Deadline for implementation of revised Schedule ‘M’ in respect of small and medium manufacturers extended
New Delhi: According to a press release, the Ministry of Health & Family Welfare has conditionally extended the deadline for small and medium-sized manufacturers with annual sales of Rs. 250 crores or less to implement the updated Schedule M (Good Manufacturing Practices provision) until December 31.
The news release states that on December 28, 2023, the Indian government announced updated Schedule M regulations, changing “good manufacturing practices” to “good manufacturing practices and requirements of plan and equipment for pharmaceutical products.”
The manufacturers were separated into two groups. The first group consisted of big firms with annual sales exceeding 250 crores. These manufacturers were given a six-month timeframe to comply. A 12-month period was provided for compliance for small and medium-sized enterprises with an annual revenue of less than or equal to 250 crores.
Large manufacturers are now subject to the updated Schedule M regulations as of June 28, 2024.
In order to construct infrastructure, educate employees, and get financing, small and medium-sized firms have argued for an extended timeline. The Central License Approving Authority has been given three months, beginning on February 11, to receive Form A upgrade plans from small and medium-sized businesses. If producers provide these facts, the implementation date will be extended until December 31.
The updated Schedule M specifications are a step in the right direction for guaranteeing the safety and quality of pharmaceuticals produced in India. The pharmaceutical firms would be able to improve their competitiveness internationally as well as their home standing thanks to the new rules.
