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Post by : Shakul
India’s drug regulator has inspected nearly 90% of the country’s cough syrup manufacturers and found compliance lapses in some of them, officials said on Monday, amid increased scrutiny after India‑made syrups were linked to child deaths.
The inspections follow the discovery of a cough syrup brand called Coldrif, made by Sresan Pharmaceutical in Tamil Nadu, which was found to be contaminated with diethylene glycol and linked to the deaths of 24 children in October 2025.
Drugs Controller General of India Rajeev Raghuvanshi said the audits found issues such as poor manufacturing practices, failure to test incoming raw materials, and the use of improper processes at some facilities. He did not name specific companies that were non‑compliant.
India’s pharmaceutical industry, worth about $42 billion, is dominated by many small manufacturers, which has put pressure on regulators to improve oversight and quality standards.
To strengthen regulation, authorities plan to boost staffing, speed up approvals, and bring their operations closer to US Food and Drug Administration (FDA)‑level standards. The regulator also intends to use artificial intelligence to review applications and may bring in global industry experts for guidance.
Officials have also streamlined export clearances for drugs sent to major markets such as the United States, Europe, Australia, Japan, the UK, and Canada by removing the requirement for extra no‑objection certificates.
The inspections and enforcement actions come as part of a broader effort to restore confidence in India’s drug safety systems after toxic cough syrups caused deaths in India and abroad in recent years.
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