India has strict regulatory requirements for accessing biological resources of Indian origin under its Biological Diversity (2002) Act. This Act is applicable to Indian citizens/companies, NRIs and Foreign citizens/companies that utilize plants, animals or microorganisms (including their genetic material and byproducts) for research, commercial, Intellectual Property Rights obtainment or other purposes.
Prior approval/Intimation to Biodiversity regulatory authorities is mandatory for utilizing biological resources of Indian origin. Regulatory requirements vary based on the nature of the applicants. Contravention of the Act has serious consequences by way of imprisonment and hefty fines.
Broad ambit of the BD Act, lack of definitions for many key terms, varied interpretations of the Act, dearth of case laws for proper interpretation of the Act, to name a few, render each application for approval unique and challenging and the process of obtaining approval from the concerned authority into a complex maze that could drag on for months, if not years, thus warranting professional help. The impact on business if show cause notices are issued for contravention of the Act and the seriousness of the punishments imposed on the offender further warrants professional assistance.
Prometheus endeavors to offer end-to-end services for our Life sciences clients and our seasoned regulatory consultants ease the process of obtaining the necessary approval from Biodiversity regulatory authorities.