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 Drugs Standard Control Organization clarified that labelling, overprinting, or stickering is strictly permitted for imported drugs. These activities require a valid manufacturing license, appropriate facilities, and adherence to labelling norms. Original labels must remain visible to maintain regulatory transparency and ensure clear identification of modifications and responsibilities.
Source: bit.ly/4kjfBYw

2. The Himachal Pradesh High Court held that vicarious liability for supplying substandard drugs requires proof that an individual was responsible for the company’s operations. Without such evidence, partners cannot be held liable, and only the company itself can be prosecuted for manufacturing or selling defective drugs.
Source: bit.ly/3Hfap9o

3. India’s Ministry of Health has released draft Drugs Rules proposing mandatory testing for bacterial endotoxins or pyrogens in injectable drugs. The rules require drug sales to be supervised by a competent person, with timely reporting of any changes. Exemptions apply to non-antimicrobial drugs used in food and beverage manufacturing. Feedback from stakeholders invited by June 30, 2025.
Source: bit.ly/4jomruw

4. West Bengal’s Drugs Control Administration mandates wholesalers and retailers to verify QR codes on top-selling brands and ensure purchases through authorized channels, aiming to curb counterfeit drug circulation.
Source: bit.ly/4krbkCj

5. The Bureau of Indian Standards (BIS) seized products worth ₹90 lakh from a Bengaluru warehouse for allegedly using the ISI mark without authorization, raising concerns for compliance in product sourcing and labelling across industries.
Source: bit.ly/4jppfr4

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 released new guidelines permitting the use of recycled polyethylene terephthalate in food packaging. Only recycling technologies that effectively remove contaminants are approved. Manufacturers must conduct safety tests, follow labelling norms, maintain traceability, and undergo audits to ensure food-grade quality and compliance.
Source: bit.ly/43NdGFB

2. The Government of India has reportedly removed port restrictions and Central Leather Research Institute testing for leather exports, helping MSMEs cut costs and delays. Exporters can now ship from any port, boosting efficiency and competitiveness, especially in key markets like the US.
Source: bit.ly/43LV20N

3. Neurologists have reportedly urged for the inclusion of multiple sclerosis (MS) in the National Health Mission, Rare Disease Policy, and Ayushman Bharat. They seek better access to treatment, insurance coverage, updated disability laws, and mental health support for patients.
Source: bit.ly/3Z273N2

4. The Consumer Affairs Ministry to meet key E-commerce companies to combat dark patterns that mislead consumers on May 28, 2025 in Delhi. Major platforms, law universities, and consumer groups to participate, the meeting will also focus on compliance measures and feature discussions on consumer rights protection and industry best practices.
Source: bit.ly/4kI24cR

5. India is urging the U.S. to ease import rules and speed up Phytosanitary approvals for its fruits and vegetables, aiming for broader market access. This move seeks to boost Indian agricultural exports and balance bilateral trade relations.
Source: bit.ly/43CSNM9

Frequently asked questions (FAQs) regarding filing of self-declaration and disclosure of marketing expenditure by medical device companies in India under UCMPMD

Introduction

The Uniform Code for Medical Devices Marketing Practices, 2024 (UCMPMD) requires all medical device companies in India to submit a self-declaration-cum-undertaking from its CEO (“Self-Declaration”) and a disclosure of marketing expenditures in a prescribed format (“Marketing Expenditure Disclosure”).

As part of Marketing Expenditure Disclosure, the medical device company has to disclose the expenditure incurred by it on free evaluation samples, Continuing Medical Education (CME) event/Continuing Professional Development (CPD)/Seminars and such other events conducted by the medical device company or organized through third parties such as professional associations of HCPs. When a medical device company conducts a CME/CPD event, information relating to the associated expenditure must be disclosed on the company’s website. However, if such an event is organized by a third party, details of the expenditure, along with a statement of funding sources, must be published on the organiser’s website.
The self-declaration and expenditure disclosure for any financial year have to be submitted anytime before the expiry of two months from the end of every financial year. Accordingly, the deadline for filing the declaration is May 31, 2025 for the financial year 2024-25.
In this article, we have sought to respond to some of the frequently asked questions about these compliances.

