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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 Health and Family Welfare has constituted a committee to develop a policy governing refurbished medical devices. The committee will examine the scope of refurbished medical devices, methodology to evaluate the safety, performance, and remaining useful life of refurbished medical devices & suggest guidance for waste disposal of such refurbished devices.
Source: h7.cl/1o8qd

2. Indian government has announced a tax holiday until 2047 for foreign companies that provide cloud services globally using data centres located in India. Further, there will be no risk of foreign firms’ global income being taxed in India solely because they use Indian data centres. This move is aimed at attracting long-term investment into India’s digital infrastructure.
Source: h7.cl/1o8qp

3. Indian Government has released first national evidence-based lung cancer treatment and palliation guidelines. It offers 15 recommendations to standardise diagnosis, treatment and palliative care, improve early detection, reduce treatment disparities and ensure consistent, patient-centred care across the country.
Source: h7.cl/1o8qA

4. India’s Ministry of Consumer Affairs issued show-cause notices to major edible oil companies for violating the amended Vegetable Oils Products, Production and Availability (VOPPA) Order, 2025. Companies failed to submit monthly production data and register on official portals. Authorities have warned that continued non-compliance could lead to inspections and confiscation under the Essential Commodities Act, 1955.
Source: h7.cl/1o8qN

5. The United States Food and Drug Administration has launched the PreCheck pilot program to strengthen domestic pharmaceutical manufacturing. The initiative offers early regulatory engagement for new manufacturing facilities, improving predictability, streamlining facility assessments and accelerating readiness to supply medicines for the United States market.
Source: h7.cl/1o8qS

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 Directorate General of Trade Remedies (DGTR) has recommended a three-year safeguard duty on select steel imports, which is expected to hike costs for medical devices using 316L stainless steel (e.g., surgical tools, implants). This could pressure production margins, inflate end-user prices, and strain India’s competitiveness in domestic and export markets.
Source: short-link.me/17nS4

2. A high level inter departmental committee has reportedly commenced drafting rules to regulate the import of refurbished medical devices into India. Presently, imports are only allowed for high-end high value devices that haven’t been phased out overseas, contain no hazardous materials, and have a minimum seven-year residual life.
Source: short-link.me/1bQ2x

3. The Ministry of Health and Family Welfare has formed a national committee to draft guidelines for brain stem death certification, including for children. The expert panel will also develop training modules, certification criteria, monitoring tools, and audit systems to improve organ donation and critical care practices across the country.
Source: short-link.me/17nSk

4. NATHEALTH urges standardizing the GST input slab at 5% for healthcare and enabling input tax credit wherever output GST applies. The move aims to reduce hidden embedded taxes, estimated at 5.5–6% of provider revenue easing cost burdens on hospitals and diagnostic labs.
Source: short-link.me/1bQ2O

5. A parliamentary standing committee has reportedly recommended accelerating the rollout of a single-dose HPV vaccine to strengthen cervical cancer prevention. The panel also urged expansion of oncopathology infrastructure, especially in underserved regions like the Northeast.
Source: short-link.me/17nSB

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 Environment, Forest and Climate Change (MoEF&CC) has extended the deadline for filing Annual Returns under the Battery Waste Management Rules, 2022 until 30 September 2025. The previous deadline for filing of Annual Returns was 30 June 2025.
Source: bit.ly/46qdfmG

2. The Indian Government is reportedly set to enforce a Minimum Import Price (MIP) on approximately 10 critical pharmaceutical raw materials including Key Starting Materials (KSMs), Active Pharmaceutical Ingredients (APIs), and drug intermediates used in antibiotics and cholesterol medicines primarily imported from China
Source: bit.ly/3II4D0P

3. The Union Health Ministry is reportedly recommended to remove wholesale licensing requirement for household liquid antiseptics by reclassifying them separately from stronger, hospital-grade variants. This aims to make these products more affordable and widely available in retail stores.
Source: bit.ly/3GEEJdP

4. The Department of Biotechnology (DBT) is inviting proposals to establish Image Informatic Centres aimed at creating AI-powered imaging biobanks. These centres will collect and annotate diagnostic images linked with clinical data to develop AI algorithms for improved disease diagnosis and precision medicine.
Source: bit.ly/3GWmVuG

