Pharma companies marketing ?new drugs? would now have to submit periodic safety profiles of these products to the Drug Controller General of India (DCGI) for the first four years of the launch or face suspension or even cancellation of license. These drug firms would have to update the drug regulator on ?how safe the drug has been? in the Indian context every six months for the first two years and once every year in the third and fourth year of the drug launch by submitting a ?periodic safety update report?(PSUR).
These are efforts on part of the drug regulator to tighten the ?post marketing surveillance? in the R60,000 crore Indian drug market, a mechanism used in the regulated markets to zero down on adverse side effects a new drug may be causing in people after it has hit the market. These reports usually form the basis of decisions taken by drug regulators in developed countries to weed out some new drugs in cases where adverse effects outweigh therapeutic benefits or add caution and warning messages in the leaflets if hitherto unknown side effects are discovered for a new drug.
Pharma companies would now have to mandatorily reveal information to the drug regulator on which other countries the drug has been authorized to be marketed in or countries they have been banned in, update of actions that have been taken for safety reasons in case of the drug, individual case histories, and studies on the drug and supplement it with an overall safety evaluation in context to India. The submission PSUR has been mandated by law since more than two decades but according to sources, it was never practiced diligently in reality. ?Many companies do not bother to submit any PSUR today. Most of the handfuls which submit file a highly generalized report with no particular relevance to India defying the whole purpose,? said an official well versed with the workings of drug regulator?s office. The drug regulator?s office on an average receives close to 1600 applications related to new drugs every year. By definition, a ?new drug? under law is a molecule which is introduced for the first time in the country, an already approved drug proposed to be marketed for new usages or different indications, or on a new delivery platform or fixed dose combination drugs.
?Manufactures/importers who have not updated the PSUR as per the above requirements shall submit the same to the office of DCG(I) within three weeks ..Otherwise it will lead to suspension or cancellation of the respective new drug permission for which they will be held responsible,? an office order from DCGI office dated 28 August said.
Drug regulatory experts see this as a step in the right direction. ?The government has embarked on a hugely expensive exercise of the programme of pharmacovigilance with 23 centres across the country to determine the adverse side effects of new drugs. But actually a great source of the adverse drug reports are companies themselves. Pharma companies submit these reports as parts of standard practices in most well regulated markets. And this has actually been a mandatory requirement under law in India since 1980s,? said C.M Gulhati, an eminent drug regulatory expert.
The government in 2011 put in place a pharmacovigilance program, an adverse drug effect monitoring mechanism with All India Institute of Medical Sciences as the centre supported by hospitals, medical colleges across country as its nodes to generate country specific data on impact of drug.
