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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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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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Can cooking oil be lawfully reused in India? An analysis of law and recent KFC case

Under Indian law, it is not unlawful to reuse cooking oil, provided certain conditions and thresholds are not crossed by food businesses. In this article, we will examine the thresholds and conditions associated with reusing cooking oil. We will also examine the Madras High Court order which protected a fast-food chain outlet against arbitrary action of suspension of license for reusing cooking oil.

Thresholds and Conditions for Reuse of Cooking Oil

The Food Safety and Standards Authority of India (FSSAI) is the regulatory body responsible for quality of food for consumers. It regulates the use and reuse of cooking oil and issues directions from time to time.

The FSSAI has recommended that “re-heating and reuse of oil should be avoided as far as possible”. It has further recommended that cooking oil should be reheated a maximum of three times, and that ideally it should be heated only once. However, these recommendations are for guidance only are not binding on food businesses.

The only legal restriction on reusing vegetable cooking oil is that the Total Polar Compounds (TPC) developed in cooking oil due to reheating cannot exceed 25%[1]. According to FSSAI, any cooking oil whose TPC content is more than 25% is unsafe for human consumption and is thereby prohibited for use.

In order to keep a check on TPC content in reused vegetable cooking oil, FSSAI has directed that food businesses using 50 litres or more of cooking oil per day to maintain records detailing oil usage, including type, quantity used and discarded, and disposal date. Such food businesses are required to dispose the used cooking oil (UCO) only to FSSAI-approved aggregators or collection agencies.[2]

Adding fresh cooking oil to used cooking oil

In 2019, FSSAI directed food businesses to ensure that used cooking oil should not be topped with fresh cooking oil.[3]

Legal consequences of reusing cooking oil

Any violation of the 25% TPC threshold limit may result in suspension or cancellation of food license[4], as well as imprisonment or fine.[5]

Madras High Court’s intervention in unlawful suspension of license for reusing cooking oil

In Thoothukudi, Tamil Nadu, the FSSAI through Tamil Nadu Food Safety and Drug Administration Department (“Department”) suspended (i.e. temporarily cancelled) the license of one Kentucky Fried Chicken (“KFC”) outlet on grounds that it was reusing cooking oil and was adding a filtration agent, namely Magnesium Silicate Synthetic (“MSS”), to the cooking oil.

KFC challenged the suspension before the Madras High Court. On review, the High Court found that prima facie Magnesium Silicate Synthetic (MSS) does not appear to be a banned substance. On the contrary, it is an approved filtration agent. The Court further observed that there is no legal bar on reusing cooking oil.

For these reasons, and also on account of the fact that the Department did not follow due process before suspending the license, the Court passed an interim order staying the suspension of license and allowed the KFC outlet to resume operations.

Can Magnesium Silicate Synthetic (MSS) be added to reused cooking oil?

Magnesium Silicate Synthetic is a food additive that is primarily used as an anticaking agent and as a carrier for flavours in different food items. The Food Safety and Standards (Food Products Standards and Food Additives) Regulation, 2011 limits the use of anti-caking agents in such cases where its use is specifically permitted.[6] Synthetic Magnesium Silicate (or Magnesium Silicate Synthetic) is recognized an additive that may be used as clarifying agents or filtration aid in edible oils[7] and therefore may be lawfully used as a filtration aid in cooking oil.

Conclusion

The controversy surrounding reuse of cooking oil by restaurants seem to be manufactured, since the law surrounding reuse of cooking oil is very clear – vegetable cooking oils may be reheated and reused so long as the TPC content in the cooking oil does not exceed 25%. It is, however, recommended that cooking oil should not be reheated more than three times, though following such recommendation is not a legal requirement.

