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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 Kerala High Court ruled that brand ambassadors are not liable for unfair trade practices or deficient services under the Consumer Protection Act unless a direct transactional link with consumers is proven. Endorsers face penalties only for misleading advertisements, and are protected where due diligence to verify claims is demonstrated by law.
Source: h7.cl/1hJqC

2. State Drugs Regulator of Telangana has recently issued a stop-use advisory for a children’s syrup prescribed for allergies, hay fever, and asthma, after a CDSCO lab detected toxic ethylene glycol contamination. The public was advised to stop use immediately, report possession, and authorities ordered freezing of affected stocks to avert health risks.
Source: h7.cl/1mGN8

3. A Parliamentary Standing Committee has urged the Ministry of AYUSH to integrate allopathy and traditional medicine, recommending AYUSH departments in all AIIMS, stronger collaboration with the Health Ministry, and time-bound action to create a pluralistic, integrated healthcare system nationwide.
Source: h7.cl/1mGNc

4. The Bureau of Indian Standards has notified amendments to 22 Indian Standards covering dairy products, infant foods, milk substitutes, and special medical nutrition. Amendments were established from 15 December 2025, and existing standards will remain in force till 14 June 2026, giving business operators a defined transition period for compliance.
Source: h7.cl/1hJqz

5. The US Food and Drug Administration has relaxed the oversight of general wellness devices, clarifying that low-risk products such as fitness trackers and wellness apps will not be actively regulated as medical devices if they avoid disease-related claims. The move aims to reduce regulatory burden and encourage innovation in consumer and digital health technologies.
Source: h7.cl/1hJqP
Source: h7.cl/1hJqT

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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 CDSCO via a circular has directed all licensing authorities to ensure that retail and wholesale pharmacy stores prominently display the designated Pharmacovigilance Programme of India (PVPI) QR code and toll-free number. This initiative aims to facilitate easy and seamless reporting of adverse drug reactions (ADR) by the public, strengthening drug safety monitoring.
Source: h7.cl/1jLf0

2. FSSAI has issued an advisory for dairy units selling milk/milk products via vending machines and kiosks, directing them to maintain approved rapid-test kits on-site for detecting common adulterants. The machines must display usage instructions, enable consumer self-tests or staff-demonstrations, retain usage records, and ensure kit validity and proper storage.
Source: h7.cl/1jLfi

3. The Food Safety and Standards Authority of India (FSSAI) has reportedly directed immediate removal of fruit-based beverages, R-T-S drinks and energy drinks labelled with the term “ORS” from retail and e-commerce platforms, reaffirming that only formulations meeting WHO oral-rehydration-solution standards may use “ORS”.
Source: h7.cl/1jLft

4. Indian Government reportedly plans to amend the Drugs and Cosmetics Act by adding sale licensing conditions a per which advertising of high-risk drugs in Schedules G, H, H1 and X will be explicitly banned, including via e-commerce and digital platforms, in order to curb self-medication, misleading claims an misuse of potent medicines.
Source: h7.cl/1jLfQ

5. Indian Government is reportedly framing a broader medical-device manufacturing policy aimed at cutting the country’s heavy import dependence. The plan focuses on boosting domestic production, introducing quality standards for thousands of devices, promoting zero-defect manufacturing, and strengthening India’s global competitiveness in the healthcare technology sector.
Source: h7.cl/1eWCg

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 (FSSAI) has issued the Draft Food Safety and Standards (Alcoholic Beverages) Amendment Regulations, 2025, proposing tighter standards for special wine. The draft introduces a 0.3% sugar tolerance for “Brut” sparkling wine, removes “special wine used,” and makes standard-drink labelling mandatory. A format for public comments has been shared, and feedback is open until 3rd January 2026.
Source 1: urli.info/1jcbJ
Source 2: urli.info/1eoEY

2. The Central Drugs Standard Control Organisation (CDSCO) has reportedly instructed state drug controllers to immediately initiate inspections under the revised Schedule M for the manufacturing units that have not applied for extensions. For manufacturing units that have applied for extensions, the effective date for revised Schedule M implementation is January 1, 2026. The directive follows recent safety lapses, including the fatal cough-syrup incident.
Source: urli.info/1eoDR

3. The Goa Directorate of Food and Drugs Administration (DFDA) has directed all retail pharmacies to display QR codes to facilitate reporting of adverse drug reactions (ADRs) through the Indian Pharmacopoeia Commission’s ADR Monitoring System. QR codes must be prominently displayed to enable consumers and healthcare professionals to report ADRs.
Source: urli.info/1jcb0

4. The Indian Pharmacopoeia Commission, in partnership with NITI Aayog and the Central Tuberculosis Division, will reportedly develop new monographs for the anti-tuberculosis medicines delamanid, pretomanid and the rifapentine-isoniazid fixed-dose combination to enhance quality standards, support rational use and strengthen adverse-drug-reaction reporting.
Source: urli.info/1jcaF

5. The Food Safety and Standards Authority of India (FSSAI) has issued an advisory clarifying stating that honey samples exceeding the permissible 80 mg/kg limit for Hydroxymethylfurfural (HMF) shall be classified as “Substandard”, not “Unsafe.” The clarification follows the Scientific Panel’s view that current research is insufficient to determine health risks from higher HMF levels.
Source: urli.info/1eoD4

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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

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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 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

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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 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