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The Haryana-based pharma MSMEs are seeking a further extension on the deadline for implementing the revised Schedule M, citing financial hardship.
The Haryana Pharmaceutical Manufacturers Association (HPMA) is preparing to meet Union health minister J P Nadda to request a new deadline of December 2027 for companies with an annual turnover below Rs. 50 crore.
According to HPMA president R.L. Sharma, around 90 per cent of the state's formulation manufacturers fall under the MSME category. He states that implementing the new schedule M requires a minimum investment of Rs. 10 crore per company, which is a considerable burden for these small enterprises.
In a telephonic talk with Pharmabiz, Sharma explained that the extensive upgrades required, including new buildings, machinery, and skilled personnel, are not feasible within the current timeframe without financial assistance. The association plans to submit a memorandum outlining their challenges and asking the government for both an extension and financial support. This is not the first time the HPMA has sought relief, Sharma previously led a delegation to meet with former health minister Dr Mansukh Mandaviya two years ago with a similar request for more time.
The association's move comes after very few of the state's pharma MSMEs, constrained by finances, were able to submit their upgradation plans by the May 11, 2025 deadline. The HPMA believes that a two-year extension is essential for these companies to comply with the new standards without risking their business viability. By appealing directly to the union health minister, the association hopes to secure a more realistic timeline that accommodates the financial limitations of small-scale manufacturers in the region.
In addition to seeking an extension, the HPMA also plans to request that the union health minister intervene with the Haryana state government to halt ongoing risk-based inspections. According to Sharma, joint inspections are still being conducted at manufacturing units in the state. The association argues that these inspections should be suspended until companies have had the two-year grace period they are requesting to comply with the revised Schedule M norms, allowing them to focus on upgrading their facilities without the added pressure of regulatory checks.
Sharma provided a snapshot of the pharmaceutical landscape in Haryana, highlighting its composition. He stated that the sector is predominantly made up of micro and small-scale enterprises, including formulation units, API (active pharmaceutical ingredient) industries, medical device manufacturers, and cosmetics manufacturing firms. Sharma specified that there are approximately 125 formulation units in the state alone. These companies, he added, not only serve the entire Indian market but are also active in the export sector. While the majority of the industry consists of MSMEs, Sharma also noted that there are around 25 major pharmaceutical players in Haryana.
Regarding the proposed Pharma Park in Karnal, Sharma shared that the HPMA has already informed the central government about the project and is awaiting a green signal before commencing development work. However, the association has not been idle. With support from the central Ministry of MSME and the state industries department, the HPMA has already established a world-class Common Facilitation Centre (CFC) at the designated site. This facility is equipped to handle all the necessary laboratory tests for drug manufacturing companies, providing a significant resource for the local industry.
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