 

[1] The Food Safety and Standards (Licensing and Registration of Food Businesses) First Amendment Regulations, 2017, available at: https://www.fssai.gov.in/upload/uploadfiles/files/Gazette_Notification_Quality_Vegetable_Oil_03_11_2017.pdf  and Section 2.3.15(8) of FSS (Prohibition and Restriction on Sales) Regulations, 2011, available at: 61f381c576d16SOP_Cooking_Oil_28_01_2022.pdf (fssai.gov.in)

[2] Direction under Section 16(5) of the FSS Act regarding disposal and collection of Used Cooking Oil, available at:  5c6271f25d447Direction_Reused_Cooking_Oil_07_02_2019.pdf (fssai.gov.in)

[3] Direction under Section 16(5) of the FSS Act regarding disposal and collection of Used Cooking Oil, available at: 5c6271f25d447Direction_Reused_Cooking_Oil_07_02_2019.pdf (fssai.gov.in)

[4] Regulation 2.1.8 (4) of the Food Safety and Standards(Licensing and Registration of Food Businesses) Regulations, 2011, available at: https://www.fssai.gov.in/upload/uploadfiles/files/Licensing_Regulations.pdf

[5] Section 55, 57 and 59 of the Food Safety and Security Act, 2006 (“Act”), and Section 274, 275 of the Bharatiya Nyaya Sanhita, 2023.

[6] 3.1.7: Anticaking Agents: 1) Restriction on use of anticaking agents. No anticaking agents shall be used in any food except where the use of anticaking agents is specifically permitted. [Page 430, Part III, Section 4, the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations of 2011].

[7]Direction under Section 16(5) of the FSS Act regarding compliance w.r.t. Processing Aids under Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations of 2011, available at:  https://fssai.gov.in/upload/advisories/2024/03/65f2d680c053cApproved%20direction%20under%20Section%2016_5%20regarding%20compliance%20w.r.t.%20Processing%20Aids%20under%20FSS_FPS&FA_Regulations_2011.pdf

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Medical Fitness Certificate for Food Handlers: How to ensure compliance with this Mandatory License Condition?

All Food Business Operators (FBOs) in India must maintain a record of annual medical examination of all food handler(s) engaged by the FBO. This is a mandatory condition of the food license. The Food Safety Officer checks the record of medical examination at the time of inspection, and any shortcoming in the record-keeping may result in suspension or cancellation of license.

In this article, we will discuss key considerations for ensuring full compliance with the requirement of maintaining records of medical examinations of food handlers.

Who is a food handler?

A food handler is any person who directly handles packaged or unpackaged food, food equipment, utensils, or food contact surfaces, and is therefore expected to comply with food hygiene requirements.

Personal hygiene and sanitary requirements applicable to FBOs

In addition to the requirement of a medical examination of food handlers, all FBOs have to ensure that no person, whether handling food or not, who may be suffering from any disease or illness that is likely to be transmitted through food is allowed to enter any area where the food is handled, i.e., where the food is packaged or unpackaged, where food equipment and utensils are stored, where food contact surfaces exist, or where food is cooked or manufactured.

In addition to the above general requirement, FBOs who are involved in high-risk food businesses such as meat and dairy have additional personal hygiene and cleanliness requirements, which are discussed below.

Meat

FBOs who deal in meat must ensure that any person who comes into contact with meat in the course of his or her work must be medically examined prior to such person being engaged. FBOs who run meat shops must ensure that any person who handles meat is medically examined annually, and the medical examination includes an examination of the sputum and chest X-ray for tuberculosis. The medical examination should also include stool tests for parasitic infections (protozoal and helminthic) transmitted through ingestion, as well as for enteropathogenic bacteria such as Escherichia coli, Salmonella, Shigella species, and Vibrio cholera.

Dairy

FBOs who manufacture, process, store, or sell milk and milk products are required to ensure that the persons employed for handling raw materials or dairy products have, before joining, submitted a medical certificate that states that there is no medical impediment to working in the specific capacity or role that the person is going to be employed by the FBO.

