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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 Health Ministry has amended the New Drugs and Clinical Trials Rules, 2019, permitting bioavailability or bioequivalence (BA/BE) studies in human subjects for export purposes for certain drugs approved in India or any one of the regulated markets (USA, EU, Japan, Australia, Canada, UK) through submission of an online application as notification and its acknowledgement by the Central Licensing Authority, subject to certain conditions. The conditions are mainly ethics committee approval, record-keeping, and minimum sample size.
Source: urli.info/1iRyM

2. India’s Health Ministry has issued the draft amendments to Schedule K of the Drugs Rules, 1945. Liquid antiseptics are now categorized separately for household and hospital use, with distinct labelling and licensing conditions to ensure proper manufacturing, packaging, and sale compliance by licensed manufacturers and wholesalers.
Source: urli.info/1e4F-

3. Indian Food Authority (FSSAI) has issued an advisory to all Designated Officers, Food Safety Officers, and Enforcement Teams to ensure proper disposal of seized, rejected, and expired food, including packaging, through approved methods like incineration, sanitary landfilling, or composting. Disposals must be supervised, video-recorded, and certified by authorised food safety officials.
Source: urli.info/1iRz4

4. Indian medical devices regulator (CDSCO) has issued an updated list of about 1,700 Indian Standards (IS) under the BIS Medical Equipment and Hospital Planning (MHD) division, covering around 20 categories including surgical, diagnostic, orthopaedic, dental, and hospital-planning equipment. All medical devices manufactured, imported, and marketed in India must mandatorily conform to BIS standards for regulatory and quality compliance.
Source: urli.info/1iRz9

5. India’s Health Ministry has proposed amending Schedule H2 of the Drugs Rules, 1945, which contains a category of medicines that are mandated to carry a barcode or QR code on their label, to expand it with a new “Table 2” listing key therapeutic categories vaccines, antimicrobials, narcotic and psychotropic drugs, and anticancer drugs. Stakeholders can submit comments within 30 days.
Source: urli.info/1iRzg

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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 Commerce & Industry introduced the Jan Vishwas (Amendment of Provisions) Bill, 2025 in Lok Sabha to decriminalise 288 minor offences under 16 central laws, including the Drugs and Cosmetics Act. It proposes replacing imprisonment with monetary penalties and improvement notices to ease compliance, boost business confidence, and cut litigation. The Bill now awaits Parliamentary committee review.
Source 1: short-link.me/1bGZT
Source 2: short-link.me/1bGZX

2. India’s Central Pollution Control Board (CPCB) has introduced an automated alerts protocol for OCEMS (Online Continuous Emission/Effluent Monitoring Systems). Compliance issues now trigger tiered warnings: Yellow (Level I), Orange (Level II), and Red (Level III), requiring escalating actions from record-keeping to immediate shutdowns and detailed incident reporting.
Source: short-link.me/1bH01

3. The Health Ministry has reversed the requirement for doctors to register on the National Medical Register just months after making it mandatory. The change comes after fewer than 1 percent of doctors enrolled, facing a process tangled with Aadhaar mismatches and affidavit demands, leaving most applications unapproved.
Source: short-link.me/1bH03

4. Delhi’s Drug Control Administration issued a strict advisory to chemist associations, mandating the immediate cessation of over-the-counter sales of pregabalin and tapentadol due to rising misuse for intoxication and addiction. The directive demands accurate stock records under the Drugs Rules, 1945, and warns of strict penalties for non-compliance.
Source: short-link.me/17f6F

5. The Food Safety and Standards Authority of India has reportedly formed a committee to evaluate whether added sugar should be permitted in infant food. This follows criticism for major manufacturer of infant food for adding sugar in infant food sold in India. Current food regulations allow limited sucrose/fructose only if essential, capped at 20% of total carbohydrates.
Source: short-link.me/17f6L

