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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 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

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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 Drugs Consultative Committee (DCC) has approved a proposal to delete the exemption under Entry 13 of Schedule K for cough syrups. The move follows recent incidents involving deaths linked to contaminated cough syrups.
Source: h7.cl/1ft5I

2. The Drugs Consultative Committee (DCC) has observed gaps in monitoring drug marketers’ responsibility for product quality, safety, and efficacy, as their details are often unavailable for regulatory communication. To enhance accountability, the DCC has recommended amending the Drugs Rules, 1945 to mandate a licensing framework for all drug marketers.
Source: h7.cl/1kjPG

3. India is reportedly planning to introduce a Quality Control Order (QCO) requiring Bureau of Indian Standards compliance for food-processing machinery, aiming to curb unsafe imports, especially from China. The measure seeks to improve equipment reliability, ensure food-grade materials, strengthen domestic manufacturing, and minimise disruption for smaller processors across the industry.
Source: h7.cl/1ft5T

4. The government will reportedly introduce a Bill in the Lok Sabha seeking a new “health & national security” cess to replace the expiring GST compensation cess on cigarettes, pan masala, gutkha and other tobacco products. The aim is to keep overall tax incidence unchanged, sustaining high indirect-tax levels on “sin goods” while tying levy proceeds to public-health and national-security objectives.
Source: h7.cl/1kjPJ

5. The Food Safety and Standards Authority of India (FSSAI) has directed all state and central food-safety authorities to conduct inspections, sampling and testing of roasted chana and similar products following complaints that the banned industrial dye Auramine, which is not permitted under food-safety rules, was being illegally used for colouring. The order mandates action across manufacturing, storage, distribution and e-commerce channels and requires a consolidated compliance report to be submitted within 15 days.
Source: h7.cl/1kjQl

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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 Ministry of Health and Family Welfare has notified an amendment the Transplantation of Human Organs and Tissues Rules, 2014. The amendment specifies that in Form 15, under “Corneal Transplantation Centre,” the word “Specular” shall be replaced with “Specular (optional),” making the requirement for specular examination optional.
Source: urli.info/1eoY-

2. The Supreme Court of India has issued a notice in a petition by the Haemophilia Federation of India seeking inclusion of haemophilia under the Rights of Persons with Disabilities Act, 2016’s provision which mandates a 4% reservation in government employment for persons with benchmark disabilities (those with 40% or more disability). Further, if there cannot be an inclusion, the petitioners have prayed for striking down the exclusion.
Source: urli.info/1eoZ1

3. A report by CyberPeace warns that early exposure to online gaming is increasingly linked to obesity, sleep disruption, repetitive-strain injuries and mental-health issues among children. It urges India to adopt robust age-verification mechanisms, formal content ratings and a “living legislation” framework for game developers and publishers.
Source: urli.info/1eoZa

4. The Indian Pharmacopoeia has reportedly been officially recognised by 17 countries as the authoritative standards for medicines. This recognition will enhance the quality assurance of pharmaceutical products, eliminate duplicate testing, promote export growth, and strengthen India’s position as a reliable supplier of affordable, high-quality medicines worldwide.
Source: urli.info/1jcwP

5. Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on advertising therapeutic goods on social media, clarifying legal responsibilities for advertisers, influencers and account holders. The update outlines what qualifies as advertising, the use of testimonials, mandatory health warnings and common breaches, after removing over 13,700 unlawful ads in FY 2024 25.
Source 1: urli.info/1jcwR
Source 2: urli.info/1jcwU

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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 Central drugs licensing authority has permitted importers and manufacturers of Class C and D medical devices to affix stickers with revised Maximum Retail Price (MRPs) reflecting reduced GST rates which are effective from 22 September 2025. The stickered MRP must reflect the reduced GST, and the changes must be implemented within 3 months from the date of this order.
Source: short-url.org/19uui

2. The Himachal Pradesh High Court held that stocking allopathic medicines without a valid licence amounts to an “offer for sale” under Section 27 of the Drugs and Cosmetics Act. Displaying medicines in a clinic rack was deemed sufficient to establish intent to sell.
Source: short-url.org/1e2Yz

3. Delhi High Court has temporarily stopped the drug regulator (CDSCO) from initiating criminal proceedings against a major online marketplace accused for listing unapproved drugs. The platform contends it functions only as an intermediary and is protected under law.
Source: short-url.org/1e2YG

