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India’s new promotion code for medical devices – Key highlights and enforceability – Uniform Code for Marketing Practices in Medical Devices (UCMPMD)

India’s Department of Pharmaceuticals (DoP), which is the administrative department responsible for the formulation and implementation of policies relating to drugs and medical devices, has published a new set of guidelines called the ‘Uniform Code for Marketing Practices in Medical Devices’ or UCMPMD. These guidelines seek to lay down the ethical framework of interaction of medical device industry with healthcare practitioners (“HCPs”) and standards for promotion and marketing of medical devices in India.  

The UCMPMD borrows heavily from other industry codes in India, namely the Uniform Code of Pharmaceutical Marketing Practices (UCPMP), and international codes such as the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry. The key similarity being that it is very much a self-regulating governing code, which means that the administration of the code will be done by medical device industry association(s) in India. It is not a codified law or a legal code in a strict sense. However, any decision (or lack of decision) of an industry association in the adjudication of a complaint of breach of UCMPMD is appealable to a body comprising of representatives of DoP, which makes the UCMPMD a quasi-legal code that appears like a law but isn’t a law. The DoP, however, maintains that the medical device industry should strictly comply with UCMPMD.  

In the paragraphs below, we have summarized key provisions of UCMDMP and the consequences of a breach of UCMPMD. 

Key Highlights of UCMPMD 

Self-declaration of compliance with UCMPMD and disclosure of expenditure on marketing activities to DoP: Starting 2025, before the end of June every year, the executive head of the every medical device company will have to submit a self-declaration in the prescribed format, which will effectively state that the business was conducted in compliance with UCMPMD in the previous financial year (April – March) and that the business will continue to operate in compliance with UCMPMD in the coming financial year as well. The self-declaration also contains an undertaking that the company will ‘extend all required assistance’ to authorities for the enforcement of the code. Along with the self-declaration, the company will also have to provide a statement of disclosure of expenditure incurred in the previous financial year towards sponsorship of third-party and internal HCP educational and training programs, and in the distribution of free evaluation samples to HCPs. 

Extending travel and hospitality to HCPs: The code does not permit the medical device industry to sponsor travel and hospitality of HCPs except in limited circumstances, which are (i) when the HCP is a speaker in medical education or professional development program; or (ii) when HCP is a speaker or participant in advanced clinical training program conducted outside India, which is specifically approved by the DoP. It is possible to take an interpretation that a medical device company should be able to offer travel and hospitality to HCPs for participating in its own product training program organised in India. However until further clarity comes from the DoP, there will be a question mark over extension of travel and hospitality to HCPs for participating in training programs in India.  

Provision of modest meals during events: The UCMPMD prohibits hospitality which is of the nature of hotel stay, expensive cuisine, and resort accommodation. In other words, UCMPMD prohibits extravagant or excessive hospitality. Therefore, the provision of modest meals and other customary extension of courtesy at the event in the form of modest alcohol, should not be prohibited by UCMPMD. 

Sponsoring third-party educational programs: The code permits the medical device industry to sponsor third-party educational programs, as long as the educational programs are conducted by specified entities. The specified entities are medical colleges, teaching institutions, universities, hospitals, professional associations of HCPs, academic and research institutions such as NIPER, ICMR, DBT, CSIR laboratories, trusts and associations of the medical device industry. 

Conducting internal training and education programs (Product or hands-on training): The medical device industry is permitted to conduct training and education programs of its own, and invite HCPs to these programs. However, before conducting training and education programs, the industry has to ensure that it has put in place a guideline on expenditure incurred for such programs. At the time of conducting the program, it has to comply with the guidelines. 

Selection of speakers and attendees for educational and training programs: The code requires the medical device industry to have a well-defined policy and process for (i) selection of speakers and participants for its training and education programs specifically and (ii) incurring expenditure on training and education programs. 

Disclosure of funding towards training and education programs: The medical device industry is expected to share details of all education and training events on its website, including expenditures incurred on the events conducted by them. The expression ‘expenditure’ includes all expenses incurred for the event including sponsorship, travel, lodging, hospitality, advertisement, stalls, souvenirs etc. There is no format for disclosure that has been provided by DoP for disclosure on the website. 

