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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 NPPA’s Multi-Disciplinary Committee (MDC) flagged a typographical error in major pharmaceutical drug manufacturing company’s IPDMS Form I, reporting retail price of tablet as ₹13 per tablet instead of ₹91, leading to incorrect pricing. MDC has cautioned the manufacturer to avoid such negligence to prevent procedural delays.
Source: short-link.me/1aSCE

2. The Indian government has reportedly clarified that there is no official classification of drugs as “life-saving drugs.” However, to ensure affordability and accessibility, 930 formulations listed in the National List of Essential Medicines (NLEM) are under price control, leading to significant price reductions and improved patient access.
Source: short-link.me/16tjO

3. The Chhattisgarh High Court, in a recent interim order, has permitted Bachelor of Pharmacy (B.Pharm) graduates to apply for Pharmacist (Grade-II) posts under the National Health Mission (NHM). The court deemed the NHM’s exclusion of degree holders as arbitrary, a violation of Articles 14 and 16 of the Constitution.
Source: short-link.me/1aSCL

4. Indian pharmaceutical exports specifically generics and biosimilars -are currently exempt from the U.S. tariffs, underscoring their indispensable role in ensuring affordable, high-quality medicines for U.S. consumers. With about 40% of generics and 15% of biosimilars in the U.S. supplied by India, Pharmexcil has reportedly urged sustained collaboration to preserve stable, resilient pharmaceutical supply chains.
Source: short-link.me/1aSCW

5. United States Food and Drug Administration experts recommended dropping the “black box” warning on estrogen-based menopause therapies, especially low dose vaginal estrogen arguing the label has deterred women from effective treatment. They cited updated evidence showing benefits in reducing heart attack and bone fracture risk. In India, doctors are optimistic this move will boost confidence in hormone therapy, which remains underused despite its potential benefits for millions of postmenopausal women.
Source: short-link.me/1aSCZ

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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 Supreme Court has ruled against the notification issued by ministry of environment that had initially exempted educational institutions, industrial sheds, and hostels from mandatory environmental clearance under the Environment Impact Assessment 2006 regime. The court affirmed that projects over 20,000 sqm must now obtain prior approval typically from the State Environment Impact Assessment Authority.
Source: short-link.me/1aM5s

2. India’s Central Drugs Standard Control Organization (CDSCO) has reaffirmed that all WHO-GMP (COPP) applications must be submitted exclusively via the ONDLS portal by August 15, 2025. No further extensions will be granted for physical submissions beyond this date.
Source: short-link.me/16m-3

3. The Union Health Minister informed Parliament that India does not maintain central data on medical negligence cases. States handle such cases individually under the National Medical Commission Act, 2019. Calls for centralized tracking were raised, but the government emphasized health is a State subject with existing regulatory mechanisms.
Source: short-link.me/16m-d

4. India’s Department of Consumer Affairs has released draft rules for “Clinical Electrical Thermometers for Continuous Measurement” under the Legal Metrology Act. The draft rules outline metrological, technical, safety, and labelling standards, along with performance limits, testing methods, and manufacturer obligations. Stakeholder comments are invited by August 30, 2025.
Source: short-link.me/16m-f

5. The Mumbai CESTAT ruled that orthopaedic appliances and implants qualify for customs duty exemption under Serial No. 578, clarifying it covers assistive devices, rehabilitation aids, and goods for disabled persons. The tribunal interpreted the notification broadly and stated that the exemption applies to implants as assistive or rehabilitation aids, and not meant solely for disability use.
Source: short-link.me/1aM5T

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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 Supreme Court added the National Human Rights Commission (NHRC) to a 2018 PIL enforcing the Mental Healthcare Act, 2017. It condemned inhumane practices like chaining mentally ill patients, noted failure to set up mental health authorities and review boards, and directed the Centre to file a detailed affidavit on steps taken to implement the Act nationwide.
Source: bit.ly/4lB9e3f

