Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
1. Regulatory reforms under the Biological Diversity Amendment Act, 2023 are driving increased intellectual property filings linked to India’s biological resources. Streamlined procedures and mandatory prior registration with the National Biodiversity Authority have enhanced compliance, improved processing efficiency, and strengthened alignment between innovation, conservation priorities, and equitable benefit sharing frameworks
Source: shortlink.uk/1nbX2
2. The Jammu & Kashmir and Ladakh High Court has ruled that merely holding the position of Director or Managing Director does not automatically attract liability under the Drugs and Cosmetics Act, 1940. Liability arises only if specific allegations prove the individual was responsible for the company’s conduct or involved in the offence.
Source: shortlink.uk/1sqvC
3. The Drugs Consultative Committee(DCC) has approved a proposal to develop a real-time digital portal for tracking manufacture, import, export, sale, and stock of pharmaceutical products regulated under the Narcotic Drugs and Psychotropic Substances Act. The portal is aimed at strengthening surveillance, with potential integration involving CDSCO, State Authorities, and the Central Bureau of Narcotics.
Source: shortlink.uk/1nbXc
4. The Department of Pharmaceuticals has liberalised the RPTUAS guidelines to allow shortlisted applicants to claim the first instalment of subsidy upon submission of either a Revised Schedule M or WHO-GMP certificate. The remaining certificate may be furnished at the time of claiming the second instalment, thereby providing greater flexibility in meeting compliance requirements.
Source: shortlink.uk/1nb-y
5. India’s Directorate General of Foreign Trade expanded the mandatory Halal certification requirement under the India Conformity Assessment Scheme (I CAS) Halal to 20 additional countries, including Egypt, Kenya, Morocco, and Maldives. Exporters must obtain certification from NABCB-accredited bodies, with compliance effective within two weeks (six months for Egypt).
Source: shortlink.uk/1sqvW