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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 CDSCO has upgraded its online system to automatically generate the Market Standing Certificate (MSC), Non-Conviction Certificate (NCC) and Neutral Code for medical devices. Consequently, manufacturers and importers must reapply for these certificates, as all previously issued ones will become non-functional from April 9, 2025.
Source: bit.ly/4j7NJWL
Source: bit.ly/4j7NMBV 

2. India’s Supreme Court has introduced new guidelines for interpreting deeds and contracts. The guidelines emphasize using the literal rule, where words are given their plain meaning unless absurdity arises. If necessary, the golden rule may be applied and a shift to purposive interpretation based on the document’s context and objectives, ensuring clarity in legal agreements.
Source: bit.ly/3Rc0TWh

3. The Bombay High Court issued an ex-parte ad-interim order against unidentified individuals selling counterfeit and illegally imported oral care products, restraining them from manufacturing, packaging, or distributing lookalike goods infringing trademark and copyright. A Court Receiver was appointed to oversee the identification and inventory of the infringing goods.
Source: bit.ly/3G5i9u0

4. The Supreme Court of India will hear petitions challenging the ₹50 lakh cap on government aid for rare disease treatments, including Spinal Muscular Atrophy (SMA), following a High Court order. The SMA drug is cheaper in China and Pakistan due to negotiations with the manufacturer. The SC suggested the Centre explore similar negotiations and consider flexibility in approving aid beyond the ₹50 lakh cap on a case-by-case basis.
Source: bit.ly/4lqJ2ss

5. The Government of Kerala has reportedly introduced digital payment systems in government hospitals to streamline service fee transactions, allowing patients to pay using UPI, debit, or credit cards. In addition, they have also introduced an online outpatient (OP) ticket, M-health app, and scan and book system.
Source: bit.ly/4crteSd

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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 (FSSAI) has revised its inspection checklist for food businesses operators in General manufacturing, Milk & milk products, Meat processing, Fish products processing, and Catering, and has reclassified food-grade packaging materials from ‘Non-Critical’ to ‘Critical.’ It has also mandated that food-grade packaging materials used in these food businesses must have a Certificate of Conformity issued by an NABL-accredited laboratory.
Source: bit.ly/4jmTFei

2. The Central Drugs Standard Control Organization (CDSCO) has clarified that the brand name of the medical device must be included in the Free Sale Certificate (FSC) issued to the legal manufacturer when filing an import licence application form. If not specified in the FSC, “Not Applicable” should be mentioned.
Source: bit.ly/3YhBEWi

3. The Central Drugs Standard Control Organization (CDSCO) has clarified the packaging and labelling requirements of non-sterile medical devices intended to be sterilized before use. The finished product package must include Instructions For Use (IFU) which specify the method of sterilization to be used for the device prior to its end-use.
Source: bit.ly/3YhBEWi

4. The Central Drugs Standard Control Organization (CDSCO) has clarified that domestic manufacturers of medical devices need not obtain ISO 13485:2016 certificate to obtain a manufacturing license under the Medical Devices Rules, 2017.
Source: bit.ly/3YhBEWi

5. The state government of Kerala has started taking action against online purchase of unauthorised medicines, including anabolic steroids. Kerala state drug control department is inspecting gyms across the state to identify unauthorised medicines and their misuse.
Source: bit.ly/41XmHLv

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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. CDSCO has proposed a draft list to revise the existing classification list of cardiovascular and neurological devices, categorizing 351 cardiovascular and 202 neurological devices under a risk-based classification. Stakeholders can review and submit feedback within 30 days via a Google Form before finalization.
Source: bit.ly/3QYf29q

2. The central government has no plans to set up a special tribunal for medical negligence cases. Instead, such cases are handled by State Medical Councils, which can take disciplinary action against doctors. Appeals can be made to the National Medical Commission (NMC).
Source: bit.ly/42jt9LX