2. Indian government has initiated a formal investigation into the growing import of medical devices from China, targeting potential cybersecurity and patient data privacy threats. Rising imports across diagnostics, surgical instruments and IoT enabled monitoring systems have raised concerns over malware, or data misuse, prompting scrutiny from commerce and health authorities.
Source: bit.ly/3IFimWg

3. The Indian Council of Medical Research (ICMR) has issued an Expression of Interest inviting eligible organisations, companies and manufacturers for transfer of technology for commercial production of recombinant multi stage malaria vaccine, AdFalciVax, by August 17, 2025.
Source: bit.ly/4eWGiAi

4. The Delhi government plans to exempt restaurants and eateries from obtaining the mandatory health trade license from the Municipal Corporation of Delhi (MCD). Currently, obtaining this licence is a prerequisite for opening eateries in the city.
Source: bit.ly/46ld2B6

5. Delhi High Court has temporarily barred pharmaceutical company from manufacturing, selling importing, exporting or dealing a biosimilar of patented cancer immunotherapy drug after finding credible evidence of patent infringement and potential irreparable harm.
Source: bit.ly/46Vlkjh

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 Food Safety and Standards Authority of India (FSSAI) has proposed halting new registrations and the renewal of existing registrations for the manufacturing of certain high-risk foods, such as dairy products and infant nutrition. They have also proposed permitting only state or central licenses and implementing pre-license inspections for manufacturers in these categories. They have sought public feedback on these proposed changes by 30th May, 2025.
Source: bit.ly/3RRy4Po

2. The Bombay High Court directed the state government to consider a separate registration facility for patients who are not yet on dialysis but will soon need an organ transplant. This came after a CKD Stage-V patient was denied registration. The Court said such denial violates the right to life.
Source: bit.ly/3RM4xqh

3. India’s ministry of commerce and industry has prohibited the use of specified antibiotics, antivirals, and antimicrobial medicinal products in fish, shrimp, hatchery operations or any manufacturing, pre-processing and processing unit to prevent antimicrobial resistance and safeguard export quality.
Source: bit.ly/44ZamIz

4. India’s Central Drugs Standard Control Organization (CDSCO) has released the guidelines for the safe disposal of expired and unused medicines by hospitals and the general public. The initiative is aimed at addressing the growing concerns of antimicrobial resistance and minimizing environmental hazards. 
Source: bit.ly/4iOmj7d
Source: bit.ly/4d3ywnf

5. Under the Stockholm Convention, 40 nations worldwide have agreed to phase out the use of chlorpyrifos, a hazardous pesticide on food crops. However, India secured a five-year exemption for its use on 12 essential crops to manage certain pests and termites, as well as the lack of immediate alternatives.
Source: bit.ly/4iL0q8M

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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. A medical device company has received compensation calculated at 25% of sales generated by a counterfeiting entity. The Court opined that 25% was a conservative profit margin for awarding damages. The Court has additionally awarded exemplary damages to punish the counterfeiting entity.
Source: bit.ly/4kHWYhn

2. The Indian Pharmaceutical Alliance (IPA) has reportedly questioned the authenticity of an US study linking India-made generic medicines to higher rates of serious adverse events (SAEs) calling the claims unfounded. IPA highlighted that Indian manufacturing facilities undergo stringent inspections by regulators like the FDA, and lower costs are due to production efficiencies, not compromised quality.
Source: bit.ly/4kEqkx8

3. The Indian government is reportedly considering exemption of health and life insurance premiums from the current 18% GST. The GST Council has sought input from the Insurance Regulatory and Development Authority of India (IRDAI), with the industry advocating for a reduction to 12% instead of a complete exemption or lower rate (5%), to be able to claim Input Tax Credit (ITC) on taxes paid for business operations.
Source: bit.ly/3Fu3dFx

