If you weren’t aware, in 2017, the Indian government came out with guidelines effectively banning the commercial use of stem cells. In their public document, the use of cell & gene therapies outside of approved clinical trials was “unethical and shall be considered as malpractice”. (Except for hematopoietic stem cell therapy for certain blood disorders, like in the USA).
Now, according to Mint News, the country is proposing they move these guidelines into official law. The Indian government recently made a draft proposal (which isn’t public yet, so this is unconfirmed) to amend their drug laws, to explicitly include cell & gene therapies. This would likely bring the licensing, use, and manufacturing of these therapies under strict government oversight.
This will reportedly include:
- Cell and stem cell-derived products
- Gene therapies and rDNA-derived drugs
- Xenografts
We’ll be interested to see the draft once it’s public, what their thoughts are on autologous uncultured therapies, and what effect this has on the industry. Regenexx, an American regenerative company, has a physician in Mumbai, and you can see many instances of Indian stem cell clinics promoting their services to Americans in online forums.
Market analysis from International Market Analysis Research and Consulting Group (IMARC Group) estimates that India’s cell and gene therapy market will grow from $710.91 million in 2024 to $2.51 billion by 2033 at a compound annual growth rate of 15.10%.
Dr. Parveen Jain, senior consultant & head of oncology at Aakash Healthcare, commented: “While stem cell and gene therapy treatments offer significant potential for diagnosis and treatment, their use must be careful and strictly controlled.” Jain continued: “This regulation will also instil confidence among doctors to use these new options, knowing they meet proper standards. 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, trustworthy process for approval.”
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