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Panel asks DoP to review its decision to upgrade only 420 MSMEs under PTUAS
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Gireesh Babu, New Delhi
August 17 , 2022
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The Department of Pharmaceutical (DoP) should review its target of upgrading just 420 Micro, Small and Medium Enterprise (MSME) pharmaceutical units by the year 2026 under the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS), when almost 4,500 units remain outside the purview of World Health Organisation’s (WHO) Good Manufacturing Practices, recommends the Department Related Parliamentary Standing Committee (DRSC) on Union ministry of chemicals and fertilisers.
The Committee, which earlier criticised the government for allowing only token allocations for the Scheme in the years 2019-20, 2020-21 and 2021-22, notes that for the year 2022-23, an amount of Rs. 62 crore has been allocated though the Department has sought Rs. 100 crore as budgetary allocation. In its previous report, it has also recommended that the guidelines of the schemes should be finalised and the Ministry has finalised the guidelines within the latest meeting of the committee.
However, with regard to upgrading of MSMEs (Pharma MSMEs) the Committee had noted that out of 6790 Pharma MSME only 2006 are WHO-GMP certified and more than 4500 remained outside the purview of WHO-GMP certification. In this regard, the Department has submitted that a target to provide support to just 420 Pharma MSMEs for upgrading their technology to meet WHO-GMP or schedule M standards till March 2026 has been set up.
In an action taken report on its previous recommendations on the Demands for Grants 2022-23 of the ministry of chemicals and fertilisers (Department of Pharmaceuticals), the Parliamentary Panel headed by Member of Parliament Kanimozhi Karunanidhi said, “The Committee are surprised to note the small figure of MSMEs taken up for up-gradation that too upto 2026. When about 4,500 MSMEs remained outside the purview of WHO-GMP certification.”
“The Committee strongly recommends that the Department should review the target of upgrading just 420 MSMEs by the year 2026 and increase this figure as well try to decrease the time period involved in the process. The Committee desire that the remaining 4500 MSMEs also be upgraded to WHO-GMP certification at the earliest,” it added.
The aim of PTUAs is to provide interest subvention to the Pharmaceuticals, Medium, Small and Micro enterprises (Pharma MSMEs) to upgrade their standards both in terms of quality and technique to WHO-GMP Manufacturing practices to enable them to produce quality drugs and become globally competitive. This Scheme enables upgradation of these enterprises from Schedule M to WHO-GMP standards so that they are eligible to export in global markets and earn foreign exchange.
In its earlier report, the Committee noted that according to the Department, the reason for the difference in proposed and approved BE allocation (of Rs. 62 crore out of the Rs. 100 crore proposed by the DoP) is the present revision of scheme guidelines of PTUAS as per Expenditure Finance Committee approval. Once approved, eligible applications will be considered in FY 2022-23.
The guidelines of the Scheme “Strengthening of Pharmaceuticals Industry” (SPI) had been finalized and published in the Department's Website on March 11, 2022, which includes the sub-scheme PTUAS, according to the DoP. The sub-scheme, PTUAS has been incorporated under the Scheme SPI with the budget allocation of Rs. 300.10 crore for financial year 2021-2022 to 2025-2026. SIDBI have been appointed as the Project Management Consultant (PMC) for implementation of the Scheme. The DoP also informed the Committee that it will seek additional funds from the Ministry of Finance at RE Stage, if need be.
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