India plans strict rules for gene, stem cell therapies

Copyright © HT Digital Streams Limited All rights reserved. This will bring the manufacturing and licensing of these complex therapies under regulatory processes, ensuring the safety and quality of these cutting edge biological products. (Pixabay) Summary The move aims to regulate cell and gene therapies, and xenotransplants or animal-to-human transplants. Such therapies are important for the treatment of various cancers, and genetic and degenerative disorders. New Delhi: India plans to bring the new generation of medical treatments involving gene and stem cell therapies under strict government control as the market for such treatments grows. The proposed changes are aimed at amending the law to cover therapies such as products derived from stem cells, gene therapy and xenografts (animal-to-human transplants), according to documents reviewed by Mint. It would bring the manufacturing and licensing of these complex therapies under regulatory processes, ensuring the safety and quality of these cutting-edge biologics, two officials with knowledge of the matter said, as the draft is not yet public. The proposed amendments are part of a draft notification issued by the Ministry of Health on 16 October. They propose to amend the Drugs Rules, 1945, to expressly include cell or stem cell derived products, gene therapeutic products or xenotransplants, along with “recombinant DNA (r-DNA) derived drugs” in various sections. The ministry is expected to announce the rules soon. The move aims to regulate advanced therapies as India’s cell and gene therapy market grows. These therapies are important for treating conditions such as genetic disorders, various cancers and degenerative disorders. The Indian cell and gene therapy market is expected to grow from $710.91 million in 2024 to $2.51 billion by 2033 at a compound annual growth rate of 15.10%, according to data from International Market Analysis Research and Consulting Group (IMARC group). The stem cell therapy segment alone is expected to grow from $816 million in 2024 to $3.63 billion by 2035. “Gene therapy offers the potential to correct faulty genes, and stem cell treatments are being explored for applications in cancer, diabetes and nerve damage,” said an official familiar with the matter, speaking on condition of anonymity. The official said the new regulations aim to establish a framework that ensures the safety and quality of these complex, high-potential products, promoting both innovation and public confidence in these transformative medical advances. Inquiries sent to the spokesperson of the Ministry of Health remained unanswered. The total number of patients suffering from identified rare diseases in the country is 7,414, according to data on the portal of the National Register of Rare Diseases and Other Inherited Diseases (NRROID) maintained by the Indian Council of Medical Research (ICMR). Under the National Policy on Rare Diseases (NPRD), 2021, the government provides financial assistance of up to ₹ 50 lakh for treatment. Some of the medicines for rare diseases in India are duty free. While stem cell and gene therapy treatments offer significant potential for diagnosis and treatment, their use must be carefully and tightly controlled, Dr. Parveen Jain, Senior Consultant and Head of Department of Oncology, Aakash Healthcare, said. The government’s proposal prioritizes patient safety by ensuring that only safe and tested therapies reach the public, and against big claims made by unverified clinics, he said. “This regulation will also instill confidence in doctors to use these new options, knowing that they meet proper standards,” he said. “Furthermore, the rules are expected to protect patients from unsafe claims and accelerate innovation in the pharmaceutical and research sectors in India by establishing a clear, reliable process for approval.” Get all the Business News, Market News, Breaking News Events and Latest News Updates on Live Mint. Download the Mint News app to get daily market updates. more topics #news #india #healthcare Read next story