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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. India’s Food authority (FSSAI) has extended the validity of No Objection Certificates (NOCs) granted to imported alcoholic beverages bottled at origin or in bulk with over 10% alcohol content and with no expiry date to 365 days. If consignments remain in Customs premises beyond this period, re-validation can be done through visual inspection upon payment of a prescribed fee.
Source: bit.ly/44Lgsvu

2. India’s Drugs Consultative Committee (DCC) has reportedly proposed enabling the licensing of Bedaquiline, Delamanid, Pretomanid, and Rifapentine only through India’s National Tuberculosis Elimination Programme (NTEP), with strict label warnings. This move aims to prevent misuse, preserve drug effectiveness, and combat rising cases of drug resistant tuberculosis.
Source: bit.ly/4km2dC7

3. The National for Allied and Healthcare Professions (NCAHP) has recommended replacing the term “Paramedical” with “Allied and Healthcare” across all government and institutional communications (verbal, written or electronic). States, UTs, and relevant bodies must implement and enforce this updated terminology in all official usage.
Source: bit.ly/4ltTcYA

4. A popular U.S. snack brand will remove “100% natural” claims from its packaging after lawsuits highlighted trace herbicide residues in its ingredients. Although levels were within legal limits, consumer groups argued the label was misleading.
Source: bit.ly/3TlDeE4

5. The U.S. Food and Drug Administration (FDA) has issued warning letters to four entities, including an Indian drug manufacturer, citing violations such as non-compliance to clinical trial protocol, insanitary conditions, contamination risks, and inadequate donor screening. The FDA has directed them to implement corrective actions to ensure compliance and safeguard product quality.
Source: bit.ly/44aoWw8
Source: bit.ly/45S8eD4
Source: bit.ly/4nqNn01
Source: bit.ly/45Sv11E

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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. Food Safety and Standards Authority of India has mandated complete inspection of all packaged drinking water facilities in Maharashtra amid hygiene scare. The move entails bi-annual compliance checks across production units to ensure that all such facilities comply with food safety norms.
Source: bit.ly/4lA3LcQ

2. The Ministry of Environment, Forest and Climate Change has extended the deadline for filing annual returns by Producers, Importers, and Brand Owners (PIBOs) of plastic packaging for 2024–2025 to July 31, 2025 from June 30, 2025 as a special case. This aims to ease compliance and ensure effective plastic waste management.
Source: bit.ly/4nrkbG3

3. India’s Mumbai District Consumer Disputes Redressal Commission has held a leading biscuit manufacturer and its retailer liable for selling fungus-contaminated biscuit packets, despite the products being within their expiry date. They were directed to compensate the consumer and cover legal costs, reinforcing accountability in food safety and consumer rights.
Source: bit.ly/3GkOPjH

4. A conflict has emerged between Telangana’s Medical and Dental Councils over dentists performing hair transplants and aesthetic surgeries. The Indian Medical Council cites National Medical Commission guidelines limiting such procedures to trained dermatologists or plastic surgeons, while the Dental Council asserts that qualified Oral & Maxillofacial Surgeons are permitted and qualified under existing dental regulations to perform such procedures.
Source: bit.ly/3I9HO5L

5. India’s Food Safety and Standards Authority of India (FSSAI), is working to set clear guidelines for genetically modified (GM) foods. This move has raised concerns among some organizations about food safety and environmental impact. At the same time, the US is urging India to ease rules on GM crop imports, creating debate over consumer health, agricultural practices, and international trade standards.
Source: bit.ly/4l6Nlsk

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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 West Bengal Legislative Assembly has passed a new Bill which is an amendment to the Clinical Establishments Act, 2017. The new Bill empowers the State to regulate treatment costs in private clinics, enforce fixed and package rates, streamline licensing, and mandate electronic medical records to ensure consumer protection and transparency.
Source: bit.ly/4k87Cg8

2. India’s Consumer Affairs Ministry has reportedly directed edible oil manufacturers and importers to reduce retail prices in order to pass the benefits of the recent import duty cuts to consumers. Although the new rates are in effect, supply chain delays may postpone noticeable price reduction until late June.
Source: bit.ly/3I5h5Hm

