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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 Madras High Court has imposed a ban on the manufacture, sale, transport, and use of 28 types of single-use plastic items across the areas like the Nilgiris, Kodaikanal, and the Agathiyar Biosphere. Banned items include plastic bottles, food wrapping films, thermocol plates and cups, plastic-coated tableware, straws, carry bags, etc.
Source: bit.ly/3RmpHuX

2. Indian food regulator FSSAI, in response to an RTI, has stated that it lacks authority to regulate baby milk products under the Infant Milk Substitutes, Feeding Bottles, and Infant Foods (Regulation of Production, Supply and Distribution) Act, which regulates baby food marketing, placing enforcement responsibility on the Women and Child Development Ministry.
Source: bit.ly/4lDCPts

3. India’s Health Ministry has released a notification restricting the manufacture and sale of a popular anti cold drug until there is a warning on labels stating they should not be used in children below four years. The notification will take effect from the date of its publication in the Official Gazette.
Source: bit.ly/3Y54v08

4. Private hospitals in Nagaland have reportedly suspended admitting patients under Ayushman Bharat, Pradhan Mantri Jan Aarogya Yojana and Chief Minister Health Insurance Scheme from April 17, 2025, due to unpaid dues. The Nagaland Private Doctors Association urged authorities to resolve the issue so services can resume without further delay.
Source: bit.ly/4cAsslY

5. The UK Government has enacted significant reforms to clinical trials regulation. Effective from April 11, 2025, with full implementation by April 2026, the new rules aim to streamline trial approvals, enhance patient safety, enable innovation, and help more people benefit from participating in vital research.
Source: bit.ly/4jDT5ZC

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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 released guidelines for the establishment and operation of Common Bio-Medical Waste Treatment and Disposal Facilities (CBWTFs). These guidelines cover site selection, treatment technologies, infrastructure, record-keeping, and compliance monitoring to standardize practices across India.
Source: bit.ly/4jos50r

2. India’s Central Pollution Control Board (CPCB) has issued show cause notices to 11 Plastic Waste Processors (PWPs) for allegedly selling recycled plastic at unreasonably low prices. CPCB has ordered the cancellation of their registrations and imposed environmental compensation. The PWPs are required to respond or take appropriate action within 10 days from the date of issuance of the notice.
Source: bit.ly/42Jrbom

3. India’s Central Government has notified an amendment to the list of psychotropic substances under the Narcotic Drugs and Psychotropic Substances Act, 1985. Pursuant to this amendment, the following substances have been included in the list of psychotropic substances: 3-Chloromethcathinone (3-CMC), Dipentylone, 2-Fluorodeschloroketamine, and Bromazolam.
Source: bit.ly/4jFxhwM

4. A sunscreen brand has agreed to take down and modify its advertisement campaign disparaging a competitor brand by claiming that it is ineffective, causes skin pigmentation and makes misleading claims. The modification will include removing the term “online bestseller” and other references.
Source: bit.ly/4jmLrDm

5. The Food Safety and Standards Authority of India (FSSAI) has released a consultation on compliance with provisions of ‘Analogue in Dairy Context’ and is inviting public comments from the stakeholders. The authority aims clearly bifurcate ‘Dairy Analogues’ from regular dairy products. Stakeholders can send their suggestions by 15th June 2025.
Source: bit.ly/42w1ZBl

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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. Several global pharmaceutical companies have approached the European Commission demanding assistance in maintaining operations in the EU and to help Europe keep the pharma industry including measures to compensate them for the cost of pharmaceutical innovations. This move comes in the face of threatened U.S. tariffs on imports.
Source: bit.ly/3RgXrK6

2. A pharma giant has allegedly breached the UK’s Prescription Medicines Code of Practice Authority (PMCPA) for its cancer drug’s misleading prescribing information, which failed to clearly state that women using hormonal contraceptives needed to take additional measures to prevent pregnancy while on the drug.
Source: bit.ly/4lzu3MO

3. India’s Department of Pharmaceuticals (DoP) has invited expression of interest for selecting an agency to conduct a comprehensive study of India’s pharmaceutical and medical device supply chains, in order to identify regulatory hurdle.
Source: bit.ly/42zIx6O

