With a series of drugs approved by the US Food and Drug Authority being recalled in recent times (e.g. Permax for treatment of Parkinson's, Zelnorm for Irritable Bowel Syndrome), and alerts being issued on others (due to the clinical evidence being contradictory, the FDA has issued a potential safety alert for Type 2 diabetes drug Avandia), India's drug authorities appear to have a problem on their hands.
For one, several drugs are marketed in the country solely on the strength of the US FDA having approved them - if the FDA's clearances themselves come under a cloud, so does the drug clearance process in this country.
The other issue is what the drug controllers do when the FDA recalls a drug or issues alerts about possible problems with the drug, as in the case of Avandia, where the publication of a study in New England Journal of Medicine by a prominent US cardiologist suggested that patients taking the drug had a higher chance of suffering a heart attack.
While Indian drug authorities have still to find a way to deal with such situations, the policy on complete recalls is less fuzzy. When Merck's Vioxx and Pfizer's Bextra were withdrawn after earning billions of dollars in the US market, India followed up by banning them as well. The more recent recalls, of drugs like Zelnorm and Permax, however, have not resulted in them being banned here as well -- so, the reaction time is an issue.
The other problem is that the drug controllers in India cannot really ensure that a drug has been fully withdrawn from the market. Medicines banned in the country are still available. Nimesulide has been banned in various countries and India has banned its use for children over a year ago - yet, Nimulid doses are available for children even today. Ditto with analgin.
In other cases, despite the drug controller asking pharmaceutical firms to recall drugs and to re-issue them with new product literature carrying appropriate warnings (this drug can't be used by patients with renal problems, for instance), the drugs have been found on chemist shelves.
One problem is the shortage of drug inspectors who are supposed to ensure that chemists do not stock banned medicines. The even more serious, and related, problem is that of spurious drugs.
The estimates of spurious drugs in the country vary from a fourth to 40 per cent of the industry's turnover, which should make it obvious that the drug authorities are fighting a losing battle - the country's top pharmaceuticals firms in the organised sector, it is obvious, will not produce a medicine that is banned, but how do you stop the counterfeiter?
It does not help that just a handful of government laboratories are authorised to check counterfeit drugs. Indeed, India remains on the US list of countries with poor IPR protection precisely on account of its counterfeiting problem. That is, apart from the serious health hazard that such a situation poses, it also hurts India's trade/investment relations.
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