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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 Drugs Rules, 1945 through its first amendment introduces standards for Ayurveda, Siddha, and Unani (ASU) nasal drugs, focusing on manufacturing and standardizing dosage forms in traditional medicine. Traditional nasya preparations, including powdered churnas, grathas, and thailams, will also be standardized under these rules.
Source: bit.ly/40M88Zm

2. India’s Parliamentary Panel has recommended to Union health ministry to consider covering the cost of medicines, particularly for long-term treatments like cancer, under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PMJAY). The Committee’s 159th report highlighted that the Ministry’s submission suggests the possibility of such a provision. In a previous 151st report, the Committee had urged the government to provide free medicines for long-term illnesses to all PMJAY beneficiaries across states.
Source: bit.ly/4hIIv2s

3. India’s Union Budget 2025 has introduced the “Heal in India” initiative, aiming to boost medical tourism. Kerala is expected to be a major beneficiary due to its world-class healthcare infrastructure and traditional wellness practices like Ayurveda. The initiative aims to streamline visa norms for international patients, positioning Kerala as a leading destination for health and wellness tourism.
Source: bit.ly/4hJReS4

4. India’s Food Regulator, Food Safety and Standards Authority of India (FSSAI)
is reportedly considering new health warning on the labels of alcohol bottles, following a Bombay High Court’s directive on cancer warnings, similar to that on cigarette packs. Currently, alcohol bottles carry two health risk warnings, and industry representatives argue these are sufficient.
Source: bit.ly/3Etn0nY

5. Argentina’s government has decided to ban gender change treatments, including hormone therapy and surgeries, for minors and impose restrictions on housing trans women in women’s prisons. This move aligns with similar legislative pushbacks in countries such as the UK, Sweden, Finland, and the US, with the aim of protecting children’s mental health
Source: bit.ly/3Q7elKv

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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 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 Karnataka health department has become the first state to implement the Supreme Court’s 2023 directive on a patient’s right to die with dignity. The government issued an order appointing medical experts to a secondary medical board to determine when life-sustaining treatment can be halted for terminally ill patients.
Source: bit.ly/3CEYPlX

2. Central government of India has published amended Water Pollution Guidelines to streamline the process of obtaining consent for industrial plants that may cause water pollution with an aim to simplify compliance and enhance ease of doing business for industries. The guidelines outline procedures for obtaining, renewing, and potentially losing consent to establish or operate such plants. These guidelines exempt certain category of project from obtaining the clearances. It also states that the projects that required the Environmental Clearance (EC) as per Environmental Impact Assessment (EIA) Notification, 2006 are exempted from obtaining the Consent to Establish (CTE) separately.
Source: bit.ly/3WOVyaK

3. India’s National Medical Commission (NMC) thereby upholding the patients’ rights is considering to authorize the patients to appeal against the orders of State Medical Commission (SMC). Earlier, only doctors were authorized to file an appeal against the decision of SMC.
Source: bit.ly/4grUoZq

4. The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) are working together to improve the accuracy of In-Vitro Diagnostic (IVD) tests in India. They have released a draft manual for Standard Performance Evaluation Protocols, inviting stakeholder comments. These protocols outline methods for evaluating the performance of IVDs used to diagnose diseases like Chikungunya, Dengue, and Zika. After the consultation period, ICMR and CDSCO will review the feedback and finalize the protocols for official adoption.
Source: bit.ly/3QhIAyF

5. Major drug manufacturer in India has received approval from the Subject Expert Committee (SEC) of Central Drugs Standard Control Organization (CDSCO) to import and market tislelizumab injection, a cancer treatment drug. SEC waived the local clinical trial requirement under certain conditions, recognizing the drug as an orphan drug for an unmet medical need in India. Noting its approval in the USA, Europe, UK, Australia, China, and other countries, the committee also advised the company to submit safety and efficacy data for Indian patients, ensuring patient rights are considered.
Source: bit.ly/4hHyKSi

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 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 Madhya Pradesh High Court has ruled that rape survivors can undergo medical termination of pregnancy up to 24 weeks without requiring a court order. For pregnancies up to 20 weeks, a registered medical practitioner can perform the termination. This decision aims to streamline the process for survivors, reducing delays in accessing abortion services.
Source: bit.ly/4gkA5xi

2. The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO) have released a draft standard evaluation protocol for the performance evaluation of Human Metapneumovirus (hMPV) real-time PCR kits. This protocol provides detailed procedures for testing, including preparation of hMPV RNA evaluation panels, RNA extraction, and guidelines for real-time PCR systems. It aims to ensure the quality and reliability of diagnostic kits for hMPV. Public comments are invited till March 15, 2025.
Source: bit.ly/3WGUcOW

