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

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

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
Principal Consultant & Director
Symogen Ltd, UK

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