|
The pharma MSMEs have recommended to the Union health ministry a case-by-case extension mechanism to implement revised Schedule M.
It has been recommended that a case-by-case extension mechanism may be considered for MSME units already undertaking upgradation, along with one additional opportunity for MSMEs to submit structured compliance plans, supported by clear interpretative guidance.
Pharma MSMEs in a recent representation to the government stated that it fully supports the strengthening of GMP and Pharmaceutical Quality Systems under the revised Schedule M. However, implementation, particularly for MSMEs, requires significant time for infrastructure upgrades, equipment procurement, and validation activities. A number of units have already initiated upgradation in good faith but may require additional time to complete the process in a compliant and sustainable manner. At the same time, some MSMEs have not come forward due to lack of clarity on interpretation of certain provisions.
According to the representation, a case-by-case extension mechanism may be considered for units already undertaking upgradation, along with one additional opportunity for MSMEs to submit structured compliance plans, supported by clear interpretative guidance.
“The concern emerging from industry is not with the intent of the revised Schedule M, but with ambiguity in interpretation of certain provisions. Some requirements are being perceived as rigid structural expectations rather than flexible, risk-based controls, which creates uncertainty and delays in investment decisions. Areas such as contamination control approaches, legacy facility layouts, and other operational aspects require clearer articulation,” an industry expert explained.
The Indian Drug Manufacturers’ Association (IDMA) has, therefore, also requested the government to issue clear guidance on key provisions, including acceptance of scientifically justified alternate approaches, so that implementation remains consistent, predictable, and aligned with risk-based principles.
The Union health ministry had also revised the date of the implementation of the revised Schedule M of the D&C Act allowing pharma MSMEs an additional 12 months to comply, extending the date to December 31, 2025. To avail of this extension, pharma companies with a turnover of less than Rs. 250 crore were also directed to file an application by May 11, 2025, to the CDSCO with details of their upgradation plan.
MSMEs had sought an extension after submitting an upgradation plan by May 11, 2025, as inspections have already begun from January 2026. Around 80 per cent of the total 10,500 drug manufacturing units in India fall under the MSME category.
The Union health ministry had stated that the reason for allowing this extension is to enable pharma MSMEs to arrange the finances for upgradation and time for implementation of the required changes. It also informed that it is as per request by several associations that represent the pharma MSMEs.
Originally mandated in December 2023, the revised guidelines required units with turnovers above Rs. 250 crore to comply within six months, while those below the threshold had a one-year timeline. Drug manufacturers who met the initial deadline for large companies (June 28, 2024) have already transitioned.
Key provisions of revised Schedule M guidelines include modernized facilities to prevent contamination and improve cleanliness, validated equipment towards stringent maintenance of production equipment, environmental controls towards adherence to global standards for air, water, and waste management, Pharmaceutical Quality Systems (PQS): robust systems to guarantee consistent quality, Product Quality Reviews (PQR), which are regular evaluations to ensure ongoing compliance.
|