Schedule M rollout may face delay as MSMEs seek more time for upgrade

Small drugmakers seek a three-month extension to submit GMP compliance plans under revised Schedule M, raising concerns about delays in national rollout

drugs, pharma — CIPI said that due to financial and other constraints, small manufacturers may not be able to upgrade their facilities or even submit the gap analysis report within the stipulated deadline

4 min read Last Updated : May 07 2025 | 12:13 AM IST

An industry body representing over 7,000 pharma companies has sought three more months for small drug makers to submit the “plan of upgradation”, a precursor to complying with the revised Schedule M standards which seek to set quality standards and good manufacturing practices.

Experts, however, have raised concern saying that subsequent extensions could delay the implementation of the revised guidelines.

The government introduced the revised Schedule M following reports from various parts of the globe where Indian cough syrups and eye drops were found to be spurious and contaminated. Big pharma units have already implemented revised Schedule M guidelines.

The upgradation plan includes a gap analysis by manufacturers for key areas in the plant such as lab equipment, heating, ventilation and air conditioning systems, and utilities.

In a letter addressed to the Drug Controller General of India (DCGI), RK Jain, chairman of the Confederation of Indian Pharmaceutical Industry (CIPI), has asked for the last date of acceptance of application to be extended by three months, that is, August 10, 2025.

The government had in February this year granted a one-year extension to small drug manufacturers with annual turnover of less than ₹250 crore to comply with the revised Schedule M, which specifies good manufacturing practices (GMPs) to ensure the quality of drugs made in the country.

The stakeholders, however, were told to submit an upgradation plan within three months from the date of the notification or May 2025, to avail the extension.

CIPI said that due to financial and other constraints, small manufacturers may not be able to upgrade their facilities or even submit the gap analysis report within the stipulated deadline.

Nirali Shah, analyst with the Ashika group, said that MSMEs seeking a condition-free extension with financial and technical support reflects genuine compliance and infrastructure challenges.

Shah said that while a short-term cushion may prevent disruption at the base of the supply chain, it should not dilute accountability.

“A phased rollout is feasible, but only with firm timelines and consistent regulatory oversight,” Shah said.

The body, however, has clarified that it only seeks the extension in submitting the upgradation plan without any revision in the final deadline of extension for revised Schedule M, which stands at December 31, 2025.

“The proposed extension will enable many more manufacturers to be in-line with upgraded infrastructure as per revised Schedule M,” the letter accessed by Business Standard read.

In March, the Central Drug Standards Control Organisation (CDSCO), had announced the launch of an online application process for seeking extensions under the revised Schedule M, with manufacturers required to register on the ONDLS portal and submit applications online.

The CDSCO, which is the apex drug regulatory body and oversees Schedule M implementation, did not respond to queries till the press time.

Meanwhile, other prominent pharma bodies, such as the Indian Drug Manufacturers Association (IDMA), Laghu Udyog Bharati (LUB) and Federation of Pharmaceutical Entrepreneurs (FOPE) have not held any such discussions.

According to data shared by the Union Health Ministry, India currently has around 10,500 pharma manufacturing units. Of these, around 8,500 fall in the MSME category and only 2,000 units have a World Health Organisation-GMP certification.

However, experts have indicated that if not implemented properly, the regulation could force around 5,000 MSME units to shut operations.