Engaging HCPs as consultants and advisors: The UCMPMD allows the medical device industry to engage HCPs as consultants and advisors, provided the following conditions are met: (a) it should be for bona fide research services (b) it should be documented by a consultancy agreement and (c) there should be a consultancy fee or honorarium payment under the arrangement. The scope of expression ‘research’ is not defined, and should cover any technical and professional service which is within the scope of education and experience of the HCP. 

Extending travel and hospitality to HCPs who are consultants: The UCMPMD is silent on whether travel and hospitality may be offered to HCPs who are consultants or advisors in general. However, if an HCP is a consultant and is speaking at an educational event sponsored by the industry, then travel and hospitality may be offered to such consultants. 

Providing monetary grants or cash to HCPs: The code prohibits the medical device industry from providing monetary grants or cash to HCPs. However, it is silent on whether monetary grants may be paid to hospitals and other institutions and entities. 

Giving of gifts: It is not permissible to give gifts or pecuniary benefits or advantages of any kind to HCPs, either directly by the medical device industry or indirectly by distributors, wholesalers, or retailers. 

Promotion of medical devices: The code requires the medical device industry to promote medical devices only after receiving marketing approval, and the promotion of medical devices should be consistent with the documents submitted for obtaining marketing approval, specifically the instruction for use (IFU) or the directions for use (DFU). The promotional material given to HCPs ought to contain a declaration that “additional information is available on request”, and whenever requested such information should be made available to HCPs within a reasonable timeframe by ‘authorized sources’ of the company. The names of the HCPs should not be used for promotional purposes. In case a company pays for, or arranges, the publication of any promotional material in any journal, then it should not appear as an editorial and it ought to meet the minimum requirements for promotional material within UCMPMD. 

Claims of safety of medical device: The UCMPMD states that the words ‘safe’ or ‘safety’ should not be used without qualification and that the medical device industry should not categorically state that a medical device has no adverse consequences. 

Use of brand names: The UCMPMD states that brand names of medical devices should not be used for comparison unless prior consent of the owner of the brand name has been obtained.  

Brand Reminders: UCMPMD allows the medical device industry to provide brand reminders to the HCPs, which ought to be limited in terms of its use in healthcare settings only and should not have independent commercial value for the HCP. Some of the permitted brand reminders are: books, calendars, diaries, journals (including e-journals), dummy device models etc. The value of a brand reminder must not exceed ₹1,000 per item. There is no annual limit on the number of such reminders that can be given to HCPs. 

Use of names and photographs of HCPs: The UCMPMD restricts the medical device industry from using names and photographs of HCPs in promotional material.  

Changes in employment agreement of sales representatives: The UCMPMD states that the employment agreement between the medical device industry and sales representatives who interact with HCPs personally (also referred to as medical representatives) should contain a clause that requires them to know that the HCPs are required to ensure compliance with UCMPMD. 

Engagement of marketing agencies: Any external agency hired to support the medical device industry for promotion, marketing and sales of medical devices ought to have sound working knowledge and must comply with all provisions of the UCMPMD.  

Provision of Free Samples or Evaluation Products: The medical device industry may provide free evaluation samples of medical devices to qualified HCPs. The free samples distributed by companies cannot exceed 2% of their annual domestic sales. These samples must be provided in reasonable quantities, and the industry is required to maintain detailed records of all samples distributed, including date, quantity, value, etc. for at least five years. Additionally, all evaluation samples must be clearly labelled as ‘Evaluation Sample – Not for Sale’ or with a declaration conveying the same meaning. 

Provision of Demo Products: The medical device industry may provide demo products to HCPs. The industry is required to maintain detailed records of the quantity and value of the device, date of supply to HCP, date of receipt from HCP etc. for at least five years. Demo products are not intended for use on the patients. They may be used by HCPs for patient awareness and education. 

Is UCMPMD enforceable as a law? 

India’s Supreme Court has affirmed that for any circular, order, notification or similar direction issued by any governmental department to be considered enforceable, it has to be issued under the scheme of existing legislation. 

The UCMPMD is neither a legislation nor has it been issued under the scheme of any existing legislation. Therefore, it should not be considered enforceable as a law in India. In other words, no government department or authority including the DoP should be able to take any direct action for an alleged breach of the UCMPMD, if an importer, manufacturer or marketer of medical devices is unable to comply with UCMPMD. 

