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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 licensing authority, CDSCO has issued an alert on the theft of Lantus® SoloStar® insulin (Batch No. 5F0347B) belonging to Sanofi India during transit in Odisha. As the product requires cold-chain storage at 2–8°C, quality risks exist. CDSCO has issued an advisory to healthcare professionals, patients and regulators.
Source: short-url.org/1qgYH

2. India’s central drug regulator reportedly circulated a proposal from the Ministry of Cooperation that would allow Primary Agricultural Credit Societies (PACS) to operate Jan Aushadhi Kendras without registered pharmacists through restricted drug licences, aiming to expand access in underserved areas. The pharmacist community has raised serious concerns, arguing this move could weaken professional standards and patient safety.
Source: short-url.org/1qgYM

3. The Food Safety and Standards Authority of India has issued draft amendments to the Food Products Standards and Food Additives Regulations, 2011 proposing several changes. Stakeholders may submit objections or suggestions within sixty days from publication of the notification. The authority will consider all representations before finalising the proposed regulatory amendments.
Source: short-url.org/1qgYz

4. A court has granted interim relief in a trademark dispute involving the shape of a toilet cleaner bottle. It held that product shape can receive trademark protection even after design registration expires. Observing strong similarity between competing bottles, the court restrained sale of the allegedly infringing product pending further proceedings.
Source: short-url.org/1qgZN

5. The Madras High Court has stayed a single judge’s observation declaring the term “Vapo” as public property in a trademark dispute concerning vapour-based medicinal rubs. The Division Bench held that the finding requires further examination, while allowing continued use of the contested registered mark pending adjudication of the appeals.
Source: short-url.org/1l8DX

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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 Delhi high court granted ex-parte interim injunction to major manufacturer of toothpaste, directing social media platforms to take down the defamatory content pending further proceedings which is falsely claiming that Dant Kanti toothpaste causes cancer. The court found the claims prima facie malicious and unsubstantiated.
Source: short-url.org/1l8us

2. The High Court of Bombay has granted permanent injunction protecting registered mark ZERODOL against use of ZEKODOL-P for identical pharma products. Court found strong phonetic and visual similarity, holding confusion in medicines unacceptable. Defendant restrained and directed to pay directed to pay costs.
Source: short-url.org/1qgQf

3. The CDSCO is reportedly set to formally involve Quality Council of India-certified notified bodies in its drug regulatory audit framework to boost coverage and compliance monitoring, addressing capacity constraints in current inspections. The reform, aligned with global standards, would expand third-party audit participation alongside plans to grow internal scientific review teams.
Source: short-url.org/1qgQx

4. The Central Drugs Standard Control Organization will reportedly replace its existing SUGAM regulatory portal with a modern open-architecture digital platform, following approval by the Department of Expenditure. The new system aims to integrate the entire drug regulatory value chain, improve transparency and efficiency, and streamline licence, import/export and regulatory approval processes across India.
Source: short-url.org/1l8uE

5. The National Medical Commission has directed all medical colleges to integrate the HMIS of their attached hospitals with the Ayushman Bharat Digital Mission (ABDM-HMIS) portal within 15 days. Issued under UGMSR 2023 compliance, the move aims to enhance transparency, objective assessments and digital monitoring of medical education standards.
Source: short-url.org/1qgSQ

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Pre-filing consultation for medical device risk classification now possible in India

India’s central medical device regulator, The Central Drugs Standard Control Organization (“CDSCO”), has introduced a facility that allows importers and manufacturers of medical devices who are desirous of ascertaining the risk classification of their medical devices to receive an official confirmation on risk classification from the CDSCO.

Regulatory context
India’s medical device regulatory framework differs from most other jurisdictions. In India, risk classification of medical devices is determined by CDSCO and is not self-declared by manufacturers and importers who are making the product license application.
Additional complexity arises from the fact that manufacturing licenses for Class A and Class B devices are issued by State authorities. This has resulted in inconsistent application of risk classification thresholds, with similar products receiving different risk classifications across states. Although CDSCO has issued directions to address this issue, practical challenges continue.

Why does risk classification matter?
The risk classification determines documents and data required, government fees and timelines for obtaining the product license. Therefore, risk classification is a key commercial and strategic factor.

Pre-filing consultation facility
To align risk classification and bring regulatory certainty, CDSCO has introduced a voluntary pre-filing consultation facility to confirm medical device risk classification. The facility is only available to manufacturers and importers of medical devices other than in-vitro diagnostic medical devices (IVDs).

