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Time of India
11 hours ago
- Business
- Time of India
Centre extends deadline for revised Schedule M implementation for small, medium pharmas
Mysuru: The Union govt has extended the deadline for implementing the revised Schedule M–Good Manufacturing Practices (GMP)–for small and medium pharmaceutical enterprises (SMEs) with an annual turnover of Rs 250 crore or less, until the end of this year, said Khalid Ahmed Khan, deputy drug controller and president of the Indian Pharmaceutical Association (IPA), Karnataka state branch. 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.
The Hindu
21 hours ago
- Health
- The Hindu
Conference on pharmaceutical quality assurance through good manufacturing practices held in Mysuru
A national conference on 'Enhancing Pharmaceutical Quality Assurance through Good Manufacturing Practices' was conducted by the JSS Academy of Higher Education and Research in Mysuru on Wednesday. It was held in association with the Indian Pharmaceutical Association, Mysuru branch, along with other organisations, and included a session on Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS). A release said that the initiative aimed to ensure consistent production and control of medicinal products to meet the highest quality standards. The primary objective of the conference was to promote the understanding and implementation of Good Manufacturing Practice (GMP) principles among pharmaceutical manufacturers, emphasising the importance of adherence to GMP standards for ensuring the safety, efficacy, and quality of medicinal products, the release added. The conference also aimed to provide guidance on incorporating GMP requirements into national medicine laws and regulations, while facilitating the exchange of best practices in GMP implementation. The conference was inaugurated by Dr. Khalid Ahmed Khan, Deputy Drug Controller and president of the Indian Pharmaceutical Association (IPA), Karnataka State branch. Dr. H. Basavana Gowdappa, the vice chancellor of JSS Academy of Higher Education & Research, Mysuru, urged the industry to view GMP not merely as a regulatory requirement, but as a core responsibility. Dr. Amaresh Tumbagi, former Drug Controller of the Karnataka government, highlighted various inspections conducted under Schedule M and discussed how regulatory bodies have evolved with the revised version. Dr. Pramod Kumar T.M., Principal, JSS College of Pharmacy, Mysuru, provided insights into industry and government regulations related to GMP. Around 100 delegates from different industries and academics were present apart from the members of IPA Mysuru branch. Dharmendra Kumar Yadav, Under Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India, Yashwant Shinde, Manager, Small Industries Development Bank of India (SIDBI), and Dr. R.S. Savitha, Secretary, IPA Mysuru, were among those present.
