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Parliamentary Panel asks DoP to take adequate measures to make PTUAS more attractive
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Gireesh Babu, New Delhi
December 26 , 2023
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A Parliamentary Panel has sought the Department of Pharmaceuticals (DoP) to hold discussions with the Micro, Small and Medium Enterprises (MSME) in the pharma industry and take adequate measures to make the technology upgradation scheme attractive to the beneficiaries.
The Department-related Parliamentary Standing Committee on Chemicals and Fertilizers headed by Member of Parliament Dr Shashi Tharoor, in its 45th report on the action taken by the government on its recommendations in the 42nd report on Demand for Grants 2023-24, said that it would like the DoP to find a feasible solution to the issues related to lower uptake of the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS).
"Expressing their apprehension that pharma MSMEs units are facing issues in enjoying the benefits of the scheme, the Committee desire that the issues should be adequately and widely discussed with the Pharma MSME industry associates and State Regulators and suitable measures should be taken to make the scheme attractive for the beneficiaries," said the Committee in the latest report.
The Committee in their original report noted nil utilisation of funds during the last three years viz. 2020-21, 2021-22 and 2022-23 under PTUAS scheme was attributed to lukewarm response to the scheme despite extensive outreach conducted on its benefits.
It advised the Department to look into these factors and take remedial measures accordingly. The matter may be discussed with the stakeholders, and if needed, possibility of revising the scheme guidelines may also be looked into, it said in the previous report.
In its latest report, the Committee noted that one of the factors that the Department has stated in response to this recommendation is that there is no market or regulatory compulsion for MSMEs units to upgrade their standards to national and international regulatory standards such as WHO-GMP or Schedule M, as the case may be, despite the felt need to do so.
"The Committee would like the Department to find a feasible solution to this issue and if desirable provide suitable financial incentives to MSME units on upgradation to national and international standards," added the Panel.
It may be noted that in August, the government announced a timeline for the drug manufacturers to comply with the Good Manufacturing Practices (GMP) standards starting from August 1 and will be implemented in a phased manner. It has also revised the manufacturing standards in line with the changing requirements and international standards and work has been started in collaboration with the DoP earlier this fiscal year, said the ministry of health and family welfare.
The health ministry said that the drug manufacturers with annual turnover of more than Rs. 250 crore have to comply with the standards within six months starting from August 1, 2023. For the companies with less than Rs. 250 crore turnover, the timeline will be a year.
With the requirement for upgraded standards, the Scheme is expected to see more takers, provided any other issues remaining to be addressed are also taken up promptly.
The DoP, in its response to the Committee on the recommendations in the 42nd report, said that it has organised outreach programmes in 10 states having majority of pharma clusters and MSMEs in coordination with pharmaceutical associations to provide the wide dissemination about the sub-scheme PTUAS.
The Department took several proactive steps with a view to increase the response to the Scheme by way of amending the guidelines - for increasing the project completion period by 30 months from 18 months; achievement of technological upgradation by 30 months from 18 months from receiving the first disbursement of loan. It also expanded the eligibility criteria by adding public financial institutions registered with Reserve Bank of India along-with Scheduled Commercial Bank/All India Financial Institution.
"As explained before the Hon’ble Committee, presently, there is no market or regulatory compulsion for these pharma MSME units to upgrade their standards to national and international regulatory standards such as WHO-GMP or Schedule-M, as the case may be, despite there is a felt need," said the DoP in its reply to the Committee.
"Hence, the Department is continuously pursuing with the State Regulators and the various Industry Associations to increase the uptake of the scheme. Further, the Scheme Steering Committee in its meeting on March 13, 2023 accorded its final approval for capital subsidy to 2 projects,” it added.
The Committee said that it is satisfied to note that by introducing amendments in the scheme guidelines and eligibility criteria the scheme has received response and the Scheme Steering Committee has given final approval to 2 projects.
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