What do stricter GMP guidelines mean for Indian pharma companies?

Companies with a turnover exceeding Rs 250 crore will have a six-month transition period, while those below this range will be granted 12 months.

The government, on January 5, updated the Schedule M guidelines which prescribe requirements for pharma manufacturing units to ensure production quality that meet standards. The revised guidelines mention specific requirements for sterile products, sex-related products, radiopharmaceutical products, and biological products with respect to facility layout, air-handling systems, and equipment.

The new Good Manufacturing Processes (GMP) also focuses on quality control measures, and mechanisms for digitally maintaining records to prevent data tampering, and aims to put in place a system to recall drugs, if necessary.

According to the new notification, when adverse health information becomes available and this information relates to product quality, then appropriate measures shall be taken including product recall. These recall procedures must be written, reviewed, and updated regularly.

Additionally, it requires an authorised person for the “execution and coordination of recalls”. It also asks for the system to inform stockists, wholesalers, and suppliers, up to the retail level within the shortest period of the recall.

Companies with a turnover exceeding Rs 250 crore will have a six-month transition period, while those below this range will be granted 12 months.

GMPs are standards ensuring quality control over materials, methods, machines, processes, personnel, and facilities. Schedule M of the Drugs and Cosmetics Rules, 1945 first incorporated GMP in 1988, with the last amendment in June 2005.

According to analysts at BNP Paribas, domestic market-focused companies will get the greater benefit from the latest GMP revision. They add that implementation of the new norms would be challenging for smaller firms, which may require higher capex in the near term and a permanent increase in operating costs.

India has a fragmented drug regulatory system where each state has its drug regulator. Drugs manufactured in one state can seamlessly cross borders for sale throughout the country, but state drug regulators used to conduct an analysis of the products and release a list every month of the products found not matching standards. Ideally, failed drugs identified through random testing in government laboratories should be mandatorily recalled in a transparent manner, with the public informed of these failures. According to Central Drugs Standard Control Organisation(CDSCO) data from November 2023, out of 1,197 samples tested, 62 were found to be of substandard quality. There were no details of the recall of these products on the CDSCO website.

In the US, where Indian pharma companies supply almost 40 percent of the products, Indian companies regularly undertake voluntary recall of products for issues ranging from mislabeled packaging to contamination. Similarly, in Europe, the company can initiate a product recall and let authorities know of the reasons for the recall.