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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 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

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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. All insurance and healthcare policies are by law required to accommodate mental healthcare treatment under the Mental Healthcare Act, 2017. Therefore, even if an explicit provision exists in a current policy, it cannot be ground to refuse reimbursement for mental healthcare services availed under the policy: High Court.
Source: bit.ly/3Qm1LHg

2. The District Consumer Disputes Redressal Forum in Gujarat has recently held that insurance providers cannot rely on a discrepancy in documentation to deny a claim for treatment, provided that the justification letter of the treating doctor sufficiently addresses the eligibility of a claimant under the policy.
Source: bit.ly/41ivGqj

3. The National Human Rights Commission (NHRC) has recently held a core-group meeting to recognize the impact of progressive disabilities and possible changes in applicable law to address the same. The NHRC has also proposed to re-visit the current 40% benchmark for disabilities, to accommodate cases of persons with progressive disabilities.
Source: bit.ly/4hEfMwb

4. A Consumer technology product manufacturer has recently won its invalidation petition before a Federal Court of the United States, with this, the complainant in this matter now has complete and undisputed Intellectual Property rights in the US, over the underlying technology for detecting heart-rate in wearables.
Source: bit.ly/432ybye

5. The World Health Organization released new findings highlighting a concerning lack of awareness about alcohol’s link to cancer in Europe. It called for clear, prominent tobacco-style warnings, particularly in the region with the highest alcohol consumption. While the WHO has consistently warned about alcohol’s cancer risk and supported labeling, this is the first time it has directly called for new government regulations.
Source: bit.ly/4102Vxj

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 Ministry of Health and Family Welfare (MoH&FW) has released the Drugs Amendment Rules, 2025, extending the deadline for implementing revised Good Manufacturing Practices (GMP) under Schedule M for small and medium drug manufacturers until December 31, 2025. Manufacturers are required to submit an application to the Central Licensing Authority for seeking the extension within three months of the notification.
Source: bit.ly/4gCo0U8

2. The Supreme Court has virtually summoned the Chief Secretaries of Andhra Pradesh, Delhi, and Jammu & Kashmir to explain their failure to act on misleading medical advertisements. The Court found these states non-compliant with previous orders on enforcing Rule 170 of the Drugs Rules, which prohibits advertisements of Ayurvedic, Siddha, or Unani drugs without licensing authorities’ approval.
Source: bit.ly/42Sm6vn

3. India’s National Medical Commission (NMC) has clarified that the Telemedicine Practice Guidelines 2020 do not allow Registered Medical Practitioners (RMPs) to remotely authenticate pathology and radiology lab reports without physical presence and supervision. This follows an RTI application which sought clarification on the use of cloud-based technologies like Telepathology and Teleradiology for signing and authenticating lab reports.
Source: bit.ly/40VinKX

4. India’s Ayushman Bharat Digital Mission (ABDM) has made significant strides, with millions of Ayushman Bharat Health Accounts (ABHA) created and a large number of health records linked to ABHA. This is part of the mission’s effort to build an interoperable digital health ecosystem. Thousands of health facilities have registered on the Health Facility Registry (HFR), and many healthcare professionals are now listed on the Healthcare Professional Registry (HPR). The mission also focuses on supporting rural areas through technology interventions like telemedicine, enhancing access to healthcare services.
Source: bit.ly/41ektXT

5. The European Medicines Agency (EMA) has introduced a standard procedure for manufacturers of certain high-risk medical devices to receive scientific advice on their intended clinical development strategy and proposals for clinical investigations. This initiative aims to enhance safety and performance by offering expert guidance on regulatory requirements before devices are submitted for approval. The move is designed to foster innovation while ensuring that devices meet rigorous standards.
Source: bit.ly/4jWxfRZ

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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 AYUSH has proposed an amendment to the First Schedule of the Drugs and Cosmetics Act, 1940, expanding the list of authoritative books for Ayurveda, Siddha, and Unani Tibb drugs. The updated list now includes more vernacular books with details such as the author’s name and language. These drugs must be manufactured according to the formulae described in the books listed in the First Schedule, as defined by the Act.
Source: bit.ly/40UqMhL

2. The Ministry of AYUSH has proposed an amendment to update the list of poisonous substances in Ayurveda, Siddha, Sowa-Rigpa, and Unani systems under Schedule E(I) of the Drugs Rules, 1945. The draft amendment has been published for public awareness, with a 30-day period for objections or suggestions. The amendment categorizes the poisonous substances by their botanical names and includes the drugs in the respective systems of medicine that are prepared using these substances.
Source: bit.ly/3QdJ6NP

3. India’s drug pricing regulator has directed all retailers and dealers, including online pharmacies, to display the current price list of medicines on their websites. This move aims to empower consumers and ensure they are not overpaying for their medications.
Source: bit.ly/41bnhEY

4. India’s Odisha Registered Pharmacists Association (ORPhA) has expressed disagreement to government’s classification of pharmacists as paramedics, despite the Pharmacy Council of India (PCI) stating they are independent healthcare professionals. The association has urged the health minister to take steps to avoid the classification, highlighting that pharmacists are specialized healthcare professionals who play a vital role in patient care through their expertise in areas like pharmaceutical sciences, pharmacology, and medication therapy management.
Source: bit.ly/3EtSniq

5. India’s central government has imposed a ban on the export of raw human hair valued at less than $65 per kilogram, as per a notification issued by the Directorate General of Foreign Trade (DGFT). The notification stated that the export policy for raw human hair has been changed from “restricted” to “prohibited.” However, exports will still be permitted without restrictions if the Free on Board (FOB) value is $65 or more per kilogram.
Source: bit.ly/4gBVKAU

