Pharma Tech Incentives Extend to Non-MSMEs

The Indian government has launched a revamped scheme to help the pharmaceutical industry upgrade its technology and quality standards and align with the global norms.The Department of Pharmaceuticals (DoP) has unveiled the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS) on March 11, 2024, to help advance the technological capabilities of India’s pharmaceutical industry and align it with the global standards .

Key features of the scheme

The key features of the revised scheme include:

• Expanded eligibility criteria, now encompassing pharmaceutical manufacturing units with a turnover of less than Rs 500 crore, besides micro, small, and medium enterprises (MSMEs). The scheme prioritises MSMEs to aid smaller players in achieving high-quality manufacturing standards.
• Flexible financing options, emphasising subsidies on a reimbursement basis over the traditional credit-linked approach. The subsidies range from 10% to 20% of the investment under eligible activities, depending on the turnover of the unit.
• Integration with state government schemes, enabling units to benefit from additional top-up assistance from the respective states.
• Support for a broader range of technology upgrades, including improvements such as HVAC systems, water and steam utilities, testing laboratories, stability chambers, clean room facilities, effluent treatment, waste management, etc.
• Robust verification mechanism through a project management agency that will ensure transparency, accountability and efficient allocation of resources.

Benefits of the scheme

The revised scheme aims to support the pharmaceutical industry’s upgradation to the revised Schedule-M and WHO-GMP standards . In January 2024, the health ministry had notified the revised Schedule M norms in order to 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.

The scheme is expected to enhance the quality of pharmaceutical products manufactured across the country and boost their competitiveness in the domestic and international markets. It will also help in creating a conducive environment for innovation and research and development in the pharma sector.

Conclusion

The RPTUAS is a welcome step by the government to help the pharma industry upgrade its technology and quality standards and align with the global norms. It will benefit not only the industry but also the consumers and patients who rely on safe and effective medicines. The scheme will also contribute to India’s vision of becoming a global leader in pharma manufacturing and exports.

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