The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, aiming to enhance regulatory intervention against substandard medicines. The changes seek to provide for immediate suspension of manufacturing licenses when drugs are found Not of Standard Quality (NSQ) on specified critical quality parameters.
In a significant move towards strengthening the regulatory framework for ensuring the quality and safety of medicines in India, the Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945. These amendments aim to address concerns regarding the time gap between the declaration of a drug as NSQ and initiation of regulatory action under the existing provisions. This delay might allow substandard medicines to remain in circulation, posing potential risks to public health and making effective recall more challenging. To address this issue, the Ministry has proposed a provision for immediate suspension of the manufacturing license of the concerned drug by the Central Licensing Approving Authority or the State Licensing Authority upon receipt of a Government Analyst's report declaring the drug as NSQ with respect to Assay, Dissolution, Related Substances, Impurities, or Sterility. These parameters are critical in determining the quality of medicines. The proposed provision aims to ensure that instances of non-compliance involving these specified parameters are met with prompt regulatory action, thereby minimizing potential risks to patients.
The amendments also provide for mandatory corrective measures before revocation of the suspension. The suspension shall continue until the manufacturer undertakes an effective Root Cause Analysis to identify the reasons for the quality failure and implements appropriate Corrective and Preventive Action (CAPA) to the satisfaction of the concerned Licensing Authority. Revocation of the suspension shall be permitted only after implementation of the requisite corrective and preventive measures and their due verification by the Licensing Authority. This mechanism is intended to ensure that identified quality deficiencies are adequately addressed, and necessary safeguards are put in place to prevent their recurrence.
To further strengthen regulatory coordination and facilitate timely action, consequential amendments have also been proposed to Form 13, relating to the test report of the Government Analyst. Under the proposed mechanism, the Government Analyst's report would be endorsed to the Drugs Controller General of India (DCGI), the concerned State/UT Licensing Authority under whose jurisdiction the manufacturing site is located, as well as the manufacturer and marketer of the concerned drug. The proposed arrangement is aimed at ensuring timely communication of NSQ findings to the relevant authorities and stakeholders, thereby facilitating coordinated regulatory action and strengthening accountability across the drug manufacturing and marketing chain.
Source:
Press Information Bureau
