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.

Corporate hospitals may soon have to comply with advertisement norms applicable to doctors

India’s National Medical Commission (NMC), which regulates the conduct of medical practitioners (doctors), has endorsed the position that all hospitals should comply with the same standards of ethics as are applicable to doctors under the NMC Registered Medical Practitioner (Professional Conduct) Regulations, 2023. The operation of 2023 Regulations is currently under suspension.
Source: bit.ly/3vpJ7aV

High Court imposes damages of 244 crores in Standard Essential Patents case

India’s Delhi High Court has reportedly imposed damages amounting to INR 244 Crores on an Indian smartphone manufacturer. The Court found smartphone manufacturer guilty of infringing seven patents on 2G, EDGE, and 3G technology granted to a global telecom company. The order is expected to be out soon.
Source: bit.ly/3TxOXyI

Drug Manufacturers will have to upload all product details on Government portal soon

The Drugs Consultative Committee (DCC), a committee comprising State-level Drug Regulators, has recommended that the Central Drugs Regulator, Central Drugs Standard Control Organization (CDSCO), should set a deadline for manufacturers of drugs to upload list of drugs manufactured on an online portal called SUGAM.
Source: bit.ly/3TxP0uo

Ban on trade of ferocious dog breeds has been stayed in various States in India

India’s Kerala High Court, Karnataka High Court and Kolkata High Court has stayed a controversial circular of the Central Government which prohibited import, trading and selling of 23 breeds of dogs identified as ferocious in the circular. The circular also mandated sterilization of dogs from further breeding as pets. The circular has been challenged on the ground that it is unscientific, not based on evidence and has been issued without consultation with relevant stakeholders.
Source: bit.ly/3TVZcyi

European Medicines Agency urges sponsors of clinical trials to register on new portal before January 2025 deadline

The European Medicines Agency (EMA) has strongly advised sponsors of clinical trials that have been approved before 31 January 2023 to submit application to move the clinical trials to the new Clinical Trials Information System (CTIS) as soon as possible, considering it will take EMA up to three months to review and authorize the application. As of now, only 20% of clinical trials have been moved to the new platform.
Source: bit.ly/3TZRzHl

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.

Periodic Safety Update Reports for Medical Devices to be filed only through online portal of CDSCO
The Central Medical Devices Regulator of India (Central Drugs Standards Control Organization) has issued a circular, stating that starting on 1st April 2024 it will require and restrict all manufacturers of Medical Devices/ In-vitro Devices to make submission of Periodic Safety Update Reports, only on the online portal and that offline mode of submission of application will not be accepted going forward.
Source: bit.ly/3TEO74B

Absence of Regulation of Second-Hand Medical Devices being Imported into India flagged by Parliamentary Panel
The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers, in a recent report, has highlighted that currently India’s Central Medical Device Regulations (Medical Devices Rules, 2017) do not regulate second-hand medical devices. The Committee has recommended framing policy to ensure its quality and safety, as well as introducing possible restrictions on import of second-hand or refurbished Medical Devices into India.
Source: bit.ly/3VsdCaQ

Supreme Court Orders Director of Company as well as Endorser of offending Advertisement to be present for Contempt Proceedings relating to misleading advertisements
As part of the ongoing action being taken against a major Indian Ayurvedic Medicine manufacturer for publication of misleading advertisements regarding its products in contravention of an undertaking provided to the Court, the Supreme Court, in pursuance of determining whether to pursue contempt proceedings against the manufacturer, has issued an order requiring the physical presence of the Director of the entity as well as a prominent Ayurvedic Yoga practitioner who had given his endorsement to the claims made in the offending advertisements of the Company.
Source: bit.ly/3vu45VQ

Delhi High Court orders suspension of accounts accused of impersonation of prominent investment group despite objection that no evidence of involvement is provided.
In pursuance of ongoing action against certain anonymous persons impersonating a prominent Investment group and misleading the general public, the Delhi High Court has issued a further order to messaging platform WhatsApp to take action to remove/ block access to certain accounts/ messaging groups, despite objection from the platform that the account/ messaging groups have been prove to neither violate T&Cs of WhatsApp, nor having carried out any illegal activity.
Source: bit.ly/3vkn7hu

EU Parliamentary Committee votes to present amendment to increase exclusivity period for orphan drugs and introduce extended regulatory data-protection period.
The European Parliamentary Committee on Environment, Public Health and Food Safety has voted in favour of introducing several amendments to the current EU Pharmaceutical Directive, including a controversial proposal to increase the exclusivity period for Orphan Drugs from 10 to 11 years, as well as an extended regulatory data-protection period of 9 years; both decisions that industry experts believe may have adverse consequences for competition in the EU Pharmaceutical Market.
Source: bit.ly/3Vr9zeK

Posted on

Regulation of Artificial Intelligence in India: Scope of new advisory issued by Indian Government and assessment of impact on businesses

The Ministry of Electronic & Information Technology (MeitY) has recently issued an advisory which has the potential to regulate businesses that are using Artificial Intelligence (“AI”) models developed by them or third parties. In this article, we have analysed the scope of advisory, specifically to evaluate what compliance burden does it cast on businesses, and more importantly – which businesses are impacted, and which aren’t.

Brief background

All intermediaries in India must remain compliant with Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021 (“IT Rules) if they don’t want to risk the loss of statutory immunity (read safe harbour protection) granted to them. If an intermediary loses safe harbour, it may be made responsible for any and all illegal activities that takes place on its platform. MeitY has the powers to make and amend the IT Rules, and it is in relation to exercise of such powers, that it has issued the current advisory.

