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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. Supreme Court Calls Unethical Clinical Trials a Critical and Serious Issue, Orders Detailed Report from Government. The Supreme Court of India recently heard a Public Interest Litigation (PIL) filed by a public health rights NGO, highlighting unethical clinical trials causing serious adverse effects and deaths of the participants. The Court directed the Central Government to submit a detailed report within four weeks addressing concerns such as transparency, accountability, provisions for criminal actions against sponsors/investigators and other points raised by the petitioners.
Source:  bit.ly/4bW7QEB

2. Group of therapists have approached the Bombay High Court, alleging police harassment under the Immoral Traffic (Prevention) Act, violating their trade and dignity rights. The Maharashtra government informed the Court about a 12-member committee drafting guidelines for regulating spa and massage centers. The guidelines will cover important aspects such as licensing procedures, operational standards, and the regulation of cross-gender massages.
Source: bit.ly/4c4hG7s

3. India’s Health Department of Karnataka has clarified that Essential Narcotic Drugs (END) in the state will now be regulated under the Central Narcotic Drugs and Psychotropic Substances (NDPS) Rules, replacing the previous state regulations. As a result, hospitals and medical institutions recognized as RMIs by the state drug regulator no longer need state-level permission to stock these drugs. However, other narcotic drugs in Karnataka will continue to be regulated according to state NDPS Rules.
Source: bit.ly/4l1XDdY

4. The list of drugs taking a shift from prescription-only to over-the-counter (OTC) is reportedly to be released soon. A sub-committee is drafting guidelines, which may categorize OTC drugs for sale in pharmacies or in general stores, similar to practices in Western countries.
Source: bit.ly/4hJjCDB

5. MedTech Europe has released a report outlining the administrative burdens caused by the non-harmonized authorization process for IVD performance studies & the increased post-market and clinical reporting requirements for medical devices under the new medtech regulations. The report also proposes several solutions, including streamlining approvals for multinational studies, digitalizing processes, and allowing manufacturers to consolidate key reports.
Source: bit.ly/42jN4dJ

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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 Competition Commission of India (CCI) has reportedly raided offices of big advertisement and broadcasting firms as well as industry associations, on suspicion of fixing ad rates and undertaking price collusion. It is uncommon for CCI to raid industry associations, indicating possibility of cartelization.
The raid may affect advertisement by top brands.
Source: bit.ly/4iYMx7r

2. Pharmaceutical exporters have raised concerns about requirement to submit legal undertaking from API manufacturers in order to secure Export NOC from the Central Drug Regulator (CDSCO), on grounds that the APIs are procured from traders and not manufacturers, and manufacturers won’t readily agree to give legal undertaking. A new Export NOC system was introduced in March 2025 to expedite issuance of export NOC
Source: bit.ly/4iZDqTY

3. Representatives of leading cosmetics brands are reportedly demanding a separate law for regulation of cosmetics. The demand stems from the fact that cosmetics are regulated together with drugs under the current law i.e. Drugs and Cosmetics Act, 1940, because of which cosmetics are under system of significant licensing and inspection. The industry expects the law to require post-market notification as opposed to pre-market licensing.
Source: bit.ly/3DSCT7B

4. Google has recently announced a new health care update to its Search platform called the “What People Suggest” Feature, currently available only in the US. This new feature allows individuals with specific health conditions to compare their experiences with others. It utilizes artificial intelligence to collate online feedback from patients sharing similar diagnoses, enabling users to find insights on managing their conditions.
Source: bit.ly/421sKgK

5. The West Bengal Drug Control Administration is reportedly taking steps to closely monitoring discount pharmacies in order to eliminate counterfeit drugs. As part of the drive, inspectors will verifying purchase sources, inspect medicines, and enforce strict measures to ensure drug quality and public safety.
Source: bit.ly/4hIBxKk

