Sixty four fixed dose combination (FDC) drugs will soon be out of the shelves of the pharmacy stores in the country as the pharma associations screening committee, which was formed last month to prepare scientific data of all the contentious 294 FDC drugs, has found them combinations irrational.
Some of the combinations found irrational include, 5-bromosalicyl-4-chloranilide + salicylic acid, analgin + diazepam, ciprofloxacin + tinidazole + dicyclomine, dicyclomine + paracetamol + chlordiazepoxide, dicyclomine + paracetamol + phenylisopropyl pyrazolon, glucosamine + mecobalamine, ibuprofen + dextropropoxyphene + paracetamol, ibuprofen + paracetamol + magnesium trisilicate, mebeverine + alprazolam, nimesulide + phenylpherine + chlorpheniramane maleate + caffein, norfloxacin + tinidazole + dicyclomine, paracetamol + analgin, ranitidine + omeprazole, etc.
Paracetamol + diclofenac sodium + amoxicillin + cloxacillin + pantoprazole + lactic acid bacillus + serrapeptase, nimesulide + P-piperidinoethoxy-O-carbomethoxybenzophenone + diphenyl piperidenoethyl acetamide bromomethylate, chlorzoxazone + paracetamol + ibuprofen + diclofenac sodium, nimesulide + phenylpherine + chlorpheniramane maleate + caffeine.
According to sources, the screening committee headed by eminent pharmacologist and chairman of IDMA medical sub-committee Dr RK Sanghavi has prepared the rationality profile of all the 294 combinations and it will be submitted to the DCGI in the crucial DCGI-industry meeting on July 14. The meeting, which is scheduled to be attended by DCGI Dr Surinder Singh and senior pharmacologist Dr YK Gupta, will take up all the 294 drugs one by one for verifying the rationality of these drugs before making a final call on these drugs.
Keen to find an out of court settlement on the FDC issue that is presently entangled in the Madras high court after the CIPI moved court in October last year, Dr Surinder Sing had convened a meeting of all the major pharma associations like IDMA, CIPI, OPPI, SPIC, IPA, etc on June 10. The meeting decided to review all the contentious 294 combinations and withdraw such combinations which are found irrational. The government gave time till July 14 to the industry to come out with rationality of all the 294 FDC drugs.
The significance of the meeting was that wile the government agreed to review all the 294 contentious combinations, the industry also agreed to withdraw such combinations which are found irrational.
As the time was fast ticking away to prepare rationality profile of all the 294 combinations, the screening committee asked the manufacturers of these combination drugs to prepare and submit the scientific data of their products to the committee. All the manufacturers reacted positively and the screening committee has finalised the report. It has found 64 of them irrational which the industry will offer to withdraw from the market voluntarily, sources said.