Small, medium-sized pharma firms gear up to comply with revised Schedule M

Pharma groups had wanted two year extension, will raise concerns with govt

Small and medium-sized pharmaceutical companies are preparing to comply with the provisions of the revised Schedule M, which is upgrading facilities and maintaining good manufacturing practices, within the extended deadline of December 31, even as pharma lobby groups have raised concern about completing the job within target.

 

On January 4, the Ministry of Health and Family Welfare issued a draft notification proposing a one-year extension for small and medium-sized companies (with an annual turnover of less than Rs 250 crore) to upgrade facilities in accordance with the revised Schedule M of the Drugs and Cosmetics Act.

 

While lobby groups had been seeking a two-year extension, many have decided to use this opportunity to complete implementation. 

 

A senior official of the Indian Drug Manufacturers Association (IDMA) told Business Standard that the body had done over 20 training programmes for various members with help from the Central Drugs Standard Control Organisation. 

 

Harish K Jain, national president, Federation of Pharma Entrepreneurs (FOPE), said the move acknowledged the challenges faced by micro, small, and medium enterprises (MSMEs), enabling them to organise resources.

 

“We have asked our members to complete the implementation on a war footing, taking advantage of the one-year extension proposed, without expecting another extension,” he added.

 

The draft notification is expected to be finalised this week after the seven-day period for submitting stakeholder comments ended on Saturday.  Pharma groups, however, will still ask the health ministry for a two-year extension. “We will again write to the government for a two-year extension, up to December 2026,” Jain said. 

 

An official from the Laghu Udyog Bharati, an MSME representative body affiliated to the Rashtriya Swayamsevak Sangh, also said that the industry chamber would do the “needful” if required.  Jain also said his organisation would engage with the authorities to address its concerns, including a provision to provide flexibility in line with global practices, adding that there should not be any compromise on quality. 

 

The revised Schedule M was notified by the ministry in January last year and came into effect on January 1, 2025. 

 

Many units upgrading, challenges remain

 

Jain said while most of the members of the association had started to upgrade, there were challenges in implementation. 

 

“Some of the biggest challenges are human resources because MSMEs need to skill and upgrade their manpower. Another area is financial viability for the upgrade and financial resources, for which we need to find additional collateral guarantee for loans,” he added.  

 

Nirali Shah, analyst at the Ashika group, added that MSMEs often grappled with constrained access to capital, legacy infrastructure, and a lack of specialised technical resources. 

 

India has around 10,500 pharmaceutical units, of which 8,500 are MSMEs. Of those, approximately 2,000 MSMEs hold good manufacturing certification. 

 

Initially, pharmaceutical companies with an annual turnover exceeding Rs 250 crore were given six months to comply with the revised Schedule M norms, while those with a turnover of Rs 250 crore or less had 12 months to do so.