Consultation fee
Please note that there is no consultation fee for availing the facility to determine risk classification of medical devices.

Documents required
In order to avail the facility, the manufacturer or importer is required to submit existing device labels, instructions for use, and the regulatory status of the device in other jurisdictions (like USA, UK, EU, Australia, Canada, or Japan), etc.

Timeline for receiving response on risk classification of medical device from CDSCO
There is no prescribed timeline, and the consultation is best undertaken in parallel with preparation of the main regulatory dossier of medical devices.

Key take-aways for industry
It is pragmatic to undertake pre-consultation when the risk classification of the medical device is unclear.
Early confirmation of risk classification allows companies to plan approval pathways with greater certainty, align licensing strategy at an early stage, and reduce regulatory friction. It also supports better coordination between India-specific regulatory requirements and global product positioning.

Disclaimer: This article is intended for general information purposes only and does not constitute legal advice

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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 Food Safety and Standards Authority of India has issued draft amendments to the Food Business Licensing Regulations mandating food manufacturers to keep daily production and raw-material records and to follow FIFO/FEFO storage norms. Retailers and non-manufacturers are exempt. The move strengthens traceability, inventory control, and food safety compliance. Public comments are invited within 30 days of Gazette publication.
Source: h7.cl/1iFOX

2. Madras High Court has ruled that the word “Vapo” is a descriptive and generic term derived from “vapour” and cannot be claimed exclusively by any party, rejecting petitions seeking cancellation of trademarks for “Vaporin” products. The Court held that the rival marks and trade dress are distinct and unlikely to cause consumer confusion.
Source: h7.cl/1nG6S

3. India’s Central Government has amended Uniform Consent Guidelines under the Air and Water Acts to simplify industrial approvals and cut delays. Key changes include consolidated consents covering multiple environmental laws, faster timelines for red-category industries, and Consent to Operate remaining valid until cancelled. Inspections, audits, and cancellation powers remain to ensure environmental compliance.
Source: h7.cl/1iFAP

4. The India–EU free trade agreement is set to eliminate duties on about 90% of European medical devices imported into India, reducing tariffs that earlier went up to 27%. The agreement is expected to lower costs and improve access to advanced technologies, Indian manufacturers are seeking regulatory alignment and mutual recognition to overcome non-tariff barriers.
Source: h7.cl/1iFAU

5. The India–EU Free Trade Agreement is expected to expand opportunities for Indian traditional medicine in Europe. In EU countries where no specific regulations exist, AYUSH practitioners will be allowed to offer services based on their Indian qualifications. The agreement also provides long-term certainty for setting up AYUSH wellness centres and clinics across EU member states.
Source: h7.cl/1iFAX

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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 Indian government has proposed prohibiting the import, manufacture, sale, and distribution of certain specified antimicrobial medicinal products for animal use. It has invited public suggestions and objections from stakeholders by 22nd June 2025. The move aims to curb antimicrobial resistance and protect human health.
Source: bit.ly/4dvRgfj

2. The Supreme Court of India recently upheld dual taxation on broadcasting services, allowing both the Centre to levy service tax and states to impose entertainment tax. It ruled broadcasting as communication and entertainment as a luxury, confirming constitutional authority for concurrent taxation on cable TV, digital streaming, and OTT platforms.
Source: bit.ly/4mDyR4G

3. Under the free trade agreement (FTA), the United Kingdom reportedly will provide non-discriminatory access to Indian companies in its public procurement, while India grants UK firms limited access to high-value tenders in return. The deal ensures mutual market access while protecting India’s strategic interests, including ‘Make in India’ and SME support.
Source: bit.ly/3Sm7s9m

4. India and World Health Organisation (WHO) has signed the Memorandum of Understanding (MoU) to include AYUSH therapies in WHO’s global health classification system. This will give traditional medicine scientific recognition, enable insurance coverage, and improve global access to India’s ancient healing systems.
Source: bit.ly/3FuRgQ8

5. India’s Uttar Pradesh government, following a recent hospital fire has mandated comprehensive fire safety upgrades across all hospitals which includes installing fire-fighting systems, conducting regular mock drills, improving ventilation, and ensuring unobstructed evacuation routes. Staff training and adherence to fire safety guidelines to prevent future incidents
Source: bit.ly/45qkb2j

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FAQs on Regulation of Class A Non-Sterile, Non-Measuring Medical Devices in India

The regulatory landscape for medical devices in India has evolved significantly, with the recent focus on regulation of non-sterile, non-measuring medical devices in India.

