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. A major food manufactured in the USA has removed all certified artificial colours from its food and beverage portfolio successfully, achieving its goal of fully eliminating them by the middle of this year. This move was announced in June 2025 and was confirmed that more than 90% of its U.S. portfolio was already free from synthetic dyes. These reformulated products have started arriving for consumption in the USA.
Source: short-url.cc/1xs6v

2. Hong Kong’s Department of Health has announced that medical gases will be regulated as pharmaceutical products from June 14, 2026, requiring manufacturers, wholesalers, and retailers to obtain relevant licences. Products containing nitrous oxide and nitric oxide will be classified as prescription medicines. Non-compliance may result in fines, imprisonment, and other regulatory enforcement actions.
Source: short-url.cc/1rZJs

3. The U.S. Food and Drug Administration (FDA) has issued warning letters to multiple entities for alleged violations of current Good Manufacturing Practice (CGMP) requirements and for the unlawful marketing of GLP-1 receptor agonist drugs through telehealth platforms. These warnings address firms that do not meet quality standards and telehealth providers promoting unapproved products for weight loss. The FDA emphasised compliance with manufacturing, quality, and marketing rules, and cautioned that failure to address the identified violations could result in further regulatory action.
Source: short-url.cc/1xs6F

4. India’s Central government has amended the marine export laws for export administration, effective from 9th June 2026. To modernize export administration, the notification mandates online registration workflows and establishes revised fee schedules. The legislative intent is to digitize statutory record-keeping and enforce strict compliance protocols governing ownership transfers, facility modifications, and dealer licensing across vessels, processing plants, and storage premises.
Source: short-url.cc/1rZJV

5. The World Health Organization has urged countries to shift from visual inspection and cytology-based screening to Human Papillomavirus testing for cervical cancer prevention. The updated recommendation highlights superior accuracy in detecting high-risk infections and supports wider adoption of affordable, locally developed Human Papillomavirus tests to accelerate cervical cancer elimination efforts.
Source: short-url.cc/1xs6P

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. Maharashtra FDA Commissioner Tukaram Mundhe issued an Order on June 12, 2026 barring hospitals, doctors, and affiliated pharmacies from compelling patients to buy medicines exclusively from in-house pharmacies. Prescriptions must be handed directly to patients which gives the patients an option to pick pharmacy of their choice. This restriction put by hospitals on the choice of the patient to purchase medicines from their choice of a pharmacy amounts to unfair trade practices under the Consumer Protection Act, 2019. Further, hospitals must now display notices stating patients of their right to purchase medicines from any licensed pharmacy of their choice in English and Marathi.
Source: shortlink.uk/1xhAz

2. The Jharkhand High Court has directed a complete ban on the conduct of the “two-finger test” in all hospitals, medical colleges, and healthcare institutions across the State. Reiterating established legal and medical principles, the Court observed that the practice is unscientific, violates the dignity, privacy, and bodily autonomy of survivors of sexual assault, and has no evidentiary value in determining consent or sexual history. The Court directed the concerned authorities to ensure strict compliance with existing guidelines and legal standards governing the medical examination of sexual assault survivors, while emphasizing the need for survivor-centric and trauma-informed medical care. The ruling reinforces the prohibition on the use of the test and underscores the obligation of healthcare institutions to adhere to prescribed medico-legal protocols.
Source: shortlink.uk/1xgoW

3. The Telangana Drugs Control Administration has reportedly intensified enforcement against illegal medicine distribution by raiding an unauthorized supplier of cardiac stimulant injections and an unlicensed medical shop. Authorities warned against unauthorized sales and supply of prescription medicines.
Source: shortlink.uk/1rOoZ

4. The Supreme Court has reaffirmed that strict compliance with the PCPNDT Act, 1994 is essential to prevent sex-selective practices and female foeticide. The Court held that deficiencies in mandatory records, including Form F, are not mere technical errors but substantive violations. Emphasising the Act’s objective, it observed that accurate documentation is a crucial safeguard for effective monitoring, enforcement, and prevention of unlawful sex determination practices.
Source: shortlink.uk/1xgqd

5.India’s Ministry of Health and Family Welfare has notified an amendment to Drugs Rules, 1945 dated June 9, 2026. The amendment removes the term “Syrups” from Item (7) under Serial No. 13 of Schedule K of the Drugs Rules, 1945. This means that now syrups will be sold under a sales license only. Schedule K specifies certain classes of drugs and categories of persons or institutions that are exempt from specific provisions of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder, subject to prescribed conditions. The amendment came into force on the date of its publication in the Official Gazette.
Source: shortlink.uk/1rOqd