Mandatory vaccination of workers working in food factory    

If the FBO is a manufacturer, processor, and packer who operates a factory, then all workers working in the factory ought to be compulsorily vaccinated against an enteric group of diseases as per the recommended schedule of vaccination. Enteric groups of disease are infections caused by viruses and bacteria that enter the body through the mouth or intestinal system, primarily as a result of eating, drinking, and digesting contaminated food or liquids. Cholera, typhoid fever, Salmonella, or E. coli are some common enteric diseases. A record of the vaccination of all factory workers is required to be maintained, which may be inspected at the time of inspection. The decision regarding the scope of vaccination, i.e., which enteric diseases are to be covered by vaccination, is taken by the registered medical practitioner according to the list declared by the concerned municipal corporation of the area.

Format of Medical Fitness Certificate 

After the medical examination of food handlers, a medical fitness certificate in the prescribed format must be issued by a registered medical practitioner. It must contain the signature and seal of the registered medical practitioner. The medical fitness certificate should indicate that the registered medical practitioner has undertaken a physical examination, an eye test, and a skin examination, as well as any other tests required to confirm any communicable or infectious disease that the person is suspected to be suffering as observed during the clinical examination, if applicable. It should also indicate that “based on the medical examination, he/she is found free from any infectious or communicable diseases, and the person is fit to work in the food establishment.”

Discretionary Powers of Food Safety Officer vis-à-vis ordering medical examination of workers

If a Food Safety Officer, during an inspection, believes that the food handler is suffering from any infectious disease, he may ask for a medical examination of that person, and on such examination, if he finds out that person is suffering from an infectious disease, he has the authority to prohibit employees suffering from infectious diseases from participating in food handling activities and ensure strict adherence to health and safety.

Penalty for non-compliance

Failure to comply with these regulations can result in penalties of up to two lakh rupees and potential license cancellation under Section 58 of the Food Safety and Standards Act, 2006.

Conclusion 

All FBOs should sensitize themselves to the legal requirements of annual medical examination of staff, mandatory vaccination of workers working in food factories, and general hygiene and sanitary requirements applicable to all persons handling food or operating in an area where food is handled. Failure to meet these requirements of food laws may result in a heavy monetary fine and suspension or cancellation of the license.

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India’s Food Regulator FSSAI Introduces Instant License and Registration for Food Businesses with Some Exceptions

India’s Food Regulator Introduces Instant License and Registration for Food Businesses with Some Exceptions_1

India’s central food regulator, the Food Safety and Standards Authority of India (FSSAI), has made a policy decision to issue instant registrations and licenses to food businesses in India. The instant registration or license will be valid for one year and may be renewed in a regular course.

Background

All food businesses in India require either a registration or license to operate. Whether a food business will require a registration or license depends on (a) the scale of the business (b) the nature of the business and (c) the number of States in India in which the business will operate. A registration will be typically granted by the State-level Food Regulators, and license may be granted either by State-level or Central Food Regulator (FSSAI).

As per current timelines prescribed in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011, the food regulators may take anywhere between seven days and a month to grant a registration, and up to two months to grant a license. These timelines are sometimes compounded if, during the pre-registration / pre-license inspection, the inspector directs the applicant to make improvements before the registration/license may be granted.

Tatkal (Instant) System of Food License

To improve the ease of doing business for businesses, the FSSAI has streamlined the process for granting license such that the registration/license for food businesses could be made available instantly without inspection. Of course, the registered/licensed food business will be subject to future inspection and requirements to comply with inspection related improvements.

The said ‘Tatkal’ (instant) license facility will be made available to the following categories of food businesses: importers, wholesalers, distributors, retailers, transporters, non-atmospheric-controlled storage providers, food vending agencies, direct sellers, merchant exporters, petty retailers such as snack and tea shops, and mobile food vendors (hawkers).

However, this Tatkal registration or license will not be issued to food business operators dealing in milk, meat, and fish. Also, the applicant should not have had their registration or license suspended or cancelled in the prior three months before the date of application.

Before applying, every food business should thoroughly evaluate their application. Providing incorrect information regarding the Kind of Business or failing to meet eligibility requirements can result in fines of up to Rs. 10 lakhs.

