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. 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.
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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.
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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
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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.
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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.
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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.
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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.
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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.
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TOP 5 HEALTH LAWS AND POLICY UPDATES

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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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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.
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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).
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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
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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

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.
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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.
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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.
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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.
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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.
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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.
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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

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)
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  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
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  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

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