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. Punjab’s Food and Drugs Administration (FDA) has cancelled a pharmaceutical manufacturer’s licence and ordered a nationwide product recall following findings that allegedly linked substandard oxytocin injections to maternal deaths. The action highlights increased scrutiny of GMP compliance and data integrity, signalling stricter enforcement where product quality deficiencies may endanger patient safety.
Source: shortlink.uk/1rjtj

2. Maharashtra’s FDA has uncovered a supply of falsely labelled “sterile” surgical gloves to government hospitals in Mumbai. The gloves were allegedly unsterilised due to company’s sterilization machine was malfunctioning, prompting raids and seizure of stock. The company responsible had attempted to recall the unsterilized surgical gloves before the raid with no success. Authorities are investigating licensing violations and whether proper recall procedures were followed.
Source: shortlink.uk/1rjtr

3. A U.S. federal court has allowed a proposed class-action lawsuit to proceed against a manufacturer of a children’s nutritional drink over allegations that its marketing and packaging misled consumers into believing the product was clinically proven to help children grow taller. The court held that product claims, combined with visual branding and advertising elements, could reasonably be interpreted by consumers as referring to height growth rather than general growth and development. The lawsuit alleges that consumers were misled regarding the product’s benefits, while the company maintains that its claims are scientifically supported and appropriately describe the product’s role in supporting children’s growth and development. The case will now proceed for further judicial consideration.
Source: shortlink.uk/1rjtH

4. India’s Directorate General of Foreign Trade has exempted Special Economic Zone (SEZ) units and developers from the applicability of conditions of Quality Control Orders (QCO) and Bureau of Indian Standards (BIS) rules. This exemption will be applicable on the permissible good imported like raw materials and capital goods which are authorized for SEZ operations. However, if these imported items or their resulting manufactured products are moved into the Domestic Tariff Area (DTA), they will be required to fully comply with all applicable QCO and BIS laws. Additionally, SEZ entities will have to submit a formal undertaking to the Development Commissioner at the time of import.
Source: shortlink.uk/1rjtg

5. The United States Food and Drug Administration is conducting a scientific safety review of mifepristone, the abortion pill, using existing drug safety systems. The review could influence future distribution requirements for the medicine. While the agency maintains that mifepristone is safe and effective when used as directed, abortion rights groups have criticized the review.
Source: shortlink.uk/1rjtT

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 Employees’ State Insurance Corporation (ESIC) has launched a centralized online patient feedback system across its hospitals and dispensaries nationwide to strengthen patient-centric healthcare delivery. The digital platform enables beneficiaries to submit feedback on healthcare services received at ESIC facilities, facilitating real-time monitoring of patient experiences and service quality. The initiative will help identify service gaps, support continuous quality improvement, and strengthen the overall healthcare experience for insured persons and their dependents.
Source: shortlink.uk/1rjWU

2. The Himachal Pradesh High Court has quashed criminal proceedings against a liquor manufacturer arising from the transport of liquor consignments where authorities found two liquor cases without a valid permit and bottles bearing batch numbers different from those specified in the permit. The Court observed that the batch-number discrepancies resulted from inadvertent labelling errors by workers, with no evidence of adulteration or revenue loss to the government. Holding that only the transport of the two unpermitted liquor cases constituted an offence, the Court compounded the matter and imposed a monetary penalty, while allowing separate departmental action for licence-condition violations to continue.
Source: shortlink.uk/1wKXJ

3. The Ministry of Health and Family Welfare has notified an amendment to Schedule V of the Drugs Rules, 1945, substituting the unit for folic acid from “mg” (milligram) to “mcg” (microgram). The amendment will come into force six months from the date of its publication in the Official Gazette.
Source: shortlink.uk/1rjX4

4. The Ministry of AYUSH has amended the NCISM appointment rules to reduce the minimum experience required for appointment as Secretary to the Commission from 15 years to 7 years. The amendments also clarify that serving government officials appointed to NCISM or its Autonomous Boards will be treated as being on deputation and provide alternative provident fund coverage where General Provident Fund subscription is unavailable. This strengthens the institutional and human-resource framework of the NCISM, which oversees standards in Indian systems of medicine.
Source: shortlink.uk/1rjWU

5. The National Pharmaceutical Pricing Authority (NPPA) is considering raising prices of key platinum-based cancer drugs like cisplatin and carboplatin after manufacturers flagged steep increases in raw material costs, especially platinum. Authorities are balancing concerns over patient affordability with the risk of supply shortages if prices remain unchanged.
Source: shortlink.uk/1wKXQ

