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. Parliament passes Jan Vishwas Bill 2026, bringing major relief to India’s cosmetics sector. Minor violations in the case of cosmetics (other than spurious or adulterated) which were previously punishable with up to one year’s imprisonment will now be resolved outside courts through a civil penalty framework, with fines of Rs.1 lakh or three times the value of confiscated goods, whichever is higher.
Source: shortlink.uk/1sCvW

2. The Central Government has amended Para 2.62 of the Foreign Trade Policy 2023 to streamline the issuance and verification of Certificates of Origin (CoO). The amendment clarifies that only Directorate General of Foreign Trade (DGFT)-authorised agencies can issue CoOs, and mandates exporters to use identical invoice numbers in both CoOs and corresponding shipping bills to enable automated verification.
Source: shortlink.uk/1sCw6

3. India’s leading manufacturer of Paracetamol tablets and active pharmaceutical ingredients plans to digitise manufacturing records, enhance quality oversight, and increase real-time monitoring after the U.S. Food and Drug Administration cited record-keeping gaps, cleaning lapses, and contamination control failures at its largest Telangana facility. While production continues, the warning may delay approvals for new products targeting the U.S. market.
Source: shortlink.uk/1sCwc

4. U.S. Food and Drug Administration (US FDA) recently issued a warning to Texas medical spa after finding it used more Botox than it had officially bought. Inspectors also discovered an unlabeled vial and poor record-keeping. Authorities said the spa may have sourced products from unauthorized suppliers, raising concerns about safety and possible risks to patients receiving treatments.
Source: shortlink.uk/1nnzV

5. The Government is reportedly considering mandating that vaccines and biological products undergo batch testing exclusively at authorised government institutions such as the National Institute of Biologicals, potentially excluding private labs. The move aims to strengthen quality oversight, standardise testing, and enhance regulatory control over biologics manufacturing and release.
Source: shortlink.uk/1sCwi

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 High Court granted interim relief to Pharmaceutical company by restraining other pharmaceutical company from using “ALKAKIND” or similar marks. The Court held that the “KIND” suffix has acquired distinctiveness through extensive use, creating a strong likelihood of consumer confusion and reinforcing trademark protection for established pharma brands.
Source: shortlink.uk/1n47Q

2. The Government of India has issued the Safety of Household, Commercial and Similar Electrical Appliances (Quality Control) Order, 2026, making BIS certification mandatory for 90 categories of electrical appliances. It will come into force on 1 October 2026, with phased timelines for MSMEs. Non-compliance will attract penalties under the BIS Act, 2016.
Source: shortlink.uk/1n48h

3. Indian pharma manufacturers have reportedly urged the National Pharmaceutical Pricing Authority of India to approve up to a 50% price increase for platinum-based chemotherapy drugs such as carboplatin, cisplatin, and oxaliplatin, after platinum prices nearly doubled from ₹3,869 to ₹8,000 per gram in six months, making production financially unviable and risking supply disruptions.
Source: shortlink.uk/1n48q

4. The Drug Technical Advisory Board (DTAB) has proposed extending PSUR timelines under the New Drugs and Clinical Trials Rules, 2019 for modified or sustained release drugs, novel drug delivery systems, and advanced biologics across their lifecycle, with annual and triennial reporting beyond four years. Currently, PSURs are submitted semi-annually for two years and annually thereafter.
Source: shortlink.uk/1sisG

5. India’s affordable generic medicines under the Jan Aushadhi scheme may see price increases as shipping disruptions linked to the West Asia conflict have raised raw material costs and constrained supply. The supply crunch is affecting local manufacturing, with smaller pharma units facing margin pressure, potentially impacting availability of low-cost medicines across Jan Aushadhi Kendras.
Source: shortlink.uk/1n48A

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 Plastic Waste Management Rules, 2016, has been amended by introducing phased mandatory recycled plastic content targets, carry-forward provisions for shortfalls, and stronger audit mechanisms. Pharma, FMCG, and packaging companies must reassess packaging strategies and EPR compliance, as regulators expand enforcement and introduce verification through registered environmental auditors and certificate-based compliance mechanisms.
Source: shortlink.uk/1mYB5

2. The Government has notified the Transgender Persons (Protection of Rights) Amendment Act, 2026, introducing stricter penalties for coercion, forced identity changes, and abuse, while formalising medical board certification and identity updates. The amendment also mandates reporting by medical institutions post-gender surgery, signaling stronger accountability obligations across healthcare providers and institutions.
Source: shortlink.uk/1mYB9

