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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 Central Drugs Standard Control Organization clarified that labelling, overprinting, or stickering is strictly permitted for imported drugs. These activities require a valid manufacturing license, appropriate facilities, and adherence to labelling norms. Original labels must remain visible to maintain regulatory transparency and ensure clear identification of modifications and responsibilities.
Source: bit.ly/4kjfBYw

2. The Himachal Pradesh High Court held that vicarious liability for supplying substandard drugs requires proof that an individual was responsible for the company’s operations. Without such evidence, partners cannot be held liable, and only the company itself can be prosecuted for manufacturing or selling defective drugs.
Source: bit.ly/3Hfap9o

3. India’s Ministry of Health has released draft Drugs Rules proposing mandatory testing for bacterial endotoxins or pyrogens in injectable drugs. The rules require drug sales to be supervised by a competent person, with timely reporting of any changes. Exemptions apply to non-antimicrobial drugs used in food and beverage manufacturing. Feedback from stakeholders invited by June 30, 2025.
Source: bit.ly/4jomruw

4. West Bengal’s Drugs Control Administration mandates wholesalers and retailers to verify QR codes on top-selling brands and ensure purchases through authorized channels, aiming to curb counterfeit drug circulation.
Source: bit.ly/4krbkCj

5. The Bureau of Indian Standards (BIS) seized products worth ₹90 lakh from a Bengaluru warehouse for allegedly using the ISI mark without authorization, raising concerns for compliance in product sourcing and labelling across industries.
Source: bit.ly/4jppfr4

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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. The Indian government has proposed prohibiting the import, manufacture, sale, and distribution of certain specified antimicrobial medicinal products for animal use. It has invited public suggestions and objections from stakeholders by 22nd June 2025. The move aims to curb antimicrobial resistance and protect human health.
Source: bit.ly/4dvRgfj

2. The Supreme Court of India recently upheld dual taxation on broadcasting services, allowing both the Centre to levy service tax and states to impose entertainment tax. It ruled broadcasting as communication and entertainment as a luxury, confirming constitutional authority for concurrent taxation on cable TV, digital streaming, and OTT platforms.
Source: bit.ly/4mDyR4G

3. Under the free trade agreement (FTA), the United Kingdom reportedly will provide non-discriminatory access to Indian companies in its public procurement, while India grants UK firms limited access to high-value tenders in return. The deal ensures mutual market access while protecting India’s strategic interests, including ‘Make in India’ and SME support.
Source: bit.ly/3Sm7s9m

4. India and World Health Organisation (WHO) has signed the Memorandum of Understanding (MoU) to include AYUSH therapies in WHO’s global health classification system. This will give traditional medicine scientific recognition, enable insurance coverage, and improve global access to India’s ancient healing systems.
Source: bit.ly/3FuRgQ8

5. India’s Uttar Pradesh government, following a recent hospital fire has mandated comprehensive fire safety upgrades across all hospitals which includes installing fire-fighting systems, conducting regular mock drills, improving ventilation, and ensuring unobstructed evacuation routes. Staff training and adherence to fire safety guidelines to prevent future incidents
Source: bit.ly/45qkb2j

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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. Health Ministry’s proposal to amend the Drugs and Magic Remedies Act, aimed at curbing misleading medical advertisements, has been stalled since year 2022. The outdated Act allows deceptive ads, especially in AYUSH and modern medicine sectors, to persist unchecked has been revealed by an RTI.
Source: bit.ly/4kvddgY

2. Karnataka Government has suspended all Jan Aushadhi Kendras inside government hospitals, ensuring patients receive all medicines free of cost from hospital pharmacies. Kendras outside hospitals will remain open.
Source: bit.ly/4dtDZE2

3. GS1, the non-profit standards organisation is set to replace traditional barcodes with advanced 2D bar code technology by 2027 to improve product traceability, safety, and transparency, allowing consumers and businesses to access key details like origin, expiry, and recall information with one scan.
Source: bit.ly/45ahMsP

4. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is enhancing its Manufacturer’s Online Reporting Environment (MORE) to improve medical device safety. Effective June 16, 2025, manufacturers must submit Manufacturer Incident Reports (MIRs) and Field Safety Corrective Actions (FSCAs) through the updated MORE platform. The changes aim to strengthen post-market surveillance and facilitate better risk management
Source: bit.ly/3SRvQje

5. US Government is pressing India for tariff reductions on medical equipment as part of ongoing bilateral trade negotiations. After the US imposed a steep 26% tariff on Indian medical device exports in April 2025 up from previous rates of near-zero to 6%. India is seeking full exemption from these duties, which have been temporarily suspended for 90 days until July 9.
Source: bit.ly/4kv9WOu

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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 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

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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 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