1. Where is the self-declaration and disclosure of marketing expenditure form required to be submitted?

The Self Declaration is required to be submitted with the industry association of which the medical device company is a member. The Self-Declaration, once submitted to the association, will get published on the website of such industry association.

If a medical device company is not part of any association, or is part of more than one association, it can submit the self-declaration at dop.ucpmp@gov.in.

In addition, the Self-Declaration and Marketing Expenditure Disclosure are required to be submitted on the UCPMP Portal of the Department of Pharmaceuticals (DoP). The said portal was not functioning at the time of publication of this article.

2. Is it legally mandatory to submit a self-declaration and disclosure of marketing expenditure?

While UCMPMD is not a law, we understand that various medical device associations have taken interest in enforcing compliance of the UCMPMD among its members. If a medical device company is not a member of an association, then there may not be any real consequence for it if it fails to submit a Self-Declaration and Marketing Expenditure Disclosure.

3. Is the requirement of submission of self-declaration and disclosure of marketing expenditure applicable to only importers or manufacturers of medical devices or to marketers and distributors of medical devices as well?

The UCMPMD applies to any medical device company which is engaged in activities covered by the UCMPMD, including promotion and marketing of medical devices, and therefore applies to not just importers and manufacturers , but also to marketers and distributors of medical devices.

4. Do small and medium-size medical device companies have to submit self-declaration and disclosure of marketing expenditure?

Small and medium-sized medical device companies are not exempt from applicability of UCMPMD. Therefore, they should also submit the Self-Declaration and Marketing Expenditure Disclosure.

5. What happens if a medical device company does not submit self-declaration and disclosure of marketing expenditure?

If a medical device company fails to submit the required Self-Declaration and Marketing Expenditure Disclosure, it may face disciplinary action from its industry association. Such actions can include suspension, expulsion, public reprimand, or the requirement to issue corrective statements. Please note that there are no direct and upfront legal consequences for non-submission.

6. If a medical device company CEO submits a self-declaration of compliance with UCMPMD but it is later found that the company has not complied with UCMPMD, will there be any personal consequence for the CEO of the Company for giving a false declaration?

No. There should not be any personal consequences for the CEO of the medical device company, in case it is later discovered that the medical device company has breached the UCMPMD. While the UCMPMD states that “the Chief Executive Officer is itself responsible for the adherence to this Code”, the UCMPMD itself does not stipulate any penalty or consequence for CEO in case of non-adherence , and Indian Courts have repeatedly held that the CEO is not liable for acts or omissions of the Company unless there is a causal connection between CEO and said acts and omissions (for example, where they have knowledge of breach or consent to specific acts or omissions by the company).

7. Is it mandatory to co-operate with regulatory authorities in any enforcement or regulatory action after giving an undertaking to that effect?

The Self-Declaration contains an undertaking that the medical device company will extend all required assistance to authorities for the enforcement of the UCMPMD. However, if for any reason, the medical device company does not wish to co-operate with the authorities, then there should not be any legal consequences for the medical device company for doing so. The consequences, if any, may arise at the level of industry association (refer response to FAQ 5) or from an optics perspective where non-co-operation despite promise may be perceived as evidence of wrongdoing or guilt.

8. What if a medical device company submits incorrect or incomplete information in the disclosure of marketing expenditure?

The Marketing Expenditure Disclosure form contains a reference to Section 405 of Companies Act, 2013 which provides for punishment in case the information provided is incorrect or incomplete in any material respect. However, from legal perspective, it appears highly improbable that Section 405 can be used by authorities against a medical device company for submitting incorrect or incomplete information, because Section 405 has certain pre-conditions for enforcement which are not met by UCMPMD. Moreover, Section 405 can only be used against companies, and not proprietorships or partnership firms.

Please note, however, that any information (including incorrect or incomplete information) may be flagged to regulators including tax authorities which may result in tax related consequences.