3. The Government has notified the Cookware, Utensils and Cans for Foods and Beverages Quality Control Order, 2026, mandating Bureau of Indian Standards certification for specified products, including stainless steel utensils, sinks, and metal cans, with phased implementation and limited exemptions for exports, existing stock, and research imports.
Source: shortlink.uk/1mYBl

4. The Jan Vishwas (Amendment of Provisions) Bill, 2026 was introduced in Lower House of Indian Parliament, which proposes decriminalisation of 717 provisions across 79 central laws, replacing imprisonment with monetary penalties and administrative actions. The reform aims to reduce regulatory burden, promote ease of doing business, and shift toward trust-based governance, significantly impacting compliance frameworks for businesses across sectors
Source: shortlink.uk/1mYBq

5. The Centre has proposed amendments to the Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021, to bring social media users sharing news and current affairs under regulatory oversight. The draft expands government advisory compliance, strengthens content monitoring, and empowers authorities to review user-generated news content. Stakeholder comments are invited until April 14, 2026.
Source: shortlink.uk/1mYBx

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 Government is preparing a policy response after seeking inputs from the pharmaceutical industry on the ongoing shortage and price surge of critical solvents and chemicals. Industry reported sharp increases in inputs like isopropyl alcohol and other petrochemical-based solvents, impacting production costs and supply continuity, prompting urgent intervention and long-term supply-chain stabilisation measures.
Source: shortlink.uk/1mYxw

2. The Delhi High Court has reserved its verdict on an interim plea filed by Asian News International in a copyright infringement case against OpenAI. The case questions whether copyrighted news content can be used to train AI models like ChatGPT without permission, marking a first-of-its-kind legal challenge in India.
Source: shortlink.uk/1mYy0

3. The Government is considering invoking the Essential Commodities Act, 1955 to regulate prices of bulk drugs and active pharmaceutical ingredients amid supply disruptions linked to West Asia tensions. The Department of Pharmaceuticals is consulting industry stakeholders to curb hoarding, stabilize prices, and ensure uninterrupted medicine production.
Source: shortlink.uk/1mYxH

4. The Food Safety and Standards Authority of India has released FAQs on the Food Safety and Standards (Licensing and Registration of Food Businesses) Amendment Regulations, 2026, clarifying key reforms including perpetual licence validity, revised turnover thresholds, expanded petty food business definition, and risk-based inspections to simplify compliance and strengthen food safety oversight.
Source: shortlink.uk/1sbDB

5. The Food Safety and Standards Authority of India has notified the Food Safety and Standards (Labelling and Display) First Amendment Regulations, 2026, introducing revised labelling exemptions, non-retail container requirements, and updated warning declarations. The amendments will come into force from 1 July 2027, giving industry transition time for compliance.
Source: shortlink.uk/1mYxL

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 Food Safety and Standards Authority of India (FSSAI) has issued an advisory directing all milk producers (other than members of dairy cooperative societies) and milk vendors to obtain mandatory FSSAI registration or licensing before commencing or continuing operations. States and UTs have been instructed to conduct special registration drives and enforcement checks to ensure compliance and curb milk adulteration.
Source: shortlink.uk/1mYp6

2. Supreme Court reportedly declines plea seeking mandatory Nucleic Acid Amplification Testing in blood banks, stating medical policy decisions must rest with domain experts and governments. The Court noted financial implications and advised the petitioner to approach authorities, while concerns over transfusion transmitted infections and patient safety were highlighted.
Source: shortlink.uk/1mYnK

3. The Central Drugs Standard Control Organisation (CDSCO) has delegated key regulatory functions related to veterinary drugs to its zonal offices. Zonal offices will now process Test License (Form 11) applications for import and issue NOCs for Form 29 licenses for manufacturing veterinary drugs for testing or analysis, excluding biologicals.
Source: shortlink.uk/1sbtE

4. India’s Drugs Technical Advisory Board, in its 93rd meeting, recommended amending the Drugs Rules, 1945 to introduce licensing provisions for drug marketers. The move aims to strengthen regulatory oversight and monitoring of entities that market drugs manufactured by other companies under their own label.
Source 1: shortlink.uk/1mYo2
Source 2: shortlink.uk/1mYo4

