Three controversial drugs — nimesulide, suspension to treat pain and fever in children, cisapride for stomach acid reflux, and phenylpropanolamine (PPA), a component of popular cold and cough syrups — have been declared unsafe by the Union health ministry's Drugs Technical Advisory Board (DTAB) and will be banned.
Experts, however, say the ban has come too late. It is because most pharmaceutical companies in India have stopped manufacturing these drugs following their ban in many developed countries, including the Britain, Canada, Sweden, Denmark, Australia, New Zealand and Japan. Nimesulide has never been filed for food and drug administration evaluation for sale in the US, where it is not marketed.
"It's an eyewash. The combined worth of all three drugs is just Rs20 crore of India's Rs50,000-crore pharma market. If the Drug Controller General of India (DCGI) wants an effective ban that benefits people, he should ban nimesulide tablets, which accounts for 99% of the R300 crore nimesulide market," said Dr Chandra M Gulati, Delhi-based editor of the journal, Monthly Index of Medical Specialities.
Apart from India, nimesulide is marketed in 49 other countries worldwide, including Italy, France, Portugal, Greece, Switzerland, Belgium, Mexico and Brazil. In Italy, the drugs controlelr was filmed by the police in May 2008 accepting bribe to ensure nimesulide-containing Aulin would be cleared for marketing.
In India, nimesulide tablets are routinely prescribed for inflammation, pain and fever because they have a longer-lasting effect. Unlike paracetamol, which usually acts for 4-6 hours, nimesulide brings down pain and fever for 12-18 hours. However, the side effects include liver damage. The World Health Organization recommends paracetamol, which should be the first drug of choice for fever, followed by ibuprofen.
The other unsafe drugs banned are cisapride, which was found to cause irregular heartbeats. It has Rs2 crore market. PPA is a component of cold and cough remedies and commands a Rs3.5 crore market.
Despite repeated attempts, DCGI Dr Surinder Singh could not be reached for comment.