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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 has issued the Medical Textiles (Quality Control) Second Amendment Order, 2025. As per this amendment, any manufacturer or importer certified by the Bureau, or those who have applied for certification, and who have declared their existing stock of products, manufactured or imported prior to the implementation date specified in the principal order dated 23rd October 2024, will be permitted to sell, offer for sale, or display such non-BIS-marked stock until 31st December 2025.
Source: short-link.me/19ypP
Source: short-link.me/19yp3
Source: short-link.me/19ypb

2. India’s Ministry of Environment, Forest and Climate Change has extended the deadline for filing annual returns by Producers, Importers, Brand Owners, and Plastic Waste Processors for Year 2024-25 till 30th September 2025.
Source: short-link.me/15cIv

3. The Indian government has implemented a Central Sector Scheme to promote awareness about Ayurveda, Yoga, Unani, Siddha, and Homoeopathy through fairs, media campaigns, research, and quality certification. Measures also include strengthening drug testing, safety monitoring, international collaborations, and regulatory compliance for traditional medicine systems.
Source: short-link.me/19yqL

4. The Ministry of AYUSH has implemented the Central Sector Scheme “AYURGYAN” to boost research, education, and innovation in traditional medicine. It supports capacity building, clinical research, and interdisciplinary studies, including Ayurveda biology. The scheme promotes evidence-based AYUSH practices through collaborations with academic institutions and national research councils.
Source: short-link.me/19yqQ

5. Food Safety and Standard Authority of India has recently issued an advisory directed all licensed food businesses to display the QR code or download link of the “Food Safety Connect” app at their premises. This enables consumers and regulators to verify license details and lodge complaints easily, promoting transparency, digital access, and improved compliance in the food safety ecosystem.
Source: short-link.me/19yqW

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 Environment, Forest and Climate Change has notified the Environment Protection (Management of Contaminated Sites) Rules, 2025 to identify, assess, and remediate contaminated sites across India. The rules mandate state pollution boards to coordinate sampling, remediation, cost recovery, and risk-based action plans using a centralized online portal for monitoring and enforcement.
Source: bit.ly/3IMIeiU

2. The National Medical Commission released formal guidelines on the ethical conduct and broadcasting of live surgeries. Key provisions include mandatory explicit patient consent, anonymisation protocols, supervision by ethics boards, clear educational intent, and strict limits on commercial elements. The notice responds to Supreme Court scrutiny and aims to safeguard patient welfare in live surgical demonstrations.
Source: bit.ly/3IOGaqH
Source: bit.ly/45lJceG

3. India’s Drug Controller General has mandated state regulators to instruct manufacturers to closely monitor NDMA levels in ranitidine API and finished formulations, reduce shelf life, and implement risk-based controls. This follows a DTAB recommendation for a broader expert review and an ICMR safety study amid carcinogen concerns.
Source: bit.ly/4of1dTy
Source: bit.ly/3IPcABh

4. Delhi Drug Control Department has issued directive addressed to pharmacies to install CCTV cameras by July 31, 2025, to curb the sale of over-the-counter dual-use drugs without a valid prescription. Pharmacists across Delhi are voicing financial and procedural concerns over the government’s advisory.
Source: bit.ly/4mdEgOD

5. Delhi High Court directed the Centre to establish clear and enforceable guidelines for the collection and transport of medical samples. In response, the government has formed expert panels that have finalized draft standards, which are now under legal review and expected to be officially notified within three months.
Source: bit.ly/41freYK

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 has issued the first amendment to Food Products Standards & Food Additives Regulations, introducing norms for meat sausages, dehydrated tarragon, changes in packaged drinking water specifications, and revisions to food colour and additive rules. The regulations take effect from 1 February 2026.
Source: bit.ly/44C2uMH

2. The Supreme Court of India has recently ruled that stem cell banking including enrolment, collection, processing, and storage of umbilical cord blood qualifies as a healthcare service. It held that such services support preventive and therapeutic care, and are therefore exempt from service tax.
Source: bit.ly/3Ixa7eK

