In response to the growing market for advanced medical treatments, India plans to impose stringent regulations on gene and stem cell therapies, as well as on xenografts, which involve transplants from animals to humans. This initiative aims to amend existing laws to encompass therapies derived from stem cells and gene therapies, according to documents reviewed by Mint.
The forthcoming changes will bring the manufacturing and licensing of these intricate therapies under governmental oversight, thereby enhancing the safety and quality of these innovative biological products. Officials familiar with the developments, who opted to remain anonymous, highlighted that the draft notification released by the Ministry of Health on October 16 proposes modifications to the Drugs Rules of 1945. These amendments will explicitly include products derived from stem cells, gene therapeutic products, and xenografts alongside recombinant DNA-derived drugs.
The ministry is expected to finalize and publish these regulations soon. This move is crucial as India”s market for cell and gene therapies is on the rise, with these treatments playing a significant role in addressing various conditions, including genetic disorders, multiple types of cancer, and degenerative diseases. According to the International Market Analysis Research and Consulting Group, the Indian cell and gene therapy market is projected to grow from $710.91 million in 2024 to $2.51 billion by 2033, reflecting a compound annual growth rate of 15.10%. The stem cell therapy sector alone is anticipated to increase from $816 million in 2024 to $3.63 billion by 2035.
An official noted that gene therapy has the potential to fix defective genes, while stem cell treatments are being researched for their application in cancer, diabetes, and nerve injuries. The new regulations are designed to create a framework that ensures the safety and efficacy of these high-potential products, thus promoting innovation while establishing public confidence in these transformative medical advancements.
Despite multiple inquiries, responses from the health ministry spokesperson have not yet been received. Current data from the National Registry for Rare Disease and Other Inherited Disorders, maintained by the Indian Council of Medical Research, indicates that there are 7,414 patients suffering from identified rare diseases within the country. Under the National Policy for Rare Diseases implemented in 2021, the government offers financial assistance of up to ₹50 lakh for treatments, with some rare-disease medications in India being tax-exempt.
While the potential of stem cell and gene therapies is significant for both diagnosis and treatment, caution and stringent oversight are necessary, emphasized Dr. Parveen Jain, a senior consultant and head of the oncology department at Aakash Healthcare. He stated that the government”s proposal prioritizes patient safety by ensuring that only safe and rigorously tested therapies are available to the public, countering exaggerated claims made by unverified clinics. Dr. Jain also expressed that these regulations would bolster doctors” confidence in utilizing these new treatment options, as they would adhere to established standards. Furthermore, the anticipated rules are expected to shield patients from unsafe claims while accelerating innovation in India”s pharmaceutical and research sectors by instituting a reliable approval process.
