Pharmaceutical firms get year’s extension for upgrade

In a major relief to micro, small and medium pharmaceutical firms, the Ministry of Health and Family Welfare today extended the deadline for complying with the revised Schedule-M provisions of the Drugs and Cosmetics Act ,1940, till December 31.

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As the deadline to do so had expired on December 18, 2024, the non-compliant firms could have faced closure.

According to the notification issued today, the small and medium sector manufacturers with turnover of Rs 250 crore or less can seek a year’s extension for the implementation of the provisions. They will be required to apply before the Central Licence Approving Authority within a period of three months along with their plan of upgrade for seeking this extension.

The firms will have to furnish key details like strategy for compliance with the revised Good Manufacturing Practices norms before the three-month period while also giving a justification of the time required for compliance.

Key issues like section-wise gap analysis of the plant, equipment, lab equipment, technical staff, documentation, etc., would have to be provided to ensure that they were seriously pursuing the upgrade and not merely seeking time, stated the notification.

As per a notification issued in December 2023 by the Union Ministry, those failing to comply with the stipulations by December 28, 2024 could have faced suspension of their licence or a penalty. The revised norms will bring them on a par with the World Health Organisation’s norms.

Citing fund constraint as the upgrade requires a minimum investment of Rs 5 to Rs 6 crore, the Himachal Drug Manufacturers Association (HDMA) had been demanding three years for implementation.

Dr Rajesh Gupta, president, HDMA, and also all-India head of Laghu Udyog Bharti, who had been pursuing the issue with the Union Health and Family Welfare Minister JP Nadda, termed it as a major relief. He said the pharmaceutical firms would have to work really hard to achieve the target within a year.

The majority of the MSMEs, which comprise a major chunk of the pharma firms in Himachal, had failed to comply with the revised norms in the past year and were looking for an extension. Out of the 650-odd firms in the state, more than 90 per cent comprise MSME firms.