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 Legal Metrology (General) Rules, 2011 has been amended to introduce mandatory metrological and technical standards for continuous clinical electrical thermometers used in human and veterinary care. The rules prescribe accuracy thresholds, testing protocols, labelling norms, environmental tolerance, and type-approval requirements impacting manufacturers, importers, and hospital-grade device suppliers.
Source: short-url.org/1k3IL

2. The Delhi High Court is examining a challenge to mandatory vegetarian/non-vegetarian dot labelling on toothpaste and toiletry products. Noting conflicting regulatory positions, the Court has directed Legal Metrology authorities and the Drugs Controller General of India (DCGI) to hold a joint meeting to determine whether such labelling should remain compulsory or voluntary. The matter is listed for further hearing on April 27.
Source: short-url.org/1p8RE

3. The Union Health Ministry will unveil SAHI (Strategy for AI in Healthcare for India) and BODH (Benchmarking Open Data Platform for Health AI) at the India AI Summit 2026, under the Ayushman Bharat Digital Mission, the initiatives institutionalise AI governance, validation and privacy-preserving benchmarking nationwide.
Source: short-url.org/1k3Iu

4. India’s Delhi High Court has reportedly urged authorities to ensure real-time hospital bed and emergency service data through the NextGen e-Hospital digital platform. It ordered full implementation across government hospitals, including linkage to a mobile app for public access, and called for technical support and broader adoption to improve emergency care and patient treatment.
Source: short-url.org/1p8Ry

5. The All India Organisation of Chemists and Druggists (AIOCD) has reportedly warned Prime Minister Narendra Modi that AI-generated fake medical prescriptions are enabling illegal online drug sales by unregulated e-pharmacies. The group wants government to action to withdraw certain regulations, close illegal platforms, and ban AI-generated prescriptions to protect public health.
Source: short-url.org/1p8Rs

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 drug authority (CDSCO) reportedly flagged 35 drugs manufactured in Telangana as Not of Standard Quality (NSQ), including painkillers, antacids and antibiotics. These medicines, failed quality or labelling standards, resulting in regulatory and manufacturing oversight gaps. Affected batches are reportedly recalled, and show-cause notices are issued.
Source: h7.cl/1oCiU

2. The Indian Pharmacopoeia Commission (IPC) has entered into three strategic Memoranda of Understanding (MoUs) with the Goa State Pharmacy Council (GSPC), Quality Council of India (QCI), and HLL Infra Tech Services Limited. These collaborations aim to strengthen pharmacovigilance systems, enhance professional competencies, and promote uniform standards for medicine quality and patient safety across India.
Source: h7.cl/1oCj1

3. India and United States has agreed under an interim trade framework to address long-standing barriers for US medical devices, eliminate restrictive import licensing procedures, and review adoption of US or international standards within six months to boost market access. The move is part of broader efforts to improve MedTech trade and bilateral economic cooperation
Source: h7.cl/1jzb3

4. Delhi High Court disposed of a trademark infringement suit after parties reached an amicable settlement. The defendant acknowledged superior trademark rights of the plaintiff in trademark “Blue Heaven”, agreed to permanent injunction, withdrew trademark applications, paid damages and costs, removed online listings, and enabled refund of court fees as ordered.
Source: h7.cl/1oCj9

5. Indian Council of Medical Research is reportedly rolling out an AI-based surveillance system under the National One Health Mission to detect zoonotic diseases early. By integrating human, animal, and environmental data, it will identify unusual patterns, provide real-time decision support, and help prevent local outbreaks from escalating into pandemics.
Source: h7.cl/1jzeb

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 Drug and Medical Device Regulator, The Central Drugs Standard Control Organisation (CDSCO), has issued a public notice that it will reject applications if the queries to the applications are not responded within 90 days from the date of receipt of the query on its official application portal called SUGAM portal. A time-bound reminder and rejection mechanism for timely disposal of the pending applications has been introduced. Applications pending for two years will now be rejected after 30 days notice if no response is submitted.
Source: h7.cl/1i6LX

