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. The Central Government has amended the New Drugs and Clinical Trials Rules, 2019 to streamline manufacture of new and investigational drugs for testing purposes. The amendment permits limited manufacturing for analytical and non-clinical testing based on prior intimation, except for specified high-risk categories, and reduce timelines from ninety to forty-five working days.
Source: h7.cl/1iiiB
2. India’s Food Safety and Standards Authority (FSSAI) has proposed amendments to its licensing regulations to tighten compliance. Delayed filing of the annual Food Safety Compliance Return beyond 31 May will attract graded penalties, and non-filing beyond 180 days will lead to deemed licence suspension. The draft also clarifies storage practice and record-keeping requirements for manufacturers, with exemptions for non-manufacturers and retailers. Public comments are invited latest by 19th March 2026.
Source: h7.cl/1nhPE
3. India’s Central Insecticides Board and Registration Committee has decided that pesticides highly sensitive to acidic or alkaline water must carry specific label and leaflet instructions on optimal water pH. Applicants and registrants have been advised to ensure compliance while seeking registration and finalising labels.
Source: h7.cl/1iiiN
4. India’s Health Ministry has asked the National Medical Commission (NMC) to examine and take appropriate action regarding appeals filed by individuals who are not registered medical practitioners against decisions made by State Medical Councils. This could affect rights of patients and the public to seek redress against decisions affecting healthcare practice and professionals.
Source: h7.cl/1iiiS
5. The Committee for Control and Supervision of Experiments on Animals (CCSEA) has issued a structured inspection schedule and standard operating procedures for animal facilities of Clinical Research Organisations and research and development laboratories. It mandates three inspections over a year, clarifies roles of IAEC nominees, and introduces standard feedback and confidentiality requirements.
Source: h7.cl/1nhPP