as brand name, goodwill, and dealer network that are transferred to their Indian subsidiary, withdrawing any discretion to the tax officer to question the value so determined.

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U.K. Pharma Balks At Value-Based Pricing Ideas June 7, 2012, Fierce Pharma Drugmakers are squaring off against the U.K.'s price-setting proposals. As Britain approaches its new value-based pricing system--set to come into effect in 2014--an industry association warns that the government's…

ACTA Will Make Life Saving Drugs Costlier For The Poor May 31, 2012, The Economic Times Joseph Munyi, a Kenyan citizen, has been living with HIV for 8 years and, much like other HIV patients, is unemployed. He has been receiving his medication free of charge on account of government programmes and outreach programmes of Medicine Sans Frontieres. His medication comes in the form of generic drugs. However, this situation may not last long as economic interests of few may end up impeding many a public spirited citizen of the world from executing her bounden duty as a human to ameliorate the conditions of the underprivileged.

Trade & Others

MSF Appeals European Nations Not To Ratify Anti-Counterfeiting Trade Agreement June 25, 2012, Pharmabiz, Ramesh Shankar Even as the European Parliament is meeting in July to give its final voting on the proposed Anti-Counterfeiting Trade Agreement (ACTA), the international medical humanitarian organization Médecins Sans Frontières (MSF) has appealed to the contracting states not to sign and ratify the Agreement unless all concerns related to access to medicines are fully addressed. Terming the Agreement as a 'Blank Cheque for Abuse', MSF said that the Agreement is flawed and should not be accepted in its current form. Enlisting the concerns, the international NGO said that ACTA is not restricted to trademark counterfeiting.

India, Brazil & China Defend Generic Drugs At WTO June 25, 2012, The Economic Times India, Brazil and China have defended the right of poor countries to access cheap generic medicines at the World

Trade Organisation, resisting attempts by the US, Japan and some other developed countries to club counterfeits or copies of patented drugs with fake or spurious ones. "The cases of seizure of high quality generic or off-patent drugs by third countries that hold patents for these could gain legitimacy if counterfeits are confused with fakes," an Indian official told ET. "We cannot allow this as it could seriously hinder access to cheap drugs by the poor."

Anti-Overtime Ruling A Disguised Blessing For Reps, Recruiters Say June 21, 2012, Fierce Pharma The Supreme Court denied pharma sales reps their overtime. But it may have saved many of their jobs--not to mention their bonuses, industry recruiters say. If the ruling had gone in the reps' favor, drugmakers would have been on the hook for billions in back pay--and that outlay could have triggered another round of salesforce layoffs, Dow Jones reports. The ruling came in GlaxoSmithKline's ($GSK) overtime case, and it likely saved the company hundreds of millions, if not billions. Other companies with pending suits would have faced similar liabilities. Plus, the ruling would have inspired other reps to sue their companies for back pay. Voilá, billions in immediate costs.

Indian Drug Outlook Favourable: ICRA & Moody’s June 21, 2012, The Economic Times Outlook on the Indian pharmaceutical industry remains favourable, says ICRA & Moody report released on Wednesday. Domestic formulation market grew by 13-16% per annum in last five years. According to the report, domestic formulation market size stood at Rs 58,300 crore, ranked third in terms of volume and tenth in terms of value, globally. The domestic growth was driven mainly by expansion in volumes and new introductions. Lifestyle-related disorders are driving growth at faster pace in chronic segments along with increasing healthcare spending.

Pfizer Expects To Wrap Up Prempro Suits For $1.2B Total June 19, 2012, Fierce Pharma The price tag Pfizer's Prempro settlements is now in. The drugmaker has paid $896 million to wrap up about 60% of the patient lawsuits, Bloomberg reports. That's about 6,000 cases, all alleging that its hormone-replacement drugs caused breast cancer.

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Pfizer has also set aside more money--$330 million--to cover the rest of its Prempro liability. That's for about 4,000 suits still outstanding. Total: $1.226 billion for 10,000 cases, or a little more than $120,000 per case, on average.

Drug Export Up 27% At Rs 60,000 Crore In FY 12 June 19, 2012, The Economic Times India's exports of drugs, pharmaceutical & fine chemicals grew 27% to Rs 60,000 crore for the year ended March 2012, according to data compiled by Pharmaceutical Exports Council of India (Pharmexcil). The export figure is now close to the size of the Indian formulations market which currently stands at around Rs 62,000 crore, which is growing at 15-20% annually. However, the exports and the local formulations numbers are not comparable as the exports data include sale of active pharmaceutical ingredients or basic raw materials used to make drug. The revenues of the domestic market takes into account only branded finished medicines.

Takeda To Stop Selling 13 Pfizer Drugs In Japan June 16, 2012, Reuters Takeda Pharmaceutical Co, Japan's biggest drugmaker, said on Monday it will stop distributing 13 Pfizer Inc drugs it now sells in Japan at the end of this year and Pfizer itself will begin selling them from 2013. The 13 drugs include antibiotic Minomycin, anticancer agents Torisel and Mylotarg, and depression treatment Amoxan. The list did not include Viagra. Takeda said it will continue to distribute Prevenar, a pneumococcus vaccine for children, and the haemophilia B drug BeneFIX. It also said it and Pfizer will continue to work together on the arthritis drug Enbrel.

Lipitor Generic’s Mkt Shrinks 96% In US On Over-Crowding June 16, 2012, The Economic Times A higher-than-expected price erosion of cholesterol-lowering Lipitor, the world’s best selling drug, is set to affect the earning of Indian drug makers Ranbaxy Laboratories and Dr. Reddy’s. The market of atorvastatin, the generic version of Lipitor, shrunk 96% in the US on May 30-the first day after expiration of Ranbaxy Laboratories’ 180 day marketing exclusivity – as several new players entered the market

Australia’s PIC Reports To Ministers On Treatment And Reimbursement Of Similar Biologics June 14, 2012, Pharma Letter The Australian Pharmaceuticals Industry Council (PIC), with industry group members AusBiotech, Medicines Australia and the GMiA (representing generic drugmakers), has today reported to the federal government on the preferred treatment of follow-on biologics for reimbursement. The PIC has been considering the issue of regulation of similar biologic medicinal products (SBMPs) - also known as biosimilars - and specifically their treatment for reimbursement, following a request by the former Minister for Health and Aging for the PIC to try to reach a sector-wide consensus on a policy for managing the listing and pricing of biosimilars on the Pharmaceutical Benefits Scheme (PBS).

Drugstores Accuse Pfizer, Teva Of Blocking Effexor Generics June 14, 2012, Fierce Pharma CVS Caremark and Rite Aid have signed on to the Effexor XR conspiracy theory. In an antitrust lawsuit, the drugstore chains allege that Pfizer's ($PFE) Wyeth unit and Teva Pharmaceutical Industries ($TEVA) colluded to delay generic versions of the blockbuster antidepressant. As Reuters points out, it's just the latest accusation of generic-blocking shenanigans boosting sales of Effexor XR, the extended-release version of venlafaxine. Back in December, Walgreen, Kroger, Safeway, Supervalu and HEB Grocery together filed a similar suit against the two drugmakers. Both companies have denied the allegations.

Indian Companies Eye $1billion Generic Opportunity June 13, 2012, The Times of India It's literally a billion-dollar opportunity. In the wake of patent expiries on three blockbuster drugs over the last six-seven months, an opportunity worth nearly $1.3 billion is up for grabs for domestic generic players. With three drugs - Lipitor, Zyprexa and more recently Plavix - going off-patent, along with a sharp rupee depreciation, a significant revenue upside has emerged for players like Ranbaxy, Dr Reddy's and others. Of this, Ranbaxy is believed to have mopped up an estimated $600-million revenue already from generic Lipitor since it was launched in December last year, analysts say.

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CRAMS Holds Big Opportunity For Indian Generic June 8, 2012, The Times of India A global study has resized worldwide market for contract research and development services, with pharmaceutical industry increasing its reliance on outsourcing to accelerate development of new medicines. A host of domestic companies- Jubilant, Piramal, Divis Labs, Quintiles, Biocon and Syngene- offering businesses like manufacturing, custom research and clinical trials, are trying to catch a piece of the action.

