Industry urges DoP to expedite implementation of PTUAS
Recommends changes in the existing criteria of PTUAS
The pharma industry raised the issues related to the implementation process of Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) scheme, in a recently held DoP meeting with industry stakeholders. Although the scheme was announced in 2014, the industry is yet to avail the scheme benefits. Therefore, in this meeting chaired by Dr PD Vaghela, Secretary, DoP, industry representatives requested the Department of Pharmaceuticals (DoP) to expedite the implementation process of PTUAS and made some recommendations.
Mahesh Doshi, President, IDMA informed, “During the recently held meeting, we requested the authority to expedite the implementation process of PTUAS for the benefit of the pharmaceutical industry in India. We have also made some suggestions to the authority in the existing scheme like; the maximum loan eligibility criteria for availing the scheme should be increased from Rs 4 crores to Rs 10 crores and they should de-link the export criteria for the scheme because the present outline of the scheme requires export to be achieved equal to the loan amount. We are hopeful that the authority takes our recommendations into consideration for the growth of the industry.”
Amit Chawla, Secretary, MP- Small Scale Drug Manufacturers Association said, “We seek support from both, the Central Government as well as State FDA authorities, in rolling out PTUAS in the country. The scheme needs attention to create awareness programmes about explaining the possible benefits of upgrading technology. This can be initiated by the MSMEs and explained by the pharma allied industry. Product specifications can be explained by them which will help manufacturers to enhance the productivity of the final output in terms of time, energy and working capital.”
He continued, “In my opinion, on a priority basis, the central government should appoint SIDBI as an implementing authority to expedite the process, as documentation takes a long time. However, to address issues like unavailability of a SIDBI branch to a specific city, the lead bankers of these cities can be designated as the lead banker authority. If this scheme becomes operational then we see all the players, small, medium and big, getting benefitted from the PTUAS.”
Nipun Jain, Chairman, Small and Medium Pharma Manufacturers Association expressed, “Although the PTUAS scheme was announced a couple of years ago, the Ministry is yet to appoint a lead banker who will act as a facilitator to the industry in availing the scheme benefits.”
He also pointed out that the central government announced PLI scheme is a good move towards making Indian pharma industry self-reliant, however, PTUAS does not have any investment restriction therefore it will benefit all the players. “Taking into consideration these aspects, we urge to the government authorities to expedite the implementation process for the benefit of the sector as well as the country,” he said
Vinod Kalani, President, Rajasthan Pharmaceutical Manufacturers Association, (Jaipur) said, “The central government announced PTUAS is a good scheme and it should be implemented on a priority. It will certainly help the MSME pharma companies to upgrade their plant and machinery systems, automation, quality assurance/ quality compliance activities etc. as defined and required in the WHO-GMP guidelines. This will boost and enhance even the formulation research and development activities in the country in the MSME segment. And the outcome of the scheme will be seen in a shorter period as against other announced schemes.”
What is the scheme about?
Explaining how the plan came about, Vinod Arora, Ex VP Ranbaxy, Principal Advisor – IGMPI informed, “There was a meeting at the Ministry of Health and Family Welfare, Government of India, Nirman Bhawan office a few years back wherein the gap between the WHO GMP and Schedule M of Drugs & Cosmetic Act & Rules were discussed including how frequently they are updated etc. And post the meeting, the review of the gaps with senior members were discussed and an action plan was worked out with an objective of strengthening the existing infrastructure facilities in order to make Indian pharma industry a global leader in the pharma sector.”
The objective of PTUAS is to facilitate Small and Medium Pharma Enterprises (SMEs) to upgrade their plant and machinery according to the World Health Organization (WHO)/Good Manufacturing Practices (GMP) standards, so to enable them to participate and compete in global markets.
Assistance in the form of interest subvention against the sanctioned loan by any scheduled commercial bank/financial institution, both in the public and private sector will be provided to pharma SMEs based on their proven track record. The scheme is to be implemented through a Public Sector Financial Institution (PSFI), which is yet to be identified by the Government.
As per the scheme, the upper limit of interest subvention on loans for technology/infrastructure up-gradation has been restricted to six per cent per annum for a period of three years on reducing balance basis. The maximum loan eligible for this purpose will be Rs four crore, which can be availed by the concerned SME. A total of Rs 144 crore has been earmarked for the scheme. All beneficiary pharma SMEs to whom benefit of interest subvention to be extended must obtain WHO GMP certification in two and half years from the date of the first disbursement. In addition, the pharma SMEs under this scheme need to ensure that they achieve incremental export revenue in excess of the sanctioned loan amount within 36 months of the last draw of the loan failing which the loan will be converted to a normal one. There will be a midterm review after completion of one year.