Sale of Banned Pharmaceutical Drugs in India

Presented By: Group 18

Nidhi Bansal (09BM8028)Shilpa Gautam (09BM8085) Gaurav Khare ((06CE3811) Saurabh K Gupta (06AG3804)

Content•Introduction•Research Methodology •Analysis•Ethical issues

▫Pharmaceutical companies▫Health ministry▫Doctors and Chemists▫Consumers

•Reasons for problem in Regulatory system•Our Suggestions to Address this problem

Introduction• India has become a dumping ground for banned drugs .• The consumers are in large numbers and there are very less

provisions for check and control by the government.• Worst : Little knowledge and slapdash attitude of buyers• Many of these drugs are banned in whole of Europe, US and

even in small countries like Bangladesh and Sri Lanka• As per the Justice Hathi report of 2003,

▫ 117 allopathic medicines from MNCs are required which are not being manufactured in India.

▫ There are about 84000 medicines which the country is being exposed to presently.

• Almost 15000 people die of the use of these drugs every year but government had turned a blind eye to this issue.

Have you taken these drugs?

Finally some action by the Government: On Jan 28, 2011 the Union Health Ministry banned the manufacture, sale and distribution of many drugs such as- nimesulide, cisapride and phenylpropanolamine (PPA)

Drug Use Reason for Ban

Analgin Painkiller Bone marrow depression

Lomofen Anti-Diarrhoeal Cancer

Nimesulide Fever, Painkiller Liver Failure

D’ Cold, Vicks Action 500

Cold and Cough Stroke

Entroquinol Anti Diarrhoeal Blindness

Research

List of Banned Pharmaceutical Products

24 Drugs- Oxyphenbutazone, phenylbutazone, actimal, algerial, butacardidon, butaproxivon, oxyphose, sugril, oxyzone, parabutazone, colloquinol, alliqin, amiquil and amizil-+, Phenylpropanolamine, Metamizole (Analgin),  Nimesulide, Cisapride, Furazolidone and Nitrofurazone, phenylpropanolamine, Quinodochlor, Phenolphthalein,  Pergolid

Research Results (Chemists)• Whether they are aware of the ban on the mentioned medicines?

The survey indicated that more than half of the interviewees were aware of the ban on these products while the

rest of chemists were unaware since they buy only those medicines which the doctors prescribe without gaining

any information about the product from the Drug Control Authority.

• Do the Chemists stock these medicines?

Almost all the chemists stores stock these medicines in their stores. Where some are aware of the banned drugs

but still they stock the general medicines like Nimesulide, Metamizole which don’t need any prescription from

the doctors and readily sell them without any check from Drug Control Authority or doctors. Even most of the

chemists are unaware of the composition used in the medicines, they are only acquainted with the drug name.

• Can people buy these medicines from the pharmacists without any prescription?

Most of the chemists gave a positive response to this , where customers can purchase the medicines even

without the prescription.

• Do you inform the customer that the medicine might have side-effects?

They said No, it’s the doctor’s duty to tell. They believed that there job is to just sell the medicines asked for by

the customer.

Research Results contd.

According to Dr. Tapojyoti Das and Dr. Solanki at B.C.Roy Hospital, IIT Kharagpur. –

• They are aware of the ban on these drugs.• Though, no circular have been circulated either from the

Drug Control Authority and/ or the Head of the Department regarding the ban.

• Doctors keep themselves updated from the internet.• Medical Representatives do not provide any information.• According to the doctors, they do not prescribe any of the

banned drugs to the patients. (Though, interview with the chemists at Frank-Ross Pharmacy suggest that some of the aforementioned drugs are being prescribed by the doctors.)

Ethical Issues

Pharmaceutical companies

Pharmaceutical companies

Consumers• Is satisfaction of consumer stakeholder always

consistent with the best interests of the firm?▫No!▫Consumer Rights? Yes, but with rights comes

the responsibilities

• Caveat emptor : Buyer Beware!burden for protecting consumer’s interest lie

with the consumer’s themselves.▫Due diligence ▫Limits of caveat emptor : UN guidelines, which

include protection of consumers from hazards to their health and safety.

Reasons for problems in the regulatory system• Inadequate or weak drug control infrastructure at the State and

Central level

• Inadequate testing facilities – this is the reason why so many drugs

which are banned in US & Europe are still available in India

• Shortage of drug inspectors

• Non-uniformity of enforcement – Very few chemist stores have a

certified Pharmacist, which is an essential requirement

• Lack of specially trained cadres for specific regulatory areas

• Non existence of data bank

• Non- availability of accurate information

• Ignorance of consumers which leads to no questioning of the system

How to tackle the spurious drugs problem?• Creation of effective interaction between the stakeholders i.e.

industry and regulators, industry and consumers, trade and

regulators and medical professional and regulators.

• Creation of intelligence cum legal cells in State and Central

offices.

• Discouragement of proliferation of drug distribution outlets.

• Making changes in law to provide enhanced penalties, making

the offences cognizable and non- bailable in the light of similar

provisions in Narcotic Drugs and Psychotropic Substances Act.

• Designation of special courts to try the cases of spurious drugs.

Suggestions contd.• Preparation of dossiers of suspected dealers and

manufactures.

• Provision of secret funds and incentives to informers.

• Creating effective networking system between States

• Checking on drug supplies to practitioners who buy and

supply drugs to their patients.

• Creation by the industry of its counterfeit drug strategies,

better surveillance and efficient complaint handling system.

• Creation of better awareness amongst consumers through

mass-media by the health ministry, NGOs and other

organisations.

• Ignorance amongst doctors needs to be addressed.

• As it is difficult for the doctors in rural areas to have an

access to the internet, their mobile numbers can be taken

up by the state drug control authorities so as to keep them

updated regarding the use of banned drugs through SMS.

• Monthly or quarterly meeting of doctors/pharmacists of an

area to educate them about side-effects of drugs and their

ban

References:• Books:

▫Andrew Crane et al., Business Ethics, 2nd edition

• Webistes:▫Central Drugs Standard Control

Organization : http://www.cdsco.nic.in/▫http://www.expressindia.com/latest-news/All-

eyes-on-banned-drugs/755175/▫http://www.themedguru.com/20110302/

newsfeature/banned-drugs-still-circulation-medical-experts-86143853.html

▫http://www.expresspharmaonline.com/20051115/market01.shtml