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?
Drug Use Reason for Ban
Analgin Painkiller Bone marrow depression
Lomofen Anti-Diarrhoeal Cancer
Nimesulide Fever, Painkiller Liver Failure
D’ Cold, Vicks Action Cold and Cough Stroke
500
Entroquinol Anti Diarrhoeal Blindness

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)
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/newsfeatur
e/banned-drugs-still-circulation-medical-experts-
86143853.html
▫ http://www.expresspharmaonline.com/20051115/m
arket01.shtml