60 Small Drug Makers Join Pharma Tech Upgrade Scheme Facing Quality Concerns

This move aims to enhance drug production standards and restore confidence in Indian pharmaceutical products globally.

To enhance pharmaceutical manufacturing quality in India, 60 small drug makers have registered for the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS).

This initiative promises financial incentives to modernize their facilities, aligning with Indian efforts to meet global good manufacturing practices (GMP).

The enrollment comes in the wake of recent incidents where Indian-made drugs distributed in North America, Africa, and Central Asia were found toxic, resulting in fatalities and raising concerns about the quality of Indian pharmaceutical exports.

Over thirty firms have already begun the process of upgrading their manufacturing units under the RPTUAS.

Last year, the Indian government revised the Drugs and Cosmetics Act, mandating that pharmaceutical companies comply with the World Health Organization (WHO) recommended GMPs.

This move aims to enhance drug production standards and restore confidence in Indian pharmaceutical products globally.

More on the Revamped Pharma Tech Scheme

The RPTUAS is designed to assist small and medium enterprises (SMEs) in the pharmaceutical sector in meeting these updated standards.

Speaking on anonymity, an official stated, "To help smaller plants, the scheme is facilitating existing pharma units to upgrade to revised standards. A portal has been opened wherein 60 plants have registered, and they are being trained or assisted to follow GMP rules and upgrade themselves. Thirty plants have already started upgrading their facilities."

The government is encouraging more companies to join the scheme and take advantage of the financial incentives available to upgrade their operations.

The initiative prioritizes MSMEs, ensuring that smaller players can also achieve high manufacturing standards.

Financial Incentives & Eligibility

Pharma firms with an average revenue of less than INR 500 Cr over the past three years are eligible for financial incentives under the scheme. The maximum incentive per unit is INR 1 Cr.

The scheme provides tiered incentives based on the firm's revenue:

- INR 1 Cr to less than INR 50 Cr: Eligible for 20% of investment.

- INR 50 Cr to less than INR 250 Cr: Eligible for 15% of investment.

- INR 250 Cr to less than INR 500 Cr: Eligible for 10% of investment.

Eligible activities for investment include heating, ventilation, and air conditioning (HVAC) systems, water and steam utilities, testing laboratories, stability chambers, clean rooms, effluent treatment, and waste management systems.

Harish K Jain, president of the Federation of Organizations of Pharmaceutical Entrepreneurs (FOPE), highlighted the scheme's importance for MSMEs and noted the growing participation.

"Most of the companies that have registered are MSMEs, and more are likely to join soon. GMP compliance requires meeting the highest standards, which is why it takes time for companies to upgrade their facilities. It is easier to start a new factory than to upgrade an existing one. We are educating our member companies on GMP standards as the new guidelines have undergone drastic changes this time," Jain said.