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 Central Drugs Standard Control Organization has directed state regulators to strengthen enforcement against the use of Chloramphenicol and Nitrofurans in food-producing animals. The move follows continued detection of these substances in export consignments, leading to international rejections and raising concerns over regulatory compliance and export competitiveness.
Source: shortlink.uk/1wKBT

2. The Food Safety and Standards Authority of India (FSSAI) has notified the Food Safety and Standards (Prohibition and Restrictions on Sales) Amendment Regulations, 2026, which came into force upon publication in the Official Gazette on 23 May 2026. Through the amendment, FSSAI has omitted clause (8) of sub-regulation 2.3.14 of the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, following consideration of stakeholder comments received on the draft regulations issued in October 2024. The amendment formally revises the existing regulatory framework governing restrictions on the sale of specified food products under the Food Safety and Standards Act, 2006.
Source: shortlink.uk/1wKCp

3. The US FDA has launched a safety study of the abortion pill, also called mifepristone, potentially enabling new restrictions on its distribution and use. The FDA has further said for mifepristone to be safe and effective. Officials say the review is already underway and science based. The study will analyse existing data and could influence abortion access policies. Abortion right was legalised through the Supreme Court’s 2022 ruling which overturned Roe v. Wade.
Source: shortlink.uk/1rjC6

4. A pharmaceutical manufacturer has received a Warning Letter from the United States Food and Drug Administration (USFDA) concerning its formulation manufacturing facility in Baddi, Himachal Pradesh. The regulatory action was issued following a review of records submitted under the US Federal Food, Drug, and Cosmetic Act and is not linked to any on-site inspection of the facility. The observations relate to the use of purified talc that did not meet the current United States Pharmacopeia (USP) requirements. The company has stated that the Warning Letter is not expected to impact ongoing operations or product supplies from the facility and has committed to undertaking the necessary corrective actions and responding to the USFDA within the prescribed timelines. The facility was last inspected by the USFDA in August 2025 and subsequently received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) classification.
Source: shortlink.uk/1wKCB

5. Hospitals across India are reportedly facing shortages of key chemotherapy drugs, including cisplatin and carboplatin, disrupting cancer treatment schedules and forcing patients to search for alternative supplies. The shortage has been linked to supply chain constraints and rising input costs, raising concerns about continuity of care and treatment outcomes.
Source: shortlink.uk/1wKCH

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 Directorate General of Foreign Trade(DGFT), issued a Public Notice dated 1 June 2026 and has notified six new Standard Input Output Norms (SIONs) under the Chemical and Allied Product Group for specified pharmaceutical products. The notification enables Regional Authorities to grant Advance Authorisations without case-specific referrals to the Norms Committee, thereby reducing processing timelines, ensuring uniformity in approvals, and promoting ease of doing business for pharmaceutical exporters.
Source: shortlink.uk/1q-yS

2. The Delhi High Court directed CDSCO to review safety concerns over semaglutide injections within two months. A patient petition claims that manual calculation of dosage deviates from global pre-filled pen standards, risking overdose, underdose, and misuse. CDSCO must determine if approval aligns with patient safety and international practices.
Source: shortlink.uk/1q-xi

3. The Indian government is reportedly drafting new organ transplant rules to introduce Donation after Circulatory Death (DCD) and strengthen frameworks for organ swaps and brain-stem death donations. The proposed reforms aim to expand the donor pool, standardise transplant procedures, and improve access to life-saving organ transplants.
Source: shortlink.uk/1q-z5

4. The Maharashtra State Consumer Disputes Redressal Commission has held that obtaining a patient’s signature on a pre-printed consent form without adequately disclosing the nature of the procedure, associated risks, possible complications, and available alternatives does not constitute valid informed consent. The Commission observed that a mere signature on a standardised form cannot satisfy a doctor’s duty of disclosure and ruled that failure to obtain proper informed consent amounts to a deficiency in service. While the Commission found no evidence of medical negligence in the performance of the surgery or post-operative care, it held the medical practitioner liable for not securing valid informed consent and awarded compensation.
Source: shortlink.uk/1q-za

5. The Central Drugs Standard Control Organisation has directed pharmaceutical manufacturers to establish and maintain pharmacovigilance systems in line with revised Schedule M requirements. Companies must maintain dedicated adverse reaction monitoring mechanisms, appoint qualified pharmacovigilance officers and keep detailed records, with compliance subject to regulatory inspections.
Source: shortlink.uk/1q-xq