Conclusion

The decision to issue tatkal (instant) registrations and licenses is a very pragmatic step taken by the Indian Government to improve the ease of doing business for food business operators. The facility will be initially available only for individuals who own food businesses (proprietors) and be rolled out in Assam, Delhi, Gujarat, Jammu & Kashmir, and Kerala. It is expected to be eventually extended to partnerships/registered firms and be available to businesses in other States and Union Territories as well.

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Mandatory undertaking before advertising food and health products and services on the internet, TV and print media in India

India’s Supreme Court has exercised its inherent constitutional powers and issued directions that, before an advertisement concerning food and health products or services is displayed/ aired/ printed/, the concerned advertiser / advertising agency will have to issue a self-declaration to the concerned electronic media / T.V. Channel / broadcaster / printer/ publisher/ electronic media stating that the “the advertisement does not make misleading claims and complies will all relevant regulatory guidelines”. A breach of these directions may result in contempt of the Supreme Court and be punishable under the Contempt of Courts Act, 1971. It may also result in breach of relevant sectoral laws, for example, in case of TV advertisements, it may result in breach of Cable Television Network Act, 1995. This has been clarified by Ministry of Information and Broadcasting in its circulars (1, 2).

The key thing to note is that the legal obligation has been cast on the owners and operators of electronic media (Google, Facebook, Instagram, YouTube etc), T.V. Channels, Radio Stations, Print and Digital News Websites etc. to ensure that the prescribed self-declaration is in place before the advertisement is accepted and published.

In order to ascertain the genuineness of the self-declaration, the Ministry of Information and Broadcasting and Press Council of India have respectively created dedicated portals where the self-declaration issued by advertisers/advertising agencies can be accessed and verified.

How to make self-declaration for advertisement over internet and print medium?

An advertiser who wishes to make any advertisement in relation to food or health products (health supplements, drugs, medical devices, dental products, nutraceuticals, food for special medical purposes, cosmetics, condoms etc.) or health services (telemedicine, physiotherapy, dental consultation etc.) over the internet or print medium should take the following steps:

Step 1 – Sign up on the dedicated portal: https://cbcindia.gov.in/cbc/advt-login

Step 2 – Fill the required details, and upload the Letter of Authorization in prescribed format

Step 3 – Generate Self-Declaration by providing mandatory details the following mandatory details:

  1. Product / Service Name
  2. Brief Description of Advertisement Content
  3. Title of Advertisement
  4. Nature of Advertisement (Internet Video, Internet Static, Print)

Step 4 – The Form of Self-Declaration will be automatically generated. It should be downloaded for signatures.

Step 5 – The signed Self-Declaration (which will be autogenerated) should be uploaded. Once uploaded, it should be directly accessible for download by Advertiser as well as general public.

How to make self-declaration for advertisement over TV and Radio.

An advertiser who wishes to make any advertisement in relation to food or health products (health supplements, drugs, medical devices, dental products, nutraceuticals, food for special medical purposes, cosmetics, condoms etc.) or health services (telemedicine, physiotherapy, dental consultation etc.) over the T.V. Channels or Radio Stations should take the following steps:

Step 1 – Sign up on the dedicated portal: bit.ly/3RZh3D5

Step 2 – Fill the required details, and upload the Letter of Authorization in prescribed format

Step 3 – Submit the following mandatory details:

  1. Product / Service Name
  2. Title of Advertisement
  3. Advertisement URL
  4. Date of First Release of Advertisement
  5. Nature of Advertisement (Internet Video, Internet Static, Print)

Step 4 – Upload the Letter of Authorization Form (template provided here: bit.ly/4bBk43E

Step 5- Upload Self-Declaration Certificate (template autogenerated)

Step 6- Submit the Form with details as described above, after uploading the Letter of Authorization and Self-Declaration Certificate.

Once submitted, it should be directly accessible for download by Advertiser as well as general public.