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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 Tamil Nadu Online Gaming Authority has introduced regulations making Know Your Customer (KYC) mandatory for players before they can engage in online real-money gaming. This ensures age verification, promotes responsible gaming, and aims to curb gaming disorder, recognized by the WHO in ICD-11.
Source: bit.ly/3XMtzsq

2. An E-commerce giant in India has introduced a new pricing policy that enables sellers to set a ‘bank settlement value, while the platform controls the final listing price after fees and discounts. Sellers express concerns that this could violate FDI norms, promote anti-competitive pricing, and disrupt pricing parity across platforms.
Source: bit.ly/3FpxrcM

3. The Canadian government has proposed regulating caffeine as a supplemental ingredient, requiring cautionary labels on products with high caffeine content to prevent excessive intake and ensuring that caffeine-containing products are clearly labelled, “Do not [eat/drink] on the same day as any other source of caffeine.”
Source: bit.ly/4bQzRx5

4. The Canadian government is set to regulate harmful ‘forever chemicals’ (PFAS) found in everyday products to address growing concerns about human health and the environment. The anticipated new regulations will restrict per- and polyfluoroalkyl substances (PFAS) in a range of everyday items, including cosmetics, clothing, and food packaging.
Source: bit.ly/3DKQhKM

5. The European Commission aims to reduce reliance on Asian countries for essential drugs, including antibiotics, through the draft Critical Medicines Act. The upcoming law seeks to promote fair pricing for European generic drugmakers, ensure stable and reliable supply chains within the EU, and strengthen public health protection and security.
Source: bit.ly/422yzvy

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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 Madras High Court has refused to pass interim order staying the controversial gaming law in Tamil Nadu, which prohibits minors under 18 years from playing games and generally imposes restrictions on gaming between 12 am and 5 pm.
Source: bit.ly/43hwJYX

2. Andhra Pradesh’s Director of Medical Education has instructed government medical colleges and hospitals to ensure doctors prescribe drugs using generic names. The ethical guidelines applicable to doctors mandate prescription in generic names, and brand name may be used in addition.
Source: bit.ly/43nG6WS

3. India’s Department of Pharmaceuticals (DoP) has established a technical committee to devise strategies aimed at enhancing supply chain resilience and reducing reliance on China for pharmaceutical products. This initiative, part of the Indo-Pacific Economic Framework, aims to strengthen key industries like healthcare and chemicals.
Source: bit.ly/43aZ1UZ

4. India’s Central Food Regulator (FSSAI) will reportedly release new Maximum Residue Level (MRL) values for 98 spices, up from the current values for 18 spices. A SOP guidance to fix MRL for pesticides is expected to be published soon as well.
Source: bit.ly/4h19LZl
Source: bit.ly/41luW2f

5. Delhi High Court has remarked that the government should put in place a legal framework to tackle “e-infringement” of trademarks in e-commerce. Since multiple parties are involved in e-commerce, it is difficult to determine who is responsible for infringement.
Source: bit.ly/4hX8TpY

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 Foreign Trade regulator, the Directorate General of Foreign Trade (DGFT) has recently issued a Trade Notice, cautioning exporters to no longer accept physical copy Certificate of Origin, and to only accept electronically issued Certificates of Origin since the deadline for using physical copies has passed on 31st December 2024.
Source: bit.ly/439cxs0
Source: bit.ly/439ayEk

2. In light of a recent international report regarding the misuse of drug combinations in various countries in the African continent, India’s Ministry of Health and Family Welfare has rescinded the export license and No Objection Certificate (NoC) of a manufacturer of the said combinations.
Source: bit.ly/4353Mzp

3. India’s Supreme Court, in its recent order has expressed that the medical educational institution admission guidelines, which requires that “both hands [should be] intact” for a person suffering from a disability to gain admission to a medical educational institution, is violative of disability rights and has no basis under law.
Source: bit.ly/3QyRKH0

4. In a recent order, the High Court of Kerala has instructed the State Government to issue a circular to all Doctors in the state, requiring the preservation of foetus in case of a Medical Termination of Pregnancy of a minor, and require permission from the State Government for the destruction of said foetus.
Source: bit.ly/4bblB1L

