In response to a series of international cough syrup-related fatalities, the Government of India has announced a major regulatory overhaul to ensure higher manufacturing standards across the pharmaceutical industry. The Health Ministry has directed all drug manufacturers to upgrade production facilities to comply with stricter Good Manufacturing Practices (GMP) under Schedule M of the Drugs and Cosmetics Rules.
Background of the Crackdown
The move follows global concern after Indian-made cough syrups were linked to child deaths in Gambia, Uzbekistan, and Cameroon. Investigations revealed contamination from toxic chemicals such as diethylene glycol (DEG) and ethylene glycol (EG) — substances prohibited in medicinal formulations. These incidents severely damaged the country’s image as the “pharmacy of the world.”
As a corrective measure, the government aims to restore global confidence by enforcing uniform quality control standards across all drug manufacturing units, especially smaller firms supplying to export markets.
Key Regulatory Measures
The Health Ministry’s directive mandates that all pharmaceutical manufacturers upgrade equipment, enhance testing protocols, and maintain digital batch records to trace production and quality control processes. Companies that fail to comply may face license suspension or export restrictions.
The Central Drugs Standard Control Organisation (CDSCO) will coordinate with state authorities to conduct nationwide inspections, ensuring that each facility adheres to the revised GMP norms.
To support smaller firms, the government is also planning a financial assistance and technical training program, helping them meet the required infrastructure and testing standards without disrupting production.
Industry Reaction
While major pharmaceutical companies have welcomed the move, smaller drugmakers have sought phased implementation timelines citing the high cost of upgrades. Industry experts believe that uniform enforcement will elevate India’s global standing in pharmaceutical exports and prevent future quality lapses.
India Advocacy Insight
This reform marks a turning point for India’s pharmaceutical sector, balancing export competitiveness with public safety. By modernizing drug manufacturing infrastructure and strengthening regulatory oversight, India aims to rebuild trust in its medicines worldwide. The initiative not only addresses the immediate crisis but also sets a long-term foundation for ethical, transparent, and globally compliant pharmaceutical production.
