The Karnataka pharmaceutical industry has worked diligently to comply with the revised Schedule M of the Drugs Rules, which governs the manufacturing and quality control of drugs. The revised Schedule M, which came into effect from 1st Jan 2025 introduced more stringent guidelines to ensure better quality, hygiene, and safety standards in pharmaceutical manufacturing. The changes are in line with the global standards, particularly the good manufacturing practices (GMP) and aim to enhance the quality by design of pharmaceuticals produced in India.
BR Jagashetty, special resource officer, Karnataka FDA, former National Adviser (Drugs Control) to MoHFW & CDSCO and former Karnataka State Drugs Controller noted that Karnataka could be one of the first in the country to be ready with compliance to revised Schedule M.
According to Harish K Jain, president, Federation of Pharmaceutical Entrepreneurs (FOPE) and director, Embiotic Labs, revised Schedule M will propel Indian pharma to next level of growth. Draft was notified in 2018 and final notification came in December 2023. Industry needs to upgrade to revised standards since it has already become law. Having said that there are various clauses specially relating to facilities which will be difficult to implement in existing facilities whether big or small. We once again urge the Government to revisit these clauses with empathy in consultation with all stakeholders.
Jatish N Sheth, president, Karnataka Drugs and Pharmaceutical Manufacturers Association and director, Srushti Pharmaceuticals, said that the revised Schedule M is to improve the quality of medicines produced in India, and Karnataka's pharmaceutical industry is adapting to these regulations. Our member company manufacturers have gone in to upgrade their facilities to meet the specific improvised requirements with regards to production plants, procedures and documentation.
The companies in Karnataka prioritize stringent quality control (QC) and quality assurance (QA) systems. Many units have state-of-the-art manufacturing and testing facilities to conduct comprehensive manufacture and analysis of finished products. This meticulous approach helps ensure compliance during audits by international and regulatory agencies, he added.
The state is a key hub for contract manufacturers as at least 9 of the top brands of companies in India are produced here. This speaks volumes of the state pharma industry’s accountability to high quality standards and delivery to stringent delivery timelines, Jatish noted.
Moreover, India accounts for the highest number of US FDA plants which stands at 752 units, Karnataka's pharmaceutical industry too has a strong track record of successful global audits, and this is a significant factor in its prominence on the world pharmaceutical map. The state's pharma sector is one of the most advanced in India and is home to numerous leading pharmaceutical companies that have earned a reputation for compliance with international and regulatory standards, said the KDPMA president.
Therefore, revised Schedule M is a just an extension of another adherence to strengthen its pathway to manufacturing pharmaceuticals to meet the required standards. This updated Schedule M is not just about compliance for the sake of regulation but it is about ensuring the highest standards of product quality, safety, efficacy and reliability, which are key to gaining and maintaining access to the increasingly competitive global pharmaceutical market, Jatish noted. |