Mumbai: In order to strengthen regulatory capabilities of regulators, the Central Drugs Standard Control Organisation (CDSCO) will roll out a series of 21 impactful training initiatives in the fiscal year 2024-25, according to a senior CDSCO official associated with the development.
The training initiatives will include 9 residential training programmes, 6 regional training programmes and 6 national workshops towards equipping regulators with advanced investigational skills including risk based inspections to usher Good Manufacturing Practices (GMPs).
With a focus on equipping regulators with advanced skills, the CDSCO conducted 23 residential training programmes tailored to address critical aspects such as risk-based inspections, prosecution launches, adoption of new therapies, and harnessing technology in Industry 4.0.
The CDSCO in collaboration with the Indian Drugs Manufacturers’ Association (IDMA) had conducted 11 such programmes for the capacity building of the regulators last year.
The workshops conducted last year were a spectacular success with in-person attendance of more than 3,200 participants and 20,000+ viewers online. The objective of the workshop was to make the participants aware of the proposed changes to the Schedule-M and prepare for implementation at the earliest.
During the workshops, it was deliberated and emphasized that there is a need to update GMP in order to retain the credibility of India as a Pharmacy to the World. In 2001, Second Amendment to the GMP was made based on 1992 WHO GMP guidelines. These guidelines were effective from December 11, 2001 for new units and January 1, 2004 for existing units which were further extended for one year. A draft notification was further issued on October 5, 2018 to upgrade and synchronize the Schedule M of the Drugs and Cosmetics (D&C) Rules, 1945 in compliance with WHO-GMP standards.
Schedule-M prescribes requirements to the manufacturing plants of pharmaceutical companies for maintenance, manufacturing, control and safety testing, storage and transport material, written procedures and records, and traceability etc. The revised GMP guidelines have come at a relevant time when India is reinforcing itself as the global pharmaceutical manufacturing hub.
The Government of India (GoI) had notified draft Schedule M on October 5, 2018 and had made a series of meetings with all drug manufacturers associations and other stakeholders.
Larger companies with a turnover of over Rs. 250 crore have been asked to implement the changes within 6-months, while medium and small-scale enterprises with turnover of less than Rs. 250 crore have been asked to do so within one year. The new version of Schedule-M is designed to ensure compliance to standards of drugs, promote exports, promote innovation and also to build trust and confidence on the quality of drugs manufactured and sold.