India To Take Up With Brazil Issues Faced By Pharma Cos June 8, 2012, Hindu Business Line India will take up with Brazil the barriers faced by Indian pharmaceutical companies, including procedural delays, and the consequent increase in costs of exports. The procedural delays happen during inspections, clearances and registration by the Brazilian authorities. The issue is part of India's campaign in Latin America to boost its pharma exports, including generic drugs, as the sector also faces similar non-tariff barriers in other Latin American countries. This will be high on the agenda at the bilateral discussions during the June 9-15 visit to Brazil by the Commerce Minister, Mr Anand Sharma, official sources said.

US Regulator Calls For Action On Fake Drugs June 7, 2012, Financial Times Laws to combat counterfeit drug trafficking are toothless and need to be toughened, Margaret Hamburg, commissioner of the US Food and Drug Administration, said on Wednesday. In an interview with the Financial Times, Ms Hamburg said current penalties for peddling fake prescription medicines were the same as those for selling fake Gucci handbags and weaker than punishments for people selling illicit drugs. “We need legal authorities to give teeth to our actions,” Ms Hamburg said. “We are increasingly concerned that this is becoming an attractive area for bad guys, including organised crime.” Her remarks came after two recent high-profile cases of fake drugs circulating through the US supply chain.

Do Doctor-Payment Sunshine Laws Work? June 5, 2012, Reuters

The mere passage of a law that requires drug companies to disclose how much money they pay doctors may not change physician prescribing practices, suggests a new study. In two states that passed so-called sunshine laws requiring drugmakers to disclose payments, doctors' choices of which drugs to prescribe for their patients did not differ much from those of peers in states without such a law. However, since the disclosure of information was to state agencies, not the general public, the state laws were less likely to influence doctors' behavior, one expert not involved in the research noted. "It was a way of doing a quick analysis to even see if there was an impact we could measure," said Kavita Nair, the study's senior author and a associate professor at University of Colorado School of Pharmacy in Aurora.

WHO Will Set Generics Apart From Counterfeits June 4, 2012, DNA World Health Organisation (WHO) has adopted a resolution to clearly define counterfeit medical products (CMP) so as to set them apart from genuine generic drugs. The resolution follows intense lobbying by India at the World Health Assembly (WHA) last week and is seen as a major diplomatic win. The country has worked through back-channel ways at the inter-governmental level for almost two years to pressurise the international organisation. This also means WHO will limit its role to public health issues and not get into the debate of intellectual property rights (IPR).....

Memos Show PhRMA, Pfizer Led Big Pharma Support For Healthcare Bill June 1, 2012, Fierce Parma The cat is out of the bag so to speak with the disclosure of memos today detailing the level of drug industry support for passage of President Obama's prized healthcare reform. It was never a secret that Big Pharma came on board to support the legislation, but memos released today by a Republican committee show that its key trade association PhRMA, led by Pfizer, elicited industry support and agreed to pay for advertising campaigns to boost its chances of passage. In return, the administration agreed to stand in the way of provisions the industry didn't like, Bloomberg reports. The memos show that drugmakers were most concerned about price controls from Medicare and the consumers getting access to cheaper drugs in other countries.

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US FDA May Impose Huge Drug User Fee On Generic Imports Soon, India To Hit Badly May 28, 2012, Pharmabiz, Suja Nair Shirodkar The US FDA may introduce a Generic Drug User Fee Act (GDUFA) soon to curb import of cheap generic drugs into that country. The proposed Act empowers the US government to fix an exorbitant fee on the import of each generic product category coming from any overseas sources. The US currently imports about 80 per cent of APIs and 40 per cent of generics made in the overseas locations. The US Food and Drug Administration (FDA) recently completed and submitted its recommendations for the proposed Generic Drug User Fee Act (GDUFA) to the Congress.

Biotechnology

Abbott Stands Alone In Challenge To Biosimilars Law June 22, 2012, Fierce Pharma So far Abbott Laboratories is having to fly solo in its challenge to the legality of the biosimilar provision in the Affordable Healthcare Act. In a citizens petition filed with the FDA in April, the biologicsmaker claimed that its rheumatoid arthritis drug Humira cannot be copied because it would be illegal to require Abbott to cough up the trade secrets that it has spent "massive amounts of money" to develop, The Wall Street Journal reports. Further, it contends that no biologic drug approved before passage of the law should be considered for biosimilar approval. There has been plenty of opposition from those groups that want to see consumers benefit from cheaper biologic drugs coming to market sooner and are concerned the challenge will hold up a new market for biosimilars.

Medical Diagnostics / Devices

No Relevant News

New Appointments

No Relevant News

Domestic IPR

Nexavar Licence Does Not Violate Trade Pact: Sharma June 15, 2012, Indian Express Commerce and Industry Minister Anand Sharma on Thursday said that issuance of compulsory licence to anti-cancer drug Nexavar by India is not violative of any provision of multi-lateral trade agreement. “We have not violated of any WTO agreement...this (invoking CL) is very much in conformity with the international agreement under the WTO,” Sharma said while addressing industry leaders of the pharmaceutical sectors in Sao Paulo, Brazil. In March, Hyderabad-based Natco Pharma was allowed to manufacture and sell cancer-treatment drug Nexavar at a price over 30 times lower than charged by patent-holder Bayer Corporation, under compulsory licensing (CL).

Patents: A Prize For Inventors Will Help June 2, 2012, Hindu Business Line A potentially game-changing idea is that if an inventor is rewarded with a huge cash award upfront in exchange for his invention becoming available immediately for public use, unseemly patent battles waged across continents will be a thing of past. Patents are country-specific, so much so that a person registering one in his home country has no choice but to also register it in all the countries where the product or process is likely to be used. Under WTO norms, dictated by the powerful Western world, the patent-holder enjoys monopoly rights over his invention for 20 years.

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Scientists Float Group To Protect Intellectual Rights June 2, 2012, Indian Express Invoking the case of Binayak Sen, four senior scientists have formed a pressure group of “elder scientists” that will take up issues related to “rights of scientists and other intellectual workers”. The group announced its formation in the latest issue of Current Science, jointly published by the Indian Academy of Sciences and the Current Science Association, and invited opinions. “Some time ago, when Binayak Sen, an eminent health activist and vice-president of the People’s Union for Civil Liberties, was sentenced by a Chhattisgarh court to life imprisonment for sedition..., nine former presidents of the three principal Academies of science in India endorsed an appeal by more than 50 Nobel laureates..., supporting Sen and urging immediate release,” the group wrote.

How P H Kurien Took On Global Patents System To Make Very Costly Drug Affordable For Poor May 30, 2012, The Economic Times It is said that only God and a few good men and women run India. One such man is P H Kurien. For readers unfamiliar with his name, Kurien was India's Controller General of Patents, Designs & Trade Marks until March 12, 2012. On March 9, 2012, just three days before he left office, he issued the first-ever compulsory licence in India for the manufacture of a drug still under patent. The licence authorized Indian company Natco to manufacture drug Naxevar for which Bayer, a German multinational company, holds the patent. This was an act of major significance for India's health. Since March 3, 2008, when it got the Indian patent, Bayer has imported Naxevar, selling its monthly dose at the whopping price of 2,80,428 or $5,420. Unsurprisingly, only 2% of Indian patients have been able to afford it.

Commerce Ministry Locks Horns With Pharma Dept Over Patented Medicines May 29, 2012, Financial Express Commerce ministry has locked horns with the department of pharmaceuticals for the latter’s alleged inaction on the plan to bring patented drugs under a price negotiation system. There is no provision for any regulation on patented drugs in the proposed new pricing policy for drugs. “The National Pharmaceutical Pricing Policy is restricted to generics alone and does not cover patented

medicines. The department of pharmaceuticals had set up a committee on price negotiations of patented medicines and there has been no substantial outcome on the committee,” the commerce ministry said in a note to the group of ministers on pharma pricing policy.

Regulatory

We Will Prove The Poor Can Access Healthcare: Dr Devi Prasad Shetty, Narayana Hrudayalaya June 25, 2012, The Economic Times If Dr Devi Prasad Shetty's vision comes true, most Indians will have access to quality healthcare. Dr Shetty says the cost of healthcare in India can come down by 50% in the next 5-10 years, and this will be forced on the hospitals by the government if service providers do not get their act together. "If you are going to say the cost of a heart surgery is 3 lakh for a rich man, it is fine. But for somebody who has sold his house, it is unacceptable," he says. Shetty, who pioneered the low-cost treatment model, said the lower cost is achievable if hospitals increased the number of procedures by 1,000 times.

