The Central Drugs Standard Control Organisation (CDSCO), in association with the Indian Drug Manufacturers’ Association (IDMA), organised a workshop on “Revision of Schedule-M” on September 30, 2023 in Mumbai. Dr S Eswara Reddy, Joint Drugs Controller of India, was the Chief Guest and keynote speaker. The event witnessed in-person attendance of more than 300 participants and 6,000+ 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.
To create awareness amongst drug manufacturers about good manufacturing practices (GMP) requirements to ensure quality of medicines, workshops on Revision of Schedule-M were organised across India in September 2023 by CDSCO in partnership with IDMA. Schedule-M prescribes requirements to the manufacturing plants of pharma 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 pharma manufacturing hub.
Dr Reddy elucidated the fine print of Revised Schedule-M with relevant examples and anecdotes. He also spoke on industry’s challenges and offered guidance on how to navigate successfully in an evolving regulatory environment. He explained the need for revision of Schedule-M, GMP requirements keeping in mind current changes in the concept of quality of drugs, convergence of Indian standards with global standards, and technological advancements in manufacturing and testing of drugs.
The Government of India (GoI) has notified draft Schedule-M in October 2018 and had serious of meeting with all drug manufacturers associations and other stakeholders. It is now under active consideration of the Ministry of Health and Family Welfare, Government of India. Larger companies with a turnover of over Rs 250 crores have been asked to implement the changes within six-months, while medium and small-scale enterprises with turnover of less than Rs 250 crores 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 quality of drugs manufactured and sold.
Dr Viranchi Shah, IDMA’s National President, extended his gratitude to CDSCO and Dr Reddy. He added, “The Indian pharma industry welcomes Revised Schedule-M. IDMA member companies are committed for ensuring adoption and ongoing compliance with determination and discipline. Today’s event was in continuation of momentum by IDMA in seeking greater collaboration and alignment between government, companies, regulators, and other stakeholders.”
Mehul Shah, General Secretary of IDMA, had the honour of delivering the opening remarks and vote of thanks. He reiterated the industry’s positive response to Revised Schedule-M by stating that Indian pharma industry is committed in its endeavour to ensure manufacturing and supply of high-quality, safe, efficacious, innovative, and affordable medicines to patients and consumers in India and worldwide.
Daara Patel, Secretary General of IDMA, said, “Under Dr Viranchi Shah’s visionary leadership, IDMA has organised a series of events in the last two years to advance cause of the nation and the Indian pharma industry especially MSME sector. We will continue to organise more such value-additive events in future.”