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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. Kerala Deputy Drugs Controller (Ayurveda) has issued a stern warning to a prominent Ayurvedic drug manufacturer, for violating Rule 170 of the Drugs and Cosmetics Rules, 1945. This rule mandates that manufacturers obtain prior approval from state licensing authorities before advertising their products, aiming to prevent misleading promotions of AYUSH drugs.
Source: bit.ly/3H0LSoi

2. The All India Organization of Chemists & Druggists has cautioned against the Centre’s plan to expand the over-the-counter (OTC) drug list, warning that unsupervised use of routine medicines could pose serious health risks and lead to misuse without expert medical guidance.
Source: bit.ly/3H2vB2n

3. Small scale pharma companies have opposed CDSCO’s new export NOC rules, calling them burdensome for them. They warn of losing export markets to competing countries and seek an extension for Schedule M compliance and a tribunal to resolve regulatory disputes efficiently.
Source: bit.ly/3GZoac9

4. Experts have reportedly identified certain fixed-dose combinations (FDCs) in personal care products such as aloe vera, jojoba oil, and orange oil, as irrational and potentially harmful, recommending their prohibition to safeguard public health.
Source: bit.ly/3SGKh9N

5. The U.S. Food and Drug Administration (FDA) is reportedly initiating action to remove from the market unapproved concentrated fluoride drugs for infants and toddlers, citing concerns over microbiome disruption, thyroid issues, weight gain, and possible IQ decline.
Source: bit.ly/4doJeVr

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

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 Drugs Standard Control Organization (CDSCO) is in the process of initiating license withdrawal procedures for unapproved fixed-dose combinations (FDCs) of antibiotics. This action follows the failure of state drug licensing authorities to submit critical data. The move is aimed at curbing irrational antibiotic use and combating antimicrobial resistance.
Source: bit.ly/4j6zhxs

2. India’s government plans to mandate QR codes on vaccines, antimicrobials, narcotics, and cancer drugs to enhance traceability and combat counterfeiting. The move also includes adding excipient details on labels for certain medicines, aiming to improve drug authenticity, safety, and public health protection across the supply chain.
Source: bit.ly/4jflqFa

3. An Indian industry group has urged the government to scrap the mandatory testing of cough syrups at government-approved laboratories before export. The group argues that this costly process delays shipments and places a heavy burden on small manufacturers. The requirement was introduced following reports linking India-made syrups to fatalities in Gambia.
Source: bit.ly/437zHNO

4. The United States Food and Drug Administration (US FDA) has issued a warning to an Indian drug manufacturer for significant violations of Current Good Manufacturing Practices (CGMP) at its production facility. The violations include unsanitary conditions, inadequate equipment cleaning, poor documentation, and unverified raw material, raising serious global concerns about product quality, safety, and regulatory compliance.
Source: bit.ly/4mjGJIg

5. The EU’s Scientific Committee on Consumer Safety (SCCS) has concluded that butylparaben at 0.14% is unsafe for children aged 0.5–10 years when used in multiple cosmetic products. However, it is considered safe in single-use dermal and oral products, excluding body lotions.
Source: bit.ly/3H8EmYu

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 ruled that volume-based discounts are lawful and do not constitute discriminatory pricing, for such discounts to be considered discriminatory they must be applied unequally to similarly situated buyers in comparable transactions.
Source: bit.ly/4mghWEN

2. India’s Supreme Court has issued a notice to the central government on a petition seeking to make it mandatory for hospitals and clinical establishments to display service rates and charge fees within limits set by the Centre, in consultation with state governments. The Court noted that the failure to enforce this requirement stems from the government’s failure to specify the service charge limits which potentially impacts citizens’ fundamental right to healthcare.
Source: bit.ly/4jXJ75U

3. The High Court of Jammu & Kashmir and Ladakh has upheld a government advisory requiring retail and wholesale pharmacies to install CCTV cameras and adopt computerized billing systems. This measure aims to curb the sale of prohibited drugs and enhance transparency in pharmaceutical operations.
Source: bit.ly/4mgjrCV

4. In a proposed Free Trade Agreement with the UK, India has reportedly decided to reduce import duties on medical devices under the Production-Linked Incentive (PLI) scheme starting only from the sixth year. This phased approach aligns consumer needs with the Make in India programme, aiming to protect domestic manufacturers while gradually opening market access for UK exporters.
Source: bit.ly/4mlyPy8

5. The U.S. government’s order to align domestic drug prices with global rates may impact Indian pharmaceutical firms, many of which rely heavily on U.S. revenues. Though primarily targeting Big Pharma, the move could subject Indian generic manufacturers to pricing pressure, potentially disrupting their business models and profitability.
Source: bit.ly/4dkH0Xt