NRHM Funds To Be Linked To States’ Performance June 25, 2012, The Times of India For the first time ever, funds allocated to states under the country's flagship National Rural Health Mission (NRHM) will be cut by almost 15% if they fail to place doctors and health workers (even on contractual basis) to districts with the worst health index. States will also have to post performance audits of health facilities online, failing which up to 7.5% of their total outlay will be deducted. For the first time, NRHM's programme implementation plan (PIP) for the year 2012-13 has put in place incentives to reward high performing states and also punish those who fail.

Pharma Units In Himachal Under Scanner For Spurious Drugs Production June 22, 2012, The Times of India Seeing around 25000 crore pharmaceutical industry of Himachal Pradesh facing credibility crisis due to the production of sub standard drugs, state government has finally started acting against the drug manufacturing units by suspending their licenses. Recently the licences

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of seven companies were suspended after drugs manufactured by them failed the test. Considering the fact 600 pharmaceutical industries located in Himachal Pradesh caters to around 50% demand of country, over the years Himachal Pradesh has become the largest suppliers of drugs and almost all the states in India are getting supplies from Himachal.

India In Race To Contain Untreatable Tuberculosis June 21, 2012, Livemint India’s slow response to years of medical warnings now threatens to turn the country into an incubator for a mutant strain of tuberculosis (TB) that is proving resistant to all known treatments, raising alarms of a new global health hazard. “We finally have ended up with a virtually untreatable strain” of TB in India, said Dr Zarir Udwadia, one of the country’s leading TB authorities. In December, Dr Udwadia reported in a medical journal that he had four TB patients resistant to all treatment. By January, he had a dozen cases, then 15.

CCI Seeks Partnership Agreements With Global Counterparts June 20, 2012, Livemint To strengthen its extra-territorial jurisdiction, the Competition Commission of India (CCI) is entering into cooperation agreements with its counterparts in other nations. Extra-territorial jurisdiction relates to acts that take place outside the country but have an effect on competition in India. India’s competition watchdog is close to signing a memorandum of understanding (MoU) with the US Federal Trade Commission’s Bureau of Competition, said a CCI official with direct knowledge of the development. A draft MoU was prepared in November and is awaiting the foreign ministry’s approval.

CDSCO Rules Out Review Or Recall Of 33 Drugs Approved Between Jan 2008 To Oct 2010 June 18, 2012, Pharmabiz, Joseph Alexander Central Drugs Standard Control Organisation (CDSCO) will not review or recall the 33 controversial drugs which were reportedly cleared without clinical trials on Indian patients during the period of January 2008 to October 2010. The regulatory authorities are of the view that all

approvals given by the competent authority so far were 'in order' and there was no need to re-examine the approvals given or recall any particular drug from the market on the grounds of errors in approval process, highly placed sources confirmed.

Improving The Picture Of India’s Healthcare June 18, 2012, Business Standard In the din of a slowing economy, falling rupee, rampaging inflation, and incessant political manoeuvrings, India’s list of challenges continues to grow. Of all these challenges, there is one that seems insurmountable already, and worse, could soon end up becoming a calamity, aggravating the suffering of hundreds of millions of Indians. This challenge relates to the provision of affordable, accessible, and accountable healthcare to every single citizen of India. On just about every single measurable indicator of healthcare infrastructure, India is rapidly deteriorating.

Pharma Cos Sell Drugs 10 Times Cost: MCA June 16, 2012, Financial Express Leading pharma companies, including GlaxoSmithkline, Pfizer and Ranbaxy, sell commonly used drugs at a rate 10 times the cost of production, a study by the Corporate Affairs Ministry has found. A study by the Cost Audit branch of the MCA found drugs like Calpol manufactured by Glaxosmithkline, Corex Cough Syrup by Pfizer, Revital by Ranbaxy Global, Omez by Dr Reddy's Labs, Azithral by Alembic and several others were being sold at a mark up of up to 1,123 per cent over the cost of production. Worried over the findings of the study, Corporate Affairs Minister M Veerappa Moily has written to the ministers of Chemical and Fertilizers M K Alagiri and Health Ghulam Nabi Azad seeking appropriate action on curbing this practice of pharma companies.

Parliamentary Panel Sceptic About Physical Targets For Improving Human Resources In Health June 15, 2012, Pharmabiz, Joseph Alexander The Parliamentary Standing Committee on Health has expressed apprehension on achieving the physical targets set for the current Five Year Plan for improving the human resources in the health sector and called for more allocation to paramedical sectors including pharmacists.

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The Department of Health has set physical targets set to be accomplished in Twelfth Five year Plan which includes training capacity of 80,000 MBBS doctors and 45,000 specialists per annum by 2020 and bringing down the doctor: population ratio from 1:2000 to 1:1000.

Azad Visits US FDA; Stresses On Importance Of Collaboration With US In Food And Drug Regulation June 14, 2012, PharmaBiz The Union minister for health and family welfare, Ghulam Nabi Azad has stressed on the importance of collaboration with the USA in food and drug regulation as this will provide exposure to the Indian regulators to international best practices in this area. Azad was speaking at the headquarters of the US Food and Drug Regulatory Administration (FDA) at Maryland. Azad is member of the high level Indian delegation visiting the USA.

CSR A Must In Cos Bill June 13, 2012, The Economic Times (epaper page2) Decks have been cleared for reintroduction of the Companies Bill,2011,in the monsoon session. If the bill is passed after endorsing all the suggestions made by the Parliamentary Standing Committee on Finance, corporate social responsibility (CSR) would, for the first time in the world, become mandatory. The report recommends that companies with net worth above.500 crore, or an annual turnover of over.1,000 crore, earmark 2% of average net profits of three years towards CSR. In the draft Companies Bill,2009,the CSR clause was voluntary though it was mandatory for companies to disclose their CSR spends to shareholders.

35% Chemists In Maharashtra Flout Abortion Drug Norms: Food And Drug Administration June 13, 2012, The Times of India Nearly 35% of drug retailers and wholesalers in the state were found flouting norms claims the Food and Drug Administration, which launched a crackdown following cases of female feticide in Beed. Out of the 954 retailers and wholesalers inspected in the last six days, 340 were served show-cause notices for irregularities in maintaining records and selling abortion drugs without a prescription. Eighty-eight chemists in the Konkan region were served show-cause notices. Sixty-five chemists in Pune, 50 in

Amravati, 46 in Aurangabad and 29 in Mumbai received notices. "Our drive exposed how many chemists were not following any norms.

FIPB To Continue As Gate-Keeper On Pharma Mergers For Now June 7, 2012, Business Line Who will be gate-keeper for the pharmaceutical industry, watching over local companies being acquired by foreign owners? The Foreign Investment Promotion board (FIPB), the Competition Commission of India (CCI) or both? Until a final call is taken by the ministries involved, the FIPB is set to continue as gate-keeper, said a source, after a meeting on the issue convened by the Finance Ministry, on Wednesday. Addressing public health concerns raised by the Health Ministry, and to streamline investment in local drug companies, guidelines will be outlined on the FIPB Web site, the source said. For instance, companies looking for local acquisitions will have to ensure they continue to manufacture essential medicines (if the acquired entity was making them); and not discontinue ongoing research in critical areas.

FDA Foresees Jump In Apps For Cancer Drugs June 6, 2012, Fiercer Biotech U.S. regulators expect to review lots of cancer drugs this year. With developers finding ways to get early readouts on efficacy, companies are expediting programs to set the stage for rapid development and speedy approvals of new anti-cancer therapies. In an interview with Reuters, FDA oncology chief Dr. Richard Pazdur predicts that the agency will receive 20 submissions for cancer drugs in 2012. It's too early to tell whether that will lead to an increase in approvals this year, but the number says a lot about intense participation in cancer drug research around the biopharma industry.

DCGI Asks State Drug Controllers To Keep Tab On Trials To Wipe Out Illegal Practices June 6, 2012, PharmaBiz With reports of illegal trials affecting public safety, the Central drug authorities have asked all the State drug controllers to keep a close tab on the clinical trials happening around and stop illegal trials especially those done individually by the doctors without due permission from the Central Drugs Standard Control Organisation (CDSCO).

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Talking to Pharmabiz, Drug Controller General of India (DCGI) Dr G N Singh admitted that there could be individual cases of doctors carrying out trials on their own for some companies, Indian or foreign, without informing the authorities. Such cases lead to unethical practices and cause troubles, he added.

