Centre proposes immediate cancellation of licenses for manufacturers producing poor quality medicines

The Central Government will now take strict action against pharmaceutical manufacturers whose products fail quality tests. The Union Ministry of Health and Family Welfare has proposed that the manufacturing licenses of producers whose medicines fail to meet prescribed standards and are classified as 'Not of Standard Quality' (NSQ) be suspended with immediate effect. According to a report by the Hindustan Times, the primary objective of this proposal is to ensure patient safety and public health.

The Ministry has proposed the addition of a new clause for 'suspension of manufacturing license' in the Drugs Rules, 1945. Under this new rule, if a government analyst's report declares a medicine as NSQ in terms of assay, dissolution, related substances, impurities, or sterility, the manufacturing license will be suspended immediately. According to the Ministry's statement, all these parameters are critical for determining the quality of medicines.

Under current existing rules, a specific regulatory process must be followed to suspend or cancel a manufacturing license, which includes issuing a show-cause notice. Due to this process, there can be a time gap between declaring a medicine as NSQ and initiating regulatory action. During this period, poor quality medicines may remain in the market, which could pose a risk to public health and make it difficult to recall the medicines from the market. The new amendment will make immediate intervention possible by reducing this time gap.

Once a license is suspended, the manufacturer must take mandatory corrective measures to make it operational again. The suspension of the license will be revoked only when the manufacturer conducts an effective 'Root Cause Analysis' to find the reasons for the quality failure and implements appropriate measures to the satisfaction of the licensing authority. The license will be restored only after this entire process is completed and a full verification is conducted to ensure compliance with all parameters.

Important amendments have also been suggested in Form 13, which pertains to the testing report of the government analyst. Under the new plan, the analyst's report will be sent to the Drugs Controller General of India, the licensing authority of the concerned State or Union Territory (under whose jurisdiction the manufacturing site is located), as well as the company manufacturing and marketing the concerned medicine. According to the Ministry, the aim of this arrangement is to timely inform the relevant authorities and stakeholders of NSQ findings, so that integrated regulatory action can be taken and accountability in the medicine manufacturing and marketing chain can be strengthened.

These proposed amendments are based on discussions held in the 65th meeting of the Drugs Consultative Committee (DCC) on December 20, 2024, and recommendations from the 92nd meeting of the Drugs Technical Advisory Board (DTAB) on April 24, 2025.

The Drugs Rules, 1945 are the primary rules governing the manufacture, sale, and distribution of medicines in India. These rules prescribe various parameters and processes to maintain the quality, safety, and efficacy of medicines.