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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 has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019, proposing to remove the provision dealing with the provisional registration of Ethics Committees. The designated authority will now directly grant final registration in Form CT-03 after scrutiny of Form CT-01, or reject with written reasons.
Source: h7.cl/1oifC

2. Bulk Drug Manufacturers Association of India has launched a marketing portal enabling Indian pharmaceutical companies to promote and source active pharmaceutical ingredients, intermediates, pallets, and contract development and manufacturing services, supporting both domestic and international markets through an integrated vendor management system with no cost registration for buyers.
Source: h7.cl/1oifJ

3. The Department of Pharmaceuticals has extended the deadline for submitting applications under the Common Facilities for Medical Device Clusters (CFMDC) sub-scheme to 15 February 2026. The scheme supports shared testing infrastructure for medical devices, including cardiac and orthopaedic implants, infusion pumps, imaging equipment, and Class B, C, and D IVDs.
Source: h7.cl/1jfLz

4. The Maharashtra government has issued a resolution by introducing a new fee structure at state-run hospitals from effective from January 16, 2026. ₹5 for OPD registration, ₹10/day for inpatient admission, and up to ₹40,000 for major surgeries like joint replacements. Diagnostic services, ICU care, and ambulance services also have updated charges. Implementation across hospitals is pending.
Source: h7.cl/1oiwW

5. The Indian Pharmacopoeia Commission is reportedly taking efforts to develop more biosimilar in alignment with governments Biopharma Shakti initiative. This move aims to align Indian quality standards with global benchmarks and strengthen the country’s biologics and biosimilars ecosystem.
Source: h7.cl/1jfLU

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 Central Government has issued draft amendments to the Drugs Rules, 1945, proposing mandatory blue vertical strip on the left side running throughout the body of the label on all antimicrobial drugs and their preparations. The move aims to enhance identification and promote responsible antimicrobial use, with stakeholder comments invited within thirty days.
Source: h7.cl/1iBM0

2. The Kerala High Court has ruled that the title “Doctor” is not exclusive to medical doctors and can be used by physiotherapists and occupational therapists. The Court held that neither the NMC Act nor state law grants doctors an exclusive right over the “Dr.” prefix, which traditionally denotes advanced learning.
Source: h7.cl/1nBW7

3. India’s ministry of consumer affairs has notified amendments to the Legal Metrology Rules, tightening standards for manual blood pressure devices. Effective January 7, 2026, the rules set stricter accuracy limits, ban unsafe connectors, and mandate durability, safety, and environmental stress testing. Manufacturers must update design, labelling, and documentation, and obtain fresh model approvals to continue selling these devices in the Indian market.
Source: h7.cl/1nBWi

4. India’s Bombay High Court has quashed a prosecution after finding serious delays in drug sample analysis beyond the mandatory 60-day limit prescribed under the Drugs Rules. The Court made strong observations regarding the laxity of the Drugs Department, holding that such lapses endanger public health by allowing sub-standard drugs to circulate.
Source: h7.cl/1iBMQ

5. The Tamil Nadu Chemists and Druggists Association has formally complained to the Pharmaceuticals and Medical Devices Bureau of India (PMBI) alleging that Jan Aushadi Kendras across the state are violating scheme guidelines by selling locally procured patented and generic medicines and operating multiple licences per individual. PMBI has confirmed such local sourcing is prohibited and attracts disciplinary action.
Source: h7.cl/1nBWD

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 Legal Metrology Division has clarified that the label declaration of “Manufactured by” is not required if the complete name and address of the brand owner is provided with the words “Marketed by” or “Brand Owner.” The declaration of manufacturer is a mandatory declaration under the Legal Metrology (Packaged Commodities) Rules, 2011.
Source: urli.info/1jgRA

2. The Department of Consumer Affairs, Legal Metrology Division, has clarified through the recently released Frequently Asked Questions that omission or obscuring of the maximum retail price is permissible on packages marked “Not for Retail Sale–For Institutional Customers Only” or “Evaluation Samples–Not for Sale”.
Source: urli.info/1jgRA