5. India’s Supreme Court has directed the central government to provide an office space within four weeks for the National Task Force (NTF) set up to address the mental health crisis among students, particularly in medical and higher education institutions. The NTF has faced hurdles in functioning due to the lack of physical infrastructure.
Source: bit.ly/44JT1mr

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 Delhi High Court to hear a Public Interest Litigation filed against major e-commerce platforms, accusing them of failing to make their apps accessible to people with disabilities, which constitutes a violation of fundamental rights. The plea also urged that return and refund processes be made more accessible for visually impaired users.
Source: bit.ly/4jK5X0b

2. India’s Kerala High Court has ruled that clubs and associations cannot be taxed for services or welfare schemes provided to their own members, calling it unconstitutional. These transactions involve only one entity, violating tax principle that a person cannot be taxed for “self-supply” of services.
Source: bit.ly/4isU4e4

3. The Indian Government reportedly plans to introduce Quality Control Orders for cosmetics to ensure product quality and curb imports of substandard items. However, industry leaders have raised concerns about overlapping regulations, as existing Cosmetic Rules, 2020 already align with the guidelines of Bureau of Indian Standards.
Source: bit.ly/4jm0PiZ

4. India has reportedly blocked imports of US dairy products like butter and cheese due to concerns over US cattle feeding practices involving animal-based proteins. India demands changes to these practices or adherence to its vegetarian certification norms. The issue could affect ongoing trade negotiations.
Source: bit.ly/3EoJveh

5. The Competition Commission of India (CCI) has reportedly ruled that leading food delivery platform’s platform fees, food prices, and delivery charges are not unfair or discriminatory. This decision came after a complaint was filed accusing the company of abusing its dominant position in the food delivery market.
Source: bit.ly/3S1JkZo

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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. Several global pharmaceutical companies have approached the European Commission demanding assistance in maintaining operations in the EU and to help Europe keep the pharma industry including measures to compensate them for the cost of pharmaceutical innovations. This move comes in the face of threatened U.S. tariffs on imports.
Source: bit.ly/3RgXrK6

2. A pharma giant has allegedly breached the UK’s Prescription Medicines Code of Practice Authority (PMCPA) for its cancer drug’s misleading prescribing information, which failed to clearly state that women using hormonal contraceptives needed to take additional measures to prevent pregnancy while on the drug.
Source: bit.ly/4lzu3MO

3. India’s Department of Pharmaceuticals (DoP) has invited expression of interest for selecting an agency to conduct a comprehensive study of India’s pharmaceutical and medical device supply chains, in order to identify regulatory hurdle.
Source: bit.ly/42zIx6O

4. Central Drugs Standard Control Organisation has directed States and Union Territories to urgently stop the manufacture, sale, and distribution of 35 unapproved Fixed Dose Combinations licensed without safety and efficacy evaluation under New Drug and Clinical Trials rules, 2019. Authorities must investigate, take action, and report compliance to ensure public health and regulatory consistency.
Source: bit.ly/4cw43hg

5. China has amended its GB 9685 standard for additives in food contact materials. The changes include expanded use in silicone rubber, revised usage limits, updated additive names, and new safety calculations. These updates, effective March 2025, aim to improve consumer safety and industry compliance.
Source: bit.ly/4cGqBfE

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

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 clarified that producers of plastic packaging in the micro & small category do not have to EPR fulfill obligations with effect from Financial Year 2023-24. However, they will have to file annual returns for the financial year 2023-24.
Source: bit.ly/3JqZRBH

2. India’s Directorate General of Trade Remedies (DGTR) has initiated an anti-dumping probe into Vietnamese imports of calcium carbonate filler masterbatch to determine how these imports affect the nation’s domestic industry. The medical sector uses this product for pouches, blister packaging, and individual-wrap containers. The DGTR will examine market patterns, injury claims, alleged dumping tactics and anti-dumping measures necessary to shield local manufacturers from unfair competition.
Source: bit.ly/3AF2Vtc

3. India’s Ministry of AYUSH has notified the Drugs (Fifth Amendment) Rules, 2024, which revise licensing procedures for homoeopathic medicines. The requirement for renewing manufacturing and loan licenses has been removed, making it valid in perpetuity subject to submission of self declaration.
Source: bit.ly/3YT6BBc

