India tightens rules for gene, stem cell therapies
India is stepping up its game on gene and stem cell therapies to make sure treatments are safe and actually work.
The Health Ministry recently proposed updates to the old Drugs Rules, so now things like gene therapies, stem cell products, and even animal tissue grafts will need proper licenses and safety checks.
It's all about making sure only high-quality, approved treatments reach people as the country's advanced therapy scene grows fast.
CDSCO will now oversee approvals for cutting-edge therapies
The CDSCO (that's India's top drug regulator) will now oversee approvals for these cutting-edge therapies, keeping up with new tech and making sure research stays ethical.
Recent homegrown cancer treatments like NexCAR19 and Qartemi show India's getting serious about doing this right.
Experts say these new rules could boost trust among doctors, stop shady clinics, and speed up innovation—though cost is still a big hurdle for most patients.
IMARC Group's predictions on India's cell and gene therapy market
India's cell and gene therapy market is set to jump from $710 million in 2024 to $2.5 billion by 2033, according to IMARC Group.
These tighter rules aim to make the industry safer and more reliable, but making treatments affordable for everyone is still a work in progress.