Industry Leaders Call For Overhauling Of CDSCO For Better Efficiency, Transparency June 4, 2012, Pharmabiz, Nandita Vijay Even as The Lancet report exposes the inadequacies of the functioning of Central Drugs Standard Control Organization (CDSCO), industry stakeholders have called for an overhaul of India's regulatory machinery on a priority basis including staffing policy of the organization. According to a stakeholder, “A competent CDCSO is of utmost importance and requires a leader who is conversant with the nuances of this highly technical and research-driven business.” Further, he added, the regulator should have a formal pharmacy education, to discharge duties efficiently.

Dr G N Singh's Term As DCGI Extended For Another 3 Months May 31, 2012, Pharmabiz The health ministry further extended the tenure of Dr G N Singh with the additional charges of the Drug Controller General of India (DCGI) by three more months effective from May 22. The order announcing the same was issued by the health ministry on May 29 and comes as a great relief to the industry which has been demanding for some stability in the position of the drug regulator of the country. Dr Singh informed that now with this order he will be able to bring in stability to his position by enacting and working on the mission of the CDSCO to safeguard and enhance public health by assuring safety, efficacy and quality of drugs, cosmetics and medical devices in the country.

New Products

Boehringer-Lilly Alliance Likely To Set Trend June 15, 2012, Livemint The business alliance between German drug maker Boehringer Ingelheim GmbH and US biotechnology firm

Eli Lilly and Co. focusing on the growing diabetes market is likely to set a new trend in the highly competitive local drug market, where foreign drug makers are aggressively taking on entrenched generic rivals. The global collaboration combining the portfolio of the two to address a particular disease segment and selling the products through a common team in various markets is the first such alliance in the drug industry.

GSK Launches Metered-Dose Inhalers In India June 7, 2012, Business Line Asthma patients will now be able to buy the enhanced version of a Metered Dose Inhaler (MDI) with a dose counter, from their local chemists. Multinational drug-maker GlaxoSmithKline Pharmaceuticals has launched the product with this new technology in the country, a first of its kind, company officials said. The inhaler has an innovative dose counter that keeps track of number of doses left. This helps the patients to take the right number of drug doses. The inhaler also has a locking system which prevents drug wastage when the inhaler is not in use.

R&D/Clinical Trials

Doctors Discuss Problems Related To Clinical Act June 22, 2012, The Times of India A meeting of city doctors under the banner of Allahabad Medical Association(AMA) was held on Thursday where the speakers discussed problems arising after the passage of Clinical Establishment Act by the government. Addressing the gathering, state president Indian Medical association (IMA) Dr Ashok Agarwal said: "the government is making medical facilities expensive for the common man in the same manner as it is increasing the prices of essential commodities including sugar, onion, petrol, pulses, rice and green vegetables.

Six New AIIMS Will Give Fillip To Medical Research: Ghulam Nabi Azad June 21, 2012, The Economic Times Admitting that inadequate number of doctors has affected medical research in the country, Union Health Minister Ghulam Nabi Azad today expressed hope that the sector would get a fillip with the coming up of six new AIIMS from next year.

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"Six new AIIMS in the country will start functioning by April next year in different states, including Jodhpur in Rajasthan. This will ease pressure on AIIMS Delhi and research work will get momentum," he said at a press conference here.

Pharma Industry Urges Govt To Woo Back Scientists June 20, 2012, Financial Express As the government begins to correct deficiencies in the drug regulatory process brought forth by a parliamentary panel, the industry has urged it to woo back Indian scientists working with reputed global drug regulatory agencies of US and UK. In a letter to union health minister Ghulam Nabi Azad, pharma sector captains through the auspices of industry body Assocham, have said, “It is fortunate that a pool of Indian origin scientists populate the world’s leading regulators like US FDA (Food and Drug Administration) and UK MHRA (Medicines and Health products Regulatory Agency).

Indian Platform For Sharing, Viewing Research Available For Foreign Institutes June 20, 2012, Business Standard Knimbus, an India-based global search and collaboration platform for researchers, is set to offer its services in foreign varsities. A platform that connects creators and users of scientific, technical and medical knowledge to online content and peer groups, Knimbus is in the process of extending services to institutes in the United States and some European countries. It has also tied up with a partner in Germany and is in the process of forging ties with about 25 universities in Bangladesh. Knimbus was co-founded by Rahul Agarwalla and Tarun Arora in November 2010, and the service went live in September 2011.

Bharat Biotech Receives $ 4 Million Award From The Wellcome Trust For Development And Clinical Trials June 19, 2012, The Economic Times Vaccine manufacturer Bharat Biotech and The University of Maryland Center for Vaccine Development (CVD) have received $ 4 million from The Wellcome Trust for clinical development of a new conjugate vaccine for treating an infectious disease. The Trust will also fund clinical trials beginning in three years to prevent the potentially lethal infectious disease

caused by invasive non-typhoidal Salmonella (NTS). This strain is most common in the sub Saharan African regions among malnourished children. About 20-30% of the children are known to die because of this infectious disease each year.

Lab- Grown Vein Transplant Milestone In Stem Cell Research June 15, 2012, Indian Express In a first, doctors in Sweden have transplanted into the body of 10-year-old girl a vein grown in the laboratory from her own stem cells. The core team that performed the procedure was led by Dr Suchitra Holgersson, a transplant medicine specialist originally from Mumbai, and included four other doctors from India. The landmark transplant was published in the British medical journal The Lancet on Thursday. The procedure “could offer a potential new way for patients lacking healthy veins to undergo dialysis or heart bypass surgery without the problems of synthetic grafts or the need for lifelong immunosuppressive drugs”, The Lancet said.

Health Min To Notify Procedures And Quantum Of Compensation To Victims Of Trials Soon June 13, 2012, Pharmabiz, Joseph Alexander The Health Ministry will soon formally notify the procedures and amount of compensation to be paid by the pharmaceuticals companies, if a volunteer dies or gets injured during a clinical trial. “The Government has already published the draft rules for the new schedule Y1 under the Drugs and Cosmetic Rules, 1945 and it is under the stipulated process of examination before the final notification. However, with a view to tighten the norms on clinical trials, several sections of the amendment have already been implemented,” Drug Controller General of India (DCGI) Dr G N Singh said. “We are in the process of finalising the detailed procedures and amount of compensation and on making the companies liable for causes of damages during the trials. This will be notified within a couple of months,” he said.

Pharma Companies Need Aggressive R&D And Patent Filing: Experts June 11, 2012, The Economic Times Indian pharmaceutical companies need to go for aggressive research and patent filing like China and Japan and unless spending on R&D is scaled up, it would be difficult to create new molecules, industry experts

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said. "Our Indian companies are just beginning to realise that they also need an R&D Department, as merely quality control would not help. Unless spending on R&D is scaled up, it will be difficult to create new molecules. It is time to go for aggressive research and patent filing just like China and Japan," Deputy Controller of Patents & Designs, Intellectual Property Office K S Kardam said at a workshop on 'Patenting Pharmaceuticals in India'.

R & D in India June 5, 2012, Indian Express Foreign direct investment may have slowed, but India still has a vibrant, sophisticated and rapidly evolving R&D sector. India should be a compelling proposition for multinational companies seeking an emerging market R&D location. The country’s large educated population, its low labour costs and its huge and rapidly emerging middle class suggest the ideal environment for global R&D investment. And back in the heady days of 2006, the country was certainly living up to that potential. FDI in R&D India was $3.8 billion, more than in China and Eastern Europe combined.

Abbott To Strengthen Its Research Capability In India, Also Scouts For University Partner To Spur Innovation June 5, 2012, PharmaBiz Abbott has now commenced its advanced nutrition research in collaboration with Syngene. The multinational drug major has set up the Abbott Nutrition R&D Centre in the Biocon Park which houses the Biocon Biopharmaceutical Research Centre (BBRC). The company is also in the process of scouting for a University partner to spur its innovation in research in the country. The company has already tie-up with the University of Illinois where it has set up a Centre for Nutrition and Cognition. In India, Abbott is looking not just to tap the talent of young researchers but also look at a similar initiative to advance its research and comprehension on the needs of the Indian nutrition market, said Dr Robert H Miller, divisional vice president, Global R&D and Scientific Affairs for Abbott Nutrition.

Dept Of Health Research Fast-Tracking Cabinet Nod For Bill To Regulate Clinical Research May 30, 2012, Pharmabiz, Joseph Alexander

After keeping it dormant for many years, the Department of Health Research is fast-tracking for the final approval from the Cabinet a comprehensive bill to regulate and monitor the entire research on the human subjects in the country. Sources said the modified Biomedical Research on Human Subjects Bill is in the final stages. “The Cabinet note is being prepared for submission and approval. The plans are afoot to place it before the Parliament this year itself and put into effect,” sources said.