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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 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. India’s Ministry of Consumer Affairs has set a timeline for compliance with amendments to the Legal Metrology (Packaged Commodities) Rules, 2011. Changes to labelling provisions will be enforced on either January 1st or July 1st, after a minimum 180-day transition period from notification. The revised rules mandate clear, legible, and standardized labels on packaged goods, ensuring consumers have key details such as net quantity, MRP, manufacturing date, country of origin, and manufacturer information. This move is aimed at enhancing consumer protection, business ease, and reducing compliance burdens for industry stakeholders.
Source: bit.ly/3CxjgRQ

2. The Supreme Court of India ruled that domicile-based reservation for postgraduate medical admissions under State Quotas violates the right to equality under Article 14 of the Constitution. However, the Court clarified that the judgment will not impact existing domicile reservations or affect students currently studying or who have already graduated under such categories.
Source: bit.ly/4juOHwG

3. India’s Central medical devices regulator, Central Drugs Standard Control Organization (CDSCO) and Indian Council of Medical Research (ICMR) has issued a draft standard In-Vitro Diagnostics (IVDs) evaluation protocol to evaluate the quality and performance of IVD’s. The protocol once approved will be used by IVD manufacturers testing labs in India. Public comments are invited on the draft standard before March 15, 2025.
Source: bit.ly/3QhIAyF

4. India’s Ministry of Health and Family Welfare has confirmed the addition of the Human Papillomavirus (HPV) vaccine to the country’s Universal Immunization Program (UIP), a major step in preventing cervical cancer, which is one of the leading causes of cancer-related deaths among women in India. While the vaccine’s inclusion in the UIP has been officially announced, the exact timeline for its roll-out has yet to be determined. The move aims to combat cervical cancer by offering free vaccination to girls aged 9-14 years.
Source: bit.ly/3WHhkgp

5. China has approved its first stem cell therapy for commercial use, despite mixed clinical trial results. The therapy is intended for patients with neurological disorders, including spinal cord injuries. The approval has raised concerns about the safety and effectiveness of the treatment, as the trials showed only limited evidence of efficacy, and there are calls for more rigorous oversight in stem cell-based treatments.
Source: bit.ly/3WI0Uoa

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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 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

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 Indian Council of Medical Research (ICMR) has issued an Expression of Interest (EoI) for organizations, companies, and manufacturers to develop and produce a lateral flow-based point-of-care device for serum ferritin quantification. Serum ferritin is an important biomarker for diagnosing iron deficiency or anemia. The deadline for submitting the EoI is February 28, 2025.
Source: bit.ly/4jCmvrJ

2. The Pharmacy Council of India (PCI) has requested pharmacists facing registration issues on the DIGI-PHARMed portal due to existing identity proof in the system, to submit their details along with a declaration. This initiative is part of the Council’s efforts to eliminate fake or incorrect data by blocking incomplete entries and asking affected pharmacists to create new profiles with valid information.
Source: bit.ly/3Ee0e3q

3. The Federation of Pharma Entrepreneurs (FOPE) is urging the Union government to address GST rationalization due to challenges like low liquidity and increasing compliance burdens in the pharmaceutical industry. FOPE highlighted that the current GST structure has created an inverted duty structure, causing significant working capital blockages and operational inefficiencies, which impacts the critical role of the Indian pharma sector in healthcare, employment, and exports.
Source: bit.ly/3WC6Nmu

4. The National Medical Commission (NMC) is investigating around 30 doctors who took foreign trips to Monaco and Paris, sponsored by a drug manufacturer under the pretext of a dermatology conference. The doctors may face censure or suspension from the Indian Medical Register for three months to over a year, depending on the severity of the violation. This follows a reprimand from the Department of Pharmaceuticals (DoP) over the drug company’s sponsorship of the Rs 1.91 crore trips.
Source: bit.ly/4aCPis9

5. India’s Chhattisgarh High Court has ruled that when determining whether a mixture of narcotic drugs or psychotropic substances constitutes a “small quantity” or “commercial quantity,” both the quantity of the offending drug and the neutral substance mixed with it should be considered.
Source: bit.ly/4jAW8Ti

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, the Central Drugs Standards Control Organization (CDSCO) has issued an instruction manual for manufacturers and importers of devices not having predicate devices, to file Periodic Safety Update Report on the Medical Device Portal.
Source: bit.ly/4g5ORaV

2. India’s Delhi High Court held in a recent order that petitions regarding patent infringement, during the lifetime of a patent will continue to be valid even after the expiry of the term of the patent itself, since the cause of action has arisen at a time when the patent was still active.
Source: bit.ly/3PL3TYU

3. India’s central level regulator of the medical profession and education, the National Medical Commission has issued a draft Teachers’ Eligibility Qualifications, where it is proposed to permit non-medical personnel with Masters and PhD level degrees to teach Anatomy, Physiology and Biochemistry at medical educational institutions.
Source: bit.ly/40HAW6o

4. A premier commercial body of India’s restaurant business operators are currently mulling legal action against quick-commerce companies which have created a business model of undercutting the restaurant business through the use of private-label food products.
Source: bit.ly/4auFgsV

5. The European Pharmacopoeia has adopted three general standards for mRNA based vaccines, (1 mRNA vaccines for human use (5.36), covering mRNA packaged in lipid nanoparticles, (2) mRNA substances for the production of mRNA vaccines for human use, and (3) NA templates for the preparation of mRNA substances. These standards are expected to set a framework of control for regulatory control and approval of mRNA vaccines across the EU and all jurisdictions that accept EU Pharmacopoeia standards.
Source: bit.ly/4ar8HMK