3. India’s Central Drug Authority (CDSCO) has released a guidance document outlining the process for manufacturers to obtain a No Objection Certificate (NOC) for exporting unapproved or approved new drugs. Key updates include mandatory online applications, one-time registration valid for a year, detailed reconciliation and a 7-day NOC issuance timeline.
Source: bit.ly/4kLR6CO

4. India’s Women & Child Development Ministry has issued an advisory to states urging them to curb edible oil usage amid rising obesity and non communicable diseases. It also reiterates previous guidance to limit added salt, sugar, and synthetic additives in Anganwadi nutrition provisions.
Source: bit.ly/4m37IH3

5. In India–EU trade negotiations, the EU seeks substantial tariff reductions on medical devices, automobiles, wine, spirits, meat, poultry, and stronger IP protections. Automotive and med tech duties currently up to 10% are in focus. India is pushing for reciprocity, including non tariff barrier reductions under phased FTA talks.
Source: bit.ly/4lZN8Hu

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 Organisation has notified that all WHO GMP (COPP) applications be submitted exclusively via the ONDLS portal, effective from 15th August, 2025 and that physical submission will no longer be accepted after this date. This deadline, initially set for 15th July, 2025, was extended by a month due to stakeholder challenges with uploading the documents on the portal.
Source: bit.ly/4eTVL4e

2. The Union Health Ministry and PIB have dismissed reports claiming mandatory warning labels on samosas, jalebis, laddoos, and similar snacks, calling them misleading and baseless. The real advisory pertains to general dietary awareness, not targeting street foods.
Source: bit.ly/46Kaqwz

3. The Delhi High Court has held that the defendant’s ORSL mark is deceptively similar to the plaintiff’s ERSI mark according to the triple identity test as the marks, products (oral rehydration solutions), and trade channels are identical.
Source: bit.ly/44UUSDP

4. The Delhi High Court has granted interim relief in favor of Jio and Reliance by ordering major e-commerce platforms to temporarily delist listings from 21 sellers who have been offering counterfeit Fast-Moving Consumer Goods (FMCG) under the “Reliance” and “Jio” trademarks.
Source: bit.ly/44LrMql

5. Indian Council of Medical Research- National Institute for Research in Reproductive and Child Health (ICMR-NIRRCH) is reportedly launching EndoCare India, a multidisciplinary care model for disorders like endometriosis, fibroids, polycystic ovary syndrome and chronic pelvic pain.
Source: bit.ly/3GQQPAp

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

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 Food regulator, the Food Safety and Standards Authority of India (FSSAI) has issued a advisory to e-commerce Food Business Operators (FBOs) to ensure that: (1) Last-mile delivery systems are made more robust, and persons handling last-mile delivery are given suitable training to handle the food items, and (2) The e-commerce FBOs are compliant with the labelling requirements as specified in relevant regulations, keeping the listings on the website consistent with content of actual food label.
Source: bit.ly/4f0zEaA

2. India’s Ministry of Finance has published an Office Memorandum seeking public comment up to the 10th of December, on certain amendments to the prevailing insurance regulations in the country. These proposed amendments include among other things, permitting a 100% Foreign Direct Investment in the insurance sector through the automatic-route, and permitting insurers to undertake offer of more than one class of insurance.
Source: bit.ly/4ifYwxT

3. India’s Central Ministry of Consumer Affairs is reportedly developing an online portal to handle the licensing, verification and stamping of weighing and measurement instruments as well as to provide a source of information on verified trade instruments for consumers.
Source: bit.ly/41km5Q6

4. The High Court of the States of Punjab and Haryana held that outside of introduction of evidence to the effect, the mere failure of a medical surgery/ procedure would itself not be sufficient to establish medical negligence claims, especially if the patient had been appropriately sensitized of the risks involved.
Source: bit.ly/49nlkrJ

5. In its finalized version of the regulations regarding Pre-determined Change Control Plans, the US Food and Drug Administration has plainly classified Artificial Intelligence (AI) as a sub-set of Machine Learning softwares when it comes to regulation of Medical Devices, and further makes it mandatory that in making submissions the version of the device software need to be submitted with the FDA to ensure version control.
Source: bit.ly/4imQQu2

