Context

∙ The Ministry of Health and Family Welfare (MoHFW) has notified revised Pharma manufacturing rules under Schedule M of the Drugs and Cosmetics Rules, 1945.

About

Schedule M prescribes the Good Manufacturing Practices (GMP) for pharmaceutical products.

∙ GMP is mandatory standards which builds and brings quality into a product by way of control on materials, methods, machines, processes, personnel, and facility/environment, etc.

∙ GMP was first incorporated in Schedule M of the Drugs and Cosmetics Rules, 1945 in 1988 and the last amendment was made in 2005.

ο With the amendment, the words ‘Good Manufacturing Practices’ (GMP) has been replaced with ‘Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products’.

Need for Revising the Guidelines

∙ The move comes in the wake of overseas deaths linked to Indian-made drugs since 2022, prompting increased scrutiny of the pharmaceutical industry.

∙ To keep pace with fast-changing manufacturing and quality domain, there was a necessity to revise the principles of GMP mentioned in current Schedule M.

∙ It brings GMP recommendations at par with global standards, especially to those of World Health Organization (WHO), and ensures production of globally acceptable quality of drug.

∙ This will elevate the quality standards of medicines, reinforcing the reputation of industry and improving patient outcomes.

Guidelines

∙ Implementation: Large companies, which have a turnover of more than Rs 250 crore, will have to implement the guidelines within the next six months.

∙ Small and medium manufacturers, which have a turnover of less than Rs 250 crore, will get a year.

∙ Data Security: Companies should have GMP-related computerised systems, which ensure that there is no tampering of data related to the processes.

∙ Testing and Final Product: Companies must market a finished product only after getting “satisfactory results” on tests of the ingredients and retain a sufficient quantity of the samples to allow repeated testing or verification of a batch.

∙ Addition of Products: It has five new categories of drugs containing hazardous substances such as sex hormones, steroids (anabolic and androgenic), cytotoxic substances, biological products and radiopharmaceuticals.

∙ Quality Risk Management: There must be a comprehensively designed and correctly implemented pharmaceutical quality system incorporating GMP and Quality Risk Management (QRM).

∙ It introduced the product quality review (PQR) by the senior management of the companies annually.

∙ Evaluation: The manufacturer shall evaluate the results of the review and corrective and preventive actions or any revalidation shall be undertaken.