Evaluation of Drugs, Patenting and Regulatory requirements of natural products and Regulatory Issues

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Evaluation of Drugs WHO & ICH guidelines for the assessment of herbal drugs. Stability testing of herbal drugs.

 

Patenting and Regulatory requirements of natural products:

Definition of the terms: Patent, IPR, Farmers right, Breeder’s right, Bioprospecting and Biopiracy. Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma & Neem.

Regulatory Issues – Regulations in India (ASU DTAB, ASU DCC), Regulation of manufacture of ASU drugs – Schedule Z of Drugs & Cosmetics Act for ASU drugs.

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