Following a series of overseas fatalities reportedly linked to pharmaceuticals manufactured in India, the union health ministry has notified its Good Manufacturing Practices (GMP). The guidelines, aligned with standards set by the World Health Organisation (WHO), aim to guarantee the quality of drugs produced in India. The emphasis is on stringent quality control measures, the implementation of digital record-keeping systems resistant to tampering, and the establishment of a robust drug recall mechanism when deemed necessary.
Large companies, with a turnover exceeding ₹250 crore, must comply within six months, while smaller manufacturers, with turnovers below ₹250 crore, have a one-year timeframe. Out of the approximately 10,500 drug manufacturing units in the country, the 2,000 major companies exporting medicines already adhere to WHO-GMP standards.
The draft guidelines, introduced in 2018, were a response to international incidents involving contaminated Indian syrups and eye drops linked to deaths in the Gambia, Uzbekistan, the United States, and Cameroon. A risk-based assessment of 254 manufacturing units and 112 public testing labs by the apex drug regulator revealed deficiencies in documentation, process validation, analytical validation, self-assessment, failure investigation, internal quality review, testing of incoming raw materials, infrastructure to prevent cross-contamination, professionally qualified employees, and the design of manufacturing and testing areas.
The updated GMP guidelines concentrate on quality control, proper documentation, and IT-supported processes to uphold the quality of pharmaceuticals. They also institute a recall mechanism for drug manufacturers, ensuring that recall operations can efficiently reach every distribution channel. The licensing authority must be informed of any intention to recall a product suspected of being defective.
The guidelines mandate regular quality reviews of all products, verification of quality and processes consistency, comprehensive investigation of deviations or suspected defects, and the implementation of preventive actions.
As reported by Indian Express, any changes affecting production or product quality must undergo validation. Furthermore, companies are required to have GMP-related computerised systems to prevent data tampering related to processes. The revised schedule M outlines requirements for various products, including biological products, agents with radioactive ingredients, or plant-derived products.