Is giving the Self-Declaration mandatory? What are the consequences of not giving the self-declaration? 

Since UCMPMD is not a law, there should not be any adverse legal consequence for not giving the self-declaration. 

However, if an entity is part of a medical device industry association, then the association may suspend or expel the entity from the association for failing to submit the undertaking. 

The association and DoP may also take other steps, such as reprimanding the entity and requiring a full apology to be published. 

If the self-declaration is submitted, but the entity fails to comply with UCMPMD, then what happens? 

In general, whether the entity gives the self-declaration (undertaking) or not, the consequences of non-compliance with UCMPMD will not change. These consequences are: 

  1. Suspension or expulsion of the entity from the concerned pharmaceutical or medical device association of which the entity is a member; 
  2. Reprimand of the entity; 
  3. Requiring the entity to publish a full apology; 
  4. Requiring the entity to issue a corrective statement; 
  5. Requiring the entity to recover any sums or articles given or received in contravention of the UCMPMD; 
  6. Recommending the matter of breach to the concerned governmental body having appropriate jurisdiction. 

Can action be taken under S. 405 of the Companies Act, 2013 against a medical device company for failure to disclose marketing expenditures? 

Section 405 of the Companies Act, 2013 applies to such orders that are notified in Official Gazette.  The UCMPMD is not an order notified in the Official Gazette. Further, any action taken under the Companies Act can be for companies regarding matters which are strictly covered under the provisions of the Companies Act and therefore, there should not be any legal consequence of failing to disclose marketing expenditure as required by DoP under UCMPMD. 

Conclusion 

The UCMPMD has brought much-needed clarity on several issues that had become a pain point for the industry when the DoP had extended the application of the pharmaceutical marketing code (UCPMP) to the medical device industry. While the UCMPMD is far from perfect, the medical device industry will prefer it than being subject to the promotion and marketing standards of the pharmaceutical industry, which sometimes results in absurdity.  

The UCMPMD is expected to undergo changes with time, however until then, it remains the official guidance on standards of interaction between HCPs and the medical device industry in India. Unfortunately, the question mark over its legality and legal enforceability may discourage the medical device industry from adopting it in full, especially on contentious issues such as paying for travel and accommodation of HCPs who accept the invite to attend internal product training and therapy awareness programs. 

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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 Department of Pharmaceuticals (DoP) released the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) providing guidelines to medical device companies for regulating monetary and non-monetary incentives given to Healthcare Professional (HCPs) for eliminating unethical conduct while organising promotional and training programs for such HCPs. The UCMPMD also sets guidelines for establishment of an ethics committee and entering of complaints on the UCMPMD portal set by the DoP.
Source: bit.ly/3AWUnOm

2. The pharmaceutical company that launched eye drops claiming that they can eliminate near-sightedness in 15 minutes has clarified that its claims were based on approved indications for treatment and Phase 3 clinical trial data and are not unethical or false.
Source: bit.ly/3z0wSn3

3. The Bombay High Court has granted an interim injunction to a Fast-Moving Consumer Goods (FMCG) company manufacturing health drinks against another FMCG company manufacturing fibre-nutritional drinks for circulating advertisements on WhatsApp groups that allegedly denigrated and disparaged the latter’s products.
Source: bit.ly/3APlUkz

4. The National Medical Commission (NMC) has withdrawn its previously issued public notice for the discontinuation of all courses offered by the College of Physicians & Surgeons (CPS), Mumbai as it was earlier regarded as being beyond the powers of the college to provide conduct examinations and award degrees. However, the earlier notification now stands withdrawn.
Source: bit.ly/3Zisquh

5. The US Court has held that expert testimony is a requirement in all medical negligence cases, and it is not enough for the claimant to establish that the doctor had not communicated the box-label warning to the patient or patient’s family, especially in cases where the patient’s claim was based on the absence of informed consent.
Source: bit.ly/3Zo6HkC

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Self-Declaration under the UCPMP 2024: Should One Submit

In March 2024, Department of Pharmaceuticals (“DoP”) published a guidance titled ‘The Uniform Code for Pharmaceutical Marketing Practices, 2024’ (“UCPMP”) which lays down the standards for interaction between pharmaceutical and medical device industry and  healthcare practitioners. The UCPMP 2024 replaced a similar 2015 guidance.

