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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 Indian Medical Association (IMA) has challenged the Maharashtra government’s decision allowing homeopaths to prescribe allopathic medicines after six months of certified training, calling it a threat to public health. The IMA has filed a petition in the Bombay High Court, urging an expedited resolution of the matter.
Source: bit.ly/4kl20ip

2. A government panel, the Drugs Consultative Committee (DCC) under CDSCO, has directed State Licensing Authorities not to issue manufacturing licenses for new drugs without prior approval from the Central Licensing Authority (CLA), as mandated by New Drugs Clinical Trial Rules 2019.
Source: bit.ly/3GC8A6l

3. India’s NITI Aayog has setup an expert panel to review quality concerns in India’s pharmaceutical manufacturing. It will assess regulatory gaps and challenges across 3,000 companies and 10,500 units. The goal is to align production with global standards, boost compliance, and ensure patient safety to uphold India’s global medicine supplier status.
Source: bit.ly/3GvWBHB

4. The Drugs Consultative Committee (DCC) has recommended inclusion of detachable Braille cards and voice-enabled QR codes on medicine packaging to enhance accessibility for visually impaired patients. The proposal aims to standardize inclusive labeling across pharma products, aligning with patient-centric and accessibility-first regulatory reforms.
Source: bit.ly/3TttpUw

5. The Drugs Consultative Committee (DCC) has approved amendments to Forms 27D/27DA and 28D/28DA under the Drugs Rules, 1945, enabling manufacturers to apply for licenses to produce stem cell-derived, gene therapy, xenograft, and modified-release products via both state and central authorities.
Source: bit.ly/3Ii5o0f

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. Several global pharmaceutical companies have approached the European Commission demanding assistance in maintaining operations in the EU and to help Europe keep the pharma industry including measures to compensate them for the cost of pharmaceutical innovations. This move comes in the face of threatened U.S. tariffs on imports.
Source: bit.ly/3RgXrK6

2. A pharma giant has allegedly breached the UK’s Prescription Medicines Code of Practice Authority (PMCPA) for its cancer drug’s misleading prescribing information, which failed to clearly state that women using hormonal contraceptives needed to take additional measures to prevent pregnancy while on the drug.
Source: bit.ly/4lzu3MO

3. India’s Department of Pharmaceuticals (DoP) has invited expression of interest for selecting an agency to conduct a comprehensive study of India’s pharmaceutical and medical device supply chains, in order to identify regulatory hurdle.
Source: bit.ly/42zIx6O

4. Central Drugs Standard Control Organisation has directed States and Union Territories to urgently stop the manufacture, sale, and distribution of 35 unapproved Fixed Dose Combinations licensed without safety and efficacy evaluation under New Drug and Clinical Trials rules, 2019. Authorities must investigate, take action, and report compliance to ensure public health and regulatory consistency.
Source: bit.ly/4cw43hg

5. China has amended its GB 9685 standard for additives in food contact materials. The changes include expanded use in silicone rubber, revised usage limits, updated additive names, and new safety calculations. These updates, effective March 2025, aim to improve consumer safety and industry compliance.
Source: bit.ly/4cGqBfE