Centre extends deadline for revised Schedule M implementation for small, medium pharmas
He was speaking at the inauguration of a national conference on 'Enhancing Pharmaceutical Quality Assurance through Good Manufacturing Practices (GMP)' and a special session on the Revamped Pharmaceutical Technology Upgradation Assistance Scheme. The event was organised by the PHD Chamber of Commerce and Industry (PHDCCI) health committee in association with the department of pharmaceuticals, Union ministry of chemicals and fertilizers, JSS Academy of Higher Education and Research (JSS AHER) and the IPA Mysuru branch, at the JSS College of Pharmacy on Wednesday.
Khan noted that due to the financial burden involved in implementing the revised quality framework, MSME firms were granted time until Dec 2025 to comply. "Firms with turnover above Rs 250 crore, as well as all newly established plants, are required to adopt the revised Schedule M immediately. These guidelines are aligned with WHO and international standards and emphasise total quality management and robust pharmaceutical systems," he added.
Khan stressed the importance of leadership and a quality-driven mindset in the pharmaceutical sector. "Even if you're not in a leadership position, you can influence those who are. Without quality, neither the industry nor its workforce can sustain," he said.
Dr H Basavana Gowdappa, VC, JSS AHER, commended the department of pharmaceuticals for launching the RPTUAS and urged the industry to treat GMP not as a regulation but a fundamental responsibility.
Amaresh Tumbagi, former drug controller of Karnataka, outlined the inspection mechanisms under the revised Schedule M and how regulatory processes have evolved. Dr Pramod Kumar TM, principal, JSS College of Pharmacy, provided insights into current industry regulations and compliance requirements. Jatin Nagpal, joint secretary, PHDCCI, Dharmendra Kumar Yadav, under secretary, department of pharmaceuticals, Yashwant Shinde, manager, SIDBI and Dr Savitha RS, secretary, IPA Mysuru local branch were also present.
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