Pharma Cos Under Govt Lens For Quality Issues

Cough syrups made by a few Indian companies allegedly led to dozens of deaths in The Gambia and Uzbekistan

New Delhi: Spurred by the reports that cough syrups made by a few Indian companies allegedly led to dozens of deaths in The Gambia and Uzbekistan in 2022, the Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health & Family Welfare have taken several measures to ensure safety and efficacy of medicines.

To assess the regulatory compliance of drug manufacturing premises in the country, CDSCO, in collaboration with State regulators, started risk-based inspections of drug manufacturing and testing firms in December 2022. The regulators have inspected 905 units, resulting in 694 actions.

Depending on the severity of non-compliance, the actions taken include orders to stop production, orders to stop testing, suspension or cancellation of licence, and issuance of warning or notice to show cause. Risk-based inspections have provided valuable insights into manufacturing practices being followed, leading to corrective actions. This resulted in discernable improvements in the regulatory framework.

Minister of State (MoS) for Chemicals & Fertilizers Anupriya Patel provided this information in the Rajya Sabha last week in written reply to a question.

It may be recalled that India’s image as a global pharmaceutical hub suffered when the World Health Organization (WHO) accused the Indian company Maiden Pharmaceuticals of exporting a syrup to The Gambia containing contained lethal chemicals ethylene glycol (EG) and diethylene glycol (DEG) - the chemicals used as car brake fluid. Another Indian firm, Marion Biotech, had sent cough syrup to Uzbekistan; it also contained EG or DEG.

The central government is providing regular training to and organizing workshops for the officials of CDSCO and state drug regulatory authorities on good manufacturing practices, Patel said, adding that since April 2023, over 35,000 persons have been trained.

The Central government amended the Drugs Rules, 1945, in December 2023, to revise Schedule M to the said rules related to good manufacturing practices and requirements of premises, plant, and equipment for pharmaceutical products. From June last year, the revised schedule has become effective for drug manufacturers with a turnover of over Rs250 crore. For manufacturers with a turnover of up to Rs250 crore, time for implementation has been granted till December 31 this year.