India Tightens Grip on Cough Syrup Production After Fatal Contaminations

India's drug regulator has inspected most of the country's cough syrup makers due to compliance lapses following deadly contaminations. The initiative aims to improve standards and protect the industry's global reputation as a pharmaceutical leader while adopting FDA-level practices and leveraging AI for better oversight.

India's drug regulator has launched extensive inspections, covering nearly 90% of the nation's cough syrup manufacturers, amidst rising scrutiny following reports of contaminated syrups linked to child deaths both domestically and internationally.

The investigation was prompted by the discovery of Coldrif, a cough syrup tainted with diethylene glycol, which led to 24 fatalities last year. Authorities have pledged rigorous action against non-compliance to eradicate malpractice in the industry, emphasized Rajeev Raghuvanshi, the Drugs Controller General of India.

In a move to elevate standards to match the U.S. FDA, the agency is addressing staff shortages, hastening drug approvals, and enhancing resources. The introduction of flexible roles and AI applications are part of broader efforts to restore confidence in India's pharmaceutical credentials.