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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. 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 Allahabad High Court recently ruled that a Food Business Operator cannot be held liable for ingredients purchased in sealed packets from a licensed manufacturer with a proper invoice, even if they are found to be unsafe. The court clarified that liability for unsafe products rests with the manufacturer or distributor.
Source: bit.ly/4hAlyip

2. India’s Department of Consumer Affairs has issued a draft Legal Metrology (Packaged Commodities) Amendment Rules, 2025 thereby relaxing the requirement to make labelling declarations at one place on the principal display panel (PDP) for the packages containing medical devices. Currently, all declarations are required to be made at one place on the PDP. The draft is open for public comments till 12th March 2025.
Source: bit.ly/40UsX4R

3. India’s Intellectual Property (IP) Office has issued a draft Guidelines for processing patent applications related to AYUSH systems, including Ayurveda, Yoga, Unani, Siddha, and Homeopathy. The guidelines aim to provide clarity to the filing and processing patent applications of Ayush systems and related inventions. Stakeholders are invited to provide feedback by February 28, 2025.
Source: bit.ly/3WZjWXa

4. India’s National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling prices of antibiotics Azithromycin and Amoxicillin-Clavulanic Acid under the Drugs (Prices Control) Order (DPCO), 2013. The revisions account for a 0.00551% impact from the Wholesale Price Index (WPI) for 2024.
Source:  bit.ly/3EBV7u4

5. Jammu and Kashmir’s Health Department had issued clear directives to ensure compliance with the prescription guidelines. However, doctors in government hospital have continued to disregard these guidelines thereby imposing a significant financial burden on the patients. Under these guidelines, doctors are required to write prescriptions in legible capital letters along with their name, designation and signatures.
Source: bit.ly/40YI1yl

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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

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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 government plans to amend the Mumbai Nursing Home Registration Rules, 1949, following concerns from the Indian Medical Association (IMA) over the 2021 amendment, which mandated staffing and infrastructure requirements for small hospitals. The new amendments aim to align regulations with industry recommendations to improve infrastructural and staffing feasibility for healthcare providers.
Source: bit.ly/3CFx3G1

2. The European Medicines Agency has set 23rd July 2025 as the date for implementation of updated International Council for Harmonisation (ICH) guidelines on Good Clinical Practises. This latest version of the guidelines encourages the sponsors to design trials that are fit for purpose and sufficient to provide confidence in the trial’s results.
Source: bit.ly/3CG9rky

3. In the 1st half of Financial Year 2025, the National Pharmaceutical Pricing Authority’s (NPPA) overcharging demands from pharma companies dropped sharply, while the number of cases surged by over 50% compared to last year. This reflects a rise in enforcement actions but a decline in penalty amounts imposed.
Source: bit.ly/4jGCGnY

4. The amended version of European Union’s (EU) Medical Devices Regulations, 2017 introduced Section 10a to enhance transparency and availability of medical devices. It mandates early notification of supply disruptions, extends IVD transition periods, enables a gradual roll-out of Eudamed, and imposes new responsibilities on economic operators.
Source: bit.ly/414XApt

5. A Parliamentary Panel has urged the Ministry of Ayush to strengthen regulations for adverse effects reporting and ensure regular post-marketing surveillance of Ayush medicines. It has requested a detailed status report on actions taken to enhance the regulatory framework for reporting adverse effects and ensuring drug safety and efficacy.
Source: bit.ly/4gzfzZP

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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) has launched an online module for filing the Annual Remission of Duties and Taxes on Exported Products (RoDTEP) Return (ARR), aimed at streamlining the process for pharma exporters. The module is available on the DGFT Portal and simplifies ARR filing, eliminating the need for physical documents.
Source: bit.ly/4hxQShu

2. India’s Parliamentary Standing Committee on Chemicals and Fertilisers has urged the Centre to actively implement recommendations from the Standing Forum on Medical Device Association, focusing on streamlining logistics and transitioning to licensing all types of medical devices.
Source: bit.ly/40XAnp8

3. The Directorate General of Foreign Trade (DGFT) has withdrawn the Track and Trace System for pharmaceutical exports under the Foreign Trade Policy (FTP), which required barcoding on primary packaging. The withdrawal is attributed to the implementation of the Ministry of Health & Family Welfare’s (MoH&FW) own barcode/QR code system, along with the fact that most export destinations have their own traceability systems.
Source: bit.ly/4aQDzqc

