FDCs of cos with no data submitted to DCGI to prove safety, efficacy banned

Shardul Nautiyal, Mumbai
Saturday, April 09, 2016, 08:00 Hrs  [IST]

Even as interim stay has been granted to 20 odd pharma companies including Abbott, Pfizer and Macleods, the Union health ministry may ban another 739 drugs based on the Kokate committee report. The Kokate committee reviewed 6214 drugs, out of which 1083 were found irrational and 344 FDCs were recently banned which comprised of over 1600 brands. 

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.

Even as the Union health ministry's ban on 344 fixed dose combination (FDC) drugs including painkillers, anti-diabetic, respiratory and gastro-intestinal medicines has made a sales impact of over Rs.10,000 crore, category of FDCs most impacted includes 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.

The Kokate committee has reviewed about 6,214 FDCs so far and classified them under four categories — irrational, require further deliberations, rational and require additional data generation. 

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 from the DCGI office was 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 should be cleared as rational in view of these 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.

Government has banned common household medicines Crocin Cold and Flu, D-Cold Total, Sumo, Oflox, Gastrogyl, Chericof, Nimulid, Kofnil, Dolo Cold, Decoff, O2, paediatric syrup T-98 and TedyKoff, as part of its decision to stop the manufacture and sale of FDCs.

Market estimates reveal that the ban impacts over 2700 medicine brands. While Abbott Healthcare will be worst hit, with an annual loss of Rs.485 crore, other companies including Lupin, Sun Pharma, Glenmark, Wockhardt, Aristo and Intas would also bear the brunt.