India’s Drug Regulator finds 90% of cough syrup units violating norms, major lapses
New Delhi: India’s drug regulator has found widespread compliance failures after inspecting nearly 90 percent of the country’s cough syrup manufacturers, exposing serious regulatory gaps in the pharmaceutical sector.
According to Kashmir Media Service, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi said around 1,100 cough syrup manufacturing units were inspected following the discovery of contaminated cough syrup “Coldrif,” produced by Sresan Pharmaceutical, which was linked to the deaths of 24 children in October last year.
The inspections revealed alarming violations, including breaches of Good Manufacturing Practices (GMP), failure to properly test raw materials, and the use of invalid or unapproved testing methods. The regulator admitted that corrective measures are being initiated but did not provide any clear timeline for compliance.
The latest findings add to growing concerns over the safety standards of India’s $42 billion pharmaceutical industry. Since 2022, India-manufactured cough syrups have been linked to more than 140 child deaths in several African and Central Asian countries, drawing global scrutiny and damaging the credibility of the country’s drug exports.
The large-scale lapses uncovered by the regulator raise serious questions about monitoring mechanisms and enforcement capacity, particularly when life-saving medicines are involved. Repeated incidents of contamination and regulatory failure point to systemic weaknesses rather than isolated mistakes.