5. The recent decision of the United State Government to terminate employment of several employees of the United States Food and Drug Administration (FDA) has the possibility to cause delay in obtaining approvals and licenses from the FDA by members of the Medical Device industry.
Source: bit.ly/4hRolDN

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 drug price control authority, the National Pharmaceutical Pricing Authority (NPPA) has issued an Office Memorandum instructing drug manufacturers to revise the prices of the drugs on which customs duty has been reduced.
Source: bit.ly/4gNNEVW

2. The Materiovigilance Programme of India’s Ministry of Health and Family Welfare has published an updated Draft Adverse Event Reporting Form for In-Vitro Medical Devices seeking public comment. The last date for receiving public comment is 5th March 2025.
Source: bit.ly/3Qn7kW2

3. In its recent meeting, the Drugs Consultative Committee (DCC), a policy advisory committee to India’s drug regulator, has raised the proposal to include Anti-microbial drugs in the definition of “New Drug” under the New Drugs and Clinical Trial (Rules), 2019 in an attempt to heighten the oversight of antimicrobial drugs.
Source: bit.ly/3QqZlao

4. India’s Union Ministry of Health and Family Welfare has revealed plans to include the human papillomavirus (HPV) vaccine in the national immunization program this year. During the recent Budget session of Parliament, Minister of State for Health stated that the details for its implementation are currently being worked out.
Source: bit.ly/4hH6dMR

5. Representatives of the Pharmaceutical industry in the United States are set to meet with the new administration in a bid to revise price-control regulations, and the United States government’s right to negotiate Drug Prices with pharmaceutical companies.
Source: bit.ly/4i5UEP4

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 Drug Regulator has notified that the application process for issuance of permission for import of additional variant of approved cosmetics into the country, will henceforth be conducted through additional module which will be activated on the SUGAM portal from the 22nd February 2025.
Source: bit.ly/3CQu6m2

2. The National Chemists’ Association has sought a meeting with India’s drug price regulator the National Pharmaceutical Pricing Authority (NPPA) to highlight concerns that the obligation on chemists to publicly display the prices of all drugs being sold, may be a very heavy burden for the industry.
Source: bit.ly/3QfYFor

3. The Pune Municipal Corporation (PMC) has issued show-cause notices to 97 private nursing homes and hospitals for violations of the Bombay Nursing Home Registration Act and Maharashtra Nursing Home Registration Rules. Key breaches include non-compliance with fire safety regulations, lack of patient complaint mechanisms, inadequate staffing, and failure to meet other legal standards like displaying contact information and maintaining proper treatment tariffs.
Source: bit.ly/41bya9P

4. In a recently published guideline, the United States Food and Drug Administration has expanded the applicability of Predetermined Change Control Plans (PCCPs) scheme, now requiring manufacturers to notify any post-market changes made to devices, which operate using Artificial Intelligence and not just those devices that use Machine Learning.
Source: bit.ly/4aZ3D2i

5. A Federal Court in the United States has recently dismissed the petition of a prominent drug manufacturer claiming “unfair business practices” by a pharmacy selling compounded versions of a patented drug, on the ground that the pharmacy has ceased to market and sell the compounded version of the drug.
Source: bit.ly/4aYtVSa

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 advertising self-regulation body, the Advertising Standards Council of India (ASCI), has issued a report analyzing the conduct of the country’s leading online influencers. Notably, the report reveals that only 29% of the influencers have even made appropriate disclosures of material connection with brands/companies their content.
Source: bit.ly/4k649jp
Source: bit.ly/40NSywt

2. In pursuance of the Central government’s BioE3 policy, which was announced in November 2024, the Central Government Minister for Science and Technology has urged State Governments to set up BioE3 Cells to promote Center-state partnership in pursuance of the BioE3 policy aims.
Source: bit.ly/4jTZjW4
Source: bit.ly/40UBchz