4. India’s Health Ministry has reportedly directed the Drug Controller General of India (DCGI) to focusing on eliminating poor-quality medicines, supporting small pharma manufacturers (MSMEs), and refining medical device regulations. The move is aimed at enhancing global trust in Indian medical products and exports.
Source: bit.ly/3DHeK3J

5. The Director General of Foreign Trade (DGFT) has invited comments on proposed changes to export policy for Special Chemicals, Organisms, Materials, Equipment and Technologies (SCOMET), which seek to fast-track grant of approval. SCOMET goods typically face strict export controls.
Source: bit.ly/3Fr2Uva

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. Export samples of “Cough Syrup” under HSN code 3004 has been exempted from testing by the Directorate General of Foreign Trade (DGFT) provided they are being exported to or are manufactured at a plant/section which is approved by the regulatory agencies of USA, UK, Canada, European Union, Japan, Australia, Singapore, Republic of Korea and Switzerland.
Source: bit.ly/3YeH6tI

2. India’s Department of Pharmaceuticals (DoP) has recently rejected the review application of a leading pharmaceutical company and upheld the action of NPPA in fixing the ceiling price of the subject formulation. DoP stated that all modified release formulations of a drug that were mentioned in National List of Essential Medicine (NLEM) 2011 – Schedule I of Drugs Price Control Order, 2013 (DPCO, will be included in the NLEM 2015 – Schedule I of DPCO even though not specifically mentioned in NLEM 2015. It may be worth noting that, NLEM 2022 unlike NLEM 2015 specifically mentions that all modified release formulations of drugs specified in the NLEM list of 2022 will be regulated as scheduled formulations.
Source: bit.ly/3NzW73a

3. Goods and Service Tax (GST) on life and health insurance premiums by senior citizens may reportedly be exempted from GST irrespective of the coverage amount. Group of Ministers (GOM) to submit its report on the GST rates on life and health insurance premiums to the GST Council by October end of this year and final decision will be taken by the GST Council.
Source: bit.ly/3Nxr1cr

4. India’s pharmaceutical exporters are waiting for a government response to their request for an exemption from the onerous payment conditions prescribed under Section 43B (h) of the Income Tax (IT) Act, 1961. They are advocating for a minimum 60-day credit period, which is in line with global market standards where credit terms frequently extend up to 120 days. According to section 43B (h), payments for goods or services must be cleared within 45 days of acceptance. Failure to comply within this period creates financial burden and prevents businesses from claiming these payments as tax deductions.
Source: bit.ly/3Nx3dFD

5. To streamline and modernize pharmaceutical export-related procedures, the Directorate General of Foreign Trade (DGFT) has implemented an electronic Appendix 4H certificate filing system. The certificates which record the consumption and stock of duty-free imported or locally sourced raw materials under the Advance Authorization (AA) and Duty-Free Import Authorization (DFIA) schemes, are fully digitalized, as highlighted in Trade Notice No. 21/2024-25. Digital submission of these certificates is now mandatory for all pharma exporters.
Source: bit.ly/3YvCbES
Source: bit.ly/48fPe0g

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 Drugs Technical Advisory Body, in its 91st meeting, has recommended the exemption of several chemical contraceptives at specific dosage values, from the labelling requirements under Schedule H which would have limited sale by prescription only.
Source: bit.ly/3ZWiqqU

2. The Directorate General of Foreign Trade has amended the export policy for cough Syrup, amending an earlier notification, exempting the requirement for pre-export testing for jurisdictions including the USA, EU, and South Korea which may already have granted approval.
Source: bit.ly/3YfvOVP
Source: bit.ly/3YeH6tI

3. The Ministry of Environment Forest and Climate change has notified the Liquid Waste Management Rules, 2024 set to come into force from 1st October; which govern the treatment and management of liquid effluents arising from domestic and industrial activities including treatment of wastewater, sludge generated during treatment of wastewater and reuse/reutilization of any wastewater or sludge generated.
Source: bit.ly/3YhCpzl

