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 30 Sep 2023 in Mumbai. Dr. S Eswara Reddy, Joint Drugs Controller of India, was the Chief Guest and keynote speaker. The event was a spectacular success with 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 Sep 2023 by CDSCO in partnership with IDMA. 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.

Dr. Reddy was earnest and generous in elucidating the fine print of Revised Schedule-M. The audience was touched by his articulation – it had relevant examples and anecdotes. He also noted his cognizance and understanding of industry’s challenges and offered guidance on how to navigate successfully in an evolving regulatory environment. He further described 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 250 Crores INR have been asked to implement the changes within 6-months, while medium and small-scale enterprises with turnover of less than 250 Crores INR have been asked to do so within 1-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. Page 2 of 2 Dr. Viranchi Shah, IDMA’s National President, in his message extended gratitude to CDSCO and Dr. S Eswara Reddy. He added, “The Indian pharmaceutical 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.”

Shri Mehul Shah, Honourable 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 pharmaceutical 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.

Shri Daara Patel, Secretary General of IDMA, and his team were lauded for excellent planning and execution of the event by dignitaries and participants. Daara added “Under Dr. Viranchi Shah’s visionary leadership, IDMA has organised a series of events in the last 2- years to advance cause of the nation and the Indian pharmaceutical industry especially MSME sector. We will continue to organize more such value-additive events in future.”