Health Ministry tightens rules to ensure pharma firms meet quality norms
New Delhi, Jan 6 (IANS) Health Ministry on Saturday issued a new set of stringent guidelines to ensure that pharmaceutical companies follow good manufacturing practices and comply with quality standards for their products.
The Central government, after consultation with the Drugs Technical Advisory Board, notified the revised rules under the Drugs (Amendment) Rules, 2023. The revised Schedule M has been notified as rules to ensure good manufacturing practices and requirements of premises, plant, and equipment for pharmaceutical products.
“The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the licence and do not place patients at risk due to inadequate safety, quality or efficacy,” said the notification which is dated December 28.
It said that the companies must market a finished product only after getting “satisfactory results” on tests of the ingredients and retain a sufficient quantity of the samples of intermediate and final products to allow repeated testing or verification of a batch.
Earlier in August, the Ministry had set a six-month deadline for small manufacturers and 12 months for large units to get their World Health Organization-Good Manufacturing Practices (WHO-GMP) certification.
Schedule M of the Drugs and Cosmetics Act, 1940, includes requirements of facilities and their maintenance, personnel, manufacture, control, safety testing, storage and transport of material, written procedures and records, and traceability for pharmaceutical products.
The revised rules include five new categories of drugs that were not previously covered under the erstwhile rules.