4. In a recent public notice, the Central Government Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) has clarified that it does not license or ratify any AYUSH products or medicines, and warned against the advertising of AYUSH products as “Miracle Cures”. This comes in the light of the Ministry of AYUSH having repealed Rule 170 of the Drugs Rules, 1945, which regulated AYSUH advertising.
Source: bit.ly/4dzToBi
Source: bit.ly/3XXf9Fi

5. The European Commission’s Medical Device Coordination Group (MDCG) has issued a voluntary document to supplement its earlier Designation, re-assessment and notification of conformity assessment bodies and notified bodies, which is intended to guide notified bodies to impose corrective and preventative action.
Source: bit.ly/4eYr4JJ

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 Food Safety and Standards Authority of India (FSSAI) has waived off the registration fees of hawkers for the grant of registration certificate and renewal of registration certificate with effect from 28th September 2024. The registration certificate will now be issued for five years only. Previously an option for selection of validity from one to five years was available to the applicant.
Source: bit.ly/4dy8EyA

2. Drug manufacturers submitting false or misleading information may reportedly face legal action from the Drugs Controller General of India (DCGI). As of now, the Drugs Rules, 1945 contains no provision addressing the problem of providing false, falsified, or misleading information for receiving regulatory approvals. As per the plan, the applicant may face debarment in addition to product suspension and cancellation for misleading the licensing authority.
Source: bit.ly/3Nh4D6V

3. An exemption has been granted for the generation of E-way bills for the transportation of job work, storage, and warehousing of goods, specifically turmeric, chilli (genus: Capsicum), and raisins, by the Maharashtra Government. This exemption applies on the condition that such goods are transported within the State of Maharashtra for a distance of up to fifty kilometers with no cap on consignment value.
Source: bit.ly/4dxlj4M

4. India’s Ministry of Health and Family Welfare (MoH&FW) is reportedly considering a proposal to classify all antibiotics as ‘new drugs’ under the New Drugs and Clinical Trials Rules, 2019. The aim is to regulate all antibiotics centrally through Central Licensing authority (CDSCO) rather than by State Licensing Authorities. The proposal also seeks to amend labelling requirements under the Drugs Rules, 1945, to address the rising concern over Antimicrobial Resistance (AMR), which has been highlighted as a global health priority.
Source: bit.ly/3ByExtw

5. Concerns over the potential harmful effects of hormonal contraceptives, particularly emergency contraceptive pills (ECP) or morning-after pills, have prompted India’s Central drug authority (CDSCO) to constitute an expert panel to discuss the possibility of requiring a doctor’s prescription before purchasing these drugs. The proposal to amend Drugs Rules is under examination by the three member committee constituted by CDSCO. As of now, hormonal contraceptives falling under Schedule K of the Drugs rules can be purchased without a prescription from a physician.
Source: bit.ly/4dFTXcT

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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. Indian pharmaceutical manufacturers will have to prove compliance with revised Good Manufacturing Practices at the time of renewal of manufacturing license, as per media reports.
Source: bit.ly/3MAGjg9

2. A woman who has filed for divorce should be treated as a divorced woman for the purposes of medical termination of pregnancy, and therefore will have the right to terminate her pregnancy: High Court
Source: bit.ly/4fNDhT7

3. The Multidisciplinary Committee of Experts (MDC), which advises the National Pharmaceutical Pricing Authority (NPPA), will invite an officer not below the rank of Deputy Controller of Patents and Designs, to evaluate eligibility for exemption of patented drug from application of price control law.
Source: bit.ly/46Ya8jY

4. A new scheme to boost domestic medical device industry in India is under works and will reportedly be launched in a month.
Source: bit.ly/4fUqrSU

5. A new portal for reporting adverse events of drugs, vaccines and medical devices has been launched by Indian Pharmacopoeia Commission. The adverse event may be reported by consumers and medical practitioners.
Source: bit.ly/4dxeUXY