Pharma MSMEs seek 2-yr extension to meet revised Schedule M norms

Ever since the Union Ministry of Health and Family Welfare has directed all pharmaceutical units to upgrade their manufacturing levels to revised Schedule M standards, the micro small and medium enterprises (MSMEs) having investment less than Rs 50 crore have been seeking the extension of the deadlines.

Applicable to the MSME from January 1, 2026, various pharmaceutical manufacturers say that they were notified without considering their objections and suggestions. Its scope was subsequently widened. “The requirements are very stringent. Although MSMEs are trying their best to comply with huge investment involved in achieving the desired objective, they fear that nearly 4,000 to 5,000 manufacturing units will be forced to shut their premises owing to huge financial implications nationally. This could trigger shortage of critical drugs in the domestic markets,” observed Dr Rajesh Gupta, president, Himachal Drug Manufacturers Association.

Elaborating further on the difficulties, he added, “The debt-ridden MSMEs are finding it difficult to make collateral arrangements in the stipulated timeframe. Therefore, an extension of two years up to April 4, 2027, is urgently required,” said Gupta who added that 21 pharma MSME associations have appealed to the union health minister to save the pharma units from closure.

“Despite our best efforts, adopting the revised standards till December 31 has become an arduous task. Since non-compliance will lead to licence suspension and cancellation, an extension of timeline is the need of the hour,” quipped Sanjay Sharma, association’s spokesperson.

They also pointed out that, “MSMEs functioning for the past three decades should be given a fair chance to comply by extending the deadline of December 2025 as they are not violating the law but are endeavouring to provide quality medicines.”

Even as the exercise is aimed at ensuring upgrade of quality standards at par with World Health Organisation norms to ensure quality in drugs manufacturing, the MSME investors pointed out: “A myth is being created by Central Drugs Standard Control authorities that once Revised Schedule-M is implemented, the ‘not of standard quality’ (NSQ) drugs estimated to be 2.64 per cent will be ruled out,” said Gupta.

He illustrated this point saying that manufacturing facilities having US-Food and Drugs Administration (FDA) approved levels also face drug recalls every month due to critical observations. Therefore, upgrade to schedule M is not a guarantee to reduce NSQ drugs.

Only 122 of the 655 firms have complied with this stipulation while at least 400 small firms having investment less than Rs 50 crore in Himachal now face an uncertain future if the Centre does not grant any extension, fear industry sources.