[e-drug] Banning of medicines in India (6)

["Pipasha Biswas" <b_pipasha@yahoo.co.uk>]

E-DRUG: Banning of medicines in India (6)
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Dear All,

Few years back I read in Indian news papers that the then Health Minister of India Mrs Sushma Swaraj had implemented (or may be I am wrong) or said that people who manufacture/produce counterfeit drugs/medicines if caught will be given death Penalty (Vijay correct me if I am wrong).  Don't know what happened to that.  Nothing was however, said or there are no punishments for regulatory authorities in many countries, who are given the responsibility to implement things and should practically be responsible for patient safety.  I am not saying that death penalty should be given, but at least severe punishment should be there like imprisonment.  

I do not know if people in India know, but in Europe there is a concept of Qualified Person in Pharmacovigilance.  As per EU Regulations, all pharmaceutical companies operating in Europe or doing business in Europe will have to have a QP in PV who has the overall reponsibility of pharmacovigilance.  If something goes wrong with the products or there is non-compliance in PV etc etc then the QP is liable to go to prison.  And this has happened with a few people already in the UK (I shall not name any people though).  Something like this needs to happen in other countries as well.  Also as per new regulations out in January 2007 for Pharmacovigilance, any company who is repeatedly non-compliant with pharmacovigilance activities will be named and shamed by the regulatory and competent authorities and be subject to repeated inspections.

I hope this is of help.

Dr Pipasha Biswas
MD MPM DM
Principal Consultant & Director
Symogen Ltd, UK
b_pipasha@yahoo.co.uk