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DoP asks industry for timely submission of complete documents to process RPTUAS applications expeditiously
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Gireesh Babu, New Delhi
October 19 , 2026
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The Department of Pharmaceuticals (DoP) has informed that it has already approved incentives nearly equivalent to the total outlay of the Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS) and the industry may submit complete documents and fulfil the prescribed requirements in a timely manner for expeditious processing of eligible applications.
The suggestion was in response to a request by Federation of Pharma Entrepreneurs (FOPE), which raised concerns regarding pending applications and requested adequate allocation and expeditious release of funds under the sub-scheme to the micro, small and medium enterprises (MSME) to upgrade facilities to meet the requirements under the revised Schedule M.
The Scheme Steering Committee (SSC) for the sub-scheme has already approved 301 applications for incentives amounting to around Rs. 300.48 crore for achieving revised Schedule M or World Health Organisation's (WHO) Good Manufacturing Practice (GMP) on their technology upgradation upto September 2026, and it is nearly equivalent to the total outlay of the sub-scheme, DoP informed the industry.
DoP launched RPTUAS in March, 2024, with a financial outlay of Rs. 300.10 crore from FY 2024-25 to 2025-26, to facilitate technology upgradation of existing pharmaceutical units to comply with revised Schedule-M and WHO-GMP quality standards
The Department informed Harish K. Jain, national president, FOPE, who urged the DoP to support the Federation members, that out of the 301 approved applicants or pharmaceutical units, 157 applicants have upgraded their pharmaceutical manufacturing units and obtained certificates of compliance with the revised Schedule M and WHO GMP.
Another 17 applicants have reported completing technology upgrades of their pharmaceutical manufacturing units and applied for the said certifications. Yet another 13 applicants have reported that they have completed their upgrade project and are in process of applying to the State Licensing Authority for certifications. In the case of 110 pharmaceutical units, the projects are under implementation and the sanction of four pharmaceutical units were cancelled by the SSC.
"Further, claims in respect of 134 pharmaceutical units, amounting to Rs. 103.98 crore, have been approved after submission of the revised Schedule M/WHO-GMP certificates and verification of their authenticity from the concerned State Drug Controllers," said the Department.
Explaining the progress of the sub-scheme, it said, "In view of above, FOPE is requested to advise its member units for timely submission of complete documents and fulfilment of the prescribed requirements so that eligible applications may be processed expeditiously."
As Pharmabiz reported earlier, Jain, in his communication to the DoP, informed that a large number of FOPE members have applied for assistance under the sub-scheme, and despite completing the required formalities, many eligible applicants have not yet received the assistance.
Upon following up with the Small Industries Development Bank of India (SIDBI), the nodal agency associated with the implementation and processing of applications, the FOPE members were informed that adequate funds have not been sanctioned to SIDBI for the same.
The resulting delay has placed pharmaceutical MSME units in an extremely difficult position. The sector is presently undergoing major regulatory and compliance-related changes pursuant to the revised Schedule M and various requirements introduced by the Central Drugs Standard Control Organisation, State Licensing Authorities and other regulatory bodies, said Jain.
As per the guidelines of RPTUAS, pharmaceutical manufacturing units having an average turnover of less than Rs. 500 crore during the preceding three years are eligible for assistance under the Scheme, subject to fulfilment of the prescribed eligibility conditions. The incentive (maximum of Rs. 2 crore) is linked to investment in eligible activities, based on the turnover of the eligible unit.
The Scheme provides for a defined process for processing applications, which includes submission of gap analysis by the applicant, its examination by the Project Management Consultant (PMC), that is SIDBI, recommendation of eligible proposals to the Scheme Steering Committee (SSC), verification of eligible expenditure and release of incentive in prescribed instalments. Release of incentive is subject to submission and verification of the requisite Revised Schedule M/WHO-GMP certificates, and Chartered Accountant-certified expenditure prescribed under the Scheme. The DoP has also prescribed timelines for release of the instalments in the Scheme guidelines.
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