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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 Food Safety and Standards Authority of India has issued an advisory directing food businesses to avoid the use of Ashwagandha (Withania somnifera) leaves in crude, extract, or any other form in food products. This is important as Ashwagandha is widely used in nutraceutical and functional food formulations, signalling tighter scrutiny on botanical ingredients. Companies may now need to review formulations and ensure regulatory compliance.
Source: shortlink.uk/1tzwL

2. The Delhi District Consumer Disputes Redressal Commission issued a non-bailable warrant against the managing director of a multinational fast food company, for failing to comply with a November 2024 order to discontinue levying packing charges, pay compensation for unfair trade practices, and repeated non-appearance. This is important as it signals stricter enforcement of consumer rulings and increased personal accountability of senior leadership.
Source: shortlink.uk/1tzwQ

3. Pharmaceutical traders have opposed draft amendments to the Medical Devices Rules, 2017, mandating disclosure of sterilization site licence numbers on labels and revising testing fees. The industry warns this may restrict vendor flexibility, delay supplies, and increase compliance burden, particularly impacting SMEs and overall supply chain efficiency.
Source: shortlink.uk/1ohJu

4. The Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules 2017 requiring manufacturers to include sterilization site licence numbers on labels when sterilization is outsourced, along with revised testing and annual fees, prompting concerns from industry stakeholders. This is important as the changes may increase compliance costs and disrupt supply chains. Companies may need to redesign labels, reassess vendors, and adjust operations.
Source: shortlink.uk/1tzwY

5. National Comprehensive Cancer Network has updated global breast cancer screening guidelines to include image-based AI risk assessment using mammograms, recommending risk evaluation starting at age 35 to enable personalized screening strategies. This shifts screening from detection to early risk prediction, enabling earlier intervention. Healthcare providers may now adopt AI-based tools and adjust screening protocols.
Source: shortlink.uk/1tzx8

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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 National Health Authority is developing a national artificial intelligence policy for healthcare to guide wider use of technology to address health challenges including diagnostics, public health programmes, and digital health platforms. This will be a major shift toward structured, large-scale adoption of technology in India’s health system. It can improve access, efficiency, and data-driven decision-making across public healthcare delivery.
Source: shortlink.uk/1tzfD

2. India’s Central government has directed states to uniformise package rates for common medical procedures, adopt uniform treatment guidelines, and implement digital claims processing through the National Health Claims Exchange to improve billing transparency and reduce pricing variations across private hospitals. These disparities have been identified in driving higher insurance premiums and affecting affordability.
Source: shortlink.uk/1ohsz

3. The Bombay High Court delivered a judgment after scrutinising enforcement under the Drugs (Prices Control) Order (DPCO), holding that overcharging determinations and recovery demands must strictly adhere to statutory methodology, including correct price fixation, computation, and grant of hearing. Finding procedural infirmities and inadequate reasoning, the Court set aside the demand and directed fresh adjudication, reinforcing due process and curbing arbitrary.
Source: shortlink.uk/1tzfM

4. The Central Drugs Standard Control Organization (CDSCO) has issued a regulatory communication outlining updated requirements related to drug approvals, compliance, and regulatory submissions for industry stakeholders. This is important as increased regulatory scrutiny may impact approval timelines and documentation standards. Companies may now need to review regulatory submissions, strengthen compliance processes, and align product lifecycle strategies with evolving CDSCO expectations.
Source: shortlink.uk/1tzfQ

5. The Drugs Technical Advisory Board has approved a proposal to amend the Medical Devices Rules, 2017 to introduce a definition of reportable events and mandate adverse event reporting, including for in-vitro diagnostic devices. This is important as it strengthens post-market surveillance and device safety oversight. Manufacturers and importers may now need enhanced reporting systems and tighter compliance processes.
Source: shortlink.uk/1ohsK

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 Pharmacopoeia Commission (IPC) has released the draft National Formulary of India (NFI) 2026, inviting stakeholder comments within 45 days of upload of the respective chapters and appendices, ahead of its proposed finalisation. The draft aims to promote rational use of medicines through evidence based prescribing guidance, standardised drug information, and measures to reduce medication errors and antimicrobial resistance.
Source: shortlink.uk/1sKC9

2. The Delhi High Court has directed the discontinuation of the “Olymviq” mark for semaglutide injections on account of its similarity with the “Ozempic” brand. A 30-day transition window has been granted to clear existing stock and shift to the alternative mark “Olymra.” The order reflects heightened judicial scrutiny of pharmaceutical trademarks, particularly in cases involving likelihood of confusion, prompting companies to reassess trademark strategies.
Source: shortlink.uk/1sKCd

3. The Drugs Consultative Committee in its sixty eighth meeting approved recommendations on scheduling of certain medicines, retaining dicyclomine in Schedule H and moving flupentixol, zopiclone, gabapentin and carisoprodol to Schedule H1. This is important as stricter controls will curb misuse and intoxication, improve monitoring and dispensing accountability.
Source: https://shortlink.uk/1sKCi

4. The Central Drugs Standard Control Organisation (CDSCO) reportedly plans to tighten oversight of medicine packaging, emphasizing clear visibility of drug names, strength, and expiry dates. Through stricter inspections and regulatory directions, it aims to reduce medication errors and improve patient safety, prompting pharmaceutical companies to enhance labelling design, printing quality, and compliance standards.
Source: shortlink.uk/1nvq0

5. The Ministry of Environment has amended the Plastic Waste Management Rules, 2016, removing the requirement to declare the percentage of recycled plastic on labels. Instead, packaging must comply with IS 14534:2023 and carry the prescribed marking, simplifying labelling obligations while ensuring adherence to recycling standards.
Source: shortlink.uk/1sKnX

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 Medical Device Regulator has proposed standardising testing fees at government laboratory by notifying fixed charges under a new schedule. There was no regulation on cost of testing fees from government labs, and small and medium scale medical device manufacturers who actually avail services of external laboratories are bound to benefit from the proposal. Notably, the proposal applies only to government laboratories and does not cover private medical device testing laboratories.
Source: shortlink.uk/1sH3N

2. The Central Government has proposed draft amendments to the Medical Devices Rules, 2017 mandating manufacturers outsourcing sterilisation must mention the sterilisation site’s licence number on device labels using specified descriptors. Currently, no such mandatory declaration exists, and the proposal aims to ensure greater accountability in third-party sterilisation processes.
Source: shortlink.uk/1nrZb

3. The Central Government has proposed amendments to the Medical Devices Rules, 2017 requiring importers of Class A non-sterile and non-measuring devices to also self-certify compliance with a Quality Management System. Currently limited to standards, this change aims to strengthen quality assurance and regulatory oversight of low-risk medical device imports.
Source: shortlink.uk/1sH41

4. The Department of Agriculture & Farmers’ Welfare has directed pesticide manufacturers, importers, and industry associations to submit data on produced, imported, and exported quantities of major insecticides, fungicides, herbicides, and Plant Growth Regulators (PGRs) by April 13, 2026. This is being undertaken to assess the impact of the ongoing Gulf Crisis on pesticide availability and supply chains.
Source: shortlink.uk/1sH4g

5. The Central Government has proposed to amend the Medical Devices Rules, 2017, to expand the scope of jurisdictions by including “European Union countries” alongside the US, UK, Australia, Canada and Japan. Pursuant to this amendment, investigational clinical data may not be required to be submitted for import of a medical device, provided that such device has been approved by the regulatory authority of EU, has been marketed in that jurisdiction for a minimum period of two years.
Source: shortlink.uk/1nrZD

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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. 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

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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 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

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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 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