More recently, the DoP has issued a Standing Order which implores importers, manufacturers and marketers of drugs and medical devices to submit a self-declaration signed by the seniormost executive of the organization promising compliance with UCPMP. If the entity is a member of an industry association, then the self-declaration has to be submitted to the industry association, and if not, then to the DoP at the email address: dop.ucpmp@gov.in.

In this article, we have examined whether there is any legal requirement for importers, manufacturers and marketers of pharmaceuticals and medical devices to provide self-declaration under UCPMP. We have also examined the consequence of providing the self-declaration and ramification of not providing such self-declaration.

Background to UCPMP Self-Declaration

The UCPMP itself has language which gives the DoP the ability to issue Standing Orders to introduce new guidelines which should be read as if they are part of UCPMP.

Through the Standing Order On 28th May 2024The DoP introduced a new self-declaration requirement in addition to the self-declaration requirement already existing under UCPMP 2024. The UCPMP had a self-declaration expectation under which the seniormost executive of the organization had to declare that the organization had complied with the UCPMP in the financial year (April – March) that had elapsed. The new self-declaration requirement, which was introduced by the Standing Order, now expects the senior executive to undertake that the organization will comply with UCPMP in the ongoing/ upcoming financial year.

Is UCPMP enforceable as a law?

India’s Supreme Court has affirmed that for any circular, order, notification or similar direction issued by any governmental department to be considered enforceable, it has to be issued under the scheme of an existing  legislation.

The UCPMP is neither a legislation nor has it  been issued under the scheme of any existing legislation. Therefore, it should not be considered enforceable as a law in India. In other words, no government department or authority including the DoP should be able to take any action if an importer, manufacturer or marketer of pharmaceuticals or medical devices is unable to comply with UCPMP.

Is a Standing Order issued under UCPMP enforceable as law?

India’s Supreme Court has held that standing orders issued in exercise of administrative powers of any department are only enforceable if such Standing Order(s) are based on powers granted under a parent statute. As indicated in paragraphs above, the UCPMP is not a law. Therefore, a Standing Order issued in pursuance of UCPMP should not be treated as enforceable by law.

Is giving the Self-Declaration mandatory? What are the consequences of not giving the self-declaration?

Since UCPMP is not law and Standing Order issued through it which expects submission of the Self-Declaration is not legally enforceable, there should not be any adverse legal consequence of not giving the self-declaration.

However, if an entity is part of a pharmaceutical or medical device industry association, then the association may suspend or expel the entity from the association for failing to submit the undertaking.

The association and DoP may also take other steps, such as reprimand the entity and require a full apology to be published, however such a step would be disproportional and therefore improbable.

If the self-declaration is submitted, but the entity fails to comply with UCPMP, then what happens?

In general, whether the entity gives the self-declaration (undertaking) or not, the consequences of non-compliance of UCPMP will not change. These consequences are:

  1. Suspension or expulsion of the entity from the concerned pharmaceutical or medical device association of which the entity is member;
  2. Reprimand of the entity;
  3. Requiring the entity to a full apology to be published;
  4. Requiring the entity to issue a corrective statement;
  5. Requiring the entity to recover any sums or articles given or received in contravention of the UCPMP;
  6. Recommending the matter of breach to concerned governmental body having appropriate jurisdiction.

However, if the undertaking is given, and there is a non-compliance of UCPMP, there may be serious consequences.

Consequences of non-compliance with UCPMP after submission of self-declaration

Under India’s penal codes, it is punishable to give a declaration which the person knows is or believes to be false, or does not believe to be true, which is received by an authority as evidence of a fact.

The language of the self-declaration states that the entity shall provide “all required assistance to authorities for the enforcement” of UCPMP.

In the event of any inquiry into non-compliance of UCPMP, if the entity does not co-operate with DoP or panel of auditors appointed by UCPMP, there is a possibility that the DoP may initiate criminal prosecution on grounds of providing a false undertaking that the entity will assist in the enforcement of the UCPMP.

Similarly, if it is established that the entity has breached UCPMP, then DoP may initiate criminal prosecution on grounds of providing false undertaking that the entity shall comply with the UCPMP.

The chance of such prosecution succeeding in trial is not guaranteed however, due to a strong technical defence that exists with every entity who has given the self-undertaking: which is that the undertaking was given without knowledge or belief that it would be treated as ‘evidence of fact’. However, the possibility of a different outcome cannot be completely ruled out.