4. The Orissa High Court has asked the Odisha Government to respond within two weeks to a PIL seeking mandatory use of Individual Donor Nucleic Acid Testing (Individual Donor Nucleic Acid Testing) in all government and affiliated blood banks. The plea argues that the existing NAT-PCR screening is outdated and less effective in early detection of HIV, Hepatitis B, and Hepatitis C infections.
Source: short-url.org/1e32Q

5. A Parliamentary Standing Committee on Finance has called on the Centre to decentralise the Ayushman Bharat-PMJAY scheme by using mobile health units and telemedicine hubs, especially in tribal and hilly regions. The move aims to improve accessibility, strengthen outreach, and ensure coverage penetrates underserved geographies.
Source: short-url.org/1e2YU

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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 drug authority has launched a new CT 04 application module on its SUGAM online portal, streamlining the issuance of import licences for cell & gene therapeutic products to simplify and accelerate regulatory compliance and imports.
Source: bit.ly/3TGuNmR

2. A Central Drugs Consultative Committee panel has noted consumer complaints over unreadable expiry dates, tiny fonts, glossy packaging, and generic-brand confusion on medicinal products. It recommends forming a DCGI-led sub committee including a packaging expert to overhaul labelling norms and evaluate regulatory requirements for packaging suppliers under Drugs Rules, 1945.
Source: bit.ly/3IpVF8h

3. Food Safety and Standards Authority of India (FSSAI) has recently directed licensing authorities to audit annual returns filed by food business operators on the FoSCoS platform. Authorities have been directed to flag inconsistencies, permit revisions via updated portal features, and enforce penalties for false declarations.
Source: bit.ly/4lpGH0p

4. The Central Board of Indirect Taxes and Customs has mandated that customs officers verify the registration of plastic raw material importers on the Centralized Extended Producer Responsibility (EPR) Portal before clearing consignments. This directive aligns with the Plastic Waste Management (Amendment) Rules, 2024.
Source: bit.ly/3TYREu9

5. The Government of India has reportedly planned to transfer the National Health Claims Exchange (Insurance claims platform) from the health ministry to the finance ministry under Insurance Regulatory and Development Authority’s oversight to combat inflated hospital bills for insured patients.
Source: bit.ly/40hID2M

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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 Medical Association (IMA) has challenged the Maharashtra government’s decision allowing homeopaths to prescribe allopathic medicines after six months of certified training, calling it a threat to public health. The IMA has filed a petition in the Bombay High Court, urging an expedited resolution of the matter.
Source: bit.ly/4kl20ip

2. A government panel, the Drugs Consultative Committee (DCC) under CDSCO, has directed State Licensing Authorities not to issue manufacturing licenses for new drugs without prior approval from the Central Licensing Authority (CLA), as mandated by New Drugs Clinical Trial Rules 2019.
Source: bit.ly/3GC8A6l

3. India’s NITI Aayog has setup an expert panel to review quality concerns in India’s pharmaceutical manufacturing. It will assess regulatory gaps and challenges across 3,000 companies and 10,500 units. The goal is to align production with global standards, boost compliance, and ensure patient safety to uphold India’s global medicine supplier status.
Source: bit.ly/3GvWBHB

4. The Drugs Consultative Committee (DCC) has recommended inclusion of detachable Braille cards and voice-enabled QR codes on medicine packaging to enhance accessibility for visually impaired patients. The proposal aims to standardize inclusive labeling across pharma products, aligning with patient-centric and accessibility-first regulatory reforms.
Source: bit.ly/3TttpUw

5. The Drugs Consultative Committee (DCC) has approved amendments to Forms 27D/27DA and 28D/28DA under the Drugs Rules, 1945, enabling manufacturers to apply for licenses to produce stem cell-derived, gene therapy, xenograft, and modified-release products via both state and central authorities.
Source: bit.ly/3Ii5o0f

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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

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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. Supreme Court Calls Unethical Clinical Trials a Critical and Serious Issue, Orders Detailed Report from Government. The Supreme Court of India recently heard a Public Interest Litigation (PIL) filed by a public health rights NGO, highlighting unethical clinical trials causing serious adverse effects and deaths of the participants. The Court directed the Central Government to submit a detailed report within four weeks addressing concerns such as transparency, accountability, provisions for criminal actions against sponsors/investigators and other points raised by the petitioners.
Source:  bit.ly/4bW7QEB

