Over 8.5K MSME pharma units get 1-yr breather to adopt Schedule M standards

Mohfw notifies extension till December 31 for companies under Rs 250 cr turnover

The government has given one-year breather to small-and-medium sized pharma units -- with annual turnover of less than Rs 250 crore -- to comply with the revised Schedule M standards which seek to set quality standards and good manufacturing practices.

 

The Union Health Ministry has now set December 31, 2025 as the deadline for around 8,500 pharmaceutical units -- which fall under MSME category-- to adopt the new standards.

 

India is a major exporter of medicines to low and middle-income (LMIC) countries which require WHO GMP certification. Currently there are around 2,000 units in the MSME category in the country having this certification. The rest need to ramp up their efforts.

 

 

The government, in December 2023, had revised the Good Manufacturing Practices (GMP) mentioned in the Schedule ‘M’ of Drugs and Cosmetics Act to ensure that compliance is at par with global standards, especially to those of WHO, and to ensure that drug production is of globally acceptable quality.

 

In it, big pharmaceutical companies with an annual turnover exceeding Rs 250 crore were given six months, whereas MSME units were given twelve months to comply with the revised standards. 

 

But firms falling under MSME categories sought a two-year extension back then citing challenges in financing machinery procurement and increasing and training of manpower. They have now one year to implement it.

 

The ministry on Wednesday released the final notification amending the Drugs Rules, 1945 for extending the deadline for small pharma companies till the end of this year.

 

Industry associations, including the Federation of Healthcare Professionals (FOPE), RSS-affiliated Laghu Udyog Bharati (LUB), and various state drug manufacturing associations representing the MSME pharma sector had requested for an extension until December 2026.

 

This was followed by the health ministry releasing a draft notification seeking stakeholder comments last month. With the formal notification of the extension, all pharmaceutical units in India are now expected to conform to the revised Schedule M from January 1, 2026.

 

The extension, however, would be subject to small pharma companies submitting an online application to the Central Licensing Approval Authority along with a plan of upgradation within three months from the date of the publication of notification.

 

“After three months, an audit of these facilities will be conducted, and action will be taken if the committed upgradation is not being implemented,” the health ministry had earlier stated.

 

Industry experts have indicated that around 8,500 out of 10,500 pharmaceutical units in India belong to the MSME sector.   

Dr Reddy’s faces Rs 1.8 crore penalty from GST authority

Hyderabad-based pharmaceutical company Dr Reddy’s Laboratories (DRL) on Wednesday announced that it has received an order seeking demand, including interest and levying a penalty, to the tune of over Rs 1.8 crore from the Joint Commissioner of Central Tax, Hyderabad Commissionerate.

 

The order was passed by the Goods and Services Tax (GST) Authority on the grounds that the company availed irregular Cenvat Credit of Service Tax.

 

“Based on our evaluation, there is no material impact on the financials, operations, or other activities of the company,” DRL said in a regulatory filing on the Bombay Stock Exchange (BSE).

 

The company stated that it will evaluate filing necessary appeals with the appellate authority in this regard.