The updated Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) is anticipated to significantly benefit MSME manufacturers within the pharmaceutical industry. It is set to enhance their capabilities, enabling them to meet superior standards and compete internationally. Focused on improving quality and building capacity, the scheme supports the wider goal of driving innovation and excellence in the sector, according to industry specialists.
Experts suggest that the industry’s stakeholders should now leverage this opportunity to upgrade their facilities to compliance with the Revised Schedule M standards.
The Indian pharmaceutical MSMEs are poised for a notable transformation with the redesigned PTUAS, as numerous companies have shown interest following a thorough gap analysis, mentioned Dr. Arunish Chawla, Secretary, Department of Pharmaceuticals (DoP), while speaking at a quality summit in Mumbai.
He stressed the gravity of maintaining high standards in pharmaceuticals, emphasizing factors such as market quality, patient trust, and industry reputation. Dr. Chawla underlined the significance of India’s upgraded requirements, paralleling the Prime Minister’s ‘Zero defect and Zero effect’ initiative.
He called for increased investment in quality and collaboration in upholding high standards to safeguard the industry’s image and ensure excellence.
RPTUAS
Renamed as RPTUAS on March 11, 2024, the scheme aims to enhance industry participation and help align production processes with international guidelines. As part of the “Strengthening of Pharmaceuticals Industry (SPI)” initiative, this sub-scheme assists existing pharma units in aligning with Revised Schedule M and WHO-GMP standards. Beneficiaries include pharmaceutical companies with turnovers below Rs. 500 crore over the past three years.
Given the initial lukewarm reception, the DoP has revised the scheme multiple times over the past two years to better appeal to MSMEs. Significant modifications were made alongside initial guidelines released on March 11, 2022, revised in July 2022, January 2023, and again on March 11, 2024.
As further improvements were necessary, these were again made on September 17, 2024, with an increased maximum incentive and the inclusion of equipment expenditure for subsidy calculation.
The revised scheme eliminates the need for an extensive gap analysis for online applications, now requiring only a standard analysis. The maximum incentive limit has been doubled to Rs. 2 crore.
Technology Support Initiative
Reflecting the global trend towards automation, India’s pharmaceutical sector is moving in tandem, intent on preserving its stature as the “Pharmacy of the World.” Acknowledging this sectoral need, the government has refined PTUAS to support new technology adoption, aiding industry growth and compliance with international standards, observes Kaushik Desai, a pharma consultant.
The scheme offers essential support for facility upgrades, ensuring the industry remains competitive in the global arena, he adds.
Participation in PTUAS can modernize operations, boost competitive edge, and foster industry growth.
Sunil Attavar, former president of Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA), remarks that the revised PTUAS is a significant boon for small and medium enterprises within the sector. Its broadened eligibility and flexible financing inspire many companies to seize these benefits and upgrade.
PTUAS Evolution
Launched more than two years ago, the DoP designed PTUAS to aid MSMEs in elevating their manufacturing capabilities to WHO-GMP or Schedule M standards.
Initially providing a 10 per cent capital subsidy on loans up to Rs. 10 crores, PTUAS was a credit-linked scheme. Despite its potential, the scheme faced criticism for limited incentives and a short repayment period, prompting further revisions.
Current guidelines factor equipment costs into subsidy calculations, allowing units between Rs. 1 crore and Rs. 50 crore in turnover to receive a 20 percent incentive, those up to Rs. 250 crore a 15 percent incentive, and units up to Rs. 500 crore a 10 percent incentive.
The DoP broadened eligibility and introduced flexible funding options, emphasizing subsidies on a reimbursement basis instead of a credit-based approach, aiming for widespread scheme adoption and comprehensive support for compliance.
The revamped PTUAS strives to bring MSMEs in line with international standards by offering financial aid for upgrading manufacturing facilities, promoting sustainable good manufacturing practices, and bolstering competitiveness. These enhancements address current operational gaps, empowering enterprises to produce premium pharmaceuticals and expand market presence.
PTUAS Application Approvals
To date, the Department has approved seven out of over 100 MSME applications under the enhanced RPTUAS. However, some industry voices express concern that the revised scheme may still fall short of assisting MSMEs in reaching Revised Schedule M and EHO GMP standards.