India's Health Ministry modifies GMP Rules - and replaces the 'GMP' Term.

The Indian pharmaceutical industry, a major exporter of generic drugs, faces scrutiny for occasional lapses in quality. In response, the Ministry of Health has issued revised regulations aligning with Annex M of the Drugs and Cosmetics Rules.

Published on January 6, 2024, these updates aim to harmonize India's Good Manufacturing Practices (GMP) with global standards, particularly those of the World Health Organization (WHO), ensuring the production of high-quality drugs meeting international criteria.

Prompted by evolving technology and quality demands, the changes include introducing a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), equipment qualification, and a computerized storage system for all drug products. Additionally, five new drug categories, including hazardous substances and biological products, have been introduced.

Manufacturers are now required to verify the quality of pharmaceuticals, ensuring compliance with licensing requirements and absence of risks to patients. This revision follows incidents of contamination and substandard drugs exported from India, including a case involving cough syrups contaminated with toxic substances.