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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

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 Government of India is considering capping billing margins charged by private hospitals on medical devices to curb overcharging and reduce treatment costs. This is important as excessive markups increase patient expenses and insurance premiums. If implemented, it will limit hospital margins, improving pricing transparency and affordability.
Source: shortlink.uk/1olUB

2. The Central Government has established the Online Gaming Authority of India (OGAI), with effect from May 1, 2026, under the Promotion and Regulation of Online Gaming Act, 2025, to regulate the gaming sector. Operating under MeitY, this multi-sectoral authority will oversee licensing, mandate registration for esports, and enforce stringent compliance requirements, with a view to enhancing user safety and strengthening regulatory oversight of online gaming.
Source: shortlink.uk/1tDQe

3. Indias central drug ministry has proposed amendment to Drugs Rules 1945 by expanding the list of licences that may be exempted from requiring a Form 29 licence for manufacturing of drugs for test or analysis. The amendment proposes to include Forms 25A (loan licences), 25F (Schedule X drugs), 28A/28B (Schedule C, C(1), and X drugs), 28D/28DA (vaccines, sera, r-DNA drugs), and 28F (umbilical cord blood stem cells). Objections and suggestions from the industry will be considered for thirty days.
Source: shortlink.uk/1tDQk

4. The Delhi High Court has restrained the use of the trademark “MARQ,” finding it deceptively similar to “MARC” and likely to confuse consumers. This reinforces trademark protection by emphasizing that minor spelling differences, use of house marks, or later registrations do not override prior rights and established goodwill.
Source: shortlink.uk/1tDQs

5. Government of India plans a Health Claims Index to transparency and standardize pricing in India health insurance sector. Using anonymized data from the National Health Claims Exchange, it will benchmark claims timelines, approvals and costs, enabling underwriting, reducing inefficiencies, and supporting informed consumer decisions, subject to scale and execution.
Source: shortlink.uk/1olUW

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 (CDSCO) has issued a regulatory update outlining revised procedural and compliance requirements for industry stakeholders, aimed at strengthening regulatory oversight and streamlining approval processes. This is important as evolving CDSCO requirements may affect licensing, submissions, and regulatory timelines. Companies may now need to review internal compliance processes and align documentation and approval strategies accordingly.
Source: shortlink.uk/1tzqM

2. The Thrissur Consumer Commission held both the seller and the e-commerce platform liable for delivering an expired consumable product, ruling it an unfair trade practice and deficiency in service. Rejecting reliance on a “non-returnable” policy, the Commission ordered refund, compensation, and costs. It emphasized that platforms must ensure grievance redressal and cannot evade liability where defective or unsafe goods are supplied through their marketplace.
Source: shortlink.uk/1tzqU

3. The Ministry of Environment, Forest and Climate Change has amended the Bio-Medical Waste Management Rules, 2016, to include the Department of AYUSH and its nominated representatives in state and district-level waste management committees. This is important as it expands regulatory oversight to AYUSH healthcare facilities and strengthens compliance expectations. AYUSH institutions and related healthcare providers may now need to align with enhanced bio-medical waste management governance and monitoring requirements.
Source: shortlink.uk/1tzqI

4. Stakeholders have urged greater drug regulator oversight of nutraceuticals, citing concerns over quality standards, therapeutic claims, and wide pricing variations, with calls to shift certain nutraceuticals from food regulation to drug-level oversight. This is important as nutraceuticals are increasingly prescribed alongside medicines but lack uniform quality and pricing controls. Companies may now face stricter compliance requirements, enhanced quality standards, and potential regulatory scrutiny.
Source: shortlink.uk/1tzqY

5. The Central Drugs Standard Control Organization (CDSCO) has introduced a prior intimation system pursuant to amendments in the New Drugs and Clinical Trials Rules, 2019 effective April 21, 2026. It applies to bioavailability and bioequivalence studies for export-only drugs, excluding certain high-risk categories. CT-05 applications must be filed via Sugam with ethics approval, while other categories remain under prior approval. This is important as evolving CDSCO requirements may affect licensing, submissions, and regulatory timelines.
Source: shortlink.uk/1ohEa

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.

India’s Central Food Regulator (FSSAI) has published draft of the certificate required to be procured by importer of vegan food, from regulatory authority of exporting authority, in order to import vegan food into India. Objections may be submitted by 30th April 2025.
Source: bit.ly/4hbimbQ

2. Karnataka State Government is reportedly working on a Not of Standard Quality (NSQ) drug recall policy. In addition to recall, if a batch of medicines is found spurious or NSQ, the manufacturing and distribution license may get suspended until corrective actions are taken.
Source: bit.ly/4ioKGc0

3. India’s Environment Ministry (MoEFCC) has issued an SOP which clarifies that white-category industries can be exempted from obtaining consent to establish (CTE) only when they submit a self-declaration of compliance with applicable environmental laws. White category industries are least polluting industries.
Source: bit.ly/43mS433

4. India’s Central Pollution Control Board (CPCB) has discovered major non-compliances during audit of plastic packaging waste recyclers such as the absence of production capacity relative to Extended Producer Responsibility (EPR) certificates issued and the absence of GST invoices for sales transactions. Brand owners should not buy EPR certificates from such recyclers.
Source: bit.ly/43fNDXY

5. India’s Supreme Court has clarified that for an activity to be construed as “manufacturing” process requiring license under Factories Act 1948, the activity need not transform goods or necessarily produce an entirely new product that is commercially recognized as different.
Source: bit.ly/43fNQdI