A drug advisory body sub-committee has asked pharmaceutical companies to prove that 324 combination medicines are safe and effective for patients to consume in order to decide whether these drugs should continue to be sold in India.
These medicines, known as fixed dose combinations (FDCs), were declared “irrational” by a Health Ministry expert committee set up in 2014 headed by former KLE University Vice-Chancellor, CK Kokate. An FDC is a cocktail medicine with two or more therapeutic ingredients packed in a single dose and administered in various forms, including syrups, tablets, inhalers, injections and skin creams. When an FDC is “irrational”, there may not be a rationale for creating such a combination and it may not be safe for use, effective or required.
To give an opportunity to drug makers to defend the 324 FDCs, the sub-committee has given the companies until June 30 to submit and present “precise data”. The committee is expected to submit its recommendations by July.
It has sought various details, including of whether the combinations were approved by apex drug regulator, which other countries they are sold in and proof that they are safe for consumption. The sub-committee has asked if these drugs were approved and marketed in India before 1988 — a cut-off that several drug makers have used in the last three years in court cases to get lifted ban on their combination drugs.
The drugs in the latest list are not the same as 350 FDCs that Health Ministry had attempted to ban in 2016 and 2017, which included popular cough syrups and painkillers like Phensedyl and Saridon. Unlike the previous list of FDCs, which were altogether valued over Rs 2,500 crore, the new list consists of combinations that contribute much less to the Indian pharmaceutical market at present. Yet, brands by larger pharma companies might figure in the latest list, as per data from pharmaceutical market research firm AIOCD Awacs PharmaTrac. This includes cough syrups, painkillers, certain eye drops, injections and dermatological products. Eight of the drugs in the list alone contribute around Rs 454 crore, with combinations like painkiller aceclofenac + paracetamol and diabetic kidney disease drug taurine + acetylcysteine contributing around Rs 290 crore and Rs 65 crore each, as per PharmaTrac.
The Kokate Committee discussed a total of 418 FDCs “in detail” in consultation with subject experts of relevant therapeutic areas, examined “all” the data submitted by the companies and also reviewed scientific data before it declared these 324 FDCs “irrational”, according to minutes of the Drugs Technical Advisory Board (DTAB) that formed the sub-committee to look into the issue in April.
“The FDCs which have been declared as irrational needs to be prohibited under Drugs and Cosmetics Act, 1940 as other safer alternatives to those combinations are available,” stated the Committee’s report, as cited by DTAB. Senior government officials earlier told The Indian Express that India has become a “dumping ground” for irrational FDCs, with thousands of combinations being sold in the market.