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DOP constitutes panel to implement PTUAS to help small firms upgrade their units to WHO-GMP
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Arun Sreenivasan, New Delhi
November 23 , 2018
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The Department of Pharmaceuticals (DoP) has set up a high-powered panel to take a much-awaited interest subvention scheme for small pharmaceutical manufacturers forward.
The Pharmaceuticals Technology Up-gradation Assistance Scheme (PTUAS), a subsidy plan on sanctioned loans, is aimed at helping drug manufacturing companies improve technology and infrastructure to migrate from Schedule M to World Health Organisation good manufacturing practice (WHO-GMP) standards. With a budgetary allocation of Rs. 144 crore for 2018-20, the initiative is expected to benefit 250 units as the maximum limit of interest subvention is set at 6 per cent on loans up to Rs. 4 crore for a period of three years.
The 10-member scheme steering committee (SSC), led by the DoP secretary, includes the Drug Controller General of India, Director General of Pharmexil and representatives of Indian Drug Manufacturers’ Association and Bulk Drug Manufacturers’ Association. It is authorised to formulate the norms for loan approval, conduct quarterly reviews and set the penalty for defaulters.
“The SSC may co-opt representatives of any pharma industry associations, lending financial institutions, R&D institutions and other government/private sector expert organisations members or special invitees as may be necessary from time to time. Joint Secretary (Policy), nodal officer of the Scheme and Secretary (Pharma) are jointly empowered to resolve issues in the implementation of Scheme in the interest of the scheme mandate, where organising the meeting of SSC may cause delay and affect its implementation,” an official circular, reviewed by Pharmabiz, reads.
As per the government proposal, the scheme could be implemented only through a public sector financial institution (PSF1) as implementing agency. However, official sources have confirmed that the PSFI is yet to be identified. It has to be selected through a competitive bidding process after invitation and submission of expression of interest.
Only machinery and electronic management systems required to help a Schedule M plant attain WHO-GMP compliance will be considered for financial assistance under the PTUS. The office of the Drugs Controller General of India has already prepared a list of equipment categories for this purpose that would be updated from time to time and procurement of only new machinery is allowed under the scheme.
All beneficiary pharma units must obtain WHO-GMP certification within 36 months from the date of first disbursement of the loan. They should also achieve incremental export revenue in excess of the sanctioned loan amount within 36 months of the last draw of the loan, failing which the assistance will be converted into a normal loan by the financial institution.
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