3. The Ministry of Agriculture and Farmers Welfare has issued draft Insecticides (Amendment) Rules, 2025, proposing to extend the compliance deadline for registration and related requirements under Insecticides Rules, 1971 from June 30, 2024 to June 30, 2026. Stakeholders may submit objections or suggestions within 30 days.
Source: urli.info/1jh3Q

4. The Gujarat High Court has held that healthcare services provided by private hospitals to in-patients are composite contracts, where the supply of medicines, implants, and consumables constitutes a “deemed sale” of goods embedded within the service, and hospitals are liable to pay VAT on the goods transferred during treatment as a works contract.
Source: urli.info/1eta4

5. India’s Delhi High Court directed Central Board of Indirect Taxes & Customs (CBIC) to frame a uniform policy on whether imports of products like “body massagers” or “sex toys” should be permitted or prohibited, noting inconsistent Customs practices. The Court said such decisions must follow national and contemporary standards, not the subjective discretion of individual officials.
Source: rb.gy/opp4oe

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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 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. The Ministry of Health and Family Welfare (MoHFW) is reportedly planning to integrate India’s Rare Donor Registry (RDRI) with the e-Rakt Kosh portal to streamline access to rare blood types like Bombay and Rh-null. This move connects over 4,000 rare blood donors with hospitals nationwide, improving response time and ensuring safer transfusions for patients with conditions like thalassemia and sickle cell disease.
Source: bit.ly/3HS9IDi

2. India’s Central Drugs Standard Control Organisation (CDSCO) has flagged 128 drug batches as Not of Standard Quality (NSQ) in its May 2025 alert. The list includes common medicines like paracetamol, dapagliflozin, dexamethasone, and others. Issues cited include assay failures, content non-uniformity, sterility, and misbranding. The alert aims to safeguard public health by informing stakeholders and enabling swift regulatory action.
Source: bit.ly/45wqAt3

3. Indian Council of Medical Research – National Institute of Immunohaematology has developed a low-cost, rapid test kit for Hemophilia A and Von Willebrand Disease. it will reduce the healthcare cost significantly and could become a worldwide solution for early diagnosis and treatment.
Source: bit.ly/4k5H4vR

4. A major eyewear company admitted before the Delhi High Court that it mistakenly used another company’s registered trademarks but had no intention of infringing them. The company removed all references. The court accepted this, recorded the admission, and issued a binding decree, formally closing the trademark-infringement case.
Source: bit.ly/43X8tvh

5. India’s Health Ministry has proposed including liver and heart transplants under the Ayushman Bharat PM-JAY insurance scheme, following recommendations from NOTTO (National Organ and Tissue Transplant Organization). Currently, only kidney transplants are covered, making life-saving procedures more accessible and affordable.
Source: bit.ly/4eePwYt

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. Drugs Technical Advisory Board (DTAB) has proposed to mandate the immediate suspension of licenses for drugs classified as Not of Standard Quality (NSQ) in the public interest. Such suspensions would remain in effect unless the concerned manufacturers submit a satisfactory Corrective and Preventive Action (CAPA) plan. The proposal also includes corresponding amendments to the Drugs Rules.
Source: bit.ly/3EFg5Zx

2. Drugs Technical Advisory Board (DTAB) has proposed to classify all antimicrobials as “New Drugs” under the New Drugs and Clinical Trials Rules, 2019. This move aims to facilitate stricter regulatory oversight in light of growing concerns over antimicrobial resistance.
Source: bit.ly/3EFg5Zx

3. Drugs Technical Advisory Board (DTAB) has proposed that manufacturers of medical devices with a valid manufacturing or loan license need not apply for a sterilization loan license. Instead, they can submit documentary evidence in support of proper sterilization when applying for a manufacturing license, provided the sterilization site’s license number is included on the device label.
Source: bit.ly/3EFg5Zx

