Govt Sanctions Rs 181.59 Cr for Pharma Upgrades Under RPTUS, Parliament Informed
New Delhi: A total of 192 applications has been approved so far, with a total sanctioned amount of Rs 181.59 crore under the Government's Revamped Pharmaceuticals Technology Upgradation Scheme (RPTUS), the Ministry of Chemicals and Fertilizers informed the Parliament while outlining measures to strengthen the quality of Indian medicines exported abroad.
During a recent Rajya Sabha session, MP Shri Meda Raghunadha Reddy had asked whether the Government was aware of recent reports by the US Food and Drug Administration (FDA) uncovering lapses at factories run by major Indian pharmaceutical companies, including unsanitary manufacturing conditions, poorly trained staff, under-investigated complaints and evidence of contaminated drugs being exported to the US. He also sought details of the steps taken to ensure the quality of drugs exported abroad, the new Good Manufacturing Practices introduced under the Drugs and Cosmetics Rules to address such deficiencies, and the mechanisms put in place to ensure timely adoption of upgraded standards by all manufacturers.
In response to the queries, Minister of State for Chemicals and Fertilizers Anupriya Patel informed that “isolated report of the drugs not meeting prescribed standards have appeared in sections of the media and websites of certain foreign regulatory authorities.”
She further clarified that “manufacturers are required to obtain license for manufacturing of drugs for export as per the provisions of the Drugs and Cosmetics Act, 1940 and the rules made thereunder, as well as to comply with the requirements of the importing country and address deficiencies observed during the inspections, if any.”
The Minister added that the Government amended the Drugs Rules, 1945 on 28.12.2023, “revising its Schedule M related to good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products manufactured for consumption in India.”
To support industry compliance with the revised standards, she highlighted that the Revamped Pharmaceuticals Technology Upgradation (RPTU) Scheme provides financial assistance for upgrades, under which “applicants are provided support up to a maximum of ₹2 crore for such upgrade. A total of 192 applications has been approved so far, with total sanctioned amount of ₹181.59 crore.”
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