2. Group of therapists have approached the Bombay High Court, alleging police harassment under the Immoral Traffic (Prevention) Act, violating their trade and dignity rights. The Maharashtra government informed the Court about a 12-member committee drafting guidelines for regulating spa and massage centers. The guidelines will cover important aspects such as licensing procedures, operational standards, and the regulation of cross-gender massages.
Source: bit.ly/4c4hG7s

3. India’s Health Department of Karnataka has clarified that Essential Narcotic Drugs (END) in the state will now be regulated under the Central Narcotic Drugs and Psychotropic Substances (NDPS) Rules, replacing the previous state regulations. As a result, hospitals and medical institutions recognized as RMIs by the state drug regulator no longer need state-level permission to stock these drugs. However, other narcotic drugs in Karnataka will continue to be regulated according to state NDPS Rules.
Source: bit.ly/4l1XDdY

4. The list of drugs taking a shift from prescription-only to over-the-counter (OTC) is reportedly to be released soon. A sub-committee is drafting guidelines, which may categorize OTC drugs for sale in pharmacies or in general stores, similar to practices in Western countries.
Source: bit.ly/4hJjCDB

5. MedTech Europe has released a report outlining the administrative burdens caused by the non-harmonized authorization process for IVD performance studies & the increased post-market and clinical reporting requirements for medical devices under the new medtech regulations. The report also proposes several solutions, including streamlining approvals for multinational studies, digitalizing processes, and allowing manufacturers to consolidate key reports.
Source: bit.ly/42jN4dJ

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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. An interministerial committee constituted by the Department of Pharmaceuticals has proposed that health-supplements and nutraceuticals should be regulated as “Drugs” to ensure better quality control and to streamline insurance regulation as well.
Source: bit.ly/40QCmfk

2. In its recent meeting, the Ayurveda Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) has proposed to amend the Drugs Rules and regulate the retail sale of AYUSH medicine, which would empower drug inspectors to inspect these premises and collect and examine samples.
Source: bit.ly/3Cve0xR

3. The CDSCO is set to hold a round-table meeting for all Cosmetics industry stakeholders, including manufacturers and marketers to discuss issues including expansion of permission for cosmetics manufacturers to manufacture topical products.
Source: bit.ly/4ey6nDX

4. The Supreme Court dismissed a Special Leave Petition filed in response to the decision of the Delhi High Court seeking Order to mandate Doctors to explain side-effects to patients, holding that since there is no obvious issue highlighted with the side-effect information legally required to be presented by manufacturers, it is not necessary to require Doctors to do the same.
Source: bit.ly/48WLP70
Source: bit.ly/3UV5MoM

5. In a recent decision, the Supreme Court held that when examining petitions concerning procedural irregularities under the Arbitration and Conciliation Act, 1996, Courts should limit their examination to merely determining whether a valid arbitration agreement is existing and whether there is a preliminary dispute regarding appointment of Arbitrators.
Source: bit.ly/4ezdTP6

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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. A recent Right to Information filing before the Ministry of Health and Family welfare has brought to  attention that the Central government has not notified or published procedure in light of the  proposed 2022 Amendment to the National Medical Commission Act, 2019 which aimed to allow appeal against decisions of the State and National Medical Commission before the autonomous Ethics and Medical Review Board.
Source: bit.ly/486DMnN
Source: bit.ly/4h3sHaZ

2. The Jammu and Kashmir High Court held in a recent decision that the insurance company does not have the discretion to reduce the eligible claim amount solely on the basis that compensation has already been given to the claimant from the government.
Source: bit.ly/48a2Bz6

3. The Department of Consumer Affairs has issued the Guidelines for Prevention and Regulation of Greenwashing and Misleading Environmental Claims, 2024. These guidelines regulates the nature of technical terms that can be used in these claims, and prescribes requirements for substantiation of the claims.
Source: bit.ly/3A3vIYi

4. The National Accreditation Board for Testing and Calibration Laboratories, has proposed to initiate a program for accreditation of bio-banking facilities modelled after the international standards as prescribed under ISO 20367:2019.
Source: bit.ly/3BJfa8z

5. The United States Drug Administrative Science Board has recommended that the United States Food and Drug Administration (USFDA) set up an office to monitor alternatives to animal testing methods, and bring them within the quality control regime of the USFDA.
Source: bit.ly/3U7gW9N