Makers of NSQ drugs may immediately lose their licences: Centre

Hindustan TimesIndependentCenterNov 5

The Indian Ministry of Health and Family Welfare has proposed amending the Drugs Rules, 1945, to allow for the immediate suspension of manufacturing licenses for companies producing drugs classified as 'not of standard quality' (NSQ). Currently, regulatory actions such as license suspension require a lengthy process involving show-cause notices, which creates a delay where substandard medicines may remain in circulation. The new proposal aims to close this gap by triggering automatic suspension upon receiving a government analyst's report indicating failures in critical parameters like assay, dissolution, or sterility. Licenses would only be reinstated after the manufacturer completes a root cause analysis and implements corrective measures approved by the licensing authority. These changes were recommended by the Drugs Technical Advisory Board and discussed by the Drugs Consultative Committee to enhance patient safety and streamline regulatory oversight.

Bias read (Center): The article relies exclusively on official government statements and technical descriptions of regulatory procedures without incorporating external criticism, opposition views, or industry pushback, resulting in a neutral, informational tone.

The HinduIndependentCenterNov 4

The Indian Union Health Ministry has proposed amendments to the Drugs Rules, 1945, to allow for the immediate suspension of manufacturing licenses for drugs classified as Not of Standard Quality based on critical parameters such as assay, dissolution, and sterility. Currently, regulatory actions like license suspension require a show-cause notice process, which creates a delay during which substandard medicines may remain in circulation. The new proposal enables licensing authorities to act promptly upon receiving a government analyst’s report, aiming to protect public health by preventing the distribution of unsafe products. Manufacturers would be required to conduct root cause analyses and implement corrective and preventive actions before any suspension could be lifted. Additionally, the ministry plans to amend Form 13 to streamline the sharing of test reports among the Drugs Controller General of India, state licensing authorities, and manufacturers.

Bias read (Center): The article relies exclusively on official government statements and neutral descriptions of procedural changes without incorporating independent expert criticism or alternative perspectives.