University Of Pune With Serum Institute Complete Animal Study On Herbal Vaccine, Adjuvants May 30, 2012, Pharmabiz, Nandita Vijay University of Pune’s Interdisciplinary School of Health Sciences and Serum Institute of India, in a collaborative research programme, have completed animal study on herbal vaccine, adjuvants. The project was supported by Department of Science and Technology. In another study, the Pune University along with US-based BioVed Pharmaceuticals Inc. went on to research on blood disorder properties in cancer bearing animals which is ready for commercialization.

Mergers & Acquisitions / Collaborations

PMO Seeks Legal Opinion On Pharma FDI Issue June 25, 2012, Financial Express The Prime Minister’s Office (PMO) has sought a legal opinion on whether the Competition Commission of India (CCI) can have the mandate of clearing or halting approvals of proposed brownfield pharma FDI deals on the grounds of public health. In a recent letter sent to the law ministry, the PMO has sought its views on the matter. This comes after the multiple arms of government - ministry of health and ministry of commerce and industry as well as a section of the domestic industry - put up sustained resistance to an earlier decision taken in October last year to empower the CCI to assume the role of the filter of brownfield pharma deals.

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Ministries Oppose PMO View On Pharma Deal Rules June 14, 2012, Business Standard The ministries of finance, commerce and health appear to have locked horns with the Prime Minister’s Office (PMO) over the regulation of cross-border deals for expansion in the pharmaceutical sector. The Indian Pharmaceutical Alliance (IPA), an association representing the domestic industry, had also recently written to the PMO suggesting joint clearance of brownfield FDI proposals for expansion in pharma by the Foreign Investment Promotion Board (FIPB) and Competition Commission of India (CCI).

Pharmabiz Editorial: Brownfield Projects & FDI June 13, 2012, Pharmabiz, P.A. Francis In October last, at a high level meeting convened by the Prime Minister, it was decided that India will continue to allow foreign direct investment in drugs and pharmaceuticals sector through automatic route for greenfield projects and in case of brownfield investments, FDI will be allowed through the Foreign Investment Promotion Board (FIPB) for six months. These acquisitions will, however, be routed through the Competition Commission of India for the six months period. During this period, when the FIPB clears the acquisitions, necessary enabling regulations will be put in place by the CCI for effectively overseeing mergers and acquisitions so as to ensure a balance between public health concerns and flow of FDI into the pharma sector.

Empower Competition: Need To Have Better Coordination Between Sector Regulators And CCI June 12, 2012, The Economic Times The corporate affairs ministry has reportedly sought to bring all sectors including telecom and banking under the ambit of the Competition Commission of India (CCI). This is a good idea. The CCI's remit is to oversee competition, check abuse of monopoly power and curtail unfair trade practices. The job cannot be left to sectoral regulators. This is not to say that the CCI should become a super-regulator. Instead, it should help sectoral regulators - be it the RBI or the telecom regulator - to arrive at informed decisions in cases where there is a violation of fair play.

GSK Extends $2.6 Billion Bid For Human Genome Sciences June 8, 2012, Fierce Pharma GlaxoSmithKline said it would and now it has. It extended its $2.6 billion hostile bid for shares of its partner Human Genome Sciences by three weeks. The original offer from GSK of $13 a share was set to expire last night, and since GSK has made it clear that it does not intend to just fold on this proposal, it pushed the deadline for investors to tender shares to June 29, the company says in an announcement today. Human Genome opposes the deal, saying it values the company far too cheaply, and has been urging shareholders to hold out until it can find a more rewarding alternative, even asking GSK to participate, The Wall Street Journal reports.

Why Fear FDI In Pharma? June 6, 2012, Business Line It would soon be time for the government to review its 2011 policy decision on foreign direct investment in the pharma sector. The occasion is ripe to consider perceptions on the impact of FDI on the industry. The FDI policy for the pharma sector was revised on November 8, 2011, essentially shifting the FDI(in relation to the brownfield investments) from the automatic to approval route. FDI in the sector is permitted up to 100 per cent. The decision was a sequel to the acquisition spree by multinational corporations — notably Matrix by Mylan (2006), Ranbaxy by Dai-ichi Sankyo (2008), Shanta Biotechnics by Sanofi Aventis (2009), Orchid Chemicals by Hospira (2009), and Piramal Healthcare by Abbott Laboratories (2010).

FDI In Drug Firms Resumes June 1, 2012, The Economic Times (epaper page 24) The Foreign Investment Promotion Board (FIPB) has resumed clearing investment proposals in Indian drug companies, a move that will revive deal flow in the. 62,000-crore domestic pharma sector. The board has cleared four proposals of foreign financial investors, but again deferred a decision on stake buys by multinational drug companies, extending uncertainty over new rules to check rising cases of promoters of domestic drug companies selling out to foreign players. At its meeting on May 9, the FIPB cleared Pethico Pharmaceuticals proposal to raise.490 crore by selling a 22% stake through the foreign currency convertible bond

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(FCCB) route; and Ankur Drugs plans to raise.40 crore by selling shares to overseas Indians.

Pricing

NPPA To Scrutinise Huge Inter Brand Price Variations Of Formulations, Launch Prices Of Products June 25, 2012, Pharmabiz, Joseph Alexander Newly appointed chairman of the National Pharmaceutical Pricing Authority (NPPA) C P Singh has urged all the stakeholders including the industry to address the crucial issue like inter-brand price differences and control over launch prices. “We would thus seek the cooperation and support of pharma manufacturers, industry associations, State Governments, voluntary organizations, NGOs and all other stakeholders in the endeavour and would like them all to ponder over ticklish issues afflicting the industry such as inter-brand price differences, differences in prices of imported and indigenously manufactured formulations and better control on launch prices,” he said.

Cost-Based Pricing To Hit Exports, Says Indian Pharmaceutical Alliance June 9, 2012, The Economic Times The Indian Pharmaceutical Alliance says the export earnings of the manufacturers will be hit if the government continues with the cost-based pricing mechanism under the proposed drug policy. A Group of Ministers is finalising the National Pharmaceutical Pricing Policy (NPPP), which seeks to fix the prices of 348 essential drugs and their combinations to make them more accessible to the poor. The drug price regulator currently uses the cost-based pricing mechanism to regulate prices of medicines made using 74 bulk drugs (ingredients). In a letter to Commerce Minister Anand Sharma last week, a group of large pharma companies said that about nine Asian and Middle-East countries,.......

GSK Pharma's Pricing Strategy May Not Extend To Alliance Products May 8, 2012, Hindu Business Line

Two years ago, British drug-maker GlaxoSmithKline's Chief Executive Mr Andrew Witty had told an Indian audience in Nashik, the company would pursue “customised pricing” of its medicines in middle and low-income countries. In India, the strategy has rolled out “as per plan”, says Dr Hasit Joshipura, GSK Pharma's Managing Director (India), referring to the differential pricing of Synflorix, a 10-in-one vaccine targeting invasive pneumococcal disease, renal cancer drug Votrient, and Revolade, treating reduce blood platelet count.

National Pharma Pricing Policy May Hurt Industry In Long-Run May 28, 2012, The Economic Times Pharma analysts in India and abroad believe that cost-based pricing in National Pharmaceutical Pricing Policy is not suitable to safeguard the interests of patients as well as the pharma industry. The National Pharmaceutical Pricing draft policy, unveiled by the department of pharmaceuticals in October last year, proposes to cap prices of 348 essential medicines and their formulations at an average price of three best-selling brands. The Group of Ministers (GoM) on National Pharmaceutical Policy are expected to meet shortly to make final recommendations to the Cabinet. Analysts opined that the regulatory authorities have wrongly been focusing on price controls in the belief that this will boost access to healthcare. But the experience of other nations, and India's past experience,.............

Regulator May Permit Rejig Of Pharma Packaging Cost May 28, 2012, Business Standard Taking cognizance of a rise in input costs, the drug price regulator, National Pharmaceutical Pricing Authority (NPPA), may allow pharma companies to raise their margins in packaging cost of medicines. The regulator has asked drug makers to furnish information related to their actual cost data, so that it can revise the norms. NPPA would also conduct a survey to evaluate prices in the market. According to an industry official, the pricing authority has also convened a meeting with representatives of various industry associations to discuss the move and finalise the modalities of the study. The regulator fixes the maximum retail price of medicines through a formula which includes factors such as packaging cost, conversion cost, material cost and excise duty.

