The proposed amendments to the Drugs Rules, 1945 aim to facilitate prompt regulatory intervention upon detection of substandard medicines and prevent their continued manufacture and distribution.
In a significant step 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 changes aim to enable prompt regulatory intervention upon detection of substandard medicines, prevent their continued manufacture and distribution, and strengthen the mechanism for ensuring compliance with prescribed quality standards, in the interest of patient safety and public health.
Under the existing provisions of the Drugs Rules, 1945,
suspension or cancellation of a manufacturing license is preceded by the prescribed regulatory procedure, including issuance of a show-cause notice. This may result in a time gap between the declaration of a drug as Not of Standard Quality (NSQ) and initiation of regulatory action. During this period, the concerned drug may continue to remain in circulation, posing potential risks to public health and making effective recall more challenging.
To address this regulatory concern, 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, as the case may be, 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 to 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 minimising potential risks to patients.
The proposed amendment also provides 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.
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
