DoP Approves 7 Applications Under Revamped PTUAS

The RPTUAS was redesigned to assist pharmaceutical units in upgrading their facilities to comply with Revised Schedule M standards and WHO’s Good Manufacturing Practice (GMP) certifications.

The Department of Pharmaceuticals (DoP) has approved seven applications from Micro, Small, and Medium Enterprises (MSMEs) under the revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS). 

Over 100 applications have been received since the scheme's relaunch on April 11, 2024.

The RPTUAS was redesigned to assist pharmaceutical units in upgrading their facilities to comply with Revised Schedule M standards and WHO’s Good Manufacturing Practice (GMP) certifications. 

Despite this, concerns have arisen within the industry regarding the scheme’s effectiveness. 

Some industry representatives argue that the current iteration of the scheme has not significantly improved the capacity of MSMEs to meet these standards.

“Under the Revamped PTUAS Scheme, an application window has been opened from April 11, 2024, and more than 100 applications have been received. Seven applications have been approved, and all the approved applicants are MSMEs. The sanction and approval letters have been issued to all approved applicants,” JP Nadda, the Minister of Chemicals and Fertilisers, confirmed.

The RPTUAS aims to support 300 units, divided equally over the fiscal years 2024-25 and 2025-26, with a total budget of INR 300 Cr. This is a reduction from the previous plan to support 420 projects with the same budget.

Revised Guidelines & Industry Response

The updated guidelines for RPTUAS were issued on March 11, 2024. The revised scheme is part of the broader “Strengthening of Pharmaceuticals Industry (SPI)” Scheme. 

The changes include a more flexible financing structure, focusing on subsidies rather than traditional credit-linked loans. 

The eligibility has been expanded to include units with a turnover of less than INR 500 Cr over the last three years.

The scheme provides financial assistance of up to INR 1 Cr for eligible units. Specifically, units with turnover from INR 1 Cr to INR 50 Cr are eligible for 20% of the investment under eligible activities. 

Units with a turnover from INR 50 Cr to INR 250 Cr are eligible for 15%, and those with a turnover from INR 250 Cr to INR 500 Cr can receive 10%.

The revised guidelines also removed the penalty clause that previously required a bank guarantee and included a stipulation that loans would be converted to normal loans if technological upgradation was not achieved within 18 months. 

This clause has been replaced with a more flexible incentive structure and integration with state government schemes.

Despite these revisions, some industry associations have requested further extensions to the compliance timeline for MSMEs. 

The industry argues that the current support is insufficient to address the challenges faced by smaller pharmaceutical units in upgrading their facilities to meet new standards.

Administrative Actions

The Ministry of Chemicals and Fertilizers has also addressed a recent complaint involving an Assistant Section Officer (ASO). The ASO was found to have sent an informal email to pharmaceutical associations using inappropriate language. 

The officer has issued an apology, and departmental proceedings have been initiated.

The PTUAS, now rebranded as RPTUAS was revised to better align with global standards and support technological advancements within the industry. 

The scheme’s objectives include upgrading pharmaceutical production facilities to meet Revised Schedule M and WHO-GMP standards, aiming to enhance global competitiveness.

The revised scheme is intended to support MSMEs in becoming self-reliant and meeting international production standards. Despite these aims, the effectiveness of the new guidelines remains a topic of discussion within the industry.