RANBAXY&

PHARMA REGULATIONS

Presentation By:

Abhishek GuptaJyoti Sawana

Started by ‘Ran’bir Singh & Gur‘bax’ Singh in 1937.

They sold the company to their cousin “Mohan Singh” in 1952.

Company went public in 1973.

Entered the US markets in 1998, other major countries- Brazil, Russia, China and Europe.

Brief History

Indian Multinational Pharmaceutical company incorporated in 1961.

“Daiichi Sankyo” acquired a controlling interest (50.1%) in 2008.

Exports to 125 countries, with manufacturing facilities available in 8 of them.

IntroductionTo

RANBAXY

Former CEO, Malvinder Singh and his brother sold their share of Ranbaxy for $2 Billion in 2008 to Daiichi- Sankyo.

Current CEO of Ranbaxy: Mr. Arun Sawhney.

Ranbaxy generated a revenue of $2 Billion in 2012, EBITDA- $290 Million in 2012.

Listed in the NSE(RANBAXY) and the BSE(500359).

Company Facts & Figures

Currently Ranbaxy has 11 plants in India:Mohali, PunjabToansa, PunjabDewas, MPPaonta Sahib, HPOkhla, New DelhiJejuri, MaharashtraPonda, GoaPaonta Sahib, HP(2nd Plant)Ghirongi, MPMohali, Punjab(2nd Plant)Baddi, HP

Apart from these, Ranbaxy has a number of externally hired laboratories in India as well.

Ranbaxy: Plants in India

CHAIN OF EVENTS: LEADING TO THE RANBAXY CRISIS

WHISTLE BLOWERS:- In 2004-05, Dinesh Thakur and Rajinder Kumar blew the whistle on Ranbaxy’s fabrication of drug test reports.

As a result, in 2008, Ranbaxy Laboratories ltd. was issued 2 warning letters by the FDA and an import alert on 2 Indian manufacturing plants (Dewas & Poanta Sahib).

Later the same year, the USFDA banned all products from the Toansa, Poanta Sahib plants.

ISSUES - RELATING PHARMA

REGULATIONS

February 2012, three batches of the proton-pump inhibitor Pantoprazole were recalled in the Netherlands due to the presence of impurities.

November 2012, Ranbaxy halted production and recalled forty-one lots of Atorvastatin due to glass particles being found in some bottles.

ISSUES - RELATING PHARMA

REGULATIONS

In May 2013, the company pleaded guilty to felony charges related to drug safety and agreed to pay $500 million in civil and criminal fines under the settlement agreement with the US department of justice.

As per the Whistleblower agreement, Dinesh Thakur received $48.1 million for his efforts in bringing Ranbaxy to justice.

ISSUES - RELATING PHARMA

REGULATIONS

September 2013, further problems were reported, including apparent human hair in a tablet, oil spots on other tablets, toilet facilities without running water, and a failure to instruct employees to wash their hands after using the toilet.

Due to the above, Ranbaxy is prohibited from manufacturing FDA-regulated drugs at the Mohali facility until the company complies with U.S. drug manufacturing requirements.

ISSUES - RELATING PHARMA

REGULATIONS

RANBAXY CURRENT CRISIS

In January 2014, the US-FDA, in one of its inspection found irregularities from the data from the Toansa plant.

The US-FDA banned all the products from this plant as well.

“Our inspection of the quality control analytical and microbiology laboratories found the facility to be in significant disrepair,” - US FDA inspector.

(Ranbaxy Toansa Plant)

Current Crisis

Ranbaxy’s Toansa factory, with its inception in 1986, is one of the oldest active pharmaceutical ingredient (API) manufacturing facilities in the country. Till the latest US ban was imposed on the unit, it was catering to over 70 per cent of Ranbaxy’s captive requirement for API or raw material used in medicine formulations.

US FDA Form 483 highlighted eight serious deviations in Ranbaxy’s Toansa factory. These included presence of flies through broken windows, building up of melting ice in refrigerator where drug samples were stored, non-maintenance of analytical instruments, etc.

Current Crisis

Effect on theRanbaxy Stock

"While we continue to assess the overall business impact on all aspects in our value chain, our direct sales impact because of the Toansa facility issue will be limited." - Arun Sawhney (CEO, Ranbaxy)

"What we know publicly is that the company has spent a lot of money upgrading its facilities, which is a part of the solution, The bigger issue is changing the culture of the company, which will take inspired leadership, not just external consultants.” – Dinesh Thakur(Former Employee, Whistleblower)

Reactions: Ranbaxy

“This is a complete cover-up act by the management. The management must look for the right kind of solutions to address the problem, instead of shifting the blame on employees.” a company employee told Business Standard, on conditions of anonymity.

“We are supporting and focusing on this action as a matter of high priority, For further approach to solve a series of problems, we think we need a comprehensive policy after this. We want to go back and prepare a more aggressive, more drastic response.” Daiichi Sankyo Senior Executive Officer Manabu Sakai

Reactions: Ranbaxy

CBS News Fox NewsCNNThe Economic TimesBusiness-Standard Fortune Magazine- Investigative article

“Dirty Medicine” WikipediaReutersMoney Control.comBSERanbaxy websiteDD News- “The Big Picture”

References

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