Tax Consequence of providing the self-undertaking under UCPMP

The Supreme Court has ruled in Apex Laboratories Pvt. Ltd. v Deputy Commissioner of Income Tax (2022) 7 SCC 98 that any expense incurred by an entity in the pharmaceutical or medical device industry, in the course of its dealings with Doctors, that results in an violation of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, in the hands of Doctors, will be an expense impermissible for deduction under Sec. 37(1) of the Income Tax Act, 1961.

The Supreme Court, however, has not ruled that any expense incurred in its dealings with Doctors by an entity in  pharmaceutical or medical device industry which may be in violation of the UCPMP will also be an expense impermissible for deduction under Sec. 37(1) of the Income Tax Act, 1961.

The recent amendment to Sec. 37(1) of the Income Tax Act, 1961 which has given “guidelines” the status of law such that any expense incurred in violation of “guidelines” would also be an expense impermissible for deduction, would not extend to UCPMP even though it is a “guideline”, because the scope of the term “guidelines” under this provision may include only those guidelines which apply to the receiving party of any expense sought to be deducted under Sec. 37(1), in the current fact scenario: Doctors. By implication, it would not cover any other guideline such as UCPMP which may apply to the pharmaceutical and medical device industry.

Therefore, the current position of law is that an expense incurred in violation of the UCPMP will be inadmissible for deduction only when the violation also results in a violation of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, or any other law or guideline. However, if the self-declaration is given by an entity then it may vitiate defences available in proceedings before the tax authorities.

Conclusion

It is clear that UCPMP is not law and therefore non-submission of self-declaration \by itself should not result in any legal action.

In fact, submission of the self-undertaking may invite more serious repercussions as opposed to non-submission of the self-undertaking. Therefore, the importers, manufacturers and marketers of pharmaceuticals and medical devices should adopt a cautious approach to submitting the self-undertaking under UCPMP.

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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

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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 Ministry of Agriculture and Farmers Welfare of India has issued Millets Grading and Marking Rules, 2024 (“Millet Rules”) which regulates packing, marking and labelling of millets intended for direct human consumption.
Source: bit.ly/4dkddNJ

2. India’s central drug regulator, the Central Drugs Standard Organisation, has circulated draft guidelines on good distribution practices for pharmaceutical products to ensure product traceability throughout the supply chain.
Source: bit.ly/4fGXKZy

3. India’s top consumer forum, the National Consumer Disputes Redressal Commission (“Commission”) has awarded a compensation of Rs.65 lakhs in a medical negligence case in which the doctors performed an elective surgery on a patient who was suffering from pre-existing ailment, which ultimately resulted in the death of the patient. The commission did not accept the defence of the hospital that the patient’s next of kin had consented to the procedure and were aware of the risks.
Source: bit.ly/3AgWYSK

4. Suicide Capsules are not medical devices or medicines: Swiss Medical Agency.
Source: bit.ly/4djGFU0

5. The Ministry of AYUSH has informed that it has identified approximately 26000 cases of misleading advertisements, but the State AYUSH departments have issued notices only 358 brands in last 4 years.
Source: bit.ly/4fJ7bYi

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s drug regulator will implement the mandate of printing of QR codes to curb counterfeiting. The top-selling brands have reportedly said that they have already started integrated QR codes and bar codes for tracking and compliance checks.
Source: bit.ly/4d80PzG

2. Indian Health Ministry has issued draft rules under the Drugs and Cosmetics Act, 1940 relating to compounding of minor offences and violations. The draft rules establish a system for companies to settle minor violations of the Act, like manufacturing drugs without proper procedures, outside of court. Companies can apply to a designated compounding authority with relevant documents, and if approved, avoid prosecution. This aims to resolve issues efficiently without lengthy court cases, but serious offenses like selling adulterated drugs are not eligible for compounding.
Source: bit.ly/3zLSKlT

3. India’s Drug Control Officers collective proposal to Indian Government for changing the name of the Drugs and Cosmetics Act, 1940 to ‘Bharatiya Aushadhi awam Chikitsa Upakaran Adhiniyam’ has received mixed responses from the industry and various stakeholders. While some have reasoned that change of name of the Act is the need of the hour and should be done as early as possible, others have questioned the need and purpose of the exercise.
Source: bit.ly/4d9IsdV

