Pharma units get 12-month extension to implement revised Schedule M of Drugs and Cosmetics Act
Pharma units get 12-month extension to implement revised Schedule M of Drugs and Cosmetics Act
The Union Health Ministry on Saturday (January 4, 2025) revised the date of implementation of the revised standards of Schedule M of the Drugs and Cosmetics Act to give pharmaceutical manufacturing industry 12 more months to comply.
Pharmaceutical firms must now comply with the improved manufacturing practices by December 31, 2025. The extension follows a request from the manufacturing units for time to upgrade their facilities.
Schedule M is a part of the Drugs and Cosmetics Act of 1945 that outlines Good Manufacturing Practices (GMP) for pharmaceutical products in India. It covers the requirements for premises, plants, and equipment used in the manufacturing process.
To keep pace with the fast changing pharmaceutical manufacturing and quality, the government revised the GMP mentioned in current Schedule ‘M’ of the Act.
The new Schedule M was notified in December 2023. In order to have a smooth transition from the present Schedule M to the revised one, it was decided to provide a transition period of six months for large manufacturers (>₹250 crore turnover) and 12 months for Micro Small and Medium Enterprises (MSMEs) (<₹250 crore turnover) respectively. The notification was published on January 5, 2024.
As per the notification, units with annual turnover of more than ₹250 crore were to comply with the revised Scheduled M standards from July 1, 2023. For units with annual turnover of less than ₹250 crore (MSMEs), the date of implementation was January 1, 2025.
However, following representations from various industry associations representing pharma MSMEs seeking extension of this deadline, a draft notification has been issued by the Department of Health and Family Welfare giving them three months’ time to register with Central Drugs Standard Control Organisation (CDSCO) as well as share their plans of upgradation with it.
“Total twelve months’ extension will be provided for such units i.e. until end of the year. After 3 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,’’ said a release issued by the Health Ministry.
“The main reasons for seeking extension are arranging finances for upgradation and time for implementation of the required changes. The issue of providing extension in the implementation date has been discussed in detail,’’ the Ministry added.
The revision of Schedule M was done to bring India’s manufacturing standards on a par with global standards, especially to those of World Health Organisation (WHO), and ensure production of globally acceptable quality of drugs.
Good Manufacturing Practices 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.
There are around 10,500 manufacturing units in the country, of which around 8,500 fall under the MSME category. India is a major exporter of medicines to Low and Middle-Income Countries (LMIC) which require WHO GMP certification. Currently, there are around 2,000 units in the MSME category in the country having WHO GMP certification.
The Department of Pharmaceuticals (DoP) launched a scheme, Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS), to provide financial support for upgradation of MSME units.
Till date, CDSCO has inspected more than 800 manufacturing units and 252 public testing labs.
“The observations from the units being audited and the feedback coming from stakeholders clearly show the improvement on ground towards implementation of GMP standards by MSMEs. There is awareness and sensitization all around and there are a good number of units which have initiated the upgradation process,’’ noted the release.
