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Indian pharma notes investments & hiring qualified teams requisite to ensure compliance to revised Schedule M
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Nandita Vijayasimha, Bengaluru
May 29 , 2024
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Investments in infrastructure, quality assurance, training, regulatory expertise, documentation, audit preparedness, and continuous improvement are essential for Indian pharmaceutical companies to ensure compliance with the revised Schedule M regulations.
Hiring qualified teams with the right expertise and skills is equally important to effectively implement these investments and navigate the evolving regulatory landscape. For the funds for the required facilities our source is primarily to avail the revamped Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS). The government had revised the scheme in March this year by extending the eligibility yardstick, flexible financing options, subsidies on reimbursement basis over the conventional credit-linked approach, said members of KDPMA.
Certainly, investments are required to modernize facilities, install state-of-the-art equipment, and ensure compliance with regulations regarding premises, utilities, and production areas, said a section of the industry from the MSME sector.
Hiring and training qualified teams are vital for implementing and maintaining compliance with revised Schedule M. Employees need to be educated about regulatory requirements, Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and other relevant guidelines to perform their roles effectively and ensure adherence to regulations, noted the industry.
According to SM Mudda, chairman, Regulatory Affairs Committee, IDMA & managing director, Misom Labs, Malta, the revised Schedule M regulation signifies a significant step forward in demonstrating an unwavering dedication to patient safety and welfare. It calls us to embrace a more holistic and proactive approach to quality management encompassing the entire product lifecycle. The crux of the revised regulation is to enhance consumer trust and bolster Brand India reputation.
Noting that formulation development is a crucial aspect of pharmaceutical research and manufacturing, involving the creation and optimization of drug formulations for various delivery systems such as tablets, capsules, injectables, and topical formulations, Harish K Jain, president, Federation of Pharmaceutical Entrepreneurs (FOPE) and director, Embiotic while deliberating on the Quality By Design principles said that drug development aims at developing a product which complies with release specifications, ability to maintain physical, chemical and microbiological properties during its entire intended shelf life.
On the parameters of compliance, like the Product Quality Review as per Schedule M, Mahesh Vyas, general manager, quality assurance, Strides Pharma Science said, “Review of starting materials and packaging materials used for the product, especially those from new sources and in particular the review of supply chain traceability of active substances is now a requisite”.
The industry will also need to closely look into adequacy of any other previous corrective actions on product processes or equipment. This along with evaluation of technical agreements to ensure that they are up to date will conform that all the tasks performed are in a timely manner and are accurate, said Vyas.
GN Prashanth, senior vice president, and head, corporate quality, Granules India who focused on the need for process validation, said that this is a systematic approach to ensure that a manufacturing method consistently produces a product meeting predetermined quality attributes.
From a broader perspective, Prashanth noted that process validation reduces the variables in the manufacturing process. Even the equipment should be seen to ensure that it operates as expected. Further, industry needs look at calibration of instruments to ensure that the data being collected is accurate. Therefore, industry should give undue attention in the revised Schedule M regime to validate processes and verify the proven acceptance ranges that helps to produce a product which will meet the specifications.
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