5. The Food Safety and Standards Authority of India has reportedly encouraged plant-based food manufacturers to include QR codes on product labels to help consumers easily access ingredient lists and nutritional information. The regulator said the move currently voluntary can address label space limitations, improve transparency, and build consumer trust in the rapidly growing plant-based food sector.
Source: shortlink.uk/1mYof

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 Supreme Court of India has urged the Union Government to enact a comprehensive law governing passive euthanasia and end of life care in India. The Court noted that the absence of legislation has repeatedly required judicial guidelines, while permitting withdrawal of life sustaining treatment for a patient in a prolonged vegetative state.
Source: short-url.org/1qSHk

2. The Drugs Technical Advisory Board (DTAB) has recommended amending entry no. 33 of Schedule K to permit only unflavoured nicotine gums (2 mg) under sale license exemptions. Nicotine lozenges (2 mg) are excluded. Sale to minors is prohibited, online access closely monitored, and marketing by the tobacco industry restricted.
Source: short-url.org/1qSHq

3. A Mumbai Sessions Court has set aside criminal proceedings against directors of an e-commerce platform in a case concerning alleged online sale of abortion pills. The court held that the company operates as an intermediary marketplace and cannot be held directly liable for products listed by third-party sellers, highlighting limits on platform liability in e-commerce
Source: short-url.org/1lJ8-

4. The Drugs Technical Advisory Board (DTAB) has recommended introducing a separate form for wholesale bulk drug licences to capture details of wholesalers dealing with NDPS substances. Qualification criteria for competent persons and adequate transition time for existing wholesaler licensees to obtain the new licence is also proposed by DTAB
Source: short-url.org/1lJ9e

5. The Central Drugs Standard Control Organization (CDSCO) has issued an advisory warning manufacturers, importers and marketing authorisation holders against direct or indirect promotion of prescription medicines, including GLP-1 receptor agonists. The regulator noted that surrogate advertising, misleading efficacy claims and promotional campaigns increasing product visibility may constitute misleading marketing practices.
Source: short-url.org/1lJ9i

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 Legal Metrology (General) Rules, 2011 has been amended to introduce mandatory metrological and technical standards for continuous clinical electrical thermometers used in human and veterinary care. The rules prescribe accuracy thresholds, testing protocols, labelling norms, environmental tolerance, and type-approval requirements impacting manufacturers, importers, and hospital-grade device suppliers.
Source: short-url.org/1k3IL

2. The Delhi High Court is examining a challenge to mandatory vegetarian/non-vegetarian dot labelling on toothpaste and toiletry products. Noting conflicting regulatory positions, the Court has directed Legal Metrology authorities and the Drugs Controller General of India (DCGI) to hold a joint meeting to determine whether such labelling should remain compulsory or voluntary. The matter is listed for further hearing on April 27.
Source: short-url.org/1p8RE

3. The Union Health Ministry will unveil SAHI (Strategy for AI in Healthcare for India) and BODH (Benchmarking Open Data Platform for Health AI) at the India AI Summit 2026, under the Ayushman Bharat Digital Mission, the initiatives institutionalise AI governance, validation and privacy-preserving benchmarking nationwide.
Source: short-url.org/1k3Iu

4. India’s Delhi High Court has reportedly urged authorities to ensure real-time hospital bed and emergency service data through the NextGen e-Hospital digital platform. It ordered full implementation across government hospitals, including linkage to a mobile app for public access, and called for technical support and broader adoption to improve emergency care and patient treatment.
Source: short-url.org/1p8Ry

5. The All India Organisation of Chemists and Druggists (AIOCD) has reportedly warned Prime Minister Narendra Modi that AI-generated fake medical prescriptions are enabling illegal online drug sales by unregulated e-pharmacies. The group wants government to action to withdraw certain regulations, close illegal platforms, and ban AI-generated prescriptions to protect public health.
Source: short-url.org/1p8Rs

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. India’s Supreme Court has directed the Food Safety and Standards Authority of India (FSSAI) to consider mandatory front-of-pack warning labels on packaged foods. This move aims to inform consumers about high levels of sugar, salt, and saturated fats, addressing rising health concerns like obesity and diabetes. The court emphasized prioritizing public health over industry resistance.
Source: h7.cl/1jEhc

2. The Indian government has tightened the IT intermediary law, by an amendment that defines synthetic media, and require social media platforms to remove flagged harmful content within three hours, enhancing accountability and curbing misuse of AI online. The amendment also obliges intermediaries offering AI tools to deploy technical (including automated) measures blocking unlawful deepfake and synthetic content.
Source: h7.cl/1jEgT