How to verify self-declaration made by advertisers

Owners and operators of electronic media, and print and digital publications, may visit the following link to verify if the self-declaration of advertiser is genuine or not: https://cbcindia.gov.in/cbc/advt-public-list

Owners and operators of T.V. Channels and Radio Stations may visit the following link to verify if the self-declaration of advertiser is genuine or not: bit.ly/4bBk43E

How to ensure that advertisement does not make misleading claims and complies with all relevant laws?

The Indian law surrounding misleading claims is scattered across various statutes, and has been shaped by Courts to keep pace with changing times. The key legislations which apply to food and health products and services are: Consumer Protection Act, 2019, The Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022, The Food Safety and Standards Act, 2006, The Food Safety and Standards (Advertising and Claims) Regulations, 2018, The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954) and Rules, 1955, The Drugs and Cosmetics Act, 1940, and Drugs Rules, 1945, The Medical Devices Rules, 2017 and The Cosmetics Rules, 2020, The Legal Metrology Act, 2009 and Legal Metrology (Packaged Commodities) Rules, 2011.

Conclusion

Considering the Supreme Court order and Circulars of the Ministry of Information and Broadcasting, all advertisers, broadcasters and publishers (both print and digital, video and static medium) must now ensure compliance with the requirement of self-declaration and familiarize themselves with misleading advertisement laws.

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Madras High Court Greenlights Online Sale of Drugs and Medical Devices in India

online_sale_of_drug_and _medical_devices

Introduction

The Division Bench of Madras High Court in its recent order has confirmed that online pharmacies and online marketplaces of medicines and medical devices can continue to operate under existing law i.e. Drugs and Cosmetics Act, 1940 and Rules, 1945.

In doing so, the Court reversed the order passed by a Single Judge Bench of the same Court in 2018, which had effectively ordered e-pharmacies and e-marketplaces to stop business.

In this article, we will discuss the developments leading up to the recent Court order.

Background of 2018 court order banning online sale of medicines

On 17.12.2018, The Single Judge Bench of Madras High Court surprised e-pharmacies and e-marketplaces by ordering that till the Central Government did not publish rules for regulation of e-pharmacies, “the on-line traders are bound not to proceed with their on-line business in drugs and cosmetics.”

The rationale behind such an order was that without any proper framework regulating the online sale of drugs, there may arise chances of potential misuse of health and safety. The Court felt that amendments to the Drugs Rules, 1945 were necessary before allowing the online sale of drugs. The Court also directed the state government to notify the proposed Drugs and Cosmetics Amendment Rules, 2018 in the state Gazette, latest by 31.01.2019, for online sale of drugs within the state.

However, after passing the order, at the request of e-pharmacies and e-marketplaces, the Court decided to defer the implementation of the order until 20.12.2018 so that they could prefer an appeal against the order.

Ad-interim stay of 2018 order

The e-pharmacies and e-marketplaces preferred an appeal against the order of the Single Judge, on 02.01.2019 the Division Bench temporarily stayed the operation of the Single Judge Bench.

The Bench felt that a sudden ban would disrupt access to medication for those who relied on online pharmacies, particularly for home deliveries. However, the Division Bench agreed with the Single Judge Bench on the need for appropriate regulation for the online sale of drugs and directed the Central Government to finalize a framework for the regulation of online sale of drugs.

Reversal of 2018 order

The Division Bench has now passed a final order in the appeal. It has explicitly allowed the online sale of drugs, with a condition that any online sale of drugs must be routed through licensed druggists and chemists only.

In doing so, it has endorsed the lawfulness of operation of e-pharmacies and e-marketplaces, which are currently doing business through dealers and retailers who have a license for sale or distribution of drugs under Drugs Rules, 1945.

The Court decided to dispose of the appeal primarily on the grounds that the Delhi High Court is already hearing a matter with identical issues and the Central government is in the process of preparing a new policy for the online sale of drugs.