3. India’s Andhra Pradesh Medical Council (APMC) has reportedly announced that permanent registrations for Foreign Medical Graduates (FMGs) will be granted only to those who comply with the National Medical Commission (NMC) guidelines. This includes verification of degrees through the respective Indian Embassies and additional internship requirements. A group of 25 FMGs has filed a writ petition in the Andhra Pradesh High Court regarding this matter.
Source: bit.ly/3WEXdzv

4. Representatives from several pharmaceutical industry groups are scheduled to meet with officials from the Central Drugs Standard Control Organisation (CDSCO). The agenda includes discussions on the implementation of Schedule M, which sets quality standards and good manufacturing practices for pharmaceutical companies. Industry representatives, particularly from MSME pharma manufacturers, are expected to request an extension of the implementation timelines for the revised Schedule M.
Source: bit.ly/3WJDVZU

5. The US FDA has identified cybersecurity vulnerabilities in certain patient monitors used in healthcare and home settings. These monitors display critical patient information such as temperature, heartbeat, and blood pressure. The FDA warns that these vulnerabilities could allow unauthorized individuals to access and potentially manipulate the monitors, leading to improper functioning. Additionally, connected networks may be compromised, and sensitive patient data, including personally identifiable and protected health information.
Source: bit.ly/3X53S6r

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. 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. The Kerala High Court has emphasized the need for caution among investigating officers when implicating doctors under the POCSO Act for failing to report offenses. The court highlighted that such actions should not be taken lightly, especially in cases where there is no clear evidence of deliberate intent or negligence. This ruling aims to protect medical professionals from unwarranted legal repercussions that could arise from misunderstandings or misinterpretations of their responsibilities.
Source: bit.ly/4jxbEiQ

2. The Allahabad High Court has criticized government doctors for referring patients to private hospitals for financial gain, labelling the practice as a “menace.” The court directed the Uttar Pradesh government to formulate a policy to prevent doctors in state medical services from engaging in private practice, emphasizing the need for them to prioritize patient care in public hospitals. This ruling aims to ensure that government healthcare professionals fulfil their responsibilities without the influence of monetary incentives.
Source: bit.ly/3Cy62Eg

3. A leading Indian food company has recalled four tonnes of red chilli powder after the Food Safety and Standards Authority of India (FSSAI) ordered the action due to excessive pesticide residue levels in product samples. The company is advising customers to return the affected 200-gram packets for a full refund and is implementing stricter quality control measures with its suppliers to prevent future issues.
Source: bit.ly/3PTGhBw

4. A parliamentary panel has urged the National Pharmaceutical Pricing Authority (NPPA) to establish Price Monitoring and Resource Units (PMRUs) in all remaining states and union territories i.e. Andaman and Nicobar Island, Tamil Nadu, Delhi, Sikkim and Manipur. The initiative aims to enhance drug price monitoring and ensure the availability of essential medicines across India. Currently, PMRUs are operational in only a few regions, and expanding their reach is seen as crucial for better consumer awareness and accessibility.
Source: bit.ly/3CeopOJ

5. India’s Union Health Ministry has requested a legal opinion regarding the extension of the compliance deadline for revised Schedule M standards for micro, small, and medium enterprises (MSMEs) in the pharmaceutical sector. The proposed final draft could grant these companies an additional 12 months to meet the new requirements, which were initially set to take effect on January 1, 2025. This extension responds to requests from MSMEs for more time to upgrade their facilities and processes.
Source: bit.ly/3EdyI62

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. In a landmark ruling, the Chhattisgarh High Court emphasized that the entire mixture of a narcotic substance, including neutral substances, must be considered when determining whether the seized quantity qualifies as “small,” “intermediate,” or “commercial” under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act).
Source: bit.ly/40LD39o

2. The Jabalpur Bench of the Madhya Pradesh High Court, in an interim order, directed the police, narcotics bureau, and Drug Controller to take immediate action against manufacture and sale of banned drugs on wholesale basis online. This move is aimed at enhancing public safety and stricter regulation of online drug sales.
Source: bit.ly/40vjl0h

3. The Union Ministry of Health has announced a key amendment to the Drugs Rules, 1945, introducing Rule 158B (VI). This mandates licensing authorities to follow newly defined guidelines under Schedule TB when issuing licenses for Ayurvedic, Siddha, and Unani (ASU) nasal sprays, aimed at bringing standardization in formulation, safety, and efficacy.
Source: bit.ly/4asMVbt

4. India’s Ministry of Environment, Forest, and Climate Change has allowed entities registered as producers, importers, or brand owners under the Plastic Waste Management Rules, 2016, to make the mandatory labeling declarations via barcodes printed on plastic packaging, product brochures, or unique identification numbers, effective from July 1, 2025.
Source: bit.ly/40Jv2ln

5. The National Medical Commission (NMC) has initiated a probe into doctors whose foreign trips to Monaco and Paris were sponsored by a well-known pharma company, for violation of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.  This follows the reprimanding of Department of Pharma (DoP) against the pharma company for violating the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) for foreign events sponsorship.
Source: bit.ly/3E9Vmw7