4. Drugs Technical Advisory Board (DTAB) has proposed amendments to the Medical Devices Rules, 2017, to include clear definitions for “registration certificate” and “registration certificate holder.”  This change aims to provide better regulatory clarity in the medical device industry.
Source: bit.ly/3EFg5Zx

5. The Indian Government is finalizing revised biosimilar guidelines to align with global standards. The updated ‘Guidelines on Similar Biologics’ focus on stricter quality standards, reducing animal testing, and promoting in-vitro studies, while adhering to the 3R principles (Replace, Reduce, Refine). The aim is to streamline approvals and ensure patient safety.
Source: bit.ly/3GFiunq

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) has approved the upward increase of (+) 1.74028% in the Wholesale Price Index (WPI) for all scheduled formulations. Importers and manufacturers of scheduled drugs and medical devices may increase the Maximum Retail Price (MRP) based on this WPI without prior approval from the government.
Source : bit.ly/3DWXVC8
Source : bit.ly/42jXgUs

2. The Central Board of Direct Taxes has raised the threshold of safe harbour provisions for Service Providers who provide R&D services relating to generic pharmaceutical drugs, from INR 200 crore to INR 300 crore.
Safe harbour provisions protect group companies who undertake international related party transactions from transfer pricing scrutiny.
Source: bit.ly/3Rpk3YK

3. A leading beverage brand has moved to Delhi High Court against Food Safety and Standards Authority of India’s ban on using “100% Fruit Juice” claim on label and advertisements of reconstituted fruit juices. The court denied an interim stay and set next hearing on April 1, 2025.
Source: bit.ly/3DUIZnX

4. The Supreme Court of India has ordered all states to set up a grievance redressal mechanism for misleading advertisements of medicines and cures within two months. It has directed all the authorities to take quick action, file cases if needed, and raise public awareness. The central government is also directed to finalize the complaint dashboard within three months.
Source: bit.ly/3FKNjXq

5. European Union has reportedly proposed to update the cosmetic ingredient glossary in Regulation (EC) No 1223/2009, replacing Commission Implementing Decision. This aims to standardize ingredient labeling and improve ingredient identification. The proposal, announced on March 13, 2025, is expected to be approved by second quarter of 2025.
Source: bit.ly/4c60PRH

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. 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 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 Pollution Control Board has further extended the timelines for the filing of Quarterly Returns and Annual Returns of E-waste under E-waste Management Rules, 2022 for all registered entities on the online EPR portal till 31st December 2024.
Source: bit.ly/4eMsXZA

2. India’s Ministry of Health and Family Welfare (MoH&FW) is considering a proposal to amend the Medical Device Rules (MDR), 2017, to introduce specific timelines for various regulatory processes. These include conducting inspections, addressing non-conformities identified during inspections, and granting manufacturing licenses for medical devices across four classes (A, B, C, and D). The proposed changes aim to streamline approvals, enhance transparency, and improve regulatory efficiency in medical device manufacturing.
Source: bit.ly/4eH8aGL

3. The Indian Council of Medical Research (ICMR) has invited proposals for clinical studies on innovative medical devices and diagnostics under its Centre for Advanced Research (CAR) scheme. Offering up to ₹15 crore per project over five years, the scheme aims to validate and promote safe, effective, and regulatory-compliant healthcare technologies in India.
Source: bit.ly/4eH70vc

4. India’s Supreme Court has suggested the Central Government to formulate a policy on the construction of exclusive feeding rooms and childcare rooms in public places. Currently, there is no concrete law or policy on the feeding rooms and childcare rooms in public places.
Source: bit.ly/3ZiaQX1

5. The U.S. Food and Drug Administration (FDA) has released a guidance document titled Chemical Analysis for Biocompatibility Assessment of Medical Devices. This document outlines chemical characterization methods that can be used as alternatives to certain biological tests to demonstrate the biocompatibility of medical devices. It aims to enhance the consistency and reliability of analytical chemistry studies conducted as part of the biocompatibility assessment process for these devices.
Source: bit.ly/3OkJtFu