Nineteen fixed dose combinations (FDC) drugs that were exempted from government ban in 2016 as they were approved prior 1988, will be coming come under fresh review for safety and efficacy.
An expert committee appointed by the Central government will check if these drug cocktails have any coherent scientific data backing their safety and efficacy claims.
Some of the popular brands that will come under latest review include Piramal Enterprises' Saridon, Abbott's Phensedyl and Tixylix, Griffon's Grilinctus, Cipla’s Cofdex, Nocold and Bromolin, Glenmark’s Ascoril C, Intas' Despol and Reckitt Benckiser's D-Cold, among others.
The committee headed by Dr MS Bhatia, Professor & Head, Psychiatry, University College of Medical Sciences, New Delhi will examine these FDCs.
"In this regard, a meeting of the expert committee was held and the Committee has desired that the concerned stakeholders shall submit the information on the rationality, safety and efficacy with respect to these FDCs along with relevant documents supporting documents in hard copy as well as soft copy .. before August 25, 2021 till 5 pm," a notification issued by Sanjeev Kumar, Deputy Drugs Controller (India).
Irrational use?
An FDC refers to a combination of two or more active ingredients into a single pill in a fixed dosage ratio. India is flooded with FDCs and at one point of time at least one in two medications sold in India is a kind of FDC.
In an attempt to weed out irrational drug combinations from the Indian market, in 2016, the government banned over 344 FDCs for a wide range of medical conditions stating that the combinations had "no therapeutic justification".
However, Supreme Court in its judgements on December 15, 2017 and February 14, 2019, directed the Central government to carry out de novo (fresh) inquiry as to whether fixed dose combinations licensed prior to 1988 should be banned under Section 26A in the Drugs and Cosmetics Act, 1940.Section 26A the Central Government can ban manufacture and sale of drugs in public interest.
An FDC is a cocktail of two or more active drug ingredients in a medicine.Some of combinations that will come under review of Nimesulide and Paracetamol dispersible tablets, Paracetamol, Phenylephrine and Caffeine, Amoxicillin and Bromhexine, Chlorepheniramine Maleate and Codeine syrup, Salbutamol and Bromhexine, among others.
The ban at the time was estimated to have cost pharmaceutical companies of about Rs 4,000 crore.