The Department of Pharmaceuticals (DoP) has revamped the scheme to help drug companies upgrade their technological capabilities and ensure the alignment with the global standards. Under the revised scheme, known as Pharmaceuticals Technology Upgradation Assistance Scheme (PTUAS), the eligibility has been expanded beyond the MSMEs sector to include any pharma manufacturing unit with a turnover of less than Rs 500 crore that need technology and quality upgradation.
Even though the revamped scheme will continue to give preference to MSMEs, it aims to broadly enhance the quality of pharmaceutical products manufactured across the country. The revamped scheme also introduces more flexible financing options, emphasising subsidies on reimbursement basis over traditional credit-linked approach. Moreover, the revised scheme allows integration with state government schemes, enabling units to benefit from additional top-up assistance.
To align with the revised Schedule-M and WHO-GMP standards, the scheme is giving support to a broader range of tech upgrades, including improvements such as HVAC systems, water and steam utilities, testing laboratories, stability chambers, clean room facilities, effluent treatment, waste management, etc.
In addition, the scheme introduces a robust verification mechanism through a project management agency that will ensure transparency, accountability and the efficient allocation of resources.
DoP said that the revised guideline aims to support the pharmaceutical industry’s upgradation to the revised Schedule-M & WHO-GMP standards. In January, the health ministry had notified the revised Schedule M norms in order to bring bring the pharma and biopharmaceutical quality standards at par with the global standards. Under the revised Schedule M guidelines, the pharma companies are required to intimate the licensing authority about recalling a drug and also report product defects, deterioration or faulty production.
The guidelines have come at a time when the Indian drugmakers, especially MSMEs, are increasingly being accused of exporting lower quality drugs.
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 about 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 and middle-income countries which require WHO GMP certification.
