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Health minister’s proactive approach on addressing challenges to bolster resilience of MSMEs
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Nandita Vijayasimha, Bengaluru
July 19 , 2024
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The Indian pharmaceutical industry is optimistic following the Union government's renewed focus on addressing the challenges faced by Micro, Small, and Medium Enterprises (MSMEs). This attention is seen as a significant step towards fostering growth and sustainability in the sector.
During Union health minister J P Nadda’s review on the Regulation of Drugs, Cosmetics and Medical Devices, he stated, “For India to become global leader, we need to have world class regulatory framework. Let us address the issues faced by MSME sector and support them to strengthen their capacity and quality.”
Appreciating Union health minister’s statement, industry captains said that this proactive approach would bolster the resilience of MSMEs, ensuring their pivotal role in India's healthcare ecosystem.
According to Harish K Jain, president, Federation of Pharma Entrepreneurs (FOPE) and director Embiotic Labs, “FOPE welcomes the statement of our Union health minister. We support the constant upgrade on product quality to match patient expectations. At the same time the industry, specially the MSMEs, as rightly pointed out by health minister Nadda, needs understanding of their issues and handholding. Any regulation anywhere globally requires support of all stakeholders to succeed. Regulations must have an element of empathy built into it and should not be at the cost of any particular stakeholder which has potential to result in medicine shortage and increase in prices.”
In this regard, FOPE also welcomes Union health minister’s call for continuous dialogue with the industry, added Jain.
Manoj Palrecha, president, Karnataka Drugs and Pharmaceutical Manufacturers Association and managing director, Lake Chemicals, said, “It is important to improve the quality standard to meet the global standards as stated by the Union health minister.
With many companies falling under the MSME category, it would be a challenge to get the qualified and experienced workforce to meet out the quality standard upgradation, as there is an acute shortage of the same, he noted.
Moreover, renovation in the existing plants to meet out the revised regulations is again not going to be easy, as stopping the production may not be a viable proposition. Also, not many companies would be in a position to put up a new facility as it involves high capital investment, several validations and related approvals which is a time-consuming process, taking anywhere around 3-4 years. This we feel the government should mull over, he said.
Also in the Revised Schedule M issued on January 5, 2024, the government could have brought in the changes by introducing the same step-by-step, but in a time bound manner as India is a price sensitive market and these upgradations take time. The government should think of doing away with the price control too, averred Palrecha.
Once Revised Schedule M gets implemented by MSMEs which is in line with WHO-GMP norms, the government must also consider doing away with an additional inspection by CDSCO to obtain the written confirmation as is being followed currently. This, if implemented, would speed up and streamline exports, Palrecha told Pharmabiz.
Alluding Union health minister Nadda’a statement as positive, Kaushik Desai, a pharma consultant, said that the call for more stakeholders meeting with regulators is the most welcome step. Such a directive will pave the way for ease of implementation of better quality standards with regulations meeting global norms. To this end, the revised Schedule M is a step in the right direction. Industry and government should work together to reinforce our status as ‘Pharmacy of the World’ with quality deliverables.
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