Order from Delhi High Court

The Delhi High Court is currently hearing a batch of writ petitions in which the petitioners have challenged the legality of the online sale of drugs and medical devices. Unlike the Madras High Court, the Delhi High Court has never held that the online sale of medicines is bad in law. The Delhi High Court has always maintained a position that the online sale of medicines and medical devices by licensed retailers is not unlawful. However, the Delhi High Court has time and again expressed concerns that the Central Government is yet to finalize a framework for the regulation of online sale of drugs and medical devices, despite the fact that the draft rules for the regulation of online sale of drugs were published in 2018 for comments and the Central Government has already received comments. The Court has now given the Central Government a last opportunity to put in place a policy framework for online drug sales by July 2024.

Conclusion

The order of the Madras High Court is welcome as it removes the ambiguity that existed in relation to the legality of the online sale of drugs and medical devices. Now, the fate of e-pharmacies and online marketplaces for medicines and medical devices is inextricably linked to the outcome of the petition filed in the Delhi High Court and the decision of the Central Government to introduce (or delay the introduction of) a framework for online sale of drugs and medical devices.

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PROCESS FOR OBTAINING BIS LICENSE UNDER MEDICAL TEXTILES (QUALITY CONTROL) ORDER, 2023

Introduction:

Medical textile products such as sanitary napkins, baby diapers, reusable sanitary pad/ sanitary napkins/ period panties, dental bib/ napkins, bedsheet, pillow cover, and shoe covers have been regulated for quality in India by  the Medical Textiles (Quality Control) Order, 2023 (the “Order”). The Order requires all manufacturers and importers of medical textile products to label the products with the Indian Standard (IS) Mark. A license over the IS Mark is issued by Bureau of Indian Standards (BIS) after it has determined that the medical textiles and the manufacturing process meet with the standards prescribed by BIS. Such license is commonly referred to as the BIS license.

Which are the standards prescribed by BIS that medical textiles have to meet?

The medical textiles covered by the Order have to mandatorily meet with the standards described in the table below.

Sl. No.Goods or articleIndian Standard (IS)Title of Indian Standard
 1.Sanitary napkinsIS 5405:2019Sanitary napkins – Specification (second revision)
 2.Baby DiaperIS 17509:2021Disposable baby diaper – Specification
 3.Reusable Sanitary Pad Sanitary Napkin Period PantiesIS 17514:2021Reusable sanitary pad/ Sanitary Napkin/ Period Panties – Specification
 4.Shoe coversIS 17349:2020Medical textiles – Shoe covers – Specification
 5.Dental bib/NapkinsIS 17354:2020  Medical textiles – Dental Bib or Napkins – Specification
 6.Bedsheet and Pillow CoverIS 17630:2021  Medical Textiles – Bed sheet and pillow cover – Specification  

How to obtain license to use Indian Standard mark on medical textiles?

The process to obtain license over the Indian Standard (IS) mark is described in Scheme – I of Schedule – II to the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018 (the “Conformity Assessment Regulations”). The process entails on-site factory inspection, review of manufacturing process, sampling/testing of products at BIS recognized labs, and strict adherence to prescribed labelling and marking requirements.

Do all manufacturers and importers of medical textiles require declaration of Indian Standard (IS) mark on label?

Yes, the Order applies to all manufacturers (Indian and foreign) of medical textiles who wish to sell medical textiles in India. Therefore, such manufacturers will have to obtain license over IS mark from BIS.

However, the Order does not apply to:

  1. Goods/articles intended for export, or
  2. Sanitary napkin, baby diaper, reusable sanitary pad / sanitary napkins / period panties manufactured by Self Help Groups (SHG)

The above-mentioned goods/articles need not be mandatorily labelled with IS Mark.

What are the timelines for the Order to become effective?

All manufacturers (domestic and foreign) of sanitary napkins, baby diapers, reusable sanitary pad/ sanitary napkins/ period panties have to ensure that any of their products sold in India on or after October 1, 2024, ought to contain an IS Mark on their label.