4. Central Drugs Standard Control Organisation has directed States and Union Territories to urgently stop the manufacture, sale, and distribution of 35 unapproved Fixed Dose Combinations licensed without safety and efficacy evaluation under New Drug and Clinical Trials rules, 2019. Authorities must investigate, take action, and report compliance to ensure public health and regulatory consistency.
Source: bit.ly/4cw43hg

5. China has amended its GB 9685 standard for additives in food contact materials. The changes include expanded use in silicone rubber, revised usage limits, updated additive names, and new safety calculations. These updates, effective March 2025, aim to improve consumer safety and industry compliance.
Source: bit.ly/4cGqBfE

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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 given Central government three months to enforce new food labelling rules which require Front-of-Pack-Warning Labels (FoPWL) for Packaged foods containing high level of sugar, salt, and saturated fat content, along with their recommended daily intake (RDA), in bold and prominent font on the front of packaging.
Source: bit.ly/3Eigy3s

2. Gujarat Food and Drug Control Administration has reportedly found fake QR codes on a top pharma brand’s medicine. Over 900 strips were seized in this counterfeit drug racket. A full-scale investigation, raids, forensic checks, and officer training are underway to trace sources and stop illegal supply chains.
Source: bit.ly/4lsuJna

3. A survey across 303 Indian districts reportedly reveals that most side effects among medicines are caused by antibiotics. One in two people reported side effects from allopathy or AYUSH medicines. Experts warn that misuse of antibiotics without prescriptions is rising antimicrobial resistance, posing serious public health concerns
Source: bit.ly/3YsVr5f

4. India’s Gujarat Food and Drug Control Administration (FDCA) has launched India’s first mobile app for licensing allopathic, cosmetic, and Ayurvedic products, issuing over 900 licenses online. The FDCA-mDMLA mobile app boosts efficiency, transparency, and ease of doing business allowing real-time access and digital services.
Source: bit.ly/4i9yvz6

5. China has reportedly approved an amendment to General Requirements for Labels and Instructions of Disinfection Products, which mandates clearer warnings, font size requirements, and restrictions on misleading branding to enhance safety, transparency, and compliance in the disinfection product industry. The amendment is effective from May 1, 2025.
Source: bit.ly/3Ehsx1f

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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 (FSSAI) has revised its inspection checklist for food businesses operators in General manufacturing, Milk & milk products, Meat processing, Fish products processing, and Catering, and has reclassified food-grade packaging materials from ‘Non-Critical’ to ‘Critical.’ It has also mandated that food-grade packaging materials used in these food businesses must have a Certificate of Conformity issued by an NABL-accredited laboratory.
Source: bit.ly/4jmTFei

2. The Central Drugs Standard Control Organization (CDSCO) has clarified that the brand name of the medical device must be included in the Free Sale Certificate (FSC) issued to the legal manufacturer when filing an import licence application form. If not specified in the FSC, “Not Applicable” should be mentioned.
Source: bit.ly/3YhBEWi

3. The Central Drugs Standard Control Organization (CDSCO) has clarified the packaging and labelling requirements of non-sterile medical devices intended to be sterilized before use. The finished product package must include Instructions For Use (IFU) which specify the method of sterilization to be used for the device prior to its end-use.
Source: bit.ly/3YhBEWi

4. The Central Drugs Standard Control Organization (CDSCO) has clarified that domestic manufacturers of medical devices need not obtain ISO 13485:2016 certificate to obtain a manufacturing license under the Medical Devices Rules, 2017.
Source: bit.ly/3YhBEWi

5. The state government of Kerala has started taking action against online purchase of unauthorised medicines, including anabolic steroids. Kerala state drug control department is inspecting gyms across the state to identify unauthorised medicines and their misuse.
Source: bit.ly/41XmHLv

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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 Council of Medical Research-led national health consortium raises concern over rising adolescent obesity and recommends stricter advertising rules on high-fat, -salt, and -sugar (HFSS) foods. It also proposes a 32% health tax on sugar-sweetened beverages and 20-30% tax on other HFSS foods to curb obesity.
Source: bit.ly/42dvtUq