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 FSSAI has issued an advisory urging Food Business Operators (“FBOs”) to ensure compliance with the Hon’ble Supreme Court’s decision in IMA & Anr vs Union of India & Ors to curb misleading advertisements.  As per the advisory, FBOs must generate and upload a self-certificate on the Ministry of Information & Broadcasting’s Broadcast Seva portal before telecasting or publishing any advertisement. (Copy of advisory attached).
Source: bit.ly/3AFzkQy

2.  The World Health Organization’s (“WHO”) Intergovernmental Negotiating Body (“INB”) Ambassador has reportedly informed that the pandemic agreement will not be adopted at the special World Health Assembly (“WHA”) next month, as countries need more time to conclude complex negotiations, including those on the proposed Pathogens Access and Benefit Sharing (“PABS”) system.
Source: bit.ly/3As8uLP

3. A response to a Right to Information (RTI) application seeking the status of Draft Drugs and Magic Remedies (Objectionable Advertisements) (Amendment) Bill, 2020 (“DMR(OA) (Amendment) Bill”) has revealed that it is still pending. The amendments were intended to enable stricter action against misleading advertisements, as well as to widen the scope of the Drugs and Magic Remedies (Objectionable Advertisements) Act by introducing 24 diseases and disorders. The DMR(OA) (Amendment) Bill has been pending with the Ministry of Health and Family Welfare, since 2020.
Source: bit.ly/3Obgtjf

4. The Delhi High Court has granted an ex-parte interim injunction restraining AquaKind Labs LLP from using the suffix “KIND” in their trade name “Aquakind” and ruling in favor of Mankind Pharma. This ruling was based on the reasoning that AquaKind Labs’ name was deceptively similar to the registered trademark “MANKIND”, potentially causing confusion in the pharmaceutical market and to the consumers.
Source: bit.ly/4hIoXMw

5. The Ministry of Environment, Forest and Climate Change has published the Water (Prevention and Control of Pollution) (Manner of Holding Inquiry and Imposition of Penalty) Rules, 2024, outlining procedures for holding inquiries and imposing penalties under section 45B of the Water (Prevention and Control of Pollution) Act (“Water Act”). The Rules will come into force upon the publication in the Official Gazette.  (Copy of rules attached.)
Source: bit.ly/3UONcyC

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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 has stayed the repeal of Sec. 170 of the Drugs, Rules 1945 which regulated Advertisement of AYUSH products by the AYUSH Ministry, to address the ultra-vires nature its policy regarding AYUSH advertisement.
Source: bit.ly/4e4qOZz
Source: bit.ly/4dDnIvK

2. The National Commission for the Indian System of Medicine has restated its position, as it has taken in an advisory issued earlier on 16th July, that practitioners of AYUSH medicine should not represent themselves as “Cannabis experts” as it may constitute a “Misrepresentation of qualification” under Regulation 27 of the National Commission for Indian System of Medicine (Ethics and Registration) Regulation, 2023.
Source: bit.ly/3APXRls
Source: bit.ly/4cLHaFl

3. The Supreme Court has issued a Notice to the Central and State Governments and their departments, seeking a response on policy position regarding braille accessibility and integration into (1) Medical packaging, (2) Consumer Goods packaging, and (3) Implementation of braille in all aspects of public and private sectors.
Source: bit.ly/3AHLUOP

4. The office of Director General of Foreign Trade has issued draft modalities for setting up E-commerce Export Hubs which will support infrastructure for cross-border e-commerce trade, and has requested for submission of detailed proposals for set-up of E-commerce Export Hubs.
Source: bit.ly/3ASWEd6

5. The Drug Enforcement Administration, part of the United States Department of Justice has issued a notice that it will be holding hearings regarding the subject-matter of a Federal level reclassification of Cannabis from a Schedule I to Schedule III substance.
Source: bit.ly/4dCiQXN