India-based drugmakers urged to improve standards amidst quality scrutiny

This follows cases of drug toxicity, resulting in fatalities in Central Asia, North America, and Africa.

India’s pharmaceutical sector is grappling with quality control issues that may affect the approval rate of new drugs. Drugmakers are urged to improve manufacturing standards to maintain the country’s position in the market, said BMI.

On September 20, India’s Department of Pharmaceuticals (DoP) announced plans to double financial incentives for drug manufacturers upgrading their facilities to approximately $200,000 (₹20m).

The announcement follows cases of drug toxicity related to Indian-manufactured medicines, resulting in fatalities in Central Asia, North America, and Africa.

In 2023, the US Food and Drug Administration (FDA) conducted over 200 inspections of Indian drug manufacturing facilities and announced plans to increase inspections last February.

Despite these challenges, the country is expected to remain a key player in the generic drug market and the primary supplier of generics to the U.S.

Last August, the FDA approved a total of 66 abbreviated new drug applications, with India accounting for 45 of those approvals.

₹1 = $0.012