All manufacturers (domestic and foreign) of dental bib/ napkins, bedsheet, pillow cover, and shoe covers have to ensure that any of their products sold in India on or after April 1, 2024, ought to contain an IS Mark on their label.

Conclusion:

It generally takes around 4 – 6 months, depending on the delay caused in responding to queries raised (if any), organizing inspection(s), sample deposition, and clearance of fee dues, etc., to receive license over IS Mark from BIS. Therefore, manufacturers and importers of medical textiles should ensure that they make the license application in time so that the business does not suffer.

For more insights on the Medical Textiles (Quality Control) Order, 2023, please refer to our article Medical Textiles (Quality Control) Order, 2023: Impact Analysis for Personal Hygiene Products.

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STATUS OF REGULATION OF AI IN INDIA: IMPACT OF NEW ADVISORY

The Ministry of Electronics and Information Technology (MeitY) issued a new advisory on Artificial Intelligence (“AI”) on March 15, 2024 (“New Advisory”), scrapping the earlier version issued on March 1, 2024. The New Advisory has diluted the strict position taken by MeiTY in its earlier advisory.

1. CHANGES

    Though, the New Advisory has retained majorly all clauses of the earlier version, there are few changes brought out in terms of the regulatory framework. These changes have been summarized below:   

    A. No More Prior Government Approval

      Previously, intermediaries and platforms were required to ensure that a proper government approval was in place prior to making under-testing/ unreliable AI tools available to Indian public.

      The New Advisory scraps the previous approval mechanism which was loaded with ambiguities.  Specifically, there was a lack of clarity on definitions for “unreliable” models and the process for obtaining approval.

      B. Focus on Labelling

      The New Advisory underscores the significance of user awareness regarding AI-generated content. Intermediaries and platforms are required to ensure appropriate labelling of AI, particularly which is under-tested/ unreliable, regarding the fallibility of outputs.

      Intermediaries and platforms have to ensure user awareness regarding fallibility of AI tools/systems and their outputs. User awareness should be created using consent popup or any other relevant mechanism. 

      This transparency empowers users to critically evaluate the information they encounter online and mitigates the potential for manipulation through AI-powered misinformation campaigns. AI-generated content, especially those vulnerable to misuse like deepfakes, must be clearly labelled for user awareness.

      C. No Reporting

      Under the previous advisory intermediaries and platforms were also mandated to submit an Action Taken-cum-Status Report (“ATS Report”) to MeitY within a 15-day timeframe. The New Advisory has removed the reporting requirement. 

      2. ISSUES  

      Even though the New Advisory states that it is applicable to Platforms, it does not clarify which entities are covered by the expression ‘Platforms’ leaving a question mark on scope of its applicability to non-intermediaries using or making available AI tools.

      Further, the is no clear guidance about testing of AI tools/systems. The government has not clarified any standards for testing the AI tools. Intermediaries and platforms have been asked to ensure labelling of under-tested/ unreliable AI tools without any clear prescription on standards of testing AI tools or clarity about authority which will certify testing and reliability of AI tools.   

      3. IMPACT

      The changes brought out in the New Advisory mark a shift in India’s regulatory approach; from zero regulation to a more measured stance on AI regulation. The New Advisory has addressed the concern raised about implementation of prior approval mechanism by removing that requirement.

      Despite the removal of approval mechanism, intermediaries and platforms still face significant risk due to lack of clarity and ambiguity in standards of testing unreliable AI systems. While the New Advisory might reduce compliance costs for intermediaries and platforms, it might inadvertently increase their chances of losing legal immunity (safe harbor) under Indian law.

      As of now, intermediaries and platforms are required ensure compliances which were enlisted in the earlier advisory except seeking government approval for using under-testing/unreliable AI tools and submitting ATS Report. We have summarized the compliances mentioned under the advisory issued on March 1, 2024, you can read it here: https://shorturl.at/JKQ13  

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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.