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Cost-Based Pricing Of Drugs Not Suitable To Safeguard Interest Of Patients & Pharma Industry In India: Experts May 26, 2012, Pharmabiz A section of pharmaceutical analysts in India and abroad have claimed that cost-based pricing would not be suitable to safeguard the interests of patients as well as the pharmaceutical industry. The regulatory authorities have wrongly been focusing on price controls in the belief that this will boost access to healthcare. But the experience of other nations, and India’s past experience, indicates the desired outcome won’t be achieved via price caps because multiple hurdles hinder healthcare access in India – and it is these that need to be addressed, they claimed.

Trade & Others

Free Medicines For All From October June 23, 2012, The Times of India India's ambitious policy to provide free medicines to all patients attending a government health facility across the country will be rolled out from October. Strongly backed by Prime Minister Manmohan Singh himself, the free-medicines-for-all scheme — being referred to as the "real game changer" — has received its first financial allocation of Rs 100 crore from the Planning Commission for 2012-13. The entire programme, however, is estimated to cost Rs 28,560 crore over the 12th five year plan. At present, the public sector provides healthcare to 22% of the country's population. The ministry estimates that this will increase to 52% by 2017 once medicines are provided for free from 1.6 lakh sub-centres, 23,000 primary health centres, 5,000 community health centres and 640 district hospitals.

April, May Pharma Sales Hint At Positive Outlook For Sector: Karvy Report June 22, 2012, Express Pharma According to a recent report by Karvy Stock Broking, the Indian pharmaceutical market witnessed a growth momentum in April and May (2MFY13). The growth observed during these two months in key acute therapies, namely anti-infectives (+16.6 per cent y-o-y); GI (+16.5 per cent y-o-y), pain (+15.1 per cent y-o-y) and respiratory (+13.6 per cent y-o-y). Anti- diabetic (+29.8

per cent y-o-y), Cardiac (+18.8 per cent y-o-y) and vitamins and minerals (+19.6 per cent y-o-y) have reported a strong growth for 2MFY13. Based on sales numbers sourced from the All India Organisation of Chemists and Druggists (AIOCD), the Karvy report analyses that overall, the growth for 2MFY13 for the period of April 2012 + May 2012 stood at 17.6 per cent, while growth for May 2012 was reported at 16.8 per cent y-o-y. Overall, the growth for the month has been lower than 18.4 per cent reported for April 2012.

India, EU Spar Over Protectionism June 22, 2012, The Times of India Ahead of next week's ministerial meeting in Brussels, officials from the European Union and India on Thursday sparred over protectionism and tax law changes made by New Delhi. EU ambassador Joao Carvinho told a press conference that the trading bloc had written to Indian authorities, citing protectionist moves such as a higher duty on imported vehicles, ban on cotton export and stipulating a local sourcing norm for telecom equipment. "It is closing markets instead of opening up," he said. In addition, he said EU had sought clarifications on the government's move to retrospectively amend the law to levy capital gains tax on Vodafone but was yet to hear from Indian authorities. Officials in the commerce department shot back, saying Carvinho was "singing the wrong tune" and pointed to independent studies to argue their case.

Aamir Bats For Generic Drugs Before House Panel June 22, 2012, Deccan Herald After creating tremors in the healthcare sector by exposing the prevalent malpractices, actor Aamir Khan on Thursday took his battle to Parliament where he stood up for generic drugs. Khan, along with three experts, appeared before the Parliamentary Standing Committee on Commerce, which is examining the issue of foreign direct investment (FDI) in pharmaceutical sector. He argued that companies will continue to make profit by selling substandard drugs to the poor. The 47-year-old actor, who highlighted the maladies of the health sector in his TV show "Satyamev Jayate" recently, was invited to appear as a witness before the Parliamentary Standing Committee (PSC) on Commerce which is examining the issue of FDI in pharma sector.

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IE Editorial: Talking Heads June 22, 2012, Indian Express After his TV show Satyamev Jayate examined distortions in healthcare, Aamir Khan’s opinion has been solicited by none less than the parliamentary standing committee on commerce. By “consulting” Khan on the question of FDI in pharmaceuticals, the panel has made expert deliberation seem like a silly gimmick. Healthcare was merely the brow-furrowing concern of the week for Satyamev Jayate, and as with any show that flits from one subject to another, its mastery of the problem was less than perfect. While the use of affordable generic drugs may seem a no-brainer, it is a risky choice in the absence of solid regulation.

Aamir Khan's Generic Prescription Shocks Medical Experts June 21, 2012, Indian Express On Thursday, actor Aamir Khan will share his ideas about healthcare with a Parliamentary panel. It was the actor’s suggestion of generic drugs as a key to affordable healthcare for India’s poor — as advocated in his weekly show Satyamev Jayate on May 27 and subsequently in his column in some newspapers — that got him the call from the panel. Experts, however, have said his idea of prescribing generic drugs is “overly simplistic” and “potentially dangerous”. Doctors quote WHO figures of 20-45 per cent spurious drugs in India to counter Aamir’s contention that they are taking patients for a ride.

Government Cracks Down On Fake Drugs Menace In India June 19, 2012, India Today The government is taking major steps to crack down on the fake drugs menace in India. The health and family welfare ministry has hired about 100 inspectors to check spurious medicines, while the department of pharmaceuticals has issued notifications asking pharma companies to use nanotechnology for identifying such drugs. According to a World Health Organization report, almost 20 per cent medicines sold in India are fake. Dr Jagdish Prasad, director general of health services in the health ministry, said: "There are more than 10,000 drug manufacturers and more than six lakh outlets that sell fake drugs. We are in the process of increasing the man force to check counterfeit drugs."

India’s Diabetes Drugs Market Grew 22% At $700 Million In FY12 June 19, 2012, The Economic Times In an indicator of the growing prevalence of diabetes in India, the domestic diabetes drugs market for FY 12 grew 22 per cent at $ 700 million, according to a Credit Suisse report. Estimates suggest that India is set to become the 'diabetes capital of the world' with the number of people with diabetes is likely to swell to 70 million from present 40 million. "The diabetes, ophthalmic and derma have the higher mix of fastest-growing molecules in FY 12. The therapy split of molecules grew by 30 per cent, of which diabetes molecule grew 22 per cent at $ 700 million," Credit Suisse research analyst Anubhav Aggarwal told PTI here.

Eulogising GST Is Inviting Illusion June 18, 2012, Business Standard Both the industry and the government are making too much of tall claims about what GST has in store for us. A chief of a federation of industries has said that it can add 1.5 per cent to GDP. The finance ministry also made similar claim in the latest bulletin issued by Press Information Bureau on May 22, 2012. I am writing this treatise to say that tall claims about the outcome of GST will prove to be infructuous. GST is good for so many reasons. But it should not be eulogised for what it is not. GST is good for the following reasons. It will remove a hugely big central excise tariff and highly enumerative service tax regime.

Domestic Drug Market Grows 16.8% In May To Cross Rs 64,500 June 16, 2012, Financial Express (epaper page 3) The Domestic pharma industry has continued to grow at 16.8% in the month of May to cross the size of Rs 64,500 crore for a period of 12 months ending May. While in May, Abbott and Cipla have retained their highest market share at 5.4% and 4.9% of the monthly drug market valued at Rs 5,500 crore, the third position is being hotly contested for according to pharma market research firm, AIOCD Awacs.

CCI Slaps Penalty On Chemist Body June 15, 2012, Hindu Business Line The Competition Commission of India has imposed a penalty of Rs 2 lakh on Chemist and Druggist Association, Goa after finding it guilty of anti-competitive practices. CCI has termed the imposition of guidelines by the

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Association that lays down the margins for wholesalers and retailers as anti-competitive and against the interests of the consumer. As part of these guidelines, the Association had prescribed a cap on the amount of the discount a wholesaler can give to the retailer and prohibited the retailer from giving any discounts to the consumers. The anti-monopoly body has directed the Association to remove the clauses in the circulars, MoU and guidelines and file an undertaking to this effect within 60 days from the date of receipt of the order.