3. The 2025 National Trade Estimate Report states that unclear licensing guidelines and import procedures under India’s Medical Device Rules have delayed U.S. exports of refurbished medical devices. Since April 2024, CDSCO has suspended approvals for existing and new import licenses, effectively blocking refurbished medical device imports.
Source: bit.ly/4lfgp1s
Source: bit.ly/41W3pWY

4. The Central Consumer Protection Authority fined three lotion companies for falsely claiming in e-commerce ads that their products whiten skin instantly. The Bureau of Indian Standards found no scientific proof. The companies removed their ads and were warned of a ₹50 lakh fine for repeat violations.
Source: bit.ly/3G2pB94

5. India’s Delhi High Court upheld Consumer Protection Authority guidelines barring automatic service charges addition in restaurant bills. It was further held that collecting such service charge under other names constitutes an unfair trade practice. Additionally, GST cannot be charged on service charges.
Source: bit.ly/4j88ukG

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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 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

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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. Supreme Court Calls Unethical Clinical Trials a Critical and Serious Issue, Orders Detailed Report from Government. The Supreme Court of India recently heard a Public Interest Litigation (PIL) filed by a public health rights NGO, highlighting unethical clinical trials causing serious adverse effects and deaths of the participants. The Court directed the Central Government to submit a detailed report within four weeks addressing concerns such as transparency, accountability, provisions for criminal actions against sponsors/investigators and other points raised by the petitioners.
Source:  bit.ly/4bW7QEB

2. Group of therapists have approached the Bombay High Court, alleging police harassment under the Immoral Traffic (Prevention) Act, violating their trade and dignity rights. The Maharashtra government informed the Court about a 12-member committee drafting guidelines for regulating spa and massage centers. The guidelines will cover important aspects such as licensing procedures, operational standards, and the regulation of cross-gender massages.
Source: bit.ly/4c4hG7s

3. India’s Health Department of Karnataka has clarified that Essential Narcotic Drugs (END) in the state will now be regulated under the Central Narcotic Drugs and Psychotropic Substances (NDPS) Rules, replacing the previous state regulations. As a result, hospitals and medical institutions recognized as RMIs by the state drug regulator no longer need state-level permission to stock these drugs. However, other narcotic drugs in Karnataka will continue to be regulated according to state NDPS Rules.
Source: bit.ly/4l1XDdY

4. The list of drugs taking a shift from prescription-only to over-the-counter (OTC) is reportedly to be released soon. A sub-committee is drafting guidelines, which may categorize OTC drugs for sale in pharmacies or in general stores, similar to practices in Western countries.
Source: bit.ly/4hJjCDB

5. MedTech Europe has released a report outlining the administrative burdens caused by the non-harmonized authorization process for IVD performance studies & the increased post-market and clinical reporting requirements for medical devices under the new medtech regulations. The report also proposes several solutions, including streamlining approvals for multinational studies, digitalizing processes, and allowing manufacturers to consolidate key reports.
Source: bit.ly/42jN4dJ

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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 Department of Pharmaceuticals (DoP) has invited applications for R&D funding in six key areas- (1) New Chemical Entity, New Biological Entity and Phyto-pharmaceuticals (2) Complex generics and Biosimilars (3) Precision medicine (Targeted innovative therapeutics) (4) Medical devices (5) Orphan Drugs and (6) Drug development for AMR funding upto INR 100 Cr (1000   illion) is available.
Source: bit.ly/41AvbXF
Source: bit.ly/4bJLVQU

