Govt revamps pharma scheme, entails financial assistance to drug cos

The Department of Pharmaceuticals has revamped a scheme which entails financial assistance to drug companies to help them upgrade their facilities to produce medicines conforming to global standards, an official release said on Monday.

As per the revamped Pharmaceuticals Technology Upgradation Assistance Scheme (PTUAS), the government has expanded the scope of the initiative beyond MSMEs to include any pharmaceutical manufacturing unit with a turnover of less than Rs 500 crore that requires technology and quality upgradation, the Chemicals and Fertilisers ministry said in a statement.

Preference however remains for MSMEs, supporting smaller players in achieving high-quality manufacturing standards, it added.

The revamped scheme also introduces more flexible financing options, emphasising subsidies on reimbursement basis, over traditional credit-linked approach.

This flexibility is designed to diversify the financing options of the participating units, facilitating a more widespread adoption of the scheme, the statement said.

Besides, in alignment with revised Schedule-M and WHO-GMP standards, the scheme now supports a broader range of technological upgrades, the ministry said.

Eligible activities include improvements such as HVAC systems, water and steam utilities, testing laboratories, stability chambers, clean room facilities, effluent treatment, waste management etc. ensuring comprehensive support for participating units, it added.

Similarly, the revised scheme allows integration with state government schemes, enabling units to benefit from additional top-up assistance.

This collaborative approach aims to maximise support for the pharmaceutical industry in their technology upgradation efforts, as per the statement.

The scheme also introduces a robust verification mechanism through a project management agency, ensuring transparency, accountability and the efficient allocation of resources, it added.

The revised guideline aims to support the pharmaceutical industry's up-gradation to the Revised Schedule-M & WHO-GMP standards, enhancing the quality and safety of pharmaceutical products manufactured in the country, the ministry stated.

In January this year, the Union Health Ministry notified the Revised Schedule M guidelines under which pharmaceutical companies will have to intimate the licensing authority about recalling a drug and also report product defects, deterioration or faulty production.

These guidelines come against the backdrop of complaints of sub-standard Indian drugs and deaths abroad reportedly due to it since 2022.

Schedule M part of Drugs and Cosmetics Act 1940 deals with 'Good Manufacturing Practices' to be followed by pharmaceutical manufacturing units in the country. There are around 10,500 manufacturing units in the country out of which around 8,500 fall under the MSME category.

India is a major exporter of medicines to low/middle-income countries (LMICs) which require WHO GMP certification.