2. The Organization of Pharmaceutical Producers of India has raised concerns with the health ministry as foreign drugmakers face delays in launching essential drugs. Despite a provision for waivers on clinical trials for drugs approved in select countries, the Drug Controller General of India has not approved any.
Source: bit.ly/3RtXxhr

3. India’s National Centre for Disease Control (NCDC), operating under the Ministry of Health and Family Welfare (MoHFW), is reportedly preparing to launch a new digital portal designed to provide real-time tracking of rabies vaccine and anti-snake venom stocks. which are not easily accessible owing to manufacturing shortage. The portal will initially be rolled out as a pilot project in five states: Andhra Pradesh, Assam, Madhya Pradesh, Delhi, and Puducherry.
Source: bit.ly/3R186bH

4. The State Consumer Disputes Redressal Commission (SDRC) of Chandigarh, India has set aside an order against a plastic surgeon for medical negligence allegation for unsatisfactory results under a liposuction procedure. SDRC ruled that unsuccessful treatment does not amount to negligence unless there is clear proof of deviation from clinical standards.
Source: bit.ly/4hTidKv

5. Reimbursements to private hospitals under the Central Government Health Scheme (CGHS) reportedly increased significantly from 24% in 2019-20 to 60% in 2023-24, driven by a rise in beneficiaries. This surge has raised concerns about fraudulent billing, overcharging, and inadequate oversight of spending.
Source: bit.ly/4jdwjYn

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 National Pharmaceutical Pricing Authority (NPPA) has approved the upward increase of (+) 1.74028% in the Wholesale Price Index (WPI) for all scheduled formulations. Importers and manufacturers of scheduled drugs and medical devices may increase the Maximum Retail Price (MRP) based on this WPI without prior approval from the government.
Source : bit.ly/3DWXVC8
Source : bit.ly/42jXgUs

2. The Central Board of Direct Taxes has raised the threshold of safe harbour provisions for Service Providers who provide R&D services relating to generic pharmaceutical drugs, from INR 200 crore to INR 300 crore.
Safe harbour provisions protect group companies who undertake international related party transactions from transfer pricing scrutiny.
Source: bit.ly/3Rpk3YK

3. A leading beverage brand has moved to Delhi High Court against Food Safety and Standards Authority of India’s ban on using “100% Fruit Juice” claim on label and advertisements of reconstituted fruit juices. The court denied an interim stay and set next hearing on April 1, 2025.
Source: bit.ly/3DUIZnX

4. The Supreme Court of India has ordered all states to set up a grievance redressal mechanism for misleading advertisements of medicines and cures within two months. It has directed all the authorities to take quick action, file cases if needed, and raise public awareness. The central government is also directed to finalize the complaint dashboard within three months.
Source: bit.ly/3FKNjXq

5. European Union has reportedly proposed to update the cosmetic ingredient glossary in Regulation (EC) No 1223/2009, replacing Commission Implementing Decision. This aims to standardize ingredient labeling and improve ingredient identification. The proposal, announced on March 13, 2025, is expected to be approved by second quarter of 2025.
Source: bit.ly/4c60PRH

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 and Family Welfare has developed ONDLS Portal for receiving applications from small and medium scale pharmaceutical manufacturers who wish to avail benefit of extension from requirement to comply with new Good Manufacturing Practices (GMP) under revised Schedule M. Such applications must be strictly submitted online before lapse of three months from February 11, 2025. Submission of hard copy applications will no longer be accepted.
Source: https://bit.ly/4iEFh0U

2. The Indian Ministry of Health is working with Bureau of Indian Standards (BIS) to develop a standardized invoice format for hospitals, nursing homes, clinics and diagnostic centers. Once notified, clinical establishments will have to follow a standard invoice format with detailed and transparent breakdown of charges incurred by patient.
Source: https://bit.ly/4c4CM5w

