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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 Indian pharmaceutical manufacturer has delayed commercial supplies of a recently launched diabetes therapy after identifying quality issues in certain production batches. The manufacturer is investigating the cause and implementing corrective measures, while confirming no impact on patient safety or existing regulatory filings.
Source: short-url.cc/1yS8o

2. India’s Rajasthan government has reportedly ordered the recall of Dinoprostone Gel, a labour-inducing medicine, after it failed quality testing. The state drug control department has directed the withdrawal of the affected batch and initiated regulatory action against the manufacturer. The recall reflects Rajasthan’s strengthened drug quality surveillance framework and is expected to increase regulatory scrutiny of pharmaceutical manufacturers supplying medicines under government procurement programmes.
Source: short-url.cc/1tkZK

3. India’s Ministry of Health and Family Welfare (MoHFW) has notified the amendment to the Drugs Rules, 1945, to designate Navi Mumbai as an additional port for the import of drugs under the prescribed regulatory framework. The amendment expands the list of notified ports for drug imports. The notification is expected to facilitate import operations, strengthen regulatory administration and improve logistical efficiency for pharmaceutical importers and other stakeholders engaged in the supply chain.
Source: short-url.cc/1tkZV

4. India’s Central Drugs Standard Control Organisation (CDSCO) has reportedly directed manufacturers to update the safety labels and prescribing information for several common antimicrobial drugs due to newly identified adverse reactions. The revised labels are intended to improve the safe use of these medicines by strengthening risk communication for healthcare professionals and patients, while reinforcing India’s pharmacovigilance and drug safety monitoring framework.
 Source: short-url.cc/1tk-1

5. India’s drug regulator, CDSCO, has reportedly proposed to bring mandatory registration for manufacturers and suppliers of pharmaceutical packaging materials and be governed under the Drugs Rules, 1945. A sub-committee will be set up to examine the necessity and feasibility for registered printing entities. Pharmaceutical packaging manufacturers are currently only indirectly regulated via drug manufacturers’ Schedule M vendor qualification systems, which regulators now deem inadequate to prevent misuse of genuine packaging.
Source: short-url.cc/1tk-6

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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 Maharashtra Food and Drug Administration has prohibited the sale, distribution and use of three skin-lightening creams after detecting dangerously high levels of mercury and lead, along with labelling violations. The action underscores stricter enforcement of safety and labelling requirements under the Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020.
Source: short-url.cc/1tgYn

2. India’s Rajasthan government has reportedly introduced a three-tier drug quality testing mechanism for medicines procured under the state’s public healthcare system due to concerns about drug quality. The enhanced measures require quality verification at multiple stages, enhanced oversight by healthcare institutions, and stricter monitoring of medicines and surgical consumables. The state has also expanded its investigation into the concerned drug manufacturer while strengthening procurement and quality assurance processes.
Source: short-url.cc/1tgWb

3. India’s Central Drug Authority, CDSCO has reportedly signed a memorandum of understanding (MoU) with Indonesia’s National Agency of Drug and Food Control (NADFC). The partnership aims to improve cooperation in regulating pharmaceuticals and medical products. The agreement allows for sharing regulatory information, technical skills, and best practices. The agreement seeks to benefit manufacturers by creating a predictable regulatory environment and enhancing international trade.
Source: short-url.cc/1yNWW

4. India’s Telangana government is set to enforce stricter regulations for private In-Vitro Fertilisation (IVF) centres to improve transparency, curb unethical practices and strengthen oversight of Assisted Reproductive Technology (ART) services. The proposed measures include frequent inspections and monitoring of licensing, medicines, record maintenance, and stricter compliance with the Assisted Reproductive Technology (Regulation) Act, 2021, and the Surrogacy (Regulation) Act, 2021.
Source: short-url.cc/1tgWl

5. The Indian Medical Association (IMA) has opposed the Maharashtra Clinical Establishments (Registration and Regulation) Bill, expressing adverse effects on the functioning of private medical establishments by imposing excessive regulations and limiting autonomy. The association has urged the state government to reconsider the draft legislation and has warned of a statewide strike and boycott of government healthcare schemes if its concerns are not addressed.
Source: short-url.cc/1tgWq

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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 Standard Control Organization (CDSCO) has invited stakeholder comments on the use of brand name extensions by pharmaceutical companies. The consultation follows concerns that different drugs marketed under the same established brand name may mislead consumers and create confusion regarding therapeutic use. Comments are invited until 17 July 2026.
Source: short-url.cc/1yKJk

2. India’s Madras High Court held that consignments imported as “waste paper” were in fact used plastic bottles, street sweepings, food waste making their import into India illegal under the Customs Act and Hazardous Waste Rules. The Court rejected the importers’ request to send the waste to Dubai, ruling that “re-export” means returning the waste to the country of origin, not to a third country chosen by the importer. The Court further condemned the practice of developed countries shifting hazardous waste to developing nations as “waste colonialism,” which undermines the environmental justice and threatens public health and ecological security. The Court refused permission to process or dispose of waste within India, to avoid becoming a “disposal destination” for foreign waste. The petitions were dismissed, the waste was ordered to be returned to the exporting countries within 60 days, and costs were imposed on the petitioners.
Source: short-url.cc/1yKL6

