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The revamped Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) is expected to provide a significant boost to MSME manufacturers in the pharmaceutical sector, empowering them to elevate their standards and compete effectively on the global stage. With its focus on quality enhancement and capacity building, the scheme aligns with the broader objective of fostering innovation and excellence within the pharmaceutical industry, opine industry experts.
The scheme now looks more attractive and the industry should utilize this opportunity to upgrade their units to the Revised Schedule M standards, they add.
India’s pharmaceutical MSMEs are set for a significant transformation with the revamped PTUAS as many companies have come forward after conducting the gap analysis, said Dr. Arunish Chawla, secretary, Department of Pharmaceuticals (DoP), talking at the sidelines of a quality summit in Mumbai.
He stressed the importance of quality in the pharmaceutical sector, focusing on three pillars: market, patient, and neighbour. He noted that maintaining market quality builds reputation and defends against malpractices, while patient quality is driven by robust regulatory systems.
Dr. Chawla emphasized that India’s upgraded standards, surpassing WHO GMP in some areas, align with the Prime Minister’s vision of ‘Zero defect and Zero effect.’
He highlighted the need for investment in quality and collective adherence to high standards to protect the industry’s reputation and ensure excellence.
RPTUAS
The PTUAS was revised and renamed as RPTUAS on March 11, 2024, with a view to increase the uptake and to help the pharmaceutical industry align its production process with best global standards. The Department is implementing the RPTUAS sub scheme as a part of “Strengthening of Pharmaceuticals Industry (SPI)” Scheme.
The objective of the RPTUAS sub-scheme was to facilitate the existing pharma units to upgrade to Revised Schedule M and WHO-GMP standards. The intended beneficiaries would include existing pharmaceutical manufacturing units having turnover of less than Rs. 500 crore over the last three years.
As the scheme did not elicit much response, the DoP revamped the scheme several times during the last more than two years, making it attractive to the MSMEs. After the initial guidelines issued on March 11, 2022, the DoP modified it in July, 2022 and January, 2023. Then on March 11, 2024, the DoP further modified the scheme to make it more attractive to MSMEs in the pharma industry in the country.
As the scheme was still not very attractive, the DoP once again revamped the scheme on September 17, 2024, with an upward revision of maximum incentive and included the expenditure incurred on product equipment for calculation of the subsidy amount.
The Department also removed the requirement for a detailed gap analysis for online application for the sub-scheme, replacing it with a normal gap analysis. The maximum limit of incentive under the scheme has been revised from Rs. 1 crore to Rs. 2 crore, while the average turnover criterion stands the same.
Scheme to support tech implementation
The Indian pharmaceutical sector has initiated technological upgradation on a massive scale to keep pace with global challenges and maintain ‘Pharmacy of the World’ status. Globally the pharmaceutical industry is moving into the next phase of automation and digitisation. But India is not far behind, said Kaushik Desai, pharma consultant.
In this regard, the central government has rightly recognised the need of the sector, and came out with industry-friendly revamped PTUAS. The scheme is mainly to support the implementation of newer technology helping industry in their growth plans and meet the regulatory compliance challenges, he added.
The industry should take advantage of this much-needed support and utilise the benefits of the scheme to upgrade their facilities to the next level and continue to remain competitive in global market, Desai added.
Overall, actively participating in PTUAS can help pharmaceutical companies modernize their operations, improve their competitiveness, and contribute to the growth and development of the industry as a whole, said Desai.
Sunil Attavar, former president, Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) said, “With the new Schedule M coming into force, the revised PTUAS will be a help to the industry, especially the SMEs. The revised scheme has broadened eligibility and flexible financing options and will motivate many companies to avail the benefits and upgrade the facilities.
Evolution of PTUAS
More than two years back, the Department of Pharmaceuticals (DoP) had launched the PTUAS for the MSME units to upgrade their manufacturing facilities as per WHO-GMP standards or Schedule M standards.
The purpose of the scheme was to make the MSMEs self-reliant and at par with global standards by supporting technological upgradation. PTUAS is a credit linked scheme which provides financial support of up to Rs. One crore to a pharma MSME aspiring to upgrade its manufacturing facility as per WHO-GMP standards.
PTUAS is a credit linked scheme which provides financial support of up to one crore to a pharma MSME aspiring to upgrade its manufacturing facility as per WHO-GMP standards or Schedule M standards. It is among the three sub-schemes of SPI to strengthen pharma MSMEs in the country. The other two sub-schemes are Assistance to Pharmaceutical Industry for Common Facilities (APICF) in clusters and Pharmaceutical & Medical Devices Promotion and Development Scheme.
Initially, the scheme had provisions for a capital subsidy of 10 per cent on loans up to a maximum limit of Rs. 10 crores with a minimum repayment period of three years or interest subvention of up to 5 per cent (6 per cent in case of units owned by SC/ST) on reducing balance basis.
Minimum repayment period of the loan sanctioned for availing of the benefit under the scheme is 3 years. But the scheme did not go down well with the MSME units as there were several lacunae in the scheme.
Normally any capital subsidy scheme benefit is minimum 20 per cent subsidy, but in the case of PTUAS it was only 10 per cent. Besides, the repayment period is only three years. Any capital investment required minimum seven years repayment.
With the revised guidelines, the expenditure incurred on production equipment will also be considered for calculation of subsidy amount to the pharma units, along with the already existing items including utilities such as HVAC, water and steam, clean room facility, testing lab and stability chamber, effluent treatment or waste management facility, consultation and certification expenses, and any other item with the recommendation of the Technical Committee.
According to the new guidelines, the units with an average turnover from Rs. 1 crore to less than Rs. 50 crore can avail incentive of 20 per cent of investment under eligible activities, units with turnover from Rs. 50 crore to less than Rs. 250 crore to get an incentive of 15 per cent of investment under eligible activities, and 10 per cent of investment under eligible activities for units with turnover from Rs. 250 crore to less than Rs. 500 crore.
Through the latest revision, the DoP has broadened the eligibility criteria, flexible financing options emphasizing subsidies on reimbursement basis over traditional credit-linked approach envisaging widespread adoption of the scheme and comprehensive support for compliance with new standards.
The revamped PTUAS aims to support MSMEs in upgrading their technology and infrastructure to meet international standards. The scheme provides financial assistance to pharma MSMEs for upgrading their manufacturing facilities, adopting good manufacturing practices, and enhancing their overall competitiveness. By addressing gaps in their current capabilities, the scheme enables these enterprises to produce high-quality pharmaceutical products and expand their market reach.
DoP approves 7 applications under revamped PTUAS
The Department of Pharmaceuticals (DoP) has received over 100 applications for the support under the revamped the Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS) and approved seven from the Micro, Small and Medium Enterprises (MSMEs), according to a statement by the Central government.
The statement comes out at a time when a section of the industry alleged that the revamped scheme is also not helping the MSMEs to upgrade their facilities to the Revised Schedule M standards and the World Health Organisation’s (WHO) Good Manufacturing Practice (GMP) certifications.
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