Combinations involve risk to patients; 6K brands worth Rs 2,500 cr market size to vanish
Citing safety concerns, the Union Health Ministry on Wednesday announced ban on manufacturing, sale or distribution of 328 Fixed Dose Combinations (FDCs) drugs with immediate effect. This includes brands like Piramal’s Saridon, Macleods Pharma’s Panderm Plus cream and Alkem Laboratories’ Taxim AZ.
The Ministry has also restricted the manufacture, sale or distribution of six FDC drugs subject to certain conditions. The ban follows recommendations from its technical advisory board Drugs Technical Advisory Board (DTAB).
FDC drugs are two or more medicines combined in a fixed ratio into a single dosage form. Experts allege that FDCs are developed to escape price control measures.
Market players pointed out that the banned combinations on the list belong to several therapeutic areas like cough and cold syrups, gastrointestinal and anti-infective formulations, and dermatological medicines.
The respiratory portfolio will bear the highest impact, followed by anti-diabetic and anti-infective drugs.
They also said the move means that around 6,000 medicine brands belonging to different companies and with a combined market size of Rs 2,000-2,500 crore may soon vanish from the drug market in the country.
The Centre in March 2016 had prohibited the manufacture for sale and distribution of 349 FDC drugs. However, the move was challenged by the affected manufacturers in High Courts and the Supreme Court.
Complying with the December 2017 Supreme Court judgment, the DTAB examined the matter and in its report to the Centre recommended prohibition of the FDCs saying there was no therapeutic justification for the ingredients contained in them and that these FDCs may involve risk to human beings. Earlier, an expert committee appointed by the Centre had made similar observations.
Considering the recommendations of DTAB and the expert committee, the Health Ministry, through a gazette notification, banned the FDCs.
The ban has been called for by DTAB since the 328 combination of medicines, also known as FDCs, are unjustified as far as their therapeutic potential is concerned.
DTAB said these combinations may lead to overuse. According to the technical body, there is no need to expose the patients to that many ingredients when one will do the work.
The notification stated, “Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC…any kind of regulation or restriction to allow for any use in patients is not justifiable.”
According to the notifications, the Ministry also plans to clamp down on the manufacture, sale and distribution of six FDCs, two of which are used in the treatment of diabetes.
The 59th report of the Parliamentary Committee on Health and Family Welfare too had pointed out that in 2012 the Central Drugs Standard Control Organisation (CDSCO) had, by various acts of omission and commission, failed to restrict the number of irrational FDCs.
A glaring omission pointed out was that many FDCs were being marketed after receiving approval from State regulatory agencies, whereas marketing approval can only be provided by the CDSCO.
Amit Sengupta, national convener of Jan Swasthya Abhiyan, said that inappropriate use of FDC medicines poses a major threat to public health. The combinations can lead to additional toxicity, limit choice of prescribing physicians, increase treatment cost, lead to under or overdosing. In the case of antibiotics, FDC medicines can contribute to more rapid development of antimicrobial resistance, said the Jan Swasthya Abhiyan convener.