Frequently Asked Questions

Does every herbal product require full CDSCO New Phytopharmaceutical Clinical Drug...

Does every herbal product require full CDSCO New Phytopharmaceutical Clinical Drug approval? No — a classical ASU medicine documented in an official formulary requires only Schedule T GMP compliance and correct labelling, not full CDSCO clinical review; the NPCD pathway applies specifically to genuinely new phytopharmaceutical drugs making novel therapeutic claims not covered by existing classical or pharmacopoeial precedent.

Can traditional use evidence alone support a patent application for a herbal formulation? No — traditional knowledge already in the public domain, whether documented in classical texts or through established community use, cannot be patented, and India's Traditional Knowledge Digital Library exists specifically to provide evidence defeating such biopiracy claims; patentability requires a genuinely novel technical contribution beyond the pre-existing traditional knowledge itself.