4. India’s Pharmacy Regulator, the Pharmacy Council of India (“PCI”) has extended the deadline for submission of statutory documents till 31st July, 2024 by new institutions and existing institutions that have applied for introduction of new course. PCI stated that the documents should be submitted on its compliance portal only. No other mode other than the PCI Compliance portal will be entertained for submission of documents.
Source: bit.ly/3y0YeZE

5. Indian Health Minister stresses on India’s need for world class regulatory framework for Pharma and Medical Device Industry to ensure better quality of products. The Minister also stated the importance of transparency in India’s apex drug regulator the Central Drugs Standard Control Organisation (CDSCO). The Union Health Minister stated that it is important for CDSCO to be in continuous dialogue with the drugs and medical devices industry to understand their issues and support them to fulfill the quality expectations and standards of CDSCO.
Source: bit.ly/4d5XuBd

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TOP 5 HEALTH LAWS AND POLICY UPDATES

The Department of Pharmaceuticals (DoP) has extended the deadline for filing a self-declaration under the Uniform Code for Pharmaceutical Marketing Practices, 2024 (UCPMP) to July 31st, 2024. The prior date for filing the self-declaration was June 30th, 2024.
Source: bit.ly/4coX09h

The Central Drugs Standard Control Organization (CDSCO is considering making the international nomenclature of cosmetic ingredients (INCI) mandatory on all cosmetic product labels to improve transparency and identification. The unified INCI method will help customers understand product compositions while assisting dermatologists and regulators in monitoring component safety. The move is intended to avoid confusion, improve compliance, and increase the marketability of safe products.
Source: bit.ly/3L6jz6J

A Super Speciality Hospital and one of its doctors were ordered by the State Consumer Disputes Redressal Commission (SCDRC) to compensate its patients for medical negligence. The reason for the directive was that the specialist doctor had given his responsibility to a junior and neglected to attend to the patient, which led to an incorrect diagnosis and treatment, which constituted medical misconduct.
Source: bit.ly/3zrpKQn

The Central Drugs Standard Control Organization has ordered the closure of more than 36% of the 400 drug manufacturing facilities located throughout India after an increase in inspection following deaths associated with substandard cough syrups.
Source: bit.ly/4eKMs5Y

In an effort to regulate false and misleading nutritional claims and health claims made by e-commerce platforms, the Food Safety and Standards Authority of India (FSSAI) is planning to impose stricter controls on advertisement and sale of protein supplements and shakes in India.
Source: bit.ly/45KzjpF

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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.

Draft Guidance on Vaccine Approval and Quality Monitoring at port of Import published by Central Drug Regulator for Public Commect
The Central Government has recently published a draft of guidance on (1) regulatory framework for conducting vaccine related clinical trials, marketing approval, manufacture, import/ export and post marketing assessment and (2) Risk Based Approach for monitoring quality of imported drugs, medical devices and IVDs at customs ports. Public Comment is sought on these above Guidance Notes, within 30 days of publication i.e. by 10th May 2024.
Source: bit.ly/3xIoiIv
Source: bit.ly/4cVOpvL

Merchants Association Request Central Government Intervention to Stabilize trade of Medicines and Medical Devices with Africa
The Federation of Pharmaceutical and Allied Products Merchant Exporters, an industry association of small and medium sized importers and exporters, has advocated for fiscal and trade policy intervention including continued efforts to stabilize Rupee value, by the Government to stabilize the export of Medicine and Medical Products to Africa, which has seen a sharp decline due to rising shipping tariffs caused by ongoing geopolitical conflicts.
Source: bit.ly/3Q8qlvT

Threefold Increase in FDI in Healthcare and Medical Device Sector in India during latter half of FY 2023-2024
Foreign Direct Investment (FDI) into the Hospital and Diagnostic Sectors in the country has increased by about 90% in the last quarter of 2023-24, as compared to the same quarter the previous year. Moreover, the Medical and Surgical Implements Sector has also seen a nearly 1/3rd growth by proportion during the same time. The total FDI received in hospital and medical devices sector stood at USD 462 Million.
Source: bit.ly/3U6Km70

