Mumbai: In a decisive move to bolster the pharmaceutical industry’s compliance with international quality standards, the Gujarat Food and Drug Control Administration (FDCA) and the Indian Drug Manufacturers Association (IDMA) Gujarat Chapter have embarked on an extensive training initiative. This program targets 300 Gujarat-based manufacturers, focusing on the effective implementation of the Revised Schedule M Guidelines.
Dr. HG Koshia, commissioner of Gujarat FDCA, underscored the urgency of this initiative, stating, “There is an urgent need to equip manufacturers on the implementation of the revised norms to sustain our credibility as the Pharmacy of the World. The Central Drugs Standard Control Organisation (CDSCO) has also conducted several regional training programs and workshops to usher in effective understanding of the new guidelines to build a quality culture for all stakeholders including regulators. This has brought the onus on us to adopt collaborative initiatives to meet the evolving international regulatory requirements of the developing and developed markets.”
The CDSCO has been proactive in this regard, having conducted 23 residential training programs over the past year. These sessions were meticulously designed to address critical aspects such as risk-based inspections, prosecution launches, the adoption of new therapies, and harnessing Industry 4.0 technologies. These efforts have led to the successful training of 1,100 regulators, enhancing regulatory efficacy and adherence to the revised Schedule M regulations.
The new version of Schedule M, notified on October 5, 2018, aims to ensure compliance with drug standards, promote exports, and build trust in the quality of drugs manufactured and sold. The Union Health Ministry’s directive on August 2, 2023, mandates that large pharmaceutical companies, with turnovers exceeding Rs. 250 crore, must achieve WHO-GMP certification within six months, while medium and small-scale enterprises have been given a 12-month timeframe.
Under the revised norms, the term ‘Good Manufacturing Practices’ (GMP) has been expanded to ‘Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products,’ reflecting a more comprehensive approach to quality assurance in the pharmaceutical sector.
“This collaborative initiative by Gujarat FDCA and IDMA is set to significantly enhance the quality and credibility of India’s pharmaceutical exports, reinforcing the nation’s position as a global leader in the pharmaceutical industry,” Dr. Koshia concluded.
