Hyderabad: The ban on 328 fixed dose combinations (FDC) is estimated to cost the pharmaceutical market Rs 2,300 crore. The Union health ministry banned these combination drugs on September 7 as they were found to be unsafe. Manufacturers say the industry will suffer a major loss in the next quarter due to the ban.
The Centre has retained only 15 FDCs which were being manufactured before 1988 out of the ban as they were found to be safe. The other 328 FDCs were termed irrational and inefficacious by the Drugs Technical Advisory Board in its report submitted to the Supreme Court.
Dr Sanjay Reddy, president of the Telangana Pharmacists Association, explained, “The manufacturers were making combinations with higher dosages which is not required for the human body. The committee has found gross violations and it was high time that the ban was imposed.”
He said that instead of three or four combination drugs they can use a single or double molecule but clinical studies have to be presented to the committee. “Drugs which are suitable to the Indian population have to be manufactured,” he said.
The concept of single-molecule drugs gave way to fixed combinations as it was found to be convenient for patients. A senior doctor said, “Some combinations contained chemicals which were required not for the body. A common example is the medicine for body pain and fever. People popped the pill even when they didn’t have pain and that beca-me a major problem.”
The best selling brands which will be affected by this ban are the ointment Panderm (Macleods), Tab Amaryl MP (Sanofi), Tab Aceproxyvon (Wockhardt), Tab Nimulid MR (Panacea), Tab Gluconorm (Lupin), Tab Glyciphage LPG (Franco Indian Pharmaceuticals), Tab Nicip Plus and Syrup Oflox OZ (Cipla), Syrup Tusq X (Blue Cross Laboratories), Ointment Quardiderm (MSD Merck).
The drugs ‘Gluconorm PG 1’ and ‘Gluconorm PG 2’ of Lupin, have been exempt from the ban.
