Ban three unsafe drugs namely nimesulide, cisapride and phenylpropanolamine

DCGI finally took a decision to ban three unsafe drugs namely nimesulide, cisapride and phenylpropanolamine after several years of debate on their safety. The drugs were found to have serious side effects since early 2000 and many developed countries had already banned all of them. The Drugs Technical Advisory Board has been examining the safety profiles of the three drugs for several years and has now recommended their withdrawal from the market as their adverse effects outweigh the benefits. Among the three drugs, nimesulide was the most controversial one.

The drug was banned in US, Britain, Canada, Sweden, Denmark, Australia, New Zealand, Japan and other 168 countries but it was being freely sold in India by prominent drug companies like Dr Reddy's, Panacea Biotech and some others. Cisapride is another unsafe drug found to increase motility in the upper gastrointestinal tract of patients. The drug is also withdrawn from the markets of many countries due to its side effects. In India, the possible dangerous side effects of the drug has been brought to the notice of the Drug Controller General of India first time sometime by the Ahmedabad based Consumer Education and Research Centre in April 2000. DCGI has promptly ordered an investigation to assess the safety profile of the drug in the Indian context. The drug remained in the market almost ten years since then. PPA used in cold and cough remedies was banned in North America and western Europe some years ago. But, in India, PPA -containing cough and cold remedies such as D’Cold, Vicks Action-500, Wincold, etc are freely available in the market. Gatifloxacine, tegaserod and deanxit. are the other three drugs which are being reviewed by DTAB for their side effects. These drugs have also been banned in some of the developed countries.

Two drugs which have been banned in India last year are rosiglitazone, a high profile and widely prescribed diabetic drug and rimonabant, an anti obesity drug. Both the drugs have been withdrawn from the European markets early last year for their serious side effects. In India, the DCGI had placed rosiglitazone, under the scanner of national pharmacovigilance programme in August, 2007 in the wake of US FDA warning against the use of the drug. And it took three years for DCGI to decide whether its marketing should be allowed to be continued in the Indian market. Apart from these, quite a few drugs have been withdrawn from the markets of developed countries and India in the recent past.

These actions by drug authorities establish the fact that there has been a steady rise in post marketing complications of newly approved drugs especially during the last ten years. That is what is forcing regulatory authorities to pull out more and more approved drugs from the markets. This trend shows that there is something seriously wrong with the whole system of new drug approval by world's top regulatory bodies including in India. A stricter evaluation of safety and efficacy of any new drug is therefore called for before it is allowed for marketing in the country by DCGI to protect the public health. Marketing approval by US FDA or European drug regulatory authority should not be the criterion for approving a new drug in India any more.