The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to provide for the immediate suspension of manufacturing licences for drugs declared Not of Standard Quality (NSQ) on specified critical quality parameters.

 

The proposed amendments seek to enable prompt regulatory intervention upon the detection of substandard medicines, prevent their continued manufacture and distribution, and strengthen compliance mechanisms in the interest of patient safety and public health.

 

The Ministry said that under the existing provisions, suspension or cancellation of a manufacturing licence is preceded by the prescribed regulatory procedure, including the issuance of a show-cause notice. The proposed amendment also provides for mandatory corrective measures before the suspension is revoked. The suspension will continue until the manufacturer undertakes an effective Root Cause Analysis and implements appropriate Corrective and Preventive Action (CAPA) to the satisfaction of the concerned Licensing Authority.

 

The Ministry said that revocation of the suspension will be permitted only after the requisite corrective and preventive measures have been implemented and duly verified by the Licensing Authority. It added that the amendments are expected to strengthen post-marketing regulatory surveillance, facilitate timely action against substandard medicines, and promote greater accountability among manufacturers and marketers.

 

The draft amendments have been notified for public consultation, and objections and suggestions have been invited from stakeholders and members of the public within 30 days. Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, or sent by email to drugsdiv-mohfw@gov.in.