4. The State Drug Controller of Tamil Nadu has reportedly clarified that there is no legal provision for issuing separate licenses for pharmaceutical marketing companies or marketers. Pharmaceutical marketers and other stakeholders have been advocating for an amendment to the Drugs and Cosmetics Act (D&C Act) to include a provision for granting separate licenses for pharmaceutical marketers.
Source: bit.ly/3CbsZNh

5. In an effort to reduce exaggerated health claims made by supplement manufacturers about illness treatment or risk reduction, the government panel have proposed to transfer power from the Food Safety and Standards Authority of India (FSSAI) to a drugs regulator. The expert group was initially formed to examine how to handle the challenges that overlap between drugs and nutraceuticals.
Source: bit.ly/3YSrjRG

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 National Pharmaceutical Pricing Authority (NPPA) in public interest has approved 50% increase of ceiling price of eleven scheduled formulations of eight drugs from the current ceiling prices along with annual price increase as per the Wholesale Price Index (WPI) in April. This comes as a recommendation from the Inter-Ministerial Committee.
Source: bit.ly/3zOtSKV

2. Income Tax Appellate Tribunal (ITAT) of Ahmedabad has upheld the disallowance of amount claimed by a leading pharmaceutical company relating to promotional activities for doctors like accommodation, freebies etc and declared it as inadmissible for tax deductions. The activities were claimed as marketing tools rather than business necessities
Source: bit.ly/4eZ8fH7

3. India’s Central Drug Authority (CDSCO) along with National Regulatory Authority of India (NRA) and affiliated institutions after an evaluation by global experts have satisfied the WHO’s requirements for a functional vaccine regulatory system. Safety, efficacy, and quality are three basic parameters for the assessment of vaccines.
Source: bit.ly/4eJmn6S

4. The National Council for Clinical Establishments (NCCE) has recommended to allow the physiotherapists to own and run the clinics as per the amendment proposed in the Clinical Establishments (CE) Act, 2010. The decision comes as a relief to the physiotherapists and their organizations, which has been fighting legally to attain its right to own and run a clinic, which was not allowed as per the Act notified in 2010.
Source: bit.ly/3BMLs2s

5. The Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce & Industry, has issued a Trade Notice to give clarification on the import and re-import provisions for “Exhibits and Samples” that are exported for display or exhibition purposes. This move is expected to support businesses and industries, including the pharmaceutical industry participating in both domestic and foreign exhibitions to facilitate effortless import or re-import of goods for exhibition or display without imposing further bureaucratic obstacles.
Source: bit.ly/4h7x9FD

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 Drugs Consultative Committee (DCC) has reportedly recommended to make Sugam portal database of all the products with brand names accessible to the general public to address the issue of different drug formulations of different therapeutic categories being sold with same or similar brand names in the nation.
Source: bit.ly/3XMWBbV2. The National Accreditation Board for Hospitals & Healthcare Providers (NABH) has revised the accreditation standards for hospitals which will come into effect on January 1, 2025. No surveillance assessment will be conducted as per the old accreditation standard by NABH after 31st March 2025.
Source: bit.ly/47ydjPr

3. India’s Central Food Regulator will approve import of food consignments from Bhutan on the strength of Health Certificate issued by Bhutan Food and Drug Authority provided they are manufactured by the approved list of establishments of Bhutan.
Source: bit.ly/4gmtRxY

4. U.S. Food and Drug Administration has warned a major pharmaceutical company for making false and misleading claims about the benefits of a migraine pill in a television advertisement by a famous sports person. The claims were made against the results that were demonstrated in clinical trials.
Source: bit.ly/4gtau6m

5. A group of experts constituted by NITI Aayog to prepare a framework for action for emergency response and preparedness to address future pandemic, has recommended making the Central Drugs Standard Control Organisation (CDSCO) an independent regulatory authority. They have recommended to provide CDSCO with approved Standard Operating Procedures (SOPs) for Accelerated Emergency Use Authorisation for innovations and provisions for fast-tracking the process during pandemics.
Source: bit.ly/3XNynys