DCGI to Manufacturers of 2 FDCs to Submit Applications Within 3 Months

The Drugs Controller General of India (DCGI) has instructed the makers of two fixed dose combinations (FDCs) approved before 1988, for which it requested post marketing surveillance data a year earlier, to file applications for phase IV clinical trials in the next three months.

The Central drug authority stated in a letter dated February 24 that if the manufacturers do not submit the application within three months from the letter's date, suitable regulatory measures will be suggested by the Central Drugs Standard Control Organisation (CDSCO).

On January 11, 2024, the CDSCO announced that an expert committee led by Dr. M S Bhatia has deemed two FDCs rational with specific conditions, along with the necessity of generating data on safety and efficacy for three additional FDCs.

Recognizing that the deadline has already lapsed and roughly 12 months have gone by since the notice released in January 2024, the central drug regulator stated that the majority of the companies have not presented their applications to the directorate.

In January 2024, while announcing intentions to classify these formulations as rational, the Committee suggested that the antidepressant combination should be indicated for co-occurring anxiety disorders, with a treatment duration not to surpass 6-8 weeks.

The Centre established the Committee in response to the 59th report from the Department-related Parliamentary Standing Committee on Health and Family Welfare, which noted that certain state licensing bodies had granted manufacturing licenses for various FDCs without the necessary approval from the Central Drugs Standard Control Organisation (CDSCO). This situation led to the presence of numerous FDCs in the market that have not undergone efficacy and safety testing, thereby jeopardizing patient safety.

As the issue of banning the FDCs is brought to the Supreme Court, the Apex Court suggested that the banning of 349 FDCs be referred to the Drugs Technical Advisory Board and annulled the bans on FDCs that were approved before 1988, as these cases were not intended for referral to the Kokate Committee.

Nevertheless, it will be available for the central government, should it decide, afresh, to conduct an investigation into whether those drugs ought to be included in a notification under Section 26A of the Drugs and Cosmetics Act, it stated. Following this guidance, the ministry of health and family welfare established the expert committee led by Dr M S Bhatia.