3. Federation of Indian Pharmacist Organizations (FIPO) has urged the Union Health Ministry to reject Drug Technical Advisory Board’s draft permitting sale of 16 OTC drugs (like paracetamol, clotrimazole) through unlicensed outlets without pharmacist oversight, citing risk to public safety.
Source: bit.ly/4kNtMoO

4. The 20 Nifty Pharma firms held a record ₹48,913 cr in cash as of March 31, doubling FY20 levels, and added over ₹10,200 cr in FY25. The cash reserves are aimed at funding M&A, expanding into complex therapy areas to transition into higher-margin, innovation-driven sectors.
Source: bit.ly/4kRGMdg

5. The U.S. FDA has launched a pilot program to accelerate drug reviews for companies aligned with national health priorities, such as pandemic readiness and essential drug supply. Selected firms will benefit from enhanced FDA engagement and early submissions, expediting approvals without compromising safety standards.
Source: bit.ly/3HQPWrH

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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. Government extends PLI scheme application deadline
The Government of India has extended the application deadline for the Production Linked Incentive (PLI) Scheme aimed at boosting domestic manufacturing of Critical Key Starting Materials (KSMs), Drug Intermediates (DIs), and Active Pharmaceutical Ingredients (APIs). Eligible entities can now apply until July 4, 2025.
Source: bit.ly/3SXjvKE

2. Draft of ghee fatty acid limits, new cheese powder standards, revised drinking water norms issued by India Food Ministry
India’s Ministry of Health and Family Welfare has released draft amendments to the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Key changes include updated ghee fatty acid limits, new cheese powder standards, revised drinking water norms, and additive restrictions. Public comments are invited latest by 4th August, 2025.
Source: bit.ly/4k0CfDP

3. Kerala High Court Bans Single-Use Plastics in Tourist Areas and Public Events
The Kerala High Court has banned single-use plastics in ten major hilly tourist destinations and all public events across the state, effective October 2, 2025. The move aims to curb pollution, mandates water kiosks in tourist spots, and directs strict enforcement by multiple state authorities.
Source: bit.ly/3FY3dhK

4. Essential Drug Prices Surge by Up to 20% Amid Global Conflicts
Essential drug prices in India have increased by 10 – 20% as per a leading drug traders association. Geopolitical conflicts have reportedly disrupted supply chains, leading to shortage of key raw materials like aluminium foil, used in pharmaceutical packaging and has driven up production costs for medicines.
Source: bit.ly/43RDxMM

5. Bombay HC rules treaty can’t override customs law
India’s Bombay High Court has ruled that treaty provisions do not override national customs law unless formally incorporated, affirming the jurisdiction of Indian customs authorities that issued show cause notices for alleged misuse of import exemptions.
Source: bit.ly/4ljpx4t

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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 Indian government is reportedly preparing to ramp up oversight of quick commerce platforms following a series of hygiene and food safety lapses at their dark store facilities. FSSAI plans to conduct unscheduled surprise inspections nationwide to enforce stricter compliance, particularly concerning hygiene and the sale of near-expiry products.
Source: bit.ly/43QmomR

2. The Department of Pharmaceuticals (DoP) has revised its 2024 guidelines for its Capacity Building and Skill Development sub scheme under the Strengthening of Medical Device Industry initiative. New criteria include minimum admission thresholds at least 30% in the first year and 50% in subsequent years failure of which results in withdrawal of funding.
Source: bit.ly/4dW0OR2

3. The Supreme Court of India ruled that the right to shut down a business is part of Article 19(1)(g), subject to reasonable restrictions like protecting workers and following legal procedures. It emphasized that authorities cannot delay valid closure requests or overstep their powers.
Source: bit.ly/4e2FABh

