A fresh stock of 739 drugs may soon be facing a ban by the Union Health Ministry based on the Kokate Committee report . An interim stay has been granted to approximately 20 pharma companies including Abbott, Pfizer and Macleods. Of 6214 drugs reviewed by the committee of late,1083 have been found irrational and 344 FDC’s banned, comprising of 1600 brands.
According to pharma biz.com the Kokate committee’s reviewed list of 6,214 FDCs so far have been classified under four categories — irrational, require further deliberations, rational and require additional data generation.
The health ministry, had, in a notification on March 12, banned nearly 344 FDCs following recommendations of an expert committee formed to examine the efficacy of these drug combinations. The banned FDC’s include painkillers, anti-diabetic, respiratory and gastro-intestinal medicines. Impacting sales of over Rs.10,000 crore; categories of FDCs most impacted include antibiotics, antihistaminic, caffeine and codeine combinations and NSAID
According to a panel member of Kokate committee findings, many drugs were found rational out of the 6214 examined. The companies were supposed to register and submit documentary evidence in the specified format to prove the efficacy of the drugs.
The irrationality of the FDC was assessed based on a blind process which could determine that the ingredients used in the FDC proved efficacious and safe for the patients. The FDCs were banned taking into consideration the health prospects of the common man with focus on antibiotic resistance.
FDC medicines combine two or more drugs in a single pill. When multiple drugs from the same therapeutic group, for example antibiotics, are clubbed together, it may lead to resistance, according to experts. In India, many pharma companies obtain licence from a state to make FDCs, and sell them without the consent of the Central government.
A member of the expert committee formed to assess the rationality of over 6,000 FDCs which culminated into banning of 344 medicines clarified that many of the FDCs did not face a similar fate and were cleared based on the scientific documentary evidences.
Actions by the DCGI office has been taken on companies who did not register their FDCs with the DCGI and did not show up with the requisite documentary evidence to claim the safety and efficacy of the respective FDC in question.
The DCGI, as directed by the health ministry under 33-P had called for submitting efficacy and safety data for all combination State Licensing Authority (SLA)-approved products prior to October 1, 2012. Further the Central Drugs Standard Control Organisation (CDSCO) stipulated that such applications must be made in Form 44, as there was no format specifically available for applications of SLA-approved and already marketed FDCs.
The DCGI had earlier agreed to allow all pre-1988 FDCs licensed by SLAs provided proof of pre-1988 license is submitted.
FDCs of vitamins, minerals, other nutrients; probiotics/prebiotics/synbiotics, antacids/enzyme formulations, cough and cold permutation combination products, topicals, and such simple FDCs are to be cleared as rational in view of them being unlikely to have any concern with respect to safety concerns and being used on day-to-day basis as household products.
“The SLAs had given permission to manufacture and market FDCs, whose ingredients were already in use and being prescribed regularly by the medical professionals – may be even for 20 to 30 years. Today, FDCs contribute 40 per cent of the Indian pharmaceutical market and in case these FDCs are discontinued abruptly, the Indian patients will be deprived of these affordable medicines and the manufacturers, retailers etc. i.e. the distribution chain, will be left with depleted stocks resulting in substantial loss, especially to the small scale sector. India is the world leader in FDCs and today, even regulated markets are seeing introduction of more combination products progressively. Hence the bias against FDCs, if any, would be a retrograde step and negate the great achievements made by the Indian pharma manufacturers,” an IDMA submission concluded.
Market estimates reveal that the ban has impacted over 2700 medicine brands; Abbott Healthcare being worst hit, with an annual loss of Rs.485 crore, other companies including Lupin, Sun Pharma, Glenmark, Wockhardt, Aristo and Intas are also expected to bear the brunt.