3. India’s Supreme Court has issued notices to the Central Government and National Medical Commission on a PIL seeking exemption of medical professionals from the Consumer Protection Act. The petition argues consumer law undermines doctor-patient trust and promotes defensive medicine. The Court’s decision remains pending.
Source: h7.cl/1jEhX

4. The Supreme Court reportedly directed the Gujarat Pollution Control Board to decide within a week on Pharma company’s plea to reopen its Dahej plant, producing hexafluoro-methoxypropane, a key sevoflurane intermediate. It was shut over alleged hazardous waste discharge into the Narmada River. The court denied interim relief, advising remedies via statutory authorities and the National Green Tribunal.
Source: h7.cl/1jEh-

5. United States Food and Drug Administration reportedly issued a warning that a major pharma company’s Television advertisement for its obesity pill is false or misleading as it suggested unproven superiority and benefits over other GLP one medicines. The regulator directed corrective action to ensure accuracy and protect patients.
Source: h7.cl/1oHAn

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 Ministry of Health has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019, proposing to remove the provision dealing with the provisional registration of Ethics Committees. The designated authority will now directly grant final registration in Form CT-03 after scrutiny of Form CT-01, or reject with written reasons.
Source: h7.cl/1oifC

2. Bulk Drug Manufacturers Association of India has launched a marketing portal enabling Indian pharmaceutical companies to promote and source active pharmaceutical ingredients, intermediates, pallets, and contract development and manufacturing services, supporting both domestic and international markets through an integrated vendor management system with no cost registration for buyers.
Source: h7.cl/1oifJ

3. The Department of Pharmaceuticals has extended the deadline for submitting applications under the Common Facilities for Medical Device Clusters (CFMDC) sub-scheme to 15 February 2026. The scheme supports shared testing infrastructure for medical devices, including cardiac and orthopaedic implants, infusion pumps, imaging equipment, and Class B, C, and D IVDs.
Source: h7.cl/1jfLz

4. The Maharashtra government has issued a resolution by introducing a new fee structure at state-run hospitals from effective from January 16, 2026. ₹5 for OPD registration, ₹10/day for inpatient admission, and up to ₹40,000 for major surgeries like joint replacements. Diagnostic services, ICU care, and ambulance services also have updated charges. Implementation across hospitals is pending.
Source: h7.cl/1oiwW

5. The Indian Pharmacopoeia Commission is reportedly taking efforts to develop more biosimilar in alignment with governments Biopharma Shakti initiative. This move aims to align Indian quality standards with global benchmarks and strengthen the country’s biologics and biosimilars ecosystem.
Source: h7.cl/1jfLU

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. India’s Ministry of Health has issued draft amendments to the New Drugs & Clinical Trials Rules, 2019 introducing a framework for filing of post-approval changes in new drugs. Manufacturers of new drugs may have to take prior approval from the authorities for major and moderate quality changes while minor quality changes might be implemented without prior approval and changes which might have a minimal effect can be implemented with annual submission by 1st quarter of every calendar year to the authorities.
Source: h7.cl/1odSN

2. The Delhi High Court upheld the conviction of a sweet manufacturing unit for discharging untreated effluents into public sewers leading to the Yamuna River. However, citing the 2024 amendment to the Water Act, which replaces imprisonment with monetary penalties, the court set aside the jail term and imposed an ten lakh rupees penalty, underscoring strict environmental compliance.
Source: h7.cl/1jbwq

3. The National Biodiversity Authority has launched a digital portal for electronic issuance of Certificates of Origin for cultivated medicinal plants, enabling access and benefit sharing exemptions. The initiative operationalises the amended Biological Diversity framework, offering a single window online process for traditional medicine, seed and research sectors.
Source: h7.cl/1odSP

4. The Government has amended the Plant Quarantine Order to permit the import of dried Mitragyna speciosa (Kratom) leaves from Uganda for processing, subject to a phytosanitary certificate confirming the consignment is free from soil, quarantine weed seeds, and other plant debris.
Source: h7.cl/1jbwX

5. The Karnataka High Court has stayed a penalty imposed by the Central Consumer Protection Authority on an e-commerce platform for allowing the sale of walkie-talkies without mandatory licensing disclosures. The E-commerce platform had argued that its liability is limited owing to it being a mere intermediary.
Source: h7.cl/1jbx0