4. India’s Finance Minister has announced that 36 life-saving drugs, including cancer treatments, will be exempted from basic customs duty. Additionally, 37 more medicines will also benefit from this exemption. Furthermore, 6 life-saving medicines will be added to a list with a concessional 5% customs duty. The GST rate on cancer drugs like Trastuzumab, Osimertinib, and Durvalumab has been reduced from 12% to 5%. A new 13 Patient Assistance Programme has also been introduced.
Source: bit.ly/40UODPz

5. India’s Finance Minister in its 2025-26 Union Budget, announced that gig workers will be included in the Pradhan Mantri Jan Arogya Yojana (PMJAY) health insurance scheme. This will provide healthcare coverage to nearly 10 million online platform workers, offering financial protection to a sector that previously lacked structured benefits.
Source: bit.ly/4gmQwsN

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

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

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 Pollution Control Board (CPCB) has extended the timelines for the filing of Extended Producer Responsibility (EPR) annul returns by producers of Battery waste and E-waste for the Financial Year (FY) 2023-2024 till 31st March 2025 and 31st January 2025 respectively. For E-waste the extension of timelines also applies to the filing of quarterly returns for the abovementioned FY.
Source: bit.ly/3WthHei
Source: bit.ly/4gcsPmW

2. India’s National Pharmaceutical Pricing Authority (NPPA) has issued an office memorandum (OM) requesting manufacturers and marketing companies of the scheduled formulations nicotine used for nicotine replacement therapy (NRT) to furnish the Price to Retailer (PTR) and Moving Annual Turnover (MAT) data, in value terms for October 2023, within 7 days from the issue of the OM. A format for submitting these details is also provided in the OM. This information is being sought to fix the ceiling prices of these formulations.
Source: bit.ly/4gnoEFb

3. India’s Central Drugs Standard Control Organization (CDSCO) has released a guidance document to support the development of rapid diagnostics for pathogen identification and Antimicrobial Susceptibility Testing (AST). The document offers guidance to innovators and developers on evaluating their tests and demonstrating their effectiveness.
Source: bit.ly/4heX8ue

4. The Kerala High Court (KHC) recently ruled that magic mushrooms are not classified as narcotic substances under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985. After reviewing the legal status of psychedelic fungi, the honourable court concluded that since magic mushrooms are not specifically scheduled under Act, they are not subject to its restrictions.
Source: bit.ly/3CiZv0k

5. India’s Central Pollution Control Board (CPCB) has released draft guidelines for the Pharmaceutical Industry in India, which are currently classified as highly polluting. The guidelines outline criteria for the establishment of pharmaceutical units, including mandatory minimum distances from sensitive areas. Stakeholders and the public are invited to submit their comments and suggestions on the draft guidelines by February 5, 2025.
Source: bit.ly/4h1GC0Y

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 Rajasthan High Court (RHC) recently ruled that “a laboratory report can be countersigned only by a registered medical practitioner with a post-graduate qualification in pathology.” The court made this observation while hearing a petition that sought to restrict non-MBBS practitioners from signing medical laboratory reports.
Source: bit.ly/3WnKfWx

2. India’s Central Drugs Standard Control Organization (CDSCO) recently issued a letter to the Principal Commissioner of Customs, stating that the import of pre-owned, refurbished, or second-hand medical devices into the country is prohibited. CDSCO clarified that, as of now, there are no specific provisions in place for the regulation of such devices, and therefore, customs authorities have been directed to halt the importation of these items.
Source: bit.ly/3Ce6F5S

3. The Government of India has revised the Government of India (Allocation of Business) Rules, 1961, to designate the Department of Health Research (DHR) under the Ministry of Health and Family Welfare (MoHFW) as the authority responsible for Health Technology Assessment (HTA) matters. This change underscores DHR’s role, which already oversees Health Technology Assessment India (HTAIn), in evaluating the appropriateness and cost-effectiveness of both existing and new health technologies in the country as part of its “Research Governance” mandate.
Source: bit.ly/40hgGax

4. The Pharmacy Council of India (PCI) has updated the number of blocked pharmacists on its DIGI-PHARMed portal, increasing the list from 45,355 to 91,586. Affected pharmacists are required to re-register for re-verification. This action addresses issues with duplicate, invalid, or incorrect profiles on the platform, which supports pharmacy education by providing centralized services nationwide.
Source: bit.ly/42cCXc5

5. The World Health Organization has released a draft document to guide the adoption of continuous manufacturing (CM). This document covers finished products, as well as excipients and active pharmaceutical ingredients (APIs) produced through a CM process. The WHO is inviting feedback from stakeholders via its online platform, with comments due by 7 March 2025.
Source: bit.ly/42dNWSD