2. India’s Ministry of Commerce and Industry has extended the deadline for importers and manufacturers to obtain BIS certification for aluminium utensils and food and beverage cans covered under the Quality Control Order, 2026. The revised timelines are issued in a phase wise manner based on industry category, beginning from 1 October 2026.
Source: h7.cl/1i6L0

3. Several drug companies are cautious about a new fast approval program under the United States Food and Drug Administration. They fear quicker reviews may weaken scientific scrutiny, increase legal risk, and invite court challenges, even as others support faster access to important medicines for patients nationwide safely.
Source: h7.cl/1i6Lg

4. The Maharashtra Public Health Department has launched dedicated menopause clinics in Pune to provide specialised care for women’s physical and mental health needs. Weekly OPDs will be held every Wednesday at government hospitals, offering medical management, counselling, and lifestyle guidance. The initiative aims to address menopause-related health issues across urban and rural areas.
Source: h7.cl/1n5Uw

5. India’s Ministry of Agriculture and Farmers Welfare has announced that the Seed Act, 2026, to introduces a nationwide seed traceability through QR codes, mandate seed company registration, and impose penalties up to ₹30 lakh for substandard seeds, and safeguards the traditional seed systems and strengths transparency.
Source: h7.cl/1i6Lp

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 Health Ministry has prohibited the manufacture, sale and distribution of all immediate-release oral formulations containing Nimesulide above 100 mg, citing potential risks to human safety and availability of safer alternatives. The ban, issued under Section 26A of the Drugs and Cosmetics Act, takes immediate effect across India.
Source: h7.cl/1h4DA

2. The Ministry of Health and Family Welfare has issued draft rules to amend the Drugs Rules, 1945, proposing deletion of “Syrup” from Schedule K, following approval by the Drugs Consultative Committee. Once implemented, syrups would lose regulatory exemptions. Stakeholders are invited to submit objections within 30 days of the notification.
Source: h7.cl/1h4DF

3. India’s drug regulator reportedly cancelled the import licence of a hair loss product after it was promoted as a treatment for post chemotherapy hair loss and other medical conditions. Since the product was approved only as a cosmetic, such therapeutic claims were found misleading and in violation of cosmetic regulations.
Source: h7.cl/1h4DM

4. Leading oral nicotine pouch makers are seeking CDSCO approval to market high dose products as therapeutic nicotine replacement, raising concerns among regulators and health experts about addiction, youth initiation and long-term cardiovascular risks. The move could trigger stricter regulatory scrutiny in India’s pharma and public health landscape.
Source: h7.cl/1h4DN

5. The Telecom Regulatory Authority of India (TRAI) has issued recommendations to regulate the sale of foreign SIM/eSIM cards used in M2M/IoT devices meant for export, proposing a light-touch “International M2M SIM Service Authorisation” with online approval, no entry fees, and 10-year validity to boost exports, support Make in India
Source: h7.cl/1m0FU

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 amended the Cosmetics Rules, 2020 introducing clearer expiry labelling, redefining terms, updating recordkeeping norms, and empowering authorities to suspend or cancel licences. Notable changes include labelling for exports, new batch record rules, and designation of the Central Cosmetics Laboratory.
Source: short-link.me/1aoFG

2. In order to enhance ease of doing business, India’s central drug authority (CDSCO) has streamlined the process of issuance of Dual Use NOC through Sugam Portal for importing bulk drugs for non-medicinal use. Further to reduce the compliance burden, CDSCO has initiated issue of 1 year NOC, subject to prescribed conditions for such drugs. The new online Dual use system will be effective from 31st August 2025.
Source: short-link.me/1aoEr

3. The Food Safety and Standards Authority of India (FSSAI) has mandated all food business operators such as restaurants, cafes, dhabas and cloud kitchens to display their licence or registration along with a QR code linking to the Food Safety Connect app. This helps consumers access details, lodge complaints and provide feedback, promoting transparency and accountability.
Source: short-link.me/1aoOH

