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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 Drugs Standard Control Organization (CDSCO) has issued a regulatory update outlining revised procedural and compliance requirements for industry stakeholders, aimed at strengthening regulatory oversight and streamlining approval processes. This is important as evolving CDSCO requirements may affect licensing, submissions, and regulatory timelines. Companies may now need to review internal compliance processes and align documentation and approval strategies accordingly.
Source: shortlink.uk/1tzqM

2. The Thrissur Consumer Commission held both the seller and the e-commerce platform liable for delivering an expired consumable product, ruling it an unfair trade practice and deficiency in service. Rejecting reliance on a “non-returnable” policy, the Commission ordered refund, compensation, and costs. It emphasized that platforms must ensure grievance redressal and cannot evade liability where defective or unsafe goods are supplied through their marketplace.
Source: shortlink.uk/1tzqU

3. The Ministry of Environment, Forest and Climate Change has amended the Bio-Medical Waste Management Rules, 2016, to include the Department of AYUSH and its nominated representatives in state and district-level waste management committees. This is important as it expands regulatory oversight to AYUSH healthcare facilities and strengthens compliance expectations. AYUSH institutions and related healthcare providers may now need to align with enhanced bio-medical waste management governance and monitoring requirements.
Source: shortlink.uk/1tzqI

4. Stakeholders have urged greater drug regulator oversight of nutraceuticals, citing concerns over quality standards, therapeutic claims, and wide pricing variations, with calls to shift certain nutraceuticals from food regulation to drug-level oversight. This is important as nutraceuticals are increasingly prescribed alongside medicines but lack uniform quality and pricing controls. Companies may now face stricter compliance requirements, enhanced quality standards, and potential regulatory scrutiny.
Source: shortlink.uk/1tzqY

5. The Central Drugs Standard Control Organization (CDSCO) has introduced a prior intimation system pursuant to amendments in the New Drugs and Clinical Trials Rules, 2019 effective April 21, 2026. It applies to bioavailability and bioequivalence studies for export-only drugs, excluding certain high-risk categories. CT-05 applications must be filed via Sugam with ethics approval, while other categories remain under prior approval. This is important as evolving CDSCO requirements may affect licensing, submissions, and regulatory timelines.
Source: shortlink.uk/1ohEa

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. Indonesia’s health ministry has directed food companies to introduce coloured labels indicating nutritional content, within two years. Red and green labels will indicate high and low sugar, salt, and fat content respectively. Companies must revise packaging and validate nutritional content to meet the new labelling requirements, but detailed sanctions for non-compliance have not been informed yet.
Source: shortlink.uk/1nEyC

2. Gujarat Food and Drug Control Administration has reportedly directed all ayurvedic medicine manufacturers to register on the ayudmla.gujarat.gov.in portal and upload complete legacy records, mandating digital compliance for licensing processes across the state. It strengthens regulatory oversight and promotes digital compliance in the ayurvedic sector.
Source: shortlink.uk/1sU3e

3. The Bangalore District Chemists and Druggists Association and other retail pharmacy groups have urged regulators to mandate licensing requirements for e-pharmacies displaying medicines online, similar to physical stores under the Drugs and Cosmetics Act, 1940. This is important as it highlights growing concerns around patient safety, regulatory gaps, and unfair competition. If implemented, e-pharmacy platforms may face stricter compliance, licensing requirements, and potential changes to their marketplace and digital medicine distribution models.
Source: shortlink.uk/1sU3h

4. A leading weight loss drug manufacturer has partnered with OpenAI to deploy artificial intelligence across drug discovery, manufacturing, and operations, while training its workforce globally. The initiative will help to enhance productivity, strengthen competitive positioning in the obesity therapeutics market, and improve overall efficiency without immediate workforce reductions.
Source: shortlink.uk/1nEyI

