Mon Feb 23 12:56:29 UTC 2026: # India’s Drug Regulator Cracks Down on Cough Syrup Manufacturers After Deadly Contamination

The Story:
India’s drug regulator, the Drugs Controller General of India (DCGI), has inspected nearly 90% of the country’s cough syrup manufacturers and found significant compliance lapses. This action follows the discovery of cough syrup contaminated with diethylene glycol, linked to the deaths of 24 children in October 2025. The contaminated product, Coldrif, was produced by Sresan Pharmaceutical in Tamil Nadu. The regulator aims to address systemic issues within the industry and align its operations with global standards like the U.S. FDA.

Key Points:

  • Inspections covered approximately 1,100 cough syrup manufacturers.
  • Breaches included violations of good manufacturing practices, failure to test raw materials, and use of invalid processes.
  • India-made cough syrups have been linked to over 140 deaths in Africa and Central Asia since 2022.
  • The regulator plans to create 1,500 new positions, including contract roles, and utilize AI for application reviews.
  • Export clearances have been streamlined for shipments to the U.S., Europe, Australia, Japan, the UK, and Canada.
  • Additional 1,250 drug manufacturing units have also been inspected.

Key Takeaways:

  • India’s pharmaceutical industry faces serious quality control challenges.
  • The DCGI is under immense pressure to improve oversight and prevent future tragedies.
  • Efforts are underway to modernize the regulatory process and enhance its effectiveness.
  • The reputation of India as the “pharmacy of the world” is at stake.
  • Increased scrutiny and stricter regulations are expected for cough syrup manufacturers.

Impact Analysis:

  • Short-Term: Increased inspections and potential shutdowns of non-compliant manufacturers may lead to temporary supply chain disruptions and shortages of certain medications.
  • Medium-Term: The streamlining of export clearances could boost legitimate pharmaceutical exports to regulated markets, provided manufacturers meet quality standards.
  • Long-Term: Successful implementation of the DCGI’s modernization plans could restore confidence in India’s pharmaceutical industry and enhance its global competitiveness, but failure to adequately address the underlying issues could lead to further reputational damage and stricter import regulations from other countries.

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