4. The Indian government enacted the Vegetable Oil Products, Production and Availability (VOPPA) Regulation Order, 2025, replacing the 2011 framework. It mandates mandatory registration for all vegetable oil producers, monthly online reporting of production, stocks, sales, and pricing, and grants authorities inspection and enforcement powers to boost market transparency and curb hoarding.
Source: short-link.me/1aoEM

5. Karnataka’s Health & Family Welfare Department has filed 29 legal cases under the Drugs & Cosmetics Act, and has served show-cause notices to 231 pharmacies for dispensing prescription drugs without prescriptions; simultaneously, authorities have flagged food vendors using synthetic colors and have issued warnings.
Source: short-link.me/1aoEW

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

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 Drugs Technical Advisory Board is reportedly reviewing a proposal to limit the sale of over-the-counter drugs. Only 27 essential medicines, including painkillers, antacids, and oral contraceptives, may be allowed without a prescription, with strict controls on dosage and pack size.
Source: bit.ly/4jqjkD0

2. Delhi High Court has upheld the Government’s move to restrict the sale of an anti-cold drug without warning labels against use in children below 4 years after April 15, 2025. For earlier batches, companies must publish notices in two national newspapers, which won’t count as advertisements or violations of license conditions.
Source: bit.ly/3SaUOK0

3. India’s drug regulator has reportedly approved eye drops aimed at controlling myopia progression in children. This pediatric formulation, the first of its kind to be approved in India, has successfully completed Phase III trials and will be available as a prescription drug.
Source: bit.ly/444JxCp

4. A group of doctors with disabilities has urged the World Health Organisation to include sunscreen in its Essential Medicines List, citing its importance for people with albinism who are highly susceptible to UV radiation. They argued that sunscreen is a vital medical need and not a cosmetic.
Source: bit.ly/44KmxJ9

5. The U.S. FDA reportedly plans to phase out several synthetic food dyes linked to health concerns like attention deficit hyperactivity disorder (ADHD) and obesity. Two dyes will be banned soon, with six more to be removed by 2026, and new natural color additives will be approved.
Source: bit.ly/3EFTFXQ

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

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

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. A Public Interest Litigation before the Bombay High Court is being opposed by the Association of Oral and Maxillofacial Surgeons of India, arguing on the basis of a notification of the Dental Council of India dated 6th December 2021, that specialized Oral and Maxillofacial Surgeons registered with State Dental Councils should be permitted to carry on hair transplant surgeries.
Source: bit.ly/49yFtLx

2. The Central AYUSH Minister (Ayurveda, Unani, Siddha and Homeopathy) has stated in response to query in the Indian Parliament, that the ministry has followed a policy of co-location of AYUSH facilities at primary healthcare centres to encourage patients to make choice of treatment.
Source: bit.ly/41ssp8c

3. A lawsuit has been filed in the United States against the manufacturers of consumer food products, alleging that the products manufactured by the companies are “ultra-processed” and prone to causing chronic diseases among consumers.
Source: bit.ly/4goMQXO

4. The Union Health Ministry of India has reportedly urged states to classify snakebites as a notifiable disease, meaning it must be reported to the government by hospitals. This follows the launch of the National Action Plan for Prevention and Control of Snakebite Envenoming (NAPSE), which aims to reduce snakebite deaths by 50% by 2030. One of NAPSE’s recommendations is that snakebites be made a notifiable disease to better track and address the issue.
Source: bit.ly/4gxDPvG

5. The Ministry of Health and Family Welfare has stated that data on disciplinary actions against Registered Medical Practitioners (RMPs) over the past five years is not centrally maintained. It has advised states to promote the prescription of generic drugs and conduct prescription audits in public health facilities. The Indian Medical Council’s 2002 regulations mandate that physicians prescribe drugs by their generic names, legibly and preferably in capital letters, ensuring rational and appropriate use.
Source: bit.ly/3ZRLujb