RS Panel Begins Probe On Petition Stating 35% Of World’s Spurious Drugs Made In India June 15, 2012, Pharmabiz, Ramesh Shankar The Committee on Petitions of the Rajya Sabha has initiated the process for a probe into a petition, filed by one Rahul Gaur, a resident of Noida in UP, praying to put a check on manufacture of spurious drugs in the country and other related issues. In the petition, Gaur has pointed out that around 35 per cent of world’s spurious drugs are produced in India. The committee, under the chairmanship of Bhagat Singh Koshyari, MP, Rajya Sabha, has started consultations with the wide cross-section of the society and has invited written memoranda from experts and others on the issue.

Soon, Government Hospitals To Sell Generic Medicines June 9, 2012, The Times of India Generic medicines will be introduced in all government hospitals in the state from June, health minister Suresh Shetty said on Friday. Actor Aamir Khan, who had highlighted the issue of female foeticide in his TV series Satyamev Jayate, in a letter to the Maharashtra government had asked it to introduce generic medicines, as is being done in Rajasthan. According to the US Food and Drug Administration (FDA), a generic drug is identical to or the bioequivalent of a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.

Doctor Given 60 Days To Explain Law ‘Violations’ May 8, 2012,The Times of India

One more doctor in the town of Beed finds himself under the scanner for allegedly flouting the Pre-Conception and Prenatal Diagnostics Techniques (PCPNDT) Act. Gynaecologist Dr Sanjay Vir, who runs the 45-bed Vir Hospital, was reportedly caught violating PCPNDT norms in June 2011, but the tehsildar's office took almost a year to complete the formalities and put up the case in the local court. The Beed court on Thursday gave Sanjay 60 days to reply to the findings of the tehsildar team. A team of state officials, while inspecting Vir Hospital last year, had found errors in the way the hospital records were maintained, the way form F was filled and a discrepancy in the number of patients undergoing treatment.

Parliamentary Panel Calls For Better Supply System Following Stock-Outs Of Drugs For HIV Treatment May 8, 2012, Pharmabiz, Joseph Alexander The Parliamentary Standing Committee on Health and Family Welfare has asked the National AIDS Control Organisation (NACO) to immediately reform the pharmaceutical supply management system for HIV medicines, in the wake of wide-spread stock-outs of medicines for the patients across the country in the recent past. The committee also took objection to the claim by the Department of AIDS Control that the performance of the procurement agency – Rail India Technical and Economic Services (RITES)—was satisfactory after one year of service.

Sting Op Stings, KEM Bans Med Representatives June 7, 2012, DNA The KEM hospital has banned medical representatives from entering the wards and the outpatient department. The hospital took the decision after a sting operation by Zee Business showed a doctor from the medicine department accepting a gift voucher of Rs5,000, along with a list of medicines from a leading pharmaceutical company’s sales representative. The hospital has put up boards in front of the casualty and the medical wards directing medical representatives and private laboratory personnel to stay off the wards. While it is no secret that doctors are routinely bribed to get them to prescribe costly medicines of particular brands, the civic hospital is, probably, the first to put up such a public notice.

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India’s Top 10 Cos Record 21% Growth In Sales In 2011-12, Sun Rises To 3rd Rank June 1, 2012, Pharmabiz, Sanjay Pingle India's top 10 pharmaceutical companies, with sales above Rs.4,000 crore, have reported a consolidated net sales growth of 21 per cent during the year 2011-12 and EBDITA growth of over 25 per cent. However, their net profit after forex adjustments declined sharply by 46.3 per cent to Rs.4,452 crore from Rs.8,288 crore in the previous year. This was mainly due to provisions made by Ranbaxy in connection with the US Department of Justice and forex adjustments. With more focus on global markets, limited exclusivity for some products after patent expiration and acquisitions and mergers, the ranking of these companies changed significantly during 2011-12.

Health Min Plans New Initiatives To Boost Use Of Generic Drugs In Public Hospitals, Clinics May 28, 2012, Pharmabiz, Joseph Alexander In a bid to further promote the generic drugs in public sector, the Health Ministry is planning to initiate more steps like expanding the list of generic drugs for rate contract and using special software for government hospitals to include the names of generic equivalents along with the prescriptions. “National Informatics Centre (NIC) has prepared software to be used by all Government hospitals and CGHS Wellness Centres by which if doctors prescribe branded drugs, the printed prescriptions will contain not only prescribed branded drugs but also their generic equivalents.

Biotechnology

DBT Utilizes Over 90% Of Allocation During 11th Plan Period June 22, 2012, Pharmabiz, Joseph Alexander Setting a new benchmark for all the departments at the Centre, the Department of Biotechnology (DBT) was successful in utilizing over 90 per cent of funds allocated to it during the last Five Year Plan period and implemented most of the initiatives proposed for the period. Against the proposed amount of Rs.900 crore, the DBT got Rs.675 crore during the year of 2007-08. Later it was

revised at Rs.683 crore and the department was able to spend Rs.618 crore, which was 90.48 per cent of the allocation.

DBT Is Pressing For 3-Fold Increase In Allocation For 12th Plan Period June 21, 2012, Pharmabiz, Joseph Alexander Backed up by the claim of implementing most of the initiatives proposed during the 11th Plan period, the Department of Biotechnology (DBT) is pressing for a three-fold increase in the allocation for the 12th Five Year Plan for which the final documents are being made. “Considering the maximal utilization of allocations and implementation trends of the department, increasing needs of bio-industrial development and clearly focused programmes for 12th Plan, the working group of the Planning Commission has recommended an investment of Rs.17887.81 crore for 2012-2017 at the rate of three-fold fold increase over 11th plan allocation,” a senior official of the DBT said.

India Announces New Biosimilar Regulatory Guidelines June 19, 2012, BioSpectrum Asia India has announced the much-awaited new and simple regulatory guidelines for similar biologics which have been approved and marketed in USA or Europe for more than four years. The guidelines, released for the first time, at the ongoing BIO industry conference here on June 19 provided requirements for preclinical evaluation of those recombinant products that are claimed to be similar to the already approved biopharmaceutical products, referred as ‘ similar biologics'. Therefore the regulators will partly rely on the information from the already approved products for ensuring safety, purity, potency and effectiveness. Releasing the guidelines, Dr Maharaj K Bhan, India's top biotech policy maker and secretary, department of biotechnology (DBT) said........

Biotech Improved In 2011; Future Uncertain: Report June 19, 2012, Reuter The aggregate financial performance of biotechnology companies in four of the world's major markets -- the United States, Europe, Canada and Australia -- improved in 2011, but funding for small companies is increasingly scarce, raising questions as to whether that growth is sustainable long term, according to a new report. Revenue growth rose 10 percent last year, excluding revenue from three large companies that were acquired,

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the first time top-line growth has reach double digits since the financial crisis hit the industry in 2009, according to a new report by accounting firm Ernst & Young.

India, Bio IntSpain To Begin Collaborative Programmes In Biotech Sector Soon May 8, 2012, Pharmabiz, Ramesh Shankar India and Spain will soon begin collaborative programmes in the field of biotechnology under the Indo-Spanish programme for technological co-operation in the field of biotechnology. The programme is open to collaborative R&D projects in all areas of biotechnology e.g. health biotechnology, industrial biotechnology, nanobiotechnology, agro-biotechnology, including biofuels and bioenergy. The objective of this joint Indo-Spanish programme is to promote and fund market-driven research and technology development as well as to encourage partnerships and business-led R&D&I collaborative projects in the field of biotechnology.

Dr Reddy's, Merck Serono In Pact To Develop Biotech Drugs June 7, 2012, Business Standard Hyderabad-based pharmaceutical major, Dr Reddy’s Laboratories Limited, has entered into a partnership with Merck Serono, a division of Germany-based Merck KGaA, to co-develop a portfolio of biosimilar compounds (biotechnology drugs) in oncology, primarily focused on monoclonal antibodies (MAbs).

Medical Diagnostics / Devices

Weak Rupee May Push Medical Equipment Prices: Experts June 20, 2012, The Economic Times A weakening rupee may adversely impact the country's medical equipments market, as it is largely dependent on imports and the prices could shoot up if the downtrend continues in the Indian currency, experts say. The companies are also deferring their major medical equipment purchases in the wake of declining rupee value. "As medical equipment industry is primarily import-dependent, rupee depreciation is going to impact

the industry," consultancy firm Tecnova India's Associate Vice President Ankit Suri said.

Blood Test To Tell Breast Cancer Soon June 6, 2012, Times of India A simple blood test could soon be available to better diagnose and treat early-stage breast cancer patients. In a major breakthrough, published in the British medical journal Lancet, scientists from Texas have announced that they discovered a test that detects circulating tumour cells (CTCs) in the blood. Currently, diagnosis of earlystage breast cancer often relies on lymph-node removal, which can have unpleasant side-effects.