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 health ministry has notified the revised fees for testing or analysis for drugs, vaccines, and AYUSH medicines given under Schedules B and B(1) of the Drugs Rules, 1945. The revised fees will be applicable in three months post-publication in official gazette. The fees shall automatically increase by 5% annually. For the tests that are not listed in the Schedule, charges will be determined by the Director or the Government Analyst of the Laboratory or institute. This update will focus on strengthening India’s testing infrastructure while increasing compliance expenses for manufacturers.
Source: shortlink.uk/1qPI3

2. The Delhi High Court dismissed the appeal challenging exclusive rights in the mark“REDDY” for pharmaceutical goods, affirming cancellation of a conflicting registration and restraining its continued use. The ruling reinforces the importance of acquired distinctiveness, market reputation, and consumer protection in trademark enforcement within regulated industries.
Source: shortlink.uk/1weId

3. This official corrigendum by India’s NPPA, dated May 27, 2026, corrects the manufacturer and brand names under serial number 4 of Table-B in its previous Ringer Lactate ceiling price order (S.O. 1584(E)) (p. 2). The manufacturer is now M/s Fresenius Kabi India, with brands ‘Freeflex bags’ and ‘Eurohead bottle’ (p. 2).
Source: shortlink.uk/1qPID

4. National Pharmaceutical Pricing Authority may reportedly refer the methodology for fixing ceiling prices of intravenous (IV) fluids to its Multi-Disciplinary Committee (MDC) of experts after identifying inconsistencies in pricing across formulations and special-feature packaging. The review will improve transparency and consistency in the pricing of IV fluids while addressing concerns over packaging-related pricing variations.
Source: shortlink.uk/1weIH

5. The Food Safety and Standards Authority of India (FSSAI) has sought an explanation from a leading quick commerce platform following a consumer complaint alleging illness after consuming curd purchased through the platform. The regulator has reportedly requested a detailed Action Taken Report (ATR) and sought information regarding food safety compliance, while noting multiple recent complaints relating to allegedly spoiled, unhygienic, or damaged food products sold through the platform’s marketplace sellers. The development underscores increasing regulatory scrutiny of food safety obligations in the e-commerce and quick commerce sector, particularly concerning platform accountability for products sold by third-party sellers.
Source: shortlink.uk/1weIQ

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 held that access to trauma care is a fundamental right under Article 21, directing all States and UTs to unify emergency helplines under 112, establish trauma registries, operationalise cashless treatment for road accident victims, and enforce ambulance tracking standards within set timelines. The ruling significantly expands constitutional obligations on healthcare infrastructure, emergency services, insurers, and public health governance across India. It also needs to have physical and digital grievance redressal systems for good samaritans. This classification is not restricted to national highways but extends to state highways and district roads too.
Source: shortlink.uk/1qB9n

2. The government has reportedly referred 27 doctors to the National Medical Commission (NMC) for disciplinary action in connection with a pharmaceutical freebies case involving sponsored foreign trips under the guise of rendering of knowledge dissemination service. The matter relates to alleged acceptance of luxury travel and hospitality benefits linked to pharmaceutical promotional activities, with State Medical Councils now expected to examine the cases pursuant to violation of MCI Code of Ethics. The development intensifies scrutiny around pharma-doctor engagement practices, and enforcement of professional conduct regulations within the healthcare sector.
Source: shortlink.uk/1vZFF

3. The Central Consumer Protection Authority (CCPA) initiated regulatory action against unauthorized online sale of hazardous chemicals like ammonium nitrate, PETN, gun powder, and picric acid. Notices were issued to e-commerce platforms, seller details shared with PESO, and platforms began delisting products to ensure consumer safety and compliance
Source: shortlink.uk/1vZFK

4. Pharmaceutical manufacturers are increasingly focusing on contamination control infrastructure, particularly Air Handling Unit (AHU) filter maintenance systems, to support compliance with revised Schedule M requirements. Industry experts note that heightened regulatory expectations around hygiene, traceability, cross-contamination prevention, and cleanroom maintenance are driving interest in automated AHU filter cleaning and maintenance technologies.
Source: shortlink.uk/1vZFU

5. Government of India is reportedly planning to launch a dedicated childhood cancer registry which aims to systematically collect data on cancer cases in children in collaboration with the Indian Council of Medical Research (ICMR). India records around seventy-five thousand new cancer cases annually, many detected late. The government plans awareness, data collection, and collaborations to improve early diagnosis and treatment outcomes.
Source: shortlink.uk/1qB8R

