Upgradation of existing WHO-GMP plant for higher standards not included under PTUAS: DoP

New Delhi, September 29, 2022:

Even as any pharma Micro, Small and Medium Enterprise (MSME) unit with proven track record to upgrade technology to meet World Health Organisation's Good Manufacturing Practice (WHO-GMP) or Schedule M Standards can apply under the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS), upgradation of existing WHO-GMP plant for higher standards of WHO-GMP or EU GMP or US FDA is not included in the eligibility criteria at present, clarifies the Department of Pharmaceuticals (DoP).

Responding to the Frequently Asked Questions (FAQs) on the scheme, it said that any pharma MSME unit with proven track record to upgrade technology to meet WHO-GMP or Schedule M Standards can apply under the PTUAS.

The unit can approach any scheduled commercial bank both in public and private sector for the loan. Only those applications for which loan has been approved by Lending Institution within 90 days preceding the application date to PMC will be taken up for benefit under the scheme.
 
Application for the subsidy under the scheme should be submitted in the portal

However, on a specific query that whether capital investments for upgradation of an existing WHO-GMP compliant plant to higher standards of WHO GMP or EU-GMP or US FDA eligible for assistance under PTUAS scheme, the DoP said that the objective of the scheme is “To facilitate Micro, Small and Medium Pharma Enterprises of proven track record to upgrade their technology to meet WHO-GMP or Schedule M standards”.

"Upgradation of existing WHO GMP plant for higher standards of WHO GMP or EU GMP or US FDA is not included in the eligibility criteria at present," it said.

Up to maximum of 5% per annum (6% in case of units owned and managed by SC/STs) of interest subvention for loan and loan component eligible under the scheme taken to the upper limit of Rs. 10 crore for a maximum period of three years on reducing balance for sanctioned loans by any scheduled commercial banks/financial institutions, both in the public and the private sector is the limit of the scheme.

Credit linked capital subsidy of 10% on loan component eligible under the scheme. Maximum limit of loan will be Rs. 10 crore.

Sanction and disbursement of the loan shall be from Scheduled Commercial Banks from whom the unit desires to get financial assistance. Processing of subsidy shall be undertaken by SIDBI based on the application received in the portal. Sanction and release of subsidy is under the purview of the Empowered Committee of DoP.
 
Another query was that whether a private limited company with two existing manufacturing units, out of which, one unit (Unit-1) is WHO GMP Certified, is planning to upgrade its second unit (Unit-2) to Schedule M can be covered under PTUAS? The same enterprise is planning to set up a new unit i.e., Unit-3 with Schedule M / WHO GMP standard and whether both of these be covered under PTUAS, was another question.

The DoP replied that the Unit 2 can be covered under PTUAS subject to the proposal and investment meeting the criteria under the scheme and subject to SSC approval. New unit proposed, Unit 3 may not be covered under PTUAS as the requirement of loan component may not be within the prescribed limit of 10 crore as per scheme guidelines.

"Moreover, the scheme is primarily to facilitate Micro, Small and Medium Pharma Enterprises of proven track record to upgrade their technology," it added.

Commenting on the role of SIDBI as Project Management Committee (PMC) in Strengthening of Pharmaceutical Industry (SPI), the DoP said that the Project Management Consultant, engaged by the Department, is expected to act as a bridge between the Department/Scheme Steering Committee (SSC) and the applicants/beneficiaries and will help for the expeditious implementation of the projects in a systematic, professional and transparent manner.

Its responsibilities include preliminary examination of the proposals, and preparation of evaluation reports that will be placed before the SSC for final selection of proposals, besides, developing an online portal to receive the applications and maintain the required details of all the applicants, it added. PharmaBiz