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TOP 5 HEALTH LAWS AND POLICY UPDATES

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

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

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 Delhi government’s ban on sending genetic samples outside the city for prenatal tests like NIPT and PGT, reportedly, faces strong opposition from diagnostic labs in Delhi. The labs have raised concerns that it will overload local labs, cause delays, increase costs, and limit access for patients in NCR and nearby states, urging reconsideration of the directive.
Source: short-url.org/1gmX1

2. The Bombay High Court has in a customs case held that allowing re-testing of seized goods is a trade facilitation measure. Denials must be rare and when made should be supported by written reasons. The court emphasized that refusal to retest should not be the norm.
Source: short-url.org/1gmXa

3. The Indian government will reportedly require all hospitals, both public and private, to include an Adverse Drug Reaction reporting form in every patient admission record. This under the Pharmacovigilance Programme of India aims to standardise monitoring of drug safety and better protect patients from adverse effects.
Source: short-url.org/1bHWo

4. The Committee for Control and Supervision of Experiments on Animals (CCSEA) has clarified that beagle dogs procured from breeders registered with State Animal Welfare Boards or State Animal Husbandry Departments are strictly for breeding colonies, not for experimentation. For testing, dogs must be sourced from CCSEA registered establishments.
Source: short-url.org/1bHWu

5. To ease certificate issuance delays, India’s central drug licensing authority reportedly has plans of shifting data verification in the CoPP (Certificate of Pharmaceutical Product) process to later stages instead of initial stage and conduct verification themselves bypassing initial scrutiny by state regulators.
Source: short-url.org/1gmXq