9. Are the costs of sponsorship of speakers who are HCPs required to be disclosed?

It depends. The Marketing Expenditure Disclosure requires disclosure of cost of sponsorship of CME events organized by company or sponsored by company (and organized by third party).

If a medical device company has budgeted expenditure towards cost of travel and hospitality of HCPs in events either organized or sponsored by it, then it ought to be disclosed. However, it ought not to be disclosed as a separate line item (only aggregate total expenditure ought to be disclosed).

If, however, a medical device company has sponsored costs of travel of HCP who is a speaker, at an event that is neither organized or sponsored by it, then such an expenditure is permitted and may not have to be disclosed.

10. Are the costs of travel and hospitality of HCPs who are consultant required to be disclosed?

No. The disclosure requirement does not extend to travel and hospitality costs for HCPs who serve as consultants or advisors under a valid contract, since such engagement with the HCP are permitted and also falls outside the scope of CME,CPD events.

11. Are the costs of travel and hospitality of HCPs who are customers required to be disclosed?

The costs of sponsoring travel and hospitality of existing or potential customers of medical equipment, who happen to be HCPs, is a grey area under UCMPMD. However, the disclosure requirement specifically extends to payments or support for CME, CPD, training, seminars, conferences, and workshops. Applying the principle of ejusdem generis, only those payments or benefits that are similar in nature to CME, CPD, training, seminars, conferences, or workshops fall under the disclosure requirement. Therefore, costs of travel and hospitality of HCPs who are customers may not be required to be disclosed.

12. If the foreign affiliate of the medical device company has sponsored the cost of travel and hospitality of the HCP, are such costs required to be disclosed?

The UCMPMD does not apply to foreign affiliates of medical device companies. So, if a foreign affiliate of a medical device company sponsors travel and hospitality of an Indian HCP, whether for India or International travel, it should not be governed by UCMPMD. Please note that there is a principle of law which states that what cannot be done directly cannot also be done indirectly. Therefore, the medical device company in India shouldn’t use (and shouldn’t appear to be using) foreign affiliate to pay for travel and hospitality of Indian HCPs.

13. Are commercial packs which are provided free of charge (FOC) to customers for demonstration or commercial evaluation supposed to be disclosed?

The UCMPMD would ideally cover FOC products that are given for demonstration or sample purposes, since such activities may fall within the scope of promotion or marketing. Therefore, such commercial packs may have to disclosed as well.

On a separate note, it is worth nothing that UCMPMD requires companies to maintain detailed records of all free evaluation samples distributed, including the quantities and recipients.

14. Is the expenditure incurred on putting stalls at events or advertisement at events required to be disclosed by medical device companies?

Yes, the definition of “expenditure” is non-exhaustive and includes various forms of actions such as advertising, installation of stalls, and providing souvenirs. Hence, a medical devices company undertaking such expenditures can be said to be organising a CME Event through a third party, triggering disclosure requirements.

[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.]

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

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. Health Ministry’s proposal to amend the Drugs and Magic Remedies Act, aimed at curbing misleading medical advertisements, has been stalled since year 2022. The outdated Act allows deceptive ads, especially in AYUSH and modern medicine sectors, to persist unchecked has been revealed by an RTI.
Source: bit.ly/4kvddgY

2. Karnataka Government has suspended all Jan Aushadhi Kendras inside government hospitals, ensuring patients receive all medicines free of cost from hospital pharmacies. Kendras outside hospitals will remain open.
Source: bit.ly/4dtDZE2

3. GS1, the non-profit standards organisation is set to replace traditional barcodes with advanced 2D bar code technology by 2027 to improve product traceability, safety, and transparency, allowing consumers and businesses to access key details like origin, expiry, and recall information with one scan.
Source: bit.ly/45ahMsP

4. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is enhancing its Manufacturer’s Online Reporting Environment (MORE) to improve medical device safety. Effective June 16, 2025, manufacturers must submit Manufacturer Incident Reports (MIRs) and Field Safety Corrective Actions (FSCAs) through the updated MORE platform. The changes aim to strengthen post-market surveillance and facilitate better risk management
Source: bit.ly/3SRvQje

