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 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

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 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. Regulatory reforms under the Biological Diversity Amendment Act, 2023 are driving increased intellectual property filings linked to India’s biological resources. Streamlined procedures and mandatory prior registration with the National Biodiversity Authority have enhanced compliance, improved processing efficiency, and strengthened alignment between innovation, conservation priorities, and equitable benefit sharing frameworks
Source: shortlink.uk/1nbX2

2. The Jammu & Kashmir and Ladakh High Court has ruled that merely holding the position of Director or Managing Director does not automatically attract liability under the Drugs and Cosmetics Act, 1940. Liability arises only if specific allegations prove the individual was responsible for the company’s conduct or involved in the offence.
Source: shortlink.uk/1sqvC

3. The Drugs Consultative Committee(DCC) has approved a proposal to develop a real-time digital portal for tracking manufacture, import, export, sale, and stock of pharmaceutical products regulated under the Narcotic Drugs and Psychotropic Substances Act. The portal is aimed at strengthening surveillance, with potential integration involving CDSCO, State Authorities, and the Central Bureau of Narcotics.
Source: shortlink.uk/1nbXc

4. The Department of Pharmaceuticals has liberalised the RPTUAS guidelines to allow shortlisted applicants to claim the first instalment of subsidy upon submission of either a Revised Schedule M or WHO-GMP certificate. The remaining certificate may be furnished at the time of claiming the second instalment, thereby providing greater flexibility in meeting compliance requirements.
Source: shortlink.uk/1nb-y

5. India’s Directorate General of Foreign Trade expanded the mandatory Halal certification requirement under the India Conformity Assessment Scheme (I CAS) Halal to 20 additional countries, including Egypt, Kenya, Morocco, and Maldives. Exporters must obtain certification from NABCB-accredited bodies, with compliance effective within two weeks (six months for Egypt).
Source: shortlink.uk/1sqvW

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 Delhi High Court ruled that India’s central food authority, Food Safety and Standards Authority of India (FSSAI) cannot regulate animal or cattle feed under the Food Safety and Standards Act, 2006, holding that the law is limited to food meant for human consumption. The Court quashed FSSAI regulations restricting use of meat and bone meal in feed for milk- and meat-producing animals, citing lack of statutory authority.
Source: shortlink.uk/1sjFt

2. Telangana Health Minister has reportedly declared cancer a notifiable disease and launched a cancer registry to improve surveillance and care. With thousands of new cases, the initiative aims to strengthen data driven planning, expand treatment infrastructure, and introduce artificial intelligence based screening across government hospitals.
Source: shortlink.uk/1n5jM

3. The Drugs Technical Advisory Board has decided not to pursue the proposal to mandate pharmaceutical companies to allocate at least 1 percent of net profits towards free medicines under Corporate Social Responsibility (CSR). The decision follows clarification that CSR obligations fall under the Companies Act, 2013 and not under Drugs and Cosmetics Act and Rules made thereunder.
Source: shortlink.uk/1n5jP

4. The Directorate General of Foreign Trade (DGFT) of India, has permitted export of an additional 5 lakh metric tonnes of wheat flour and related products under HS Code 1101, while maintaining the “prohibited” export status. This quota comes over and above the 5 LMT allowed in January 2026, with detailed export modalities to be notified separately.
Source: shortlink.uk/1sjGG

5. The Court granted an ex parte ad interim injunction restraining the use of the mark “HIMALAYA THE NUTRA HEALTH CARE”, holding it to be deceptively similar to the plaintiff’s registered trademarks and trade dress. The Court noted the plaintiff’s long-standing presence, and global operations, and found that the impugned mark was likely to cause consumer confusion, constituting prima facie infringement
Source: shortlink.uk/1sjFF

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 central government has warned pharmacies, clinics, and online platforms of licence cancellation, fines, and legal action for unauthorised sale of GLP-1 weight-loss drugs. Regulators flagged misuse amid rising availability of generic semaglutide, reiterating that prescriptions are restricted to endocrinologists, internal medicine specialists, and cardiologists only, with nationwide inspections already underway.
Source: shortlink.uk/1mYE-

