Dear Friends,
many drugs in india are being sold without any trials and many drugs that are banned in western countries are being allowed in india. earlier the director health used to be state drug controller but the new drug act in place he has been replaced by a drug controller who is seniormost with b pharma qualification.
the tribune has raised a serious issue of qualification of drug controller of india and state drug controllers as they need to be public health professionals with pharma background who know the importance of clinical trials and ethical issues involved in them.
may be we need a pil in this regard.
DRUG CONTROLLER ELIGIBILTY: B PHARMA!
In the US, Chief of FDA, the drug regulator, is a top public health professional who was, in 1997, called in by the then US President to serve as Assistant Secretary in the US Department of Health. The present incumbent is an experienced medical doctor and scientist. But in India, the Drug Controller General’s minimum prescribed qualification is B Pharma. “We fail to understand how a B Pharma is being equated to an MD in Pharmacology or Microbiology. Considering pharma industry is growing at an annual rate of 10 per cent, qualifications of DCGI need urgent revision to bring in people who have clinical or research experience on drugs that super-specialists can prescribe,” the panel said. The DCGI is, on an average, granting one drug approval a month.
many drugs in india are being sold without any trials and many drugs that are banned in western countries are being allowed in india. earlier the director health used to be state drug controller but the new drug act in place he has been replaced by a drug controller who is seniormost with b pharma qualification.
the tribune has raised a serious issue of qualification of drug controller of india and state drug controllers as they need to be public health professionals with pharma background who know the importance of clinical trials and ethical issues involved in them.
may be we need a pil in this regard.
DRUG CONTROLLER ELIGIBILTY: B PHARMA!
In the US, Chief of FDA, the drug regulator, is a top public health professional who was, in 1997, called in by the then US President to serve as Assistant Secretary in the US Department of Health. The present incumbent is an experienced medical doctor and scientist. But in India, the Drug Controller General’s minimum prescribed qualification is B Pharma. “We fail to understand how a B Pharma is being equated to an MD in Pharmacology or Microbiology. Considering pharma industry is growing at an annual rate of 10 per cent, qualifications of DCGI need urgent revision to bring in people who have clinical or research experience on drugs that super-specialists can prescribe,” the panel said. The DCGI is, on an average, granting one drug approval a month.
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