After several years of debate regarding the safety of nimesulide, cisapride and phenylpropanolamine (PPA) the DCGI has finally decided to ban these three unsafe drugs.
After several years of debate
regarding the safety of nimesulide, cisapride and phenylpropanolamine (PPA) the
Drug Controller General of India (DCGI) Dr. Surinder Singh has finally decided
to ban these three unsafe drugs. Since the adverse effects of these drugs
outweigh the benefits the Drugs Technical Advisory Board (DTAB) that had been
examining the safety of the three drugs for several years has now
recommended their withdrawal from the market.
Nimesulide was the most
controversial among the three drugs. Many developed countries like US, Britain,
Canada, Sweden, Denmark, Australia, New Zealand, Japan and other 168 countries had
already banned these drugs. However it is freely sold in India by prominent
pharmaceutical companies like Dr Reddy's, Panacea Biotech and several others. Cisapride,
another unsafe drug was found to increase upper gastrointestinal tract motility.
Due to its side effects even this drug is banned in many countries. The drug
continued to remain in the market even though the possible dangerous side
effects of the drug had been brought to the notice of the DCGI 10years back. PPA
used in cold and cough remedies is
freely available in India. However it was banned in North America and Western
Europe some years ago. The DTAB is now reviewing the use of Gatifloxacin, tegaserod
and deanxit which have been banned in some of the developed countries. In the
past diabetes drug Rosiglitazone and anti-obesity drug Rimonabant have been
banned from the Indian markets.
This shows the need for stricter
evaluation of safety and efficacy of any new drug before introducing it in the
market.
Source-Medindia