On October 14, 2022, India’s medical device regulator, the Central Drugs Standard Control Organization (“CDSCO”), notified a new category of Class A Non-Sterile Non-measuring (“NSNM”) medical devices by way of an amendment to Medical Devices Rules, 2017 (“MDR”).

These medical devices although are low risk medical devices, they still have to meet standards for safety, quality, and performance. Whether you’re a manufacturer, importer, or distributor, understanding these regulations is crucial for ensuring your products meet the necessary requirements for market entry.

 1. What are Class A medical devices?
Class A medical devices are considered to be low-risk devices. The classification of medical devices is determined according to the parameters set forth in the First Schedule of the Medical Devices Rules, 2017 (MDR). Class A devices are further divided into two categories:

  • Non-Sterile, Non-Measuring (NSNM) devices
  • Sterile and Measuring devices

2. Who determines risk classification of Class A medical devices?
The risk classification of medical devices in India is determined by the Central Licensing Authority, which is the Central Drugs Standard Control Organisation (CDSCO).

3. What are non-sterile medical devices?
Non-sterile medical devices are those that are marketed in a non-sterile state

4. What are non-measuring medical device?
The non-measuring medical devices are medical device that are not intended for use as measuring tool.

Some of the examples of measuring medical devices are:
a. Device for the delivery of liquid to the human body
e.g., medicine spoons, cups, droppers, without graduation or scale or display of measuring unit, etc.

b. Device for displaying trends of physiological parameters
e.g., Urine bags without graduation or scale, callipers for obesity.

5. Is the Class A NSNM registration applicable to Class A In-vitro diagnostic devices?
No, the Class A NSNM registration applies only to medical devices and does not extend to In-vitro diagnostic devices.

6. Whether License is required to import or manufacture Class A NSNM medical devices in India?
No, under the Medical Devices (Sixth Amendment) Rules, 2022, a license is not required for the importation or manufacture of Class A NSNM medical devices in India.

7. Is a license required for the sale of Class A NSNM medical devices?
No, there is no requirement for a license to sell Class A NSNM medical devices.

8. What is the government fee payable for registration?
There is no prescribed government fee for the registration of Class A NSNM medical devices.

9. Are price control regulations applicable to Class A NSNM medical devices?
Yes, price control regulations are applicable to Class A NSNM medical devices. The Drug (Price Control) Order, 2013 governs the regulation of prices for drugs and medical devices.

10. Is ISO 13485 and a Free Sales Certificate required for registration of Class A NSNM medical devices?
No, ISO 13485 certification and a Free Sales Certificate are not required for the registration of Class A NSNM medical devices.

11. Do Class A NSNM medical devices need to comply with the labelling requirements under MDR?
Yes, Class A NSNM medical devices are required to comply with the labelling requirements as specified under the Medical Devices Rules, 2017 (MDR). These labelling requirements are mandatory.

 12. What are the consequences of manufacturing or importing unregistered devices?
Manufacturing or importing unregistered medical devices constitutes a violation of Indian law and may result in penalties or legal action.

Note: These FAQs are provided for informational purposes based on our understanding of the relevant laws and regulations. They should not be construed as legal advice, professional guidance, or an endorsement of any particular industry practice.

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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 Supreme Court of India has ruled that company directors and officials are not vicariously liable for corporate offences without specific statutory provisions and evidence of personal involvement. While companies may be held accountable for employee’s misconduct, directors’ liability requires proof of their direct actions. Mere association with the company is insufficient to attract a liability.
Source: bit.ly/3PvHNJK

2. The Supreme Court of India, while hearing a PIL against multinational pharmaceutical companies, raised ethical concerns over clinical trials in poorer countries. It highlighted the exploitation of vulnerable populations and the lack of oversight in such practices thereby urging stricter regulations to protect participants’ rights. The Drugs and Clinical Trial Rules, 2019, notified under the Drugs and Cosmetics Act, 1940, mandate provisions like Ethics Committees and compensation for trial-related injuries or deaths.
Source: bit.ly/3DNYBt4

3. The Jammu & Kashmir and Ladakh High Court has initiated contempt proceedings against a prominent Indian law firm for allegedly misquoting a 2010 judgment related to the Sawalkote Hydro-Electric Project. The court observed that the law firm had misrepresented judicial findings in a legal notice that was issued by the court which might potentially amount to criminal contempt.
Source: bit.ly/423xnZz