5. US Government is pressing India for tariff reductions on medical equipment as part of ongoing bilateral trade negotiations. After the US imposed a steep 26% tariff on Indian medical device exports in April 2025 up from previous rates of near-zero to 6%. India is seeking full exemption from these duties, which have been temporarily suspended for 90 days until July 9.
Source: bit.ly/4kv9WOu

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 extended the deadline for filing E-Waste EPR returns till June 30, 2025, and mandates audits for all registered entities to strengthen rule compliance and traceability.
Source: bit.ly/4k8KbE8

2. Food Safety and Standards Authority of India has proposed reforms to ease food license renewals, including fixed renewal dates (Jan 15, Apr 15, Jul 15, Oct 15), 10-year validity for Trade/Retail businesses, and a 3-year minimum for registrations. These aim to standardize compliance, reduce admin burdens, enable bulk renewals. Stakeholders have been invited to submit feedback by 30th June, 2025.
Source: bit.ly/3SBuv09

3. The Drugs Controller General of India (DCGI) has revoked import registrations of several cosmetic products containing salicylic acid concentrations exceeding the prescribed limit, in violation of the Cosmetics Rules, 2020.
Source: bit.ly/4kyzz1e

4. India’s Kerala High Court rules that prescribing medicines and tests over the phone doesn’t constitute gross negligence, reinforcing protections for doctors against unwarranted criminal liability.
Source: bit.ly/4dybNQy

5. India’s Central Drugs Standard Control Organisation (CDSCO) has identified numerous MSME pharmaceutical firms in India producing substandard drugs, with April data revealing about 60 samples failing quality standards. Affected products include eye drops, anaesthetics, and supplements.
Source: bit.ly/4jirNHr

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 Punjab & Haryana High Court mandates state government to notify rules under Mental Healthcare Act, 2017 within 60 days, addressing a 7-year delay that hampers effective implementation and delivery of mental health services.
Source: bit.ly/4k3CEpU

2. India’s Central Drugs Standard Control Organisation (CDSCO) has issued a guidance document outlining the procedure for obtaining a Free Sale Certificate (FSC) for licensed medical devices in India. It simplifies the regulatory process for submitting an application and obtaining the FSC from the Central Licensing Authority.
Source: bit.ly/3FbKQW9

3. Food Safety and Standards Authority of India (FSSAI) mandates that FBOs with expired licenses or registrations in FY 2024–2025 must submit a Closure Report via the FoSCoS portal. The report must confirm no ongoing business or provide details of a new license. Reasons for non-renewal must be stated to ensure transparency and traceability in licensing.
Source: bit.ly/3Se67kQ

4. India’s Department for Promotion of Industry and Internal Trade (DPIIT) has extended the implementation of the Quality Control Order (QCO) for household and commercial electrical appliances to March 19, 2026. The update includes relaxations for Micro, Small and Medium Enterprises, R&D and export units, supporting quality and ease of business.
Source: bit.ly/4ksMTEb

5. The Drugs Control Department of Kerala has taken an action against a private hospital for illegally stocking and selling Physician’s sample medicines at inflated prices, highlighting that sample medicines can neither be stocked nor sold by hospitals.
Source: bit.ly/3FieSaJ

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. Kerala Deputy Drugs Controller (Ayurveda) has issued a stern warning to a prominent Ayurvedic drug manufacturer, for violating Rule 170 of the Drugs and Cosmetics Rules, 1945. This rule mandates that manufacturers obtain prior approval from state licensing authorities before advertising their products, aiming to prevent misleading promotions of AYUSH drugs.
Source: bit.ly/3H0LSoi

2. The All India Organization of Chemists & Druggists has cautioned against the Centre’s plan to expand the over-the-counter (OTC) drug list, warning that unsupervised use of routine medicines could pose serious health risks and lead to misuse without expert medical guidance.
Source: bit.ly/3H2vB2n