5. The Bangalore District Chemists and Druggists Association and other retail pharmacy groups have urged regulators to extend licensing norms for medicine display to e-pharmacies, seeking clarity on “offer for sale” under the Drugs and Cosmetics Act. This is important to curb unlicensed digital sales and ensure parity, potentially bringing online platforms under stricter licensing and compliance requirements.
Source: shortlink.uk/1sU3l

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 Department of Pharmaceuticals has amended the UCMPMD 2024, clarifying valuation of free evaluation samples at stockist price if self-manufactured or average purchase price if sourced externally. Companies in multiple associations may submit disclosures through one, with prior intimation to others and notification to the Department when switching.
Source: short-link.me/18ym-

2. India’s Health Ministry has proposed amendments to the New Drugs and Clinical Trials Rules, 2019, enabling simplified approval for bioavailability and bioequivalence (BA/BE) studies of oral drugs approved in India or select countries, for export purposes. The draft exempts certain drug categories and caps sample size at 48. Stakeholders may submit objections or suggestions by 27 September 2025.
Source: short-link.me/1d3UX

3. Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO) have released draft protocols for evaluating In-Vitro Diagnostics (IVDs) for tuberculosis, including drug-resistant strains. Stakeholders can submit comments by September 7, 2025. Final protocols will be based on this feedback before final clearance is given by ICMR and CDSCO.
Source: short-link.me/18ylZ

4. India’s Punjab and Haryana High Court has ruled that legible medical prescriptions is a fundamental right of patients and doctors must write prescriptions in capital letters until Digitalization. PGIMER Chandigarh’s “Doctor Desk” e-prescription system is expected to be implemented within two years.
Source: short-link.me/18ym7

5. The Ministry of Health and Family Welfare has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019. The proposals reduce approval timelines from ninety to forty-five working days and introduce a simplified notification system for manufacturing certain drugs meant for analytical and preclinical testing.
Source: short-link.me/1d3Vg

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 Pharmaceuticals Export Promotion Council of India (Pharmexcil) has invited its members to identify export challenges and propose strategies to enhance pharmaceutical exports. Members have been asked to report on specific tariff and non-tariff barriers affecting trade and suggest innovative solutions, which will be collected through a dedicated “Issues & Strategies” section on the Pharmexcil website. This initiative aims to address existing hurdles and foster collaboration for the growth of India’s pharmaceutical industry in global markets.
Source: bit.ly/4gi7n09

2. The Karnataka government has suspended the state drugs controller for not taking procedural actions against the pharma company which supplied the substandard lactate IV fluid which resulted in the death of women. The use of this faulty intravenous fluid is believed to have contributed to serious complications during surgeries at a district hospital.
Source: bit.ly/3VsRQCP

3. The Health Research Authority (HRA) has proposed to simplify the process of seeking and recording consent for low-risk clinical trials in the UK. While the method for discussing trials with potential participants remains unchanged, the new approach allows prescribers to document consent directly in a participant’s medical record instead of requiring a written consent form. This ensures that informed consent is still legally mandated, and participants can withdraw at any time, while aiming to reduce administrative burdens and enhance trial efficiency.
Source: bit.ly/3BgotNm

4. The Fertiliser Association of India (FAI) has emphasized for setting a pricing hierarchy for fertilisers based on their nutrient content and suggested that di-ammonium phosphate (DAP), priced at Rs 1,350 per 50-kg bag, should be the most expensive one due to its high nutrient value. This price is currently lower than that of muriate of potash and complex fertilisers, which raises concerns about nutrient balance in agriculture as farmers increasingly turn to alternatives with less phosphorus content.
Source: bit.ly/41iwV9i

5. The Union Ministry of Women and Child Development has launched the upgraded SHe-Box portal to streamline the reporting and monitoring of sexual harassment complaints in workplaces across India. This centralized platform allows women to file complaints easily and ensures timely processing by Internal and Local Committees in government and private sectors, promoting a safer work environment.
Source: bit.ly/49pCxk5