4. The Indian Pharmaceutical Association has reportedly urged reforms in e-prescription rules to prevent misuse through repeated use of digital prescriptions. It recommends a mandatory ‘dispensed’ stamp, encrypted prescriptions or direct doctor-to-pharmacy transmission, but experts warn this could restrict patient rights, access, and create pharmacy monopolies.
Source: bit.ly/4ejdfa1

5. FSSAI has released the Draft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2025, proposing new standards for cheese powder, removing “fish” from the animal definition, and banning additives in atta, rice, millet, and mixed millet flours. Public feedback is invited until August 8, 2025.
Source: bit.ly/4e8UW7i

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 food businesses to stop using “100%” claims on labels and promotional materials, citing them as misleading and undefined under current regulations. The move aims to protect consumers from deceptive marketing practices.
Source: bit.ly/3FidCVc

2. India’s Central Drugs Standard Control Organisation (CDSCO) has released guidelines for safe disposal of expired and unused medicines. It mandates flushing 17 high-risk drugs like fentanyl and diazepam to prevent harm. The guidance urges states to establish Drug Take Back programs under biomedical waste rules to curb misuse, environmental risks, and promote responsible pharmaceutical waste management.
Source: bit.ly/4jqNO70

3. The Bureau of Indian Standards has issued Amendment on 22 May, 2025 to IS 17349:2020, the medical textile standard for shoe covers. The revised standard enhances quality and safety. The old standard will remain in force till November 21, 2025.
Source: bit.ly/4dDEuf3

4. The International Council for Harmonisation (ICH) has released new guidelines to aid in developing medicines for pregnant populations. These guidelines emphasize the need for robust clinical data to assess drug safety and efficacy during pregnancy. Additionally, they provide updated recommendations for presenting quality information in the Common Technical Document (CTD).
Source: bit.ly/43jxTmn

5. The European Medicines Agency (EMA) is promoting faster global timelines for post-approval changes (PACs) through regulatory reliance, allowing non-EU countries to use EMA’s assessments. This reduces duplication, speeds up approvals, and improves patient access. Companies must clearly communicate PAC submissions and inform EMA when sharing data with other regulators to ensure smooth coordination.
Source: bit.ly/4jv8rzh

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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 released new guidelines permitting the use of recycled polyethylene terephthalate in food packaging. Only recycling technologies that effectively remove contaminants are approved. Manufacturers must conduct safety tests, follow labelling norms, maintain traceability, and undergo audits to ensure food-grade quality and compliance.
Source: bit.ly/43NdGFB

2. The Government of India has reportedly removed port restrictions and Central Leather Research Institute testing for leather exports, helping MSMEs cut costs and delays. Exporters can now ship from any port, boosting efficiency and competitiveness, especially in key markets like the US.
Source: bit.ly/43LV20N

3. Neurologists have reportedly urged for the inclusion of multiple sclerosis (MS) in the National Health Mission, Rare Disease Policy, and Ayushman Bharat. They seek better access to treatment, insurance coverage, updated disability laws, and mental health support for patients.
Source: bit.ly/3Z273N2

4. The Consumer Affairs Ministry to meet key E-commerce companies to combat dark patterns that mislead consumers on May 28, 2025 in Delhi. Major platforms, law universities, and consumer groups to participate, the meeting will also focus on compliance measures and feature discussions on consumer rights protection and industry best practices.
Source: bit.ly/4kI24cR

5. India is urging the U.S. to ease import rules and speed up Phytosanitary approvals for its fruits and vegetables, aiming for broader market access. This move seeks to boost Indian agricultural exports and balance bilateral trade relations.
Source: bit.ly/43CSNM9

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 Pollution Control Board (CPCB) has extended the deadline for filing E-Waste EPR returns till June 30, 2025, and mandates audits for all registered entities to strengthen rule compliance and traceability.
Source: bit.ly/4k8KbE8

2. Food Safety and Standards Authority of India has proposed reforms to ease food license renewals, including fixed renewal dates (Jan 15, Apr 15, Jul 15, Oct 15), 10-year validity for Trade/Retail businesses, and a 3-year minimum for registrations. These aim to standardize compliance, reduce admin burdens, enable bulk renewals. Stakeholders have been invited to submit feedback by 30th June, 2025.
Source: bit.ly/3SBuv09