4. The Bombay High Court emphasized that intelligence levels should not determine parental rights while deciding a case involving a woman’s right to motherhood with borderline intellectual disability. The court reviewed a petition seeking termination of the woman’s 21-week pregnancy, with a medical report confirming her fitness for pregnancy.
Source: bit.ly/3Cb5Evd

5. India’s healthcare stakeholders, ahead of Budget 2025, are urging reduced customs duties (~37%) on advanced cancer therapies, drugs, and treatment equipment. They seek tax reforms, including GST rationalization, increased healthcare spending to 2.5-3% of GDP, long-term financing options, telemedicine expansion, and infrastructure incentives. Emphasis is also laid on digital health and preventive care to ensure equitable access nationwide
Source: bit.ly/4gJousH

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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 Indian government has extended the deadline for small and medium pharmaceutical companies to comply with the revised Good Manufacturing Practices (GMP) under Schedule M of the Drugs and Cosmetics Act. The revised deadline is December 31, 2025, while the earlier deadline was January 1, 2025. This extension aims to assist smaller manufacturers in upgrading their facilities to meet stringent regulatory requirements.
Source: bit.ly/4a4HaAo

2. The Central Drugs Standard Control Organisation (CDSCO) and the Indian Council of Medical Research (ICMR) have released draft standard evaluation protocols for licensing in-vitro diagnostics (IVDs) under the Medical Devices Rules, 2017. These protocols aim to ensure quality and performance evaluation of IVDs, establishing uniformity in testing across various diagnostic kits. Stakeholders are invited to provide their feedback on the draft by February 15, 2025.
Source: bit.ly/40kTlWt

3. The Ministry of Electronics and Information Technology (MeitY) has released the draft Digital Personal Data Protection Rules, 2025, inviting public feedback until February 18, 2025. These rules aim to operationalize the Digital Personal Data Protection Act, 2023, which was enacted to enhance the framework for protecting digital personal data in India. The draft includes provisions for data localization, compliance requirements for significant data fiduciaries, timelines for storing data and ensuring that personal data is processed responsibly.
Source: bit.ly/3C63oFx

4. The Ministry of Commerce and Industry has launched the Open Network for Digital Commerce (ONDC) initiative to democratize digital commerce in India by fostering open networks for the exchange of goods and services. This initiative focuses on inclusivity, enabling small and medium enterprises (MSMEs) to access digital marketplaces while promoting innovation through open protocols. By creating a level playing field, ONDC seeks to reduce the dominance of large e-commerce platforms and enhance competition among sellers.
Source: bit.ly/4gHo1al

5. The Telangana Medical Council has issued a show-cause notice to a Hyderabad-based hospital for allegedly collaborating with unqualified practitioners and promoting fake doctors. This action follows the hospital’s involvement in sponsoring the medical program and advertising the same on social media, where unqualified individuals were reportedly encouraged. The hospital has been given a 10-day deadline to respond; failure to do so may result in punitive actions under the National Medical Commission (NMC) Act and other regulations.
Source: bit.ly/3BWAQhM

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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 pollution regulator has issued a Notification extending the deadline to 31st December 2024, for submitting quarterly filings for the FY 2023-24 for all entities registered under the Hazardous and Other Wastes (Management and Transboundary Movement) Amendment Rules, 2022.
Source: bit.ly/49ahqlK

2. A District Consumer forum in the State of Maharashtra has held that the refusal of returns by a e-commerce service provider, under a blanket “no-returns” policy constituted a “unfair trade practice” and awarded compensation to consumer whose return of sub-standard product had been rejected.
Source: bit.ly/417xJxQ

3. In a recently published response to a query received by it under the Right to Information Act, 2005, the Delhi Medical Council clarified that, since only medical practitioners registered with the council and having recognized qualifications in Allopathic medicine are permitted to practice medicine in Delhi: Dentists, who are registered with the Dental Council are not licensed to perform aesthetic and cosmetic treatment which is not medically necessary.
Source: bit.ly/3ZbT0Ur

4. After considerable negotiation, India has signed the final act of the Riyadh Design Law Treaty which aims to establish protections for Industrial Design patents, the treaty specifies procedural guardrails which member states can adopt into their own local design patent protection regulations.
Source: bit.ly/3CXRxcH
Source: bit.ly/4f5AYJz

5. The United States Supreme Court has declined to hear petition by manufacturers of tobacco products, challenging the decision of the Federal Government of the United States to include graphic visual warnings on cigarette packets.
Source: bit.ly/415u1EU

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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