India vows “immediate” action against substandard medicines

AI Summary

India plans to let drug regulators immediately suspend manufacturing licences when medicines fail routine quality checks, replacing a slower show-cause process. The proposed measure responds to repeated concerns about substandard medicines and incidents linked to products made in India.

India’s drug regulators will be empowered to immediately suspend manufacturing licences for drugs that fail routine government quality checks, to tackle quality lapses in the country’s vast pharmaceutical industry.1The proposed rules come amid growing concerns over the quality of medicines manufactured in India. The country is a major producer of generic medicines, accounting for an estimated 20% of global generic medicine supplies in 2023.Health alerts have been issued over cough syrups made in India that have been linked to child deaths in the Gambia, Uzbekistan, and India2 in 2022; a 2023 alert in the US over eye drops manufactured in India linked to bacterial infections;3 and the deaths of four women in the southern state of Karnataka in 2024, amid concerns about the quality of the intravenous fluids that they had received.4Under existing rules, suspension or cancellation of a manufacturing licence occurs after the drug manufacturer is sent a “show-cause...