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 Department of Consumer Affairs met with major edible oil industry associations on 20 May 2026 to discuss standardizing pack sizes between 200 ml and 20 litres. The initiative aims to enhance consumer protection, ensure transparency in pricing, and prevent misleading packaging. Associations representing 90% of the sector supported the proposal, recommending exemptions for minor oils and packs below 200 ml, with a three month transition period for implementation.
Source: shortlink.uk/1vJbr

2. The Central Drugs Standard Control Organisation (CDSCO) has clarified that Form CT-16 applications for import of Reference Listed Drugs (RLDs) or Investigational Medicinal Products (IMPs) for export-oriented BA-BE studies may be submitted on a standalone basis through the NSWS portal. The clarification addresses operational issues due to lack of system linkage between CT-05 prior intimation applications and CT-16 applications on the SUGAM portal.
Source: shortlink.uk/1vJby

3. The Karnataka Pharma Retailers & Distributors Organization (KPRDO) has urged the government to immediately curb misleading advertisements and aggressive promotional practices relating to prescription, life-saving, and scheduled medicines, particularly across social media platforms. The organisation has also called for the creation of a specialised enforcement team and digital monitoring mechanism to address regulatory violations under the Drugs & Cosmetics Act and the Drugs & Magic Remedies Act. The recommendations could also intensify scrutiny on pharmaceutical advertising, online promotional activities, pharmacy practices, and trade compliance across the healthcare and pharma sectors.
Source: shortlink.uk/1vJbD

4. India’s central food authority has notified the Food Safety and Standards (Contaminants, Toxins and Residues) Amendment Regulations, 2026, revising contaminant limits across pulses, edible oils, seafood, oilseeds, and nutmeg containing products. Updated standards cover heavy metals, aflatoxins, veterinary drug residues, and inorganic arsenic in fish oils, effective from 1 December 2026. Food businesses, seafood exporters, and nutraceutical companies must review and strengthen quality assurance systems, testing protocols, and sourcing controls to ensure compliance.
Source: FSSAI Gazette Notification, Food Safety and Standards (Contaminants, Toxins and Residues) Amendment Regulations, 2026
Source: shortlink.uk/1vJbI

5. India’s Himachal Pradesh High Court has ruled that criminal liability cannot automatically be imposed on all directors or partners of a pharmaceutical company without specific averments establishing individual roles in business conduct. The judgment tightens procedural and evidentiary requirements for regulators prosecuting ‘Not of Standard Quality’ and spurious drug cases, potentially making enforcement actions under the Drugs and Cosmetics Act more legally complex for drug regulators and enforcement agencies.
Source: shortlink.uk/1vMU6

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.

The Ministry of Health and Family Welfare has placed Pregabalin under Schedule H1 of the Drugs Rules, 1945, amid concerns over its rising misuse for sedative, euphoric, and dissociative effects, particularly among youth. The move seeks to strengthen regulatory control by restricting over-the-counter access and ensuring sale only against valid prescriptions with stricter monitoring and record-keeping requirements.
Source: shortlink.uk/1vI8d

India’s Madras High Court ruled that a mother need not undergo DNA testing to donate a kidney to her son when official records establish their biological relationship. The court set aside the transplant approval rejection and directed authorities to permit the donation immediately. This humanitarian interpretation reinforces that documentation standards should prioritise life saving procedures over rigid procedural requirements, potentially influencing future authorization committee decisions on donor recipient relationships.
Source: shortlink.uk/1vI8z

India’s central food authority is moving towards a centralised food surveillance system deploying third party agencies for sample collection, centralised laboratory testing, and digital alerts for faster regulatory action. The framework requires 50% of samples from organised supply chains. The shift signals a technology driven overhaul of food safety governance, raising compliance and traceability expectations for manufacturers, retailers, and supply chain operators.
Source: shortlink.uk/1vI8l

4. Global pharmaceutical companies are increasingly shifting high-value clinical research, regulatory, pharmacovigilance, and innovation-led functions to India as the country evolves from a low-cost outsourcing destination into a strategic global research and development hub. The shift could accelerate investments in clinical research infrastructure, advanced therapies, AI-enabled drug development, and specialised talent while strengthening India’s competitiveness as a global life sciences and biotech hub.
Source: shortlink.uk/1qk9u

5. The Competition Commission of India (CCI) has rejected allegations of monopoly and excessive pricing against 12 private hospitals in Delhi, ruling that higher prices alone do not prove abuse of dominance. The regulator found hospitals operated within competition norms, allowed external procurement, and charged within MRP, dismissing decade-long complaints.
Source: shortlink.uk/1vI8q