Karnataka pharma gives top priority to implement Revised Schedule M

The pharmaceutical industry in Karnataka is giving top priority to strengthen its compliance efforts for the Revised Schedule M. The state which is already known for its advanced production plants and global contract manufacture orders from leading international companies is putting in place the required investments, continuous training and engagement with experts.
The compliance requires investments in terms of infrastructure and equipment installation. The dedicated zones for specific products—sex hormones, steroids (anabolic and androgenic), cytotoxic substances, biological products, and radiopharmaceuticals—call for a need to assess financial resources. The guidance notified indicates that micro, small and medium enterprises (MSMEs), of less than Rs. 250 crore annual turnover are given 12 months and large manufacturers with an annual turnover of over Rs. 250 crore are given six months to comply.
Manoj Palrecha, president, Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) and managing director, Lake Chemicals said that going by the current scene, a 24-month extension will definitely be necessary as almost 80% of the companies focusing only on the domestic supplies are in the MSME category.
In an effort to brace up the process of compliance with clarity, Indian Pharmaceutical Association (IPA) Karnataka State Branch and KDPMA at a day-long event deliberated ways to combat the challenges during implementation. Here experts from the state drugs control department and industry identified areas for enhancement and optimize manufacturing processes to ensure consistent quality and compliance with regulatory standards.
The Revised Schedule M emphasizes the importance of quality assurance and the TQM principles prioritize a proactive approach towards prevention rather than detection of defects. This helps pharma companies to exceed customer expectations ensuring safety, efficacy, and aligning with the patient-centric approach of the GMP guidelines. It is here the importance of well-trained personnel cannot be overlooked to adhere to regulatory requirements pointed out Palrecha.
Sunil Attavar, former president, KDPMA, said that IPA- Karnataka Chapter’s initiative along with KDPMA to sensitize companies on Revised Schedule M is a step in right direction. There is a need for many more similar workshops to support the transition and get companies ready. Most progressive companies have been working on upgradations of infrastructure and systems since the drafts were first announced. However, continuous training and engagement with experts will be much-needed.
With technology taking centre-stage in pharma manufacturing, data-driven decision making is the key, said Palrecha adding that utilizing analytics and performance metrics to monitor manufacturing processes, identify deviations, and implement corrective actions can help maintain product quality and compliance.
“The companies need to evaluate the standard operating procedures (SOPs) for consistency and reliability in product quality with the necessary documentation and validation to minimize risks,” said Palrecha.
Dr Premnath Shenoy, president, IPA Karnataka branch observed that with the exception of a few companies, most are likely to meet requirements within the stipulated timelines. However, investments may differ from company to company. Even as most of the companies have already implemented Pharmaceutical Quality System, there is a need for them to move from level 1 & 2 to more mature level 3 and 4.
From providing a peek into the nuances of the Revised Schedule M to legal insights and MSME challenges to implement the new guideline, the IPA-Karnataka with KDPMA congregation was a platform for meaningful engagement and networking opportunities for the 200 participants, said Dr Shenoy.
Source: Pharmabiz