2. The Delhi High Court granted a 30 day stock clearance window to the pharmaceutical manufacturer for its diabetes drug under the existing brand, following its agreement to adopt a new name. Thereafter, unsold inventory will be supplied free to government hospitals under supervision, with immediate cessation of all commercial use.
Source: shortlink.uk/1mYF1

3. A Hyderabad-based paediatrician has criticised a company for introducing similar-looking packaging following the Food Safety and Standards Authority of India crackdown on misleading ORS branding. The doctor alleged that despite rebranding, the product retains strong recall value, potentially misleading consumers and raising ongoing public health concerns over confusion between therapeutic ORS and commercial electrolyte drinks.
Source: shortlink.uk/1mYF3

4. The US FDA clarified that compounded versions of GLP-1 weight-loss and diabetes drugs can only be produced during official shortages. With supply stabilising, compounders must stop manufacturing copycat versions once drugs are removed from the shortage list. The regulator warned of enforcement action against non-compliant pharmacies and telehealth providers.
Source: shortlink.uk/1sbL5

5. India’s Drugs Technical Advisory Board, has 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/1mYF8
Source 2: shortlink.uk/1mYFb

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 government clarified no proposal exists for a uniform nationwide pricing framework for medical devices. National Pharmaceutical Pricing Authority continues to regulate ceiling prices for essential devices like stents and knee implants under Drugs Prices Control Order, 2013, while monitoring non scheduled products and taking action against overcharging to safeguard consumer interests.
Source: shortlink.uk/1s0VO

2. The Ministry of Health and Family Welfare approved major reforms to strengthen food safety while improving ease of doing business. Measures include perpetual licences, higher turnover thresholds, deemed registration for street vendors, and risk based inspections, reducing compliance burden and enhancing regulatory efficiency
Source: shortlink.uk/1s0VY

3. The National Biodiversity Authority (NBA) of India has formed an expert committee to address invasive alien species threatening India’s biodiversity, ecosystems, agriculture, and health. It will create a national list, identify high-risk species, and recommend management strategies, research, and guidelines for prevention, control, and ecological restoration over a two-year period.
Source: shortlink.uk/1mOaJ

4. The Delhi High Court has issued notices to the government and CDSCO over alleged inaction on misuse of diabetes drug Ozempic for weight loss, citing non-compliance with earlier directives. The case raises concerns on regulatory oversight, off-label use controls, and potential compliance risks for pharma players amid rising scrutiny.
Source: shortlink.uk/1s0Wd

5. A Parliamentary panel has asked the Ministry of Defence to expedite pending payments to hospitals under the Ex-Servicemen Contributory Health Scheme, warning that delays are forcing private providers to opt out. The move aims to restore service continuity and protect healthcare access for over one crore beneficiaries.
Source: shortlink.uk/1mOaW

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 clarified no proposal exists for a uniform nationwide pricing framework for medical devices. National Pharmaceutical Pricing Authority continues to regulate ceiling prices for essential devices like stents and knee implants under Drugs Prices Control Order, 2013, while monitoring non scheduled products and taking action against overcharging to safeguard consumer interests.
Source: shortlink.uk/1mogz

2. The Ministry of Health and Family Welfare approved major reforms to strengthen food safety while improving ease of doing business. Measures include perpetual licences, higher turnover thresholds, deemed registration for street vendors, and risk based inspections, reducing compliance burden and enhancing regulatory efficiency
Source: shortlink.uk/1rAbJ

3. The National Biodiversity Authority (NBA) of India has formed an expert committee to address invasive alien species threatening India’s biodiversity, ecosystems, agriculture, and health. It will create a national list, identify high-risk species, and recommend management strategies, research, and guidelines for prevention, control, and ecological restoration over a two-year period.
Source: shortlink.uk/1mogO

4. The Delhi High Court has issued notices to the government and CDSCO over alleged inaction on misuse of diabetes drug Ozempic for weight loss, citing non-compliance with earlier directives. The case raises concerns on regulatory oversight, off-label use controls, and potential compliance risks for pharma players amid rising scrutiny.
Source: shortlink.uk/1mogP

5. A Parliamentary panel has asked the Ministry of Defence to expedite pending payments to hospitals under the Ex-Servicemen Contributory Health Scheme, warning that delays are forcing private providers to opt out. The move aims to restore service continuity and protect healthcare access for over one crore beneficiaries.
Source: shortlink.uk/1mogU