New Delhi: India plans to bring a new generation of treatments involving gene and stem cell therapies under strict government scrutiny as the market for such treatments grows.
The proposed changes are aimed at amending the law to include therapies such as stem cell-derived products, gene therapy and xenografts (animal-to-human transplants), according to documents reviewed by Mint.
That will bring the manufacturing and licensing of these complex therapies under regulatory processes that will ensure the safety and quality of these cutting-edge biologics, said two officials with knowledge of the matter, as the proposal is not yet public.
The proposed changes are part of a draft notification issued by the Ministry of Health on 16 October. They propose to amend the Drugs Rules of 1945 to expressly include products derived from cells or stem cells, gene therapy products or xenografts along with “drugs derived from recombinant DNA (r-DNA)” in various sections. The ministry is expected to release 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.
India’s cell and gene therapy market is expected to grow from USD 710.91 million in 2024 to USD 2.51 billion by 2033 at a CAGR of 15.10%, according to 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 therapy is being explored for use in cancer, diabetes and nerve damage,” said an official with knowledge of the matter, speaking on condition of anonymity.
The official said the new regulations aim to create a framework to ensure the safety and quality of these complex, high-potential products, and boost both innovation and public confidence in these transformative medical advances.
Inquiries sent to a spokesperson for the Ministry of Health went unanswered.
The total number of patients suffering from identified rare diseases in the country is 7,414, according to data from the National Registry for Rare Disease and Other Inherited Disorders (NRROID) portal maintained by the Indian Council of Medical Research (ICMR).
Under the National Policy on Rare Diseases (NPRD), 2021, the government provides financial assistance up to ₹50 million for treatment. Certain orphan drugs in India are tax exempt.
While stem cell therapy and gene therapy offer significant potential for diagnosis and treatment, their use must be cautious and tightly controlled, said Dr. Parveen Jain, Principal Consultant and Head of Oncology, Aakash Healthcare. The government’s proposal prioritizes patient safety by ensuring that only safe and tested therapies are made available to the public, which runs counter to the big claims made by unproven clinics, he said.
“This regulation will also instill confidence in doctors to use these new options because they know they are meeting the right standards,” he said. “Additionally, the rules are expected to protect patients from dangerous claims and accelerate innovation in the pharmaceutical and research sectors in India by introducing a clear and credible approval process.”
