- Recently, the Ministry of Health and Family Welfare in exercise of powers conferred by the Drugs and Cosmetics Act, 1940 has prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) and restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.
- About FDC –An FDC is a cocktail of two or more therapeutic drugs packed in a single dose. Several cough syrups, painkillers and dermatological drugs in India are FDCs.
–Benefits: They are known to offer specific advantages over the single entity preparations, such as increased efficacy, and/or a reduced incidence of adverse effects, possibly reduced cost and simpler logistics of distribution relevant to situations of limited resources
–Cheaper for consumer: patient can buy just one FDC medicine to treat multiple illness symptoms.
–For pharma companies, FDC’s are cheaper and easier to combine existing active ingredients to make new products than to discover new medicines. They are also not covered under the ambit of price control regime.
–According to All India Drugs’ Action Network (AIDAN), the market of unsafe, problematic FDCs in India is at least one fourth of the total pharma market valued at ₹1.3 trillion.
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- In 2016, the health ministry had banned 349 FDCs, claiming they were “unsafe” and “irrational” for consumption on the recommendation of Chandrakant Kokate committee (2015). However, the matter was contested by the affected manufacturers in various High Courts and the Supreme Court of India.
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- The Drugs Technical Advisory Board on a direction from Supreme Court, formed Nilima Shirsagar committee to review the safety, efficacy and therapeutic justification of 344 fixed dose combination (FDC) drugs. The committee also recommended the continuation of the ban along with other observations such
- Experts believe combination drugs to be unsafe because unaware e physicians can prescribe wrong dosage that can in turn make human body resistant to treatment.
- Over the years, India has become a”dumping ground “for irrational FDCs that are not approved in other countries for consumption.
- Drugs are regulated by the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetic Rules, 1945.
- Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, is the authority that approves new drugs for manufacture and import.
- State Drug Authorities are the licensing authorities for marketing drugs.
- Drugs Technical Advisory Board (DTAB): It is the highest statutory decision-making body under the Union Health ministry on technical matters. It is constituted as per the Drugs and Cosmetics Act, 1940.
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