Modern medicine Doctor body Expresses Concerns regarding Introduction of Integraded School of Medicine as Treatment
The Indian Medical Association, a professional representative body of Doctors, has expressed its concerns regarding the proposal of the Central Government to institute Integrated Medicine, which would offer treatments which are a mix of allopathic, homeopathic and traditional medicine. The Council expressed concern that due to the vast gulf in the manner of training, specialization and expertise between the various schools of medicine means that integration and cross practice treatment may pose severe risk to patient.
Source: bit.ly/3U6yi5E

EU and Japan harmonize Pharmacopoeia for ease of doing Business and regulatory Burden
The European Directorate for the Quality of Medicine and Healthcare, and the Japanese Ministry of Health, Labour and Welfare have entered into a Memorandum of Cooperation and Confidentiality, to coordinate efforts to harmonize the European and Japanese Pharmacopoeia, a move that would reduce the regulatory burden on manufacturers operating in the twin jurisdictions, with respect to carrying out compendial tests and IP approval.
Source: bit.ly/3UmRBJo

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UCPMP 2024 – Highlights and Summary of Key Differences from UCPMP 2015

India’s Department of Pharmaceuticals (DoP) has published The Uniform Code For Pharmaceutical Marketing Practices, 2024 (UCPMP 2024). The UCPMP is a code that governs the interaction between the industry and healthcare practitioners (HCPs/doctors) in India. The UCPMP 2024 replaces the UCPMP 2015, and is applicable to both pharma and medical device companies.

In the paragraphs below, we have summarized the business-critical changes between UCPMP 2024 and UCPMP 2015.  The expression ‘company’ refers to both pharma and medical device companies, unless the context suggests otherwise.

Enforceability: The UCPMP 2024 is ‘kind of’ ‘somewhat’ mandatory. The text of UCPMP 2024 does not carry the word ‘voluntary’ as UCPMP 2015 did, but at the same time, it also does not have any statutory backing. It appears that the DoP is planning to enforce it through ‘audit’ mechanism. Under UCPMP 2024, DoP has the power to order an audit of any company upon receipt of a complaint of violation of UCPMP 2024 against the company. In case the audit proves a breach, the DoP may ‘recommend’ appropriate government agencies (such as the Income Tax Department and the National Pharmaceutical Pricing Authority) to take action against the company. An appellate body, which is headed by the Secretary, DoP, also has the power to ‘prescribe’ penalties to defaulting companies. Separately, the CEO of the company has to give an undertaking that the company shall abide by UCPMP 2024 will extend all assistance to ‘authorities’ for its enforcement.

Medical Education and Training: Companies can sponsor or organize conferences, workshops and trainings for doctors by themselves without having to necessarily collaborate with another entity, such as an association of doctors. Such conferences, workshops and trainings cannot be held outside India. The details of such events and expenses incurred by the company will have to be published on the company’s website. The record of these expenses may be audited by auditors appointed by the DoP. If the DoP auditors find discrepancies in the records, they will bring them to the attention of appropriate government agencies and authorities.

Hospitality and travel: During conferences and workshops, all doctors including delegates may be served modest meals. However, delegates cannot be offered travel facilities. Speakers may be offered both hospitality and travel facility.

Brand reminders: A company may supply doctors with informational and educational materials such as e-journals and dummy device models as brand reminders, provided that the total worth of each item does not exceed Rs. 1000. There is no cap on how many brand reminders can be given to the doctor. However, a brand reminder should not have an independent commercial value for the doctor.

Engagement of HCPs as a Consultant: Companies can continue to engage doctors as consultants for research, but the research has to be ‘bona fide’. The DoP is expected to provide more clarity on this issue.

Monetary grants: Companies cannot offer monetary grants under any pretext now, including for educational purposes to doctors who are pursuing training, residency, or fellowship.

Sample packs: A company may offer a doctor up to 12 sample packs of medicines each year. However, these sample packages should be properly marked as ‘not for sale.’ The monetary value of samples distributed by a company should not exceed 2% of its domestic sales.

Further changes to UCPMP 2024: The DoP has reserved powers to modify or limit the scope of UCPMP by issuing standing orders from time to time.

It is important that industry takes cognizance of the changes because any non-compliance with UCPMP 2024 may negatively impact a company’s industry standing and perception amongst doctors.  India’s tax department has also been disallowing any expenses which have been incurred in contravention of UCPMP, so a mistake may prove very expensive.