According to a Monday official announcement, the Department of Pharmaceuticals has redesigned a program that provides drug companies with financial support to update their facilities and manufacture medications that meet international standards.
The Chemicals and Fertilizers ministry released a statement announcing the redesigned Pharmaceuticals Technology Upgradation Assistance Scheme (PTUAS), which now covers pharmaceutical manufacturing units with a turnover of less than Rs 500 crore that need to upgrade their technology and quality.
However, MSMEs continue to be preferred, helping small businesses to meet rigorous criteria for manufacturing, it continued. The redesigned program also offers more adaptable financing choices, prioritizing reimbursement-based subsidies over the conventional credit-linked model.
According to the statement, this flexibility is intended to diversify the financing choices available to the participating units, enabling a wider adoption of the plan. Additionally, the ministry stated that the program now offers a wider range of technology updates in compliance with updated Schedule-M and WHO-GMP criteria.
Improvements like HVAC systems, water and steam utilities, testing labs, stability chambers, clean room facilities, effluent treatment, waste management, etc. are eligible operations, it continued, guaranteeing complete support for involved units.
In a similar vein, the updated plan permits cooperation with state government initiatives, allowing units to get access to extra support.
According to the statement, this cooperative strategy seeks to maximize support for the pharmaceutical industry's technological advancement initiatives.
It further stated that the plan establishes a strong verification process via a project management organization, guaranteeing responsibility, openness, and the effective use of resources.
According to the ministry, the updated guideline intends to assist the pharmaceutical industry's transition to the WHO-GMP and Revised Schedule-M standards, improving the quality and safety of pharmaceutical products produced domestically.
The Union Health Ministry announced the Revised Schedule M rules in January of this year. These recommendations require pharmaceutical businesses to notify the licensing authorities when they recall a drug and to report any faults, deterioration, or improper manufacture.
These recommendations are being made against the background of reports of subpar Indian medications and deaths abroad that are purportedly caused by them since 2022.
The "Good Manufacturing Practices'' that the nation's pharmaceutical manufacturing facilities must adhere to are covered under Schedule M of the Drugs and Cosmetics Act 1940. Of the approximately 10,500 manufacturing facilities in the nation, about 8,500 are classified as MSME's.
India is a significant exporter of pharmaceuticals to low- and middle-income nations (LMICs), where WHO GMP certification is necessary.
