The India cough syrup inspection drive has covered nearly 90% of the country’s manufacturers, with authorities uncovering multiple quality and compliance issues, according to the head of the national drug regulator. The move comes amid strict monitoring following incidents where contaminated cough syrups were linked to the deaths of children in India and other countries.
India’s pharmaceutical watchdog launched the inspections after a cough syrup brand was found to contain diethylene glycol, a toxic industrial chemical. The affected product, Coldrif, was manufactured by Sresan Pharmaceutical, and was linked to the deaths of 24 children last year.
Cough Syrup Manufacturers Under Scanner
Speaking at the IPA 11th Global Pharmaceutical Quality Summit in Mumbai, Rajeev Raghuvanshi, Drugs Controller General of India (DCGI), said firm action has been taken against serious violations found during inspections.
According to him, regulators aim to clean up long-standing problems in cough syrup manufacturing by enforcing stricter standards. However, no fixed timeline has been announced for completing the corrective process.
Out of around 1,100 cough syrup manufacturers in India, nearly 90% have already been inspected. Authorities observed multiple lapses, including:
- Poor manufacturing practices
- Failure to test raw materials before use
- Use of outdated or invalid testing methods
The regulator did not disclose how many companies failed compliance checks or faced penalties.
Additional Drug Units Checked for Safety Risks
Apart from cough syrup manufacturers, the regulator has also carried out protective inspections of nearly 1,250 drug manufacturing units since 2022. These checks were conducted to identify potential safety risks before products reach the market.
While some units were reportedly asked to temporarily stop operations, officials did not share exact figures related to non-compliance.
India Pharma Industry Faces Global Pressure
India’s pharmaceutical sector, valued at over $42 billion, has come under global scrutiny after India-made cough syrups were linked to the deaths of more than 140 children across Africa and Central Asia since 2022. These incidents have impacted India’s long-standing reputation as the “pharmacy of the world.”
Regulator Targets US-Level Standards
To strengthen oversight, India’s drug regulator plans to align its systems with the U.S. Food and Drug Administration. Key steps include:
- Hiring around 1,500 new staff members
- Introducing flexible, contract-based roles
- Bringing in global experts as advisors
- Speeding up approvals using smart technology tools
The regulator has also simplified export procedures by removing the requirement for no-objection certificates for drugs exported to countries like the US, UK, Europe, Japan, Australia, and Canada. Officials say this will reduce delays and improve efficiency.