India Needs Low-Cost Diagnostic Device Connected To Cell Phone, National Health Portal: Dr Pitroda June 6, 2012, PharmaBiz India’s medical device companies will need to aggressively look at designing a low cost diagnostics technology which could be connected to a mobile phone and transmit the details to an accessible primary healthcare centre or a medical practitioner. The country also needs to have a dedicated National Health portal on similar lines of the India Water portal, sharing information on safe and sustainable water management. The National Health portal should help disseminate information in all the 30 languages spoken in the country.............

The New Diagnostics June 5, 2012, Mint Sometimes the odds are against you (a troubled family medical history), sometimes you bring it on yourself because of poor lifestyle choices. Either way, we live in a time when lifestyle diseases have taken on epidemic proportions, and India is among the worst-affected countries. The International Diabetes Federation (IDF), for example, states that in 2009 India had the maximum number of diabetics in the world, 50.8 million, followed by China with 43.2 million. In 2011, the IDF estimated that the number of diabetics in India had gone up to 61.3 million.........

New Test To Spot Diseases Early May 29, 2012, The Times of India Scientists have devised a new, ultra-sensitive test which they say could detect signs of a disease in its earliest stages. Researchers at the Imperial College London said

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their new test can accurately detect particular molecules that indicate the presence of a disease, even when these are in very low concentrations. There are already tests available for some diseases that look for such biomarkers using "biosensors". However, existing biosensors become less sensitive and predictable at detecting biomarkers when they are in very low concentrations , as occurs when a disease is in its early stages.

New Appointments / Transfers

Dr Ramakrishna Retires From DDC Post, Shanthy Gunasekaran Appointed As New DDC June 2, 2012, Pharmabiz Dr R Ramakrishna, Deputy Drugs Controller (India) retired from his post on May 31, after completing 31 years of service in the Central Drugs Standard Control Organization (CDSCO). He is succeeded by Shanthy Gunasekaran who has already joined the office on June 1, with the additional charges to handle the DDC's profile in Mumbai. Prior to joining the DDC office she was handling the affairs of the west zone from the centre as a link officer. Gunasekaran will be taking over this post temporarily from Dr Ramakrishna who had joined CDSCO in May 1981. He is believed to have played a pivotal role in completing the mission of CDSCO as per the directives of DCGI's office which stresses on the need, 'to safeguard and enhance the public health by assuring safety, efficacy and quality of drugs, cosmetics and medical devices'.

Arbind Prasad Now FICCI Dir-General May 30, 2012, Indian Express New Delhi: Arbind Prasad has been appointed as Director General of industry body FICCI. Prasad was senior Advisor (Power & Energy) and adviser for Odisha and West Bengal in the Plan panel.

S R Rao Is New Commerce Secretary May 29, 2012, Business Standard The government today appointed S R Rao as the Commerce Secretary in place of Rahul Khullar who was shifted as the telecom regulator after retirement earlier this month. Prior to this, Rao was the special telecom

secretary. Rao, a 1978 IAS from Gujarat cadre, was earlier special IT secretary. As the new commerce secretary Rao faces a tough challenge ahead in propelling India merchandise exports, which is currently facing adverse conditions due to the global economic condition. A postgraduate in social work and rural development, Rao's immediate task is to present the annual review to the Foreign Trade Policy 2009-2014, which is eagerly awaited by the exporters.

IPA Elects New Office Bearers May 28, 2012, Express Pharma Indian Pharmaceutical Association (IPA), a premier professional association of pharmacists in India, with a member base of over 10,000, has announced its newly elected office bearers for the term April 2012 to March 2014. Dr JAS Giri is the new President of IPA. Giri, Chairman, Sangfroid Industries, has served as Chairman of Industrial Pharmacy Division (2008 - 2010) of IPA. He is an active member of IPA for more than two decades and has received many awards for his meritorious services to the profession of industry and for social services. He is also a Fellow of IPA.

OPPI Related News

Pharma Cos Stay Mum As Govt Seeks Details Of Overcharging June 24, 2012, Hindustan Times Pharma companies in India are giving a cold shoulder to charges of overpricing. Literally. Even after four months of receiving overcharging notices from the department of pharmaceuticals (DoP), not even one of the 500-odd pharma companies have responded to the charges. The DoP had sent the notices to the companies through the Indian Drug Manufacturers’ Association (IDMA), the industry body of Indian companies, and the Organisation of Pharmaceutical Producers of India (OPPI), which represents global pharma companies in India. “After that, we also issued a public notice asking the companies to submit the details within 30 days but not even a single firm has replied,” Raja Sekhar Vundru, joint secretary of DoP, told Hindustan Times. The DoP now is mulling to crack the whip on these companies with the help of the National Pharmaceutical Pricing Authority (NPPA). “We are contemplating to ask the NPPA to take charge of the matter,” said Vundru.

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More Nations Adopting Indian Intellectual Property Regulations For Drug Manufacturing June 22, 2012, The Economic Times A growing number of countries are adopting India's intellectual property regulations, which give enough flexibility to local companies to produce generic versions of popular drugs to safeguard public health. Although multinational companies have criticised India for being lax in enforcing intellectual property (IP) laws, countries such as China, Argentina and the Philippines are adopting similar provisions........... .........However, MNCs disagree that India could have been a trigger for China's move. Tapan Ray, director-general of OPPI, the representative body of global drugmakers in India, said, "Amendment of a law is the prerogative of the country concerned, and it is specific to the country's requirement." India and China, which together account for about a third of the world's population, form a critical market for MNCs. IP laws favourable to MNCs enable them to increase sales in developing countries.

OPPI Organises Seminar On Cold Chain Management In Pharma Industry May 30, 2012, Express Pharma http://www.expresspharmaonline.com/index.php/sections/market-section/519-oppi-organises-seminar-on-cold-chain-management-in-pharma-industry Organisation of Pharmaceutical Producers of India (OPPI) had recently organised a seminar on 'Stakeholders Engagement—Improving Cold Chain Management in Pharmaceutical Industry'. Held in Mumbai, the seminar was attended by stakeholders in large numbers. During the seminar many do’s and dont's related to cold chain management in the pharma industry were discussed. Tapan Ray, Director General, OPPI said, “With the growth of biological products across the world and with increasing demand for products like vaccines, hormones and insulin among others, it is becoming imperative that a careful consideration is given by the authorities and stakeholders for enhancing cold chain capability of India. The increasing number of heat sensitive pharma products prompts the relevance of having in place a robust pharma cold chain in the country.”

Supply Chain Visibility And Control Must For Cold Chain Transport Say Experts May 28 – June 4, 2012, Aviation Cargo Express The Organisation of Pharmaceutical Producers of India (OPPI) organised a day long seminar on ‘Improving Cold Chain Management in Pharmaceutical Industry’ on May 7, 2012. Attended by pharma manufacturers, logistics service providers and freight forwarders as well as cargo custodians like Mumbai International Airport, the seminar featured key industry experts who imparted vital information on effective temperature sensitive logistics . Commencing the days proceedings, Tapan Ray, DG, OPPI said that the new generation of vaccines and bio technology required appropriate environment of cold chain to reach its destination in good shape. ........ .........Speaking about challenges in cold chain transportation from the pharma manufacturers perspective Ranjit Shahani, President OPPI and Vice Chairman & MD, Novartis unequivocally stated, "A temperature-abused product is counterfeit. Constant power cuts make the task of maintaining an unbroken cold chain challenging in the Indian context. Failure to maintain the cold chain affects the product, patient as well as the organisation.

OPPI Highlights Key Issues In Cold Chain Transport Of Pharma Goods May 28 – June 4, 2012, Aviation Cargo Express Insulins and vaccines sector in India growing at 25% per annum, While India’s manufacturing infrastructure is at par with the best in the world, distribution infrastructure lags behind, Cold chain infrastructure in India even at metros was in need of overhaul. A casual approach and untrained manpower was hindering growth of pharma exports. The 12th edition of the Perishable Cargo Regulations has introduced new mandatory requirements for the transportation logistics of healthcare products such as the mandatory use of the time and temperature sensitive label as of July 1st, 2012. These changes are the result of the collaboration by carriers with pharmaceutical companies and associations as well as other stakeholders in the supply chain, including but not limited to shippers, freight forwarders, terminal operators, ULD manufacturers, packaging & tracking and tracing companies.