3. India’s Supreme Court has held that even in consumer contracts which contain arbitration clauses, a consumer has the right to decide whether to pursue arbitration or approach the consumer forum for resolution of consumer dispute. The Court further reiterated that consumer disputes are non-arbitrable unless the consumer voluntarily opts for arbitration.
Source: https://bit.ly/4c4CPOK

4. The Directorate General of Foreign Trade (DGFT) has decided to withdraw the Remission of Duties and Taxes on Exported Products (RoDTEP) Scheme benefits for exports arising from Advance Authorizations (AAs), Special Economic Zones (SEZs), and Export Oriented Units (EOUs).
RoDTEP Scheme helps pharmaceutical exporters to get refund on taxes and duties on export.
Source: https://bit.ly/4c43M59

5. The Food Safety and Drug Administration (FDA) of Karnataka has reportedly increased inspections to address the issue of adulteration of tea powders and spices.
The decision has been taken due to reports of addition of harmful substances in food products, with the goal of reducing health risks to the public.
Source: https://bit.ly/4cjrdrr

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 National Consumer Disputes Redressal Commission (NCDRC) absolved a major Super Specialty Hospital from charges of medical negligence, and stated that the absence of specific specialists doesn’t imply improper treatment or breach of medical duty when a patient is under the care of a multi-disciplinary ICU team.
Source: bit.ly/4kGd0sh

2. The Karnataka government has reportedly proposed the establishment of a special court to handle cases related to the supply of fake and spurious drugs. This proposal aims to tackle drug-related frauds, speed up trials, reduce delays and impose stricter penalties on offenders.
Source: bit.ly/4bPYme3

3. As of March 12, 2025, the National Pharmaceutical Pricing Authority (NPPA) has fixed ceiling prices for 928 scheduled formulations and retail prices for over 3,200 new drugs, reducing average prices by approximately 17% leading to estimated annual savings of about ₹3,788 crore for patients.
Source: bit.ly/4bRQF7a

4. India’s Delhi High Court to examine the scope of Customs jurisdiction under the Prohibition of Electronic Cigarettes Act, 2019, following the seizure of “empty atomizer devices” which are not claimed to be licensed medical devices. Currently, the definition of electronic cigarette exempts products licensed under the Drugs and Cosmetics Act, 1940.
Source: bit.ly/4iIVRwb

5. The Food Safety and Standards Authority of India (FSSAI) has reportedly set an expert panel for reviewing the regulations for baby food, specifically focusing on prescribed limit of sugar in packaged food products for babies. This follows a report revealing Nestlé adds sugar to Indian baby food but not in high income countries.
Source: bit.ly/4hwdxdv

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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 Tamil Nadu Online Gaming Authority has introduced regulations making Know Your Customer (KYC) mandatory for players before they can engage in online real-money gaming. This ensures age verification, promotes responsible gaming, and aims to curb gaming disorder, recognized by the WHO in ICD-11.
Source: bit.ly/3XMtzsq

2. An E-commerce giant in India has introduced a new pricing policy that enables sellers to set a ‘bank settlement value, while the platform controls the final listing price after fees and discounts. Sellers express concerns that this could violate FDI norms, promote anti-competitive pricing, and disrupt pricing parity across platforms.
Source: bit.ly/3FpxrcM

3. The Canadian government has proposed regulating caffeine as a supplemental ingredient, requiring cautionary labels on products with high caffeine content to prevent excessive intake and ensuring that caffeine-containing products are clearly labelled, “Do not [eat/drink] on the same day as any other source of caffeine.”
Source: bit.ly/4bQzRx5

4. The Canadian government is set to regulate harmful ‘forever chemicals’ (PFAS) found in everyday products to address growing concerns about human health and the environment. The anticipated new regulations will restrict per- and polyfluoroalkyl substances (PFAS) in a range of everyday items, including cosmetics, clothing, and food packaging.
Source: bit.ly/3DKQhKM

5. The European Commission aims to reduce reliance on Asian countries for essential drugs, including antibiotics, through the draft Critical Medicines Act. The upcoming law seeks to promote fair pricing for European generic drugmakers, ensure stable and reliable supply chains within the EU, and strengthen public health protection and security.
Source: bit.ly/422yzvy