3. India’s Health Ministry has reportedly established an expert working group that will monitor adverse effects of medical devices and IVDs which are reported under Materiovigilance Programme of India (MvPI), and will recommend measures to improve patient safety to Indian’s medical device regulator, the Central Drugs Standards Control Organization (CDSCO).
Source: bit.ly/3ExgA7l

4. Earlier this year, The United States Food and Drug Administration has issued a proposed new rule which would have introduced a cap on the nicotine content in cigarettes and other tobacco products, in an effort to curb deaths from nicotine addiction in the country.
Source: bit.ly/3WVFdRr

5. In cases of insurance claim of medical treatment costs for chronic illness, insurance providers cannot deny a claim on technical ground of absence of in-patient treatment, if the treating Doctor had determined outpatient treatment was sufficient for the patient: High Court
Source: bit.ly/3CWwSpM

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 level drug regulator the Central Drugs Standards Control Organization (CDSCO) has issued a correction to the list of Fixed Drug Combinations for which manufacturing licenses can be obtained directly from the state regulators. The updated list is available on the website of the CDSCO at the given link.
Source: bit.ly/4hnPvSI

2. India’s Nursing professional regulator, the Nursing Council of India has issued Regulations prescribing the institutional and educational standards required to conduct the Nurse Practitioner in Pediatric Nursing Program.
Source: bit.ly/40IkEsV

3. A district level Consumer Disputes Redressal Commission has recently held that insurance providers cannot deny claims of policy-holders, on grounds of a medical issue arising out of “pre-existing conditions” if the “pre-existing conditions” is not the sole cause of the medical condition for which claim as made.
Source: bit.ly/3Q7gbLs

4. India’s Ministry of Health and Family Welfare has recently notified the updated grievance redressal system, and new physical verification procedure for empanelled hospitals aimed at improving service offering under the government’s public healthcare scheme.
Source: bit.ly/3WMQbc7

5. Industry groups make a representation to the European Policymakers to withdraw its recent AI Public Liability Directive protocol which sought to introduce non-contractual civil liability rules to artificial intelligence used by service providers, claiming that the non-contractual nature of the civil liability will disrupt existing supply-chains based on contractual understanding between service providers and receivers.
Source: bit.ly/4hK9sTp
Source: bit.ly/4hKflzQ

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 Parliamentary Standing Committee on Ministry of Chemicals and Fertilizers has made a recommendation to the country’s drug price regulation authority (the National Pharmaceutical Pricing Authority), to install and implement the Price Monitoring and Resource Units in all of States and Union Territories where they have not yet been set-up.
Source: bit.ly/4hBFqB8

2. The State Consumer Redressal Commission of the state of Delhi recently held that the obligation of a treating doctor to attend to a patient during an emergency situation, should supersede and mitigate his liability against any claim of negligence that may be levelled against him for his failure to refer the patient to a concerned specialist where such specialized treatment may be deemed necessary but for the emergency situation.
Source: bit.ly/4jAMHTG

3. India’s foreign trade regulator, the Directorate General of Foreign Trade has issued a Notification instructing Regional Authorities (Ras) to reduce the Export Obligations of exporters in sectors that have experienced a decline of more than 5% in volume. This now includes, among other product categories the export of Radioactive Isotopes from India.
Source: bit.ly/42zKAcB

4. India’s foreign trade regulator, the Directorate General of Foreign Trade has altered the procedure for obtaining a Certificate of Origin (CoO) by exporters. Notably, the Export Inspection Council (EIC) has been stripped of its previous authority to provide and print blank CoOs, and applicants will also now be required to make their applications on the online platform.
Source: bit.ly/4hALDxj
Source: bit.ly/3EpEjGm

5. The Parliamentary Standing Committee on Ministry of Chemicals and Fertilisers has recommended in its recent report, that various State Licensing Authorities should be sensitized on the best practices and procedures for the issue of license for Class A & B Medical Devices.
Source: bit.ly/4az0Lch