India Launches Crackdown on Unapproved Drugs

The Drug Controller General of India initiates a nationwide crackdown on unauthorized Fixed Dose Combinations (FDCs), urging strict regulatory actions and close monitoring to ensure compliance with drug safety norms and protect public health.

In a decisive move, India's Drug Controller General has initiated a comprehensive nationwide crackdown on unapproved Fixed Dose Combinations (FDCs). The regulatory body, according to a letter accessed by ANI, emphasizes the urgent need to inspect 90 such FDCs to ensure compliance with state or union territory drug approvals.

This sweeping action covers a range of drugs, including multivitamins, folic acid, and common pharmaceuticals like Paracetamol. The regulatory guidelines highlight that the presence of these unapproved medications, as detected by SUGAM lab tests projected for 2025, raises significant concerns over public health safety due to their classification as 'New Drugs'.

The letter underscores severe implications for public safety and legal compliance under the Drugs and Cosmetics Act, 1940. Concerned authorities are urged to investigate and enforce regulatory actions against manufacturers and distributors of these drugs, ensuring the submission of reports on measures undertaken in response to the crackdown.