MSME pharma companies get additional one year to upgrade facilities under Schedule M

New Delhi: The Health Ministry on Saturday gave small and medium pharma companies with a turnover of less than Rs 250 crore an additional 12 months to implement the revised good manufacturing practices under Schedule M of the Drugs and Cosmetics Act.

They should now comply with improved manufacturing practices by December 31, 2025. The extension comes following requests by manufacturing units to upgrade their facilities, the ministry said in a statement.

Good Manufacturing Practices (GMP) are being implemented in the country to build and bring quality into products by way of control on materials, methods, machines, processes, personnel and facility/environment etc, the ministry said.

There are around 10,500 manufacturing units in the country out of which around 8,500 fall under the MSME category.

India is a major exporter of medicines to low and middle-income countries (LMIC) that require WHO GMP certification. Currently, there are around 2000 units in the MSME category in the country having WHO GMP certification.

The pharmaceutical manufacturing and quality domain has developed and progressed significantly in the last 15-20 years, the statement said.

"Our understanding of the domain has increased because of development in pharmaceutical and manufacturing sciences. Linkage between manufacturing and product quality and interdependence between the two has been established," the statement said. To keep pace with the fast-changing pharmaceutical manufacturing and quality domain, the government revised the GMP mentioned in the current Schedule 'M' of Drugs and Cosmetics Act.

"This would bring our GMP recommendations and compliance expectation at par with global standards, specially to those of WHO, and ensure production of globally acceptable quality of drug," the statement said.

The new Schedule M was notified in December 2023.

In order to have a smooth transition from the present Schedule M to the revised Schedule M, it was decided to provide a transition period of 6 months and 12 months for large manufacturers (more than Rs 250 crore turnover) and MSMEs (less than Rs 250 crore turnover) respectively and the notification was published on 5th January 2024.

Accordingly, the Central Drugs Standard Control Organization (CDSCO), in collaboration with states and UTs, chalked out an aggressive nationwide plan for stakeholders to make them aware about the new Schedule M including its requirements, importance and technical justification, resource availability etc, the statement said.

Till date, CDSCO has completed 15 awareness sessions at different cities and manufacturing hubs. As many as 36,855 attendees have attended these session in hybrid mode and these have been received very well by the industry, especially MSMEs, it said.

As per the notification, units with annual turnover of more than Rs 250 crore were to comply with the revised Scheduled M standards from July 1, 2023.

For units with annual turnover of less than Rs 250 crore (MSMEs), the date of implementation of revised Schedule M was January 1, 2025, the statement said.

Representations have come from various industry associations representing the pharma MSME sector for the extension of this deadline. The main reasons for seeking the extension are arranging for finances for upgradation and time for implementation of the required changes, the statement stated.

The issue of providing the extension in the implementation date has been discussed in detail.

In order to facilitate the upgradation of facilities of the MSME units, a draft notification has been issued by the Department of Health and Family Welfare that they will be given three months' time to register with CDSCO and share the plan of upgradation with CDSCO.

A twelve months extension will be provided for such units i.e. until 31.12.2025. The statement said that after three months, an audit of these facilities will be conducted, and depending on the status of implementation of the plan, action will be taken if the upgradation which has been committed is not being executed.

Till date, CDSCO has inspected over 800 manufacturing units and 252 public testing labs till now. The observations from the units being audited and the feedback coming from stakeholders clearly show the improvement on the ground towards the implementation of GMP standards by MSMEs.

There is awareness and sensitisation all around and there are a good number of units that have initiated the upgradation process, the statement said This augurs well for the production of safe, efficacious and quality pharmaceuticals and drugs in the country.