3. India’s Pune Municipal Corporation (PMC) has issued show-cause notices to private hospitals for non-compliance with the Bombay Nursing Homes Registration Act, 1949, including the failure to display treatment charges and patients’ rights. PMC has directed the hospitals to rectify the identified deficiencies within the prescribed timeline. The enforcement action follows inspections conducted as part of routine compliance monitoring and in response to public complaints.
Source: short-url.cc/1tdPE

4. The Indian working group on access to medicines and treatments has urged the central government to revise the National List of Essential Medicines (NLEM) by including newer cancer medicines and monoclonal antibodies. The group states that the current NLEM does not reflect the World Health Organization (WHO) model list of essential medicines.
Source: short-url.cc/1tdQ0

5. The Food Safety and Standards Authority of India has issued show cause notices to multiple food business operators for allegedly misleading claims, including the use of terms such as “fresh,” “healthy,” “natural,” “organic,” and “vegan.” The regulator has reiterated that such claims must strictly comply with the applicable labelling and advertising regulations.
Source: short-url.cc/1tdQe

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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 Government has mandated the renewal every five years mandatory for registration certificates and license held by fertility clinics and semen banks and every three years for surrogacy clinics through the National Registry Portal. This renewal shall attract non-refundable fees which may be doubled in case of failure to comply. This Notification aims to streamline regular inspections and adherence to prescribed standards. Government run institutes are exempted under Notification.
Source: short-url.cc/1sSzt

2. The Indian Ministry of Health and Family Welfare (MoHFW) has released the operational guidelines for national ambulance services (NAS), 2026 to strengthen emergency medical response and standardise ambulance services across the country. The guidelines prescribe consistent standards for ambulance infrastructure, staffing, equipment, response times, digital integration, and quality assurance. The initiative aims to improve timely access to emergency care and, ensure consistent delivery of pre-hospital emergency medical services nationwide.
Source: short-url.cc/1sSzU

3. The Supreme Court has held that deficiencies or inaccuracies in mandatory Form F records under the PCPNDT Act are not mere technical lapses but significant statutory violations. Upholding criminal proceedings against a medical practitioner, the Court reaffirmed the importance of strict record-keeping to prevent sex-selection practices and ensure effective enforcement of the law.
Source: short-url.cc/1ynLe

4. India’s Central Drugs Standard Control Organization (CDSCO) and Maharashtra Food and Drug Administration (FDA) have suspended operations at two blood centres in Mumbai and Thane after inspections revealed serious regulatory violations including compromise of the quality and safety of blood collection, storage, and distribution as per the Drugs and Cosmetics Act, 1940 and, the Drugs and Cosmetics Rules, 1945.
Source: short-url.cc/1ynLY

5. The Central Consumer Protection Authority (CCPA) has imposed a penalty on a food manufacturer for making misleading “100% Atta Bread” and “100% Whole Wheat” claims. The Authority held that the product’s labelling and advertisements were likely to mislead consumers regarding its composition as the product contained only about 87% whole wheat flour, and such claim would give an impression to that the product is wholly composed of wheat flour, thus amounting to a misleading advertisement. The action highlights the CCPA’s continued enforcement against deceptive food labelling and misleading marketing practices to safeguard consumer interests.
Source: short-url.cc/1sSAc

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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 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

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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. 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

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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 National Pharmaceutical Pricing Authority has increased the ceiling prices of Anti-Tetanus Immunoglobulin 250 International Units and 500 International Units injections by 50 percent exercising its extraordinary powers. The revision follows concerns over rising production costs and aims to ensure continued availability of these essential life-saving medicines.
Source: short-url.cc/1ymqX

2. India’s central food authority, FSSAI, has reportedly issued show-cause notices to eight food companies in India. One such notice was issued for deceptive branding. This Notice was issued because a brand used the claim “plant-based vegan” on the packaging which was not approved under FSSAI license obtained. Such claims have higher chances of misleading the consumers by using marketing tactics to create false impressions of the brand.
Source: short-url.cc/1ymr2

3. India’s central food authority, FSSAI, has reportedly advised Food Business Operators (FBOs) to immediately discontinue the use of metallic pins, staples, and wires in food packaging materials, citing potential risks of physical contamination and consumer injury. The regulator has urged businesses to review their packaging processes and adopt safer alternatives such as food-grade adhesives, tapes, or other secure packaging methods that do not compromise food safety. The advisory forms part of FSSAI’s ongoing efforts to strengthen food safety practices and reduce the risk of foreign matter contamination across the food supply chain.
Source: short-url.cc/1sRhw

4. The Central Drugs Standard Control Organisation (CDSCO) mandates that all manufacturers and importers of hair colour cosmetics strictly adhere to the Cosmetics Rules, 2020, and applicable Bureau of Indian Standards (BIS). To safeguard public health, stakeholders must ensure absolute compliance with statutory labelling requirements, ingredient restrictions, and mandatory caution statements. Furthermore, any alterations to a product’s composition, quality specifications, or label must be formally reported to the appropriate Central or State Licensing Authority.
Source: short-url.cc/1sRhD

5. The National Pharmaceutical Pricing Authority (NPPA) has revised upward the ceiling prices of BCG, Measles Rubella and Measles vaccines pursuant to a review order. The change reflects the Department of Pharmaceuticals’ view that the 17.1% monopoly reduction should not apply to vaccines, supporting continued vaccine availability.
Source: short-url.cc/1ymqX

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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 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

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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 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

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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 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