Government Examines Three More Fixed Dose Combinations for Safety and Efficacy
Introduction: After the recent ban on 14 fixed dose combination (FDC) drugs out of a list of 19 due to their lack of therapeutic value, the Indian government has turned its attention to three additional combinations. Sources familiar with the matter have revealed that further data on the safety and efficacy of these drugs will be required before a decision is made regarding their continuation. The government’s scrutiny is part of its ongoing crackdown on the proliferation of FDC drugs in the market.
The Combinations under Review: The three FDC combinations currently under the government’s scanner are paracetamol + phenylephrine + caffeine; caffeine + paracetamol, phenylephrine + chlorpheniramine; and paracetamol + propyphenazone + caffeine. These combinations have come under scrutiny due to concerns about their safety and effectiveness.
Understanding Fixed Dose Combinations (FDCs): Fixed dose combinations involve the formulation of two or more drugs in specific fixed doses. When a combination is formulated for the first time, it falls under the category of a new drug. The manufacturing of new drugs requires prior clearance or permission from the central licensing authority before a manufacturing license can be issued by the state licensing authority.
Issues and Government Intervention: The parliamentary standing committee of the Ministry of Health and Family Welfare, in its 59th report in 2012, highlighted the problem of state licensing authorities granting manufacturing licenses for numerous FDCs without obtaining prior clearance from the Central Drugs Standard Control Organisation (CDSCO). This led to the availability of many FDCs that had not undergone efficacy and safety testing, posing risks to patients. To address this issue, the CDSCO warned state drugs controllers to require manufacturers to prove the safety and efficacy of such drugs within 18 months. Failure to comply would result in the prohibition of the manufacture, sale, and marketing of these drugs in the country.
Expert Committees and Deliberations: To address the influx of FDC applications, an expert committee chaired by C. K. Kokate was established in 2014. The committee categorized the FDCs into four groups based on their rationality and the need for further data generation and expert deliberation. Subsequently, in 2021, another expert committee led by M. S. Bhatia was constituted to examine the 19 pre-1988 FDCs. Out of these, 14 were deemed irrational and banned by the government, two were considered rational formulations, and three require additional safety and efficacy data. Manufacturers of the three FDCs have been instructed to generate market surveillance data, which will be reviewed by experts before a final decision is made.
Conclusion: The Indian government’s continued evaluation of fixed dose combinations aims to ensure the safety and efficacy of drugs available in the market. By scrutinizing the three additional FDCs and requesting further data, the government is taking proactive measures to protect the well-being of consumers. Through the efforts of expert committees and regulatory bodies, the government seeks to strike a balance between rational and irrational FDCs, ultimately prioritizing patient safety and therapeutic effectiveness.
