Through a gazette notification, the Health Ministry has banned manufacturing and selling 156 fixed-dose combination (FDC) drugs in India. These FDCs, products combining two or more active ingredients in a single dosage form, were licensed by the State Licensing Authority without obtaining prior approval from the Drug Controller General of India (DCGI). The government identified these combinations, which include antibiotics, painkillers, and multivitamins, as irrational and potentially harmful to public health. The ban, which follows the recommendations of an expert committee and the Drugs Technical Advisory Board (DTAB), underscores the thorough review process these FDCs underwent. The expert committee and the DTAB found that these FDCs lacked therapeutic justification and posed significant health risks. The central government exercised its powers under Section 26A to regulate or restrict the manufacture of drugs in the public interest, as notified in the Official Gazette.
The banned FDCs include products with combinations of 12 to 15 active ingredients. Among the 156 banned formulations, at least 22 contain Naphazoline, a decongestant commonly used to alleviate symptoms like red or puffy eyes. The ban has significant implications for several major pharmaceutical companies, including Sun Pharmaceuticals, Dr. Reddy’s Laboratories, Cipla, Alkem Laboratories, Mankind Pharma, Torrent Pharmaceuticals, and Eris Lifesciences. This move follows a similar action by the Centre last year when 14 FDCs licensed before 1988, including cough syrups, anti-allergy medications, and pain relievers, were banned based on expert advice due to potential risks to human health. Over 40 drug companies, including several industry leaders, have since approached the High Courts to challenge the ban.
Various Committees pressed into actions
The central government has been actively reviewing and banning various irrational Fixed-Dose Combinations (FDCs) due to concerns about their potential risks to users. On March 10, 2016, the government banned 344 FDCs based on the recommendations of the Professor Kokate Committee. This decision was made in the public interest, as these combinations were deemed likely to pose risks to human health when safer alternatives were available. The Kokate Committee was formed in response to the 59th report of the Department-related Parliamentary Standing Committee on Health and Family Welfare, which highlighted that some state licensing authorities had issued manufacturing licenses for several FDCs without prior approval from the Central Drugs Standard Control Organisation (CDSCO). This led to the availability of numerous untested FDCs in the market, potentially compromising patient safety.
Additionally, the Drugs Technical Advisory Board (DTAB) appointed a sub-committee led by Nilima Kshirsagar to further examine these FDCs and the involvement of major pharmaceutical companies. Abbott Healthcare and Laboratories Griffon subsequently approached the Supreme Court, arguing that 15 FDCs approved before September 21, 1988, should not have been subjected to the sub-committee’s review. Several stakeholders approached various High Courts against the notification, and the Delhi High Court quashed the notification on December 1, 2016. The Central government appealed to the Supreme Court of India. The apex court, in a judgement on December 15, 2017, recommended that the case of 349 FDCs be banned by the Centre, except for the 15 FDCs that are pre-1988 approved and 17 FDCs which have DCGI approval, to be referred to the Drugs Technical Advisory Board (DTAB) for further examination.
Drug Banned List
Drugs banned by the Ministry of Health and Family Welfare through orders on August 2, 2024
The regulation of medicines in India is based on a shared responsibility between the central government and individual states, a system rooted in legislation dating back to 1940 and India’s 1949 constitution. Despite numerous amendments, the core division of responsibilities remains unchanged: states are responsible for licensing the manufacturing, selling, and distributing of drugs, while the central government, through the Central Drugs Standard Control Organisation (CDSCO), manages the licensing of drug imports. The constitution includes “Drugs” in the Concurrent List, allowing both the national parliament and state legislatures to create laws concerning them. However, only states can legislate on “Public health” matters. Over time, the central government’s powers have expanded, notably requiring central approval to manufacture new drugs since 1961, though this requirement was removed in March 2019.
Fixed-dose combinations (FDCs) are widely utilised and approved globally, though their approval processes, regulatory frameworks, and acceptance levels can differ significantly from country to country. In many regions, including the United States, the European Union, and Japan, FDCs must undergo thorough evaluations to ensure their safety, efficacy, and therapeutic justification before marketing. Regulatory bodies in these countries, such as the FDA, EMA, and PMDA, mandate that clinical data must demonstrate that the combination is either more effective or safer than the individual components used separately. FDCs are particularly prevalent in the treatment of chronic conditions like HIV, tuberculosis, and hypertension, where the combination of medications helps to simplify treatment regimens, improve adherence, and reduce the overall pill burden for patients.
References:
- Brhlikova, P., Mehta, A., McGettigan, P. et al.Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics. J of Pharm Policy and Pract 16, 139 (2023).
- Babu (2024), Health Ministry bans 156 FDCs with immediate effect
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