India rejects drugmakers’ plea to delay plant upgrades after cough syrup deaths

India rejected drug companies’ requests to delay the year-end deadline for plant upgrades set after deaths from contaminated cough syrup, according to Reuters.
India’s $50 billion pharmaceutical industry comprises about 3,000 companies operating over 10,000 factories. Larger companies lead the market and have already upgraded their facilities, while smaller manufacturers worry that the new rules may force them out of business.
A government order issued in late 2023 requires all drugmakers to follow Good Manufacturing Practices (GMP) to prevent contamination and improve testing. Many small companies were supposed to meet new standards by December 2024. Then, the deadline was extended until Dec. 31, 2025.
Industry groups requested more time, saying high costs could force smaller companies to close. However, officials decided to move forward after discovering that Sresan Pharmaceutical, a drug manufacturer linked to recent deaths, did nothing to improve its production as was required.
Officials shared the decision this week. Once all firms comply, India will end the 2023 rule requiring extra government testing for cough syrup exports.