3. Small scale pharma companies have opposed CDSCO’s new export NOC rules, calling them burdensome for them. They warn of losing export markets to competing countries and seek an extension for Schedule M compliance and a tribunal to resolve regulatory disputes efficiently.
Source: bit.ly/3GZoac9

4. Experts have reportedly identified certain fixed-dose combinations (FDCs) in personal care products such as aloe vera, jojoba oil, and orange oil, as irrational and potentially harmful, recommending their prohibition to safeguard public health.
Source: bit.ly/3SGKh9N

5. The U.S. Food and Drug Administration (FDA) is reportedly initiating action to remove from the market unapproved concentrated fluoride drugs for infants and toddlers, citing concerns over microbiome disruption, thyroid issues, weight gain, and possible IQ decline.
Source: bit.ly/4doJeVr

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 Supreme Court has ruled that individuals convicted of food adulteration offences under the now-repealed Prevention of Food Adulteration Act cannot be granted probation. The Court clarified that the law in force at the time mandated strict punishment for such offences, and the bar on probation remains valid under the current Food Safety and Standards Act, 2006.
Source: bit.ly/3SD2x3R

2. India’s Chhattisgarh High Court has invalidated tender clauses by the Chhattisgarh Medical Services Corporation Limited that permanently barred previously blacklisted companies from bidding, even after their blacklisting period had ended. The Court emphasized that such conditions are arbitrary and violate principles of fairness in public procurement.
Source: bit.ly/45aP0Ik

3. India’s Jharkhand High Court ruled that selling goods at concessional rates alone does not amount to a sham transaction. The Court quashed notices issued for alleged discrepancies, stating that comparing sale prices to market rates is not sufficient grounds to question the authenticity of the transactions.
Source: bit.ly/4kfrgqE

4. The Indian government has invited fresh applications under the Performance-Linked Incentive (PLI) scheme to boost domestic production of bulk drugs. The focus is on 11 key product categories, including Active Pharmaceutical Ingredients (APIs), Key Starting Materials (KSMs), and intermediates. The initiative aims to reduce reliance on imports, particularly from China.
Source: bit.ly/42Zm6ti

5. A leading beverage company will revise its recycling labels following a greenwashing complaint by the European Consumer Organisation (BEUC). The updated labels will clarify that only the bottle body contains 100% recycled plastic, exclude caps and labels, and remove green imagery and the phrase “Recycle Me Again” to avoid misleading consumer.
Source: bit.ly/4khtF4V

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 Drugs Standard Control Organization (CDSCO) is in the process of initiating license withdrawal procedures for unapproved fixed-dose combinations (FDCs) of antibiotics. This action follows the failure of state drug licensing authorities to submit critical data. The move is aimed at curbing irrational antibiotic use and combating antimicrobial resistance.
Source: bit.ly/4j6zhxs

2. India’s government plans to mandate QR codes on vaccines, antimicrobials, narcotics, and cancer drugs to enhance traceability and combat counterfeiting. The move also includes adding excipient details on labels for certain medicines, aiming to improve drug authenticity, safety, and public health protection across the supply chain.
Source: bit.ly/4jflqFa

3. An Indian industry group has urged the government to scrap the mandatory testing of cough syrups at government-approved laboratories before export. The group argues that this costly process delays shipments and places a heavy burden on small manufacturers. The requirement was introduced following reports linking India-made syrups to fatalities in Gambia.
Source: bit.ly/437zHNO

4. The United States Food and Drug Administration (US FDA) has issued a warning to an Indian drug manufacturer for significant violations of Current Good Manufacturing Practices (CGMP) at its production facility. The violations include unsanitary conditions, inadequate equipment cleaning, poor documentation, and unverified raw material, raising serious global concerns about product quality, safety, and regulatory compliance.
Source: bit.ly/4mjGJIg

5. The EU’s Scientific Committee on Consumer Safety (SCCS) has concluded that butylparaben at 0.14% is unsafe for children aged 0.5–10 years when used in multiple cosmetic products. However, it is considered safe in single-use dermal and oral products, excluding body lotions.
Source: bit.ly/3H8EmYu