India’s top drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has banned the manufacture, sale, and distribution of 35 fixed-dose combination (FDC) drugs. These include commonly used painkillers, nutritional supplements, and anti-diabetic medicines.
The action comes after it was found that these FDCs were approved and marketed by state and union territory licensing bodies without prior evaluation of their safety and efficacy by the central authority.
What Are Fixed-Dose Combination (FDC) Drugs?
FDC drugs contain two or more active pharmaceutical ingredients (APIs) combined in a fixed ratio. These drugs are often prescribed for convenience or to enhance therapeutic effects. However, without proper scientific evaluation, their use can lead to:
- Adverse drug reactions
- Unintended drug interactions
- Long-term health complications
Key Concerns Raised by the Regulator
Dr Rajeev Raghuvanshi, the Drugs Controller General of India (DCGI), issued a directive on April 11 warning that the manufacture and sale of unapproved FDCs poses a serious risk to public safety.
Highlights of the regulator’s concerns:
- Some FDCs were cleared by state authorities despite falling under the category of “New Drugs,” which require central approval.
- Many were approved without scientific data on safety or efficacy.
- This violates the New Drugs and Clinical Trials (NDCT) Rules, 2019 under the Drugs and Cosmetics Act, 1940.
- Manufacturers claimed they had valid licenses from state authorities and did not break any rules.
Lack of Uniformity in Drug Approvals
The CDSCO noted inconsistencies in how the rules are enforced across India. Although some state licensing authorities issued the manufacturing licenses, others either canceled them or manufacturers voluntarily surrendered them after receiving show-cause notices.
This patchy enforcement led to confusion and highlighted the need for centralized oversight.
States and UTs Asked to Act
The DCGI has directed all state and UT drug controllers to:
- Stop manufacture, sale, and distribution of the 35 banned FDCs
- Review their approval processes for combination drugs
- Strictly comply with the NDCT Rules and Drugs and Cosmetics Act
The letter also reminded authorities of earlier warnings sent in 2013 and reiterated in multiple communications over the years, including as recently as February this year.