3. The Drugs Controller General of India (DCGI) has revoked import registrations of several cosmetic products containing salicylic acid concentrations exceeding the prescribed limit, in violation of the Cosmetics Rules, 2020.
Source: bit.ly/4kyzz1e

4. India’s Kerala High Court rules that prescribing medicines and tests over the phone doesn’t constitute gross negligence, reinforcing protections for doctors against unwarranted criminal liability.
Source: bit.ly/4dybNQy

5. India’s Central Drugs Standard Control Organisation (CDSCO) has identified numerous MSME pharmaceutical firms in India producing substandard drugs, with April data revealing about 60 samples failing quality standards. Affected products include eye drops, anaesthetics, and supplements.
Source: bit.ly/4jirNHr

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 Punjab & Haryana High Court mandates state government to notify rules under Mental Healthcare Act, 2017 within 60 days, addressing a 7-year delay that hampers effective implementation and delivery of mental health services.
Source: bit.ly/4k3CEpU

2. India’s Central Drugs Standard Control Organisation (CDSCO) has issued a guidance document outlining the procedure for obtaining a Free Sale Certificate (FSC) for licensed medical devices in India. It simplifies the regulatory process for submitting an application and obtaining the FSC from the Central Licensing Authority.
Source: bit.ly/3FbKQW9

3. Food Safety and Standards Authority of India (FSSAI) mandates that FBOs with expired licenses or registrations in FY 2024–2025 must submit a Closure Report via the FoSCoS portal. The report must confirm no ongoing business or provide details of a new license. Reasons for non-renewal must be stated to ensure transparency and traceability in licensing.
Source: bit.ly/3Se67kQ

4. India’s Department for Promotion of Industry and Internal Trade (DPIIT) has extended the implementation of the Quality Control Order (QCO) for household and commercial electrical appliances to March 19, 2026. The update includes relaxations for Micro, Small and Medium Enterprises, R&D and export units, supporting quality and ease of business.
Source: bit.ly/4ksMTEb

5. The Drugs Control Department of Kerala has taken an action against a private hospital for illegally stocking and selling Physician’s sample medicines at inflated prices, highlighting that sample medicines can neither be stocked nor sold by hospitals.
Source: bit.ly/3FieSaJ

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 Supreme Court has ruled that individuals convicted of food adulteration offences under the now-repealed Prevention of Food Adulteration Act cannot be granted probation. The Court clarified that the law in force at the time mandated strict punishment for such offences, and the bar on probation remains valid under the current Food Safety and Standards Act, 2006.
Source: bit.ly/3SD2x3R

2. India’s Chhattisgarh High Court has invalidated tender clauses by the Chhattisgarh Medical Services Corporation Limited that permanently barred previously blacklisted companies from bidding, even after their blacklisting period had ended. The Court emphasized that such conditions are arbitrary and violate principles of fairness in public procurement.
Source: bit.ly/45aP0Ik

3. India’s Jharkhand High Court ruled that selling goods at concessional rates alone does not amount to a sham transaction. The Court quashed notices issued for alleged discrepancies, stating that comparing sale prices to market rates is not sufficient grounds to question the authenticity of the transactions.
Source: bit.ly/4kfrgqE

4. The Indian government has invited fresh applications under the Performance-Linked Incentive (PLI) scheme to boost domestic production of bulk drugs. The focus is on 11 key product categories, including Active Pharmaceutical Ingredients (APIs), Key Starting Materials (KSMs), and intermediates. The initiative aims to reduce reliance on imports, particularly from China.
Source: bit.ly/42Zm6ti

5. A leading beverage company will revise its recycling labels following a greenwashing complaint by the European Consumer Organisation (BEUC). The updated labels will clarify that only the bottle body contains 100% recycled plastic, exclude caps and labels, and remove green imagery and the phrase “Recycle Me Again” to avoid misleading consumer.
Source: bit.ly/4khtF4V