India Inspects 90% of Cough Syrup Units, Finds Compliance Gaps
India’s drug regulator has inspected nearly 90% of the country’s cough syrup manufacturers and uncovered multiple compliance lapses, according to Drugs Controller General of India Rajeev Raghuvanshi. Speaking at the 11th Global Pharmaceutical Quality Summit in Mumbai, he said strict action had been taken against serious violations. The inspections follow heightened scrutiny after India-made syrups were linked to child deaths in India and overseas, including a contaminated product called Coldrif manufactured by Sresan Pharmaceutical.
Around 1,100 cough syrup manufacturers were reviewed, with authorities flagging breaches of good manufacturing practices, failure to test incoming raw materials, and the use of invalid processes. The regulator has also carried out risk-based inspections at an additional 1,250 drug manufacturing units since 2022. While officials did not disclose how many firms faced penalties or temporary shutdowns, the move signals tighter oversight of India’s $42 billion pharmaceutical sector, which has faced reputational damage after over 140 child deaths abroad were linked to tainted syrups.
The regulator now aims to align its standards with those of the U.S. Food and Drug Administration by addressing staffing gaps, accelerating approvals, and enhancing technical capabilities. Plans include creating 1,500 new roles—many on flexible contracts—and onboarding global experts as advisers. Authorities are also piloting artificial intelligence to review applications and have streamlined export clearances by removing no-objection certificate requirements for shipments to key markets such as the U.S., Europe, Japan, Australia, the UK, and Canada.
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