  1. The Indian government is reportedly considering lowering tariffs on imports of US medical devices to ease trade tensions. Such a policy decision would run counter to India’s Make in India policy and preference to procure medical devices manufactured in India for government hospitals.
    Source: bit.ly/41zI3x8
  1. The UK Government is reportedly proposing to raise the Statutory Scheme payment rate for newer branded medicines from 15.5% to 32.2%. The ‘payment rate’ is the revenue that pharma companies refund to government from sales of branded medicines to the National Health Service (NHS)
    Source: bit.ly/3DSk30j
  1. France has become the second European country, after Denmark, to ban per- and polyfluoroalkyl substances (PFAS) in certain products, including cosmetics, textiles, and ski wax addressing concerns over health and environment. The production, import, export, and sale of PFAS-containing goods will be prohibited in France from  January 2026
    Source: bit.ly/420sUVI
  1. The European Commission has proposed a bill to reduce the European Union’s dependence on India and other countries for antibiotics and other essential medicines by requiring Member States to procure medicines on parameters other than price, in order to incentivize domestic manufacturing. The bill, called Critical Medicines Act, is under consideration.
    Source: bit.ly/4ii2whc
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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 inspectors from Bureau of Indian Standards found illegal stock of consumer products at warehouses of e-commerce companies. The consumer products required BIS license to be placed on market for sale but did not carry them. E-commerce entities are required to exercise due diligence prior to stocking and listing items for sale, or face liability
Source: bit.ly/428WxW2

2. India’s Bombay High Court has ruled that an arbitration clause in invoices can be binding if the parties act on the invoices and do not raise objections. The court held that by accepting and paying the invoices, the parties implicitly agreed to the arbitration clause, making it enforceable.
Source: bit.ly/4ibuivJ

3. The Parliamentary Standing Committee on Health and Family Welfare has recommended creating a single independent drug controller for AYUSH medicines, uniform licensing processes across states and strengthening of pharmacovigilance. It also urged stricter action against misleading advertisements and improving drug safety and quality.
Source: bit.ly/3DxmFRi

4. India’s Parliamentary Standing Committee on Health has highlighted delays and lack of transparency in medical device licensing by CDSCO, pushing medical device companies to shift manufacturing abroad.
The Committee has recommended a streamlined, digitized system, faster approvals for internationally certified products, and the establishment of an advisory board to address regulatory challenges in the industry.
Source:  bit.ly/41pF6PC

5. The Insurance Regulator is reportedly gearing up for passage of The Insurance Amendment Bill 2024. Key features of the bill aim to enhance operational flexibility and attract more investment into the insurance industry by allowing 100% foreign direct investment (FDI) and by allowing insurance companies to merge with non-insurance entities for strategic partnerships and increased synergies.
Source: bit.ly/4iaOLRk

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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

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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 District Consumer Court in Jaipur has issued legal notices to certain Indian film actors for making misleading claims in a pan masala advertisement and misrepresenting the product. The petition seeks action against the actors for misleading consumers with false claims.
Source: bit.ly/3XH8gbQ

2. India’s top music labels have filed a suit against an AI company on grounds that AI Company has used copyrighted music and sound recordings to train its AI models without authorization. The outcome of the suit will bring clarity on the legality of use of copyrighted material by AI companies to train AI.
Source: bit.ly/4ilUqnz

3. Indian rubber glove manufacturers have raised concerns over the import and stockpiling of low-quality, non-medical gloves by importers in anticipation of potential notification of Medical and Surgical Gloves (Quality Control) Order (QCO). After QCO, only BIS certified gloves for medical use will be permitted to be sold in India.
Source: bit.ly/3Dna2YV

4. The former CEO of a leading U.S. diagnostic company has reportedly pleaded guilty to charges over defective lead-testing devices that posed a public health risk. The company had failed to inform US Food and Drug Administration about inability of its product to meet the claims made on the label and was prosecuted for marketing misbranded products.
Source: bit.ly/41Dod3X

5. India’s National Pharmaceutical Pricing Authority (NPPA) will reportedly consider additional data sources, including IPDMS, web sources, and market surveys, to set ceiling prices for scheduled formulations. This decision comes in wake of concerns about the limited coverage of Pharmatrac, particularly regarding hospital supply products.
Source: bit.ly/41Doh3H

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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.