An intermediary, for the purposes of IT Rules, is essentially any person or entity that receives, stores, or transmits particular electronic records on behalf of another, or provides any services in relation to the particular electronic record.

Due to the wide nature of the above definition, all internet service providers, telecommunication service providers, web hosting service providers, data centres, search engines, online marketplaces etc. are regulated as intermediaries in India.

Scope of the advisory – What compliances does it prescribe?

The advisory essentially introduces three new compliances in relation to AI models, Large Language Models(“LLMs”), generative AI, software(s) and algorithm(s) (together “AI”): (a) AI should not exhibit any inherent bias or discrimination; (b) if the AI is under-tested or unreliable, then its availability to Indian users can take place only with an explicit permission of the Government of India, along with a declaration which indicates that the output may be unreliable; and (c) if the AI is capable of generating information, audio and/or video, which may be potentially used as misinformation or deepfakes, then a permanent label, metadata or identifier should be embedded in the output which identifies the computer resource from which such misinformation or deepfake was created or originated, as well as any other computer resource that modified or played a part in the misinformation or deepfake.

Scope of the advisory – Who does the advisory apply to?

Since the advisory has been issued in relation to IT Rules which apply to intermediaries, there is no doubt that the advisory is binding on the intermediaries.

Interestingly, the IT Rules do not regulate businesses who are using or leveraging AI in order to provide goods and services to end consumers. So, the real question is, does the advisory apply to any and all business that are developing or using AI capabilities?

From a plain reading of the advisory, it appears that the advisory does not directly apply to any and all businesses, if the businesses do not qualify as an intermediary. Most businesses developing or leveraging AI would not fall under the definition of an intermediary.

Unfortunately, the language of the advisory leaves room for other interpretations as well. One interpretation is that the advisory directs intermediaries, in their capacity as gatekeepers of information that is exchanged between businesses and consumers, to ensure that AI developed or leveraged by businesses is of a ‘standard’ quality (as defined in the advisory). Since internet service providers, search engines and web hosting service providers are all intermediaries under Indian law, the advisory may be viewed as an attempt by Government of India to indirectly control businesses that are developing or leveraging AI.

The Minister of IT, however, has clarified that the advisory is applicable to significant platforms only and not to start-ups. Unfortunately, there is no definition of significant platforms. Until further clarification is received, it may be safely assumed that only large platforms will be required to take explicit permission for using under-tested and unreliable AI whereas startups will not.

What changes now for businesses?

All intermediaries operating in India have to submit Action Taken-cum-Status Report (“ATS Report”) to the Ministry. It appears that all intermediaries have taken a conservative view of the advisory and are interpreting the advisory such that it applies only to intermediaries such as platforms (e.g. social media platforms). There is no clarity on the permission process from Government of India as of now.

We expect further clarity to be received in the coming days, once MeitY has reviewed the ATS Reports. Until then, it should be business as usual for most businesses other than those who qualify as intermediary under the IT Rules.

The most important thing for businesses to do as of now, is to evaluate whether the business qualifies as intermediary under IT Rules or not. If it qualifies as an intermediary, all the compliance burden associated with the advisory (described above) will immediately shift on the business.

All pragmatic businesses may consider starting preparations to introduce a permanent label, metadata or identifier in the output, as described above.

From a policy perspective, the advisory appears to be a clear declaration of intent by the Indian Government, that it is looking to regulate AI given its disruptive powers.

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.

Airlines have to obtain single caterer license and provide invoice containing description of license number for chargeable in-flight meals
India’s food regulator, The Food Safety and Standards Authority of India (FSSAI), has issued an advisory to flight operators directing them to ensure that they have appropriate license for providing in-flight food. The regulator has also directed flight operators to ensure that appropriate invoice with license number is issued for sale of food, and that both ready-to-serve and pre-packaged food carries appropriate labelling declaration.
Source: bit.ly/48NrSxN

In medical negligence matters, exoneration by medical council will not automatically mean exoneration before consumer forum, especially if contradictory medical evidence has been furnished: Supreme Court
India’s Supreme Court has held that a consumer commission which is deciding a complaint of medical negligence against a medical practitioner, should not solely rely on favourable report from State Medical Council especially if the complainant has submitted contradictory expert testimony from another medical practitioner.
Source: bit.ly/3Isb30J

Import of medicines to get boost from India’s free-trade agreement with four countries of European Free Trade Association (EFTA)
Four European Free Trade Association states, namely, Iceland, Liechtenstein, Norway and Switzerland, have signed a Trade and Economic Partnership Agreement with India for facilitating trade and investment flows. While India has secured soft investment commitments under the Agreement, EFTA states have been given concession on import duty on pharmaceutical products exported to India and have been promised simplified customs procedure.
Source: bit.ly/3TuP8w9

Limits for automatic exemption in combination cases before CCI increased
The Indian government has increased the asset and turnover thresholds for automatic exemption under India’s anti-trust regulations. For claiming the exemptions from prior approval requirement, the value of assets being acquired should be Rs. 450 crores as opposed earlier threshold of Rs. 350 crores. Similarly, the turnover should be Rs. 1250 crores as opposed earlier threshold of Rs 1000 crores.
Source: bit.ly/3VaYle6

Electrical appliances for hair and skin care would require Indian Standard Marks for sale in India from 4th March 2025
The Department for Promotion and Industry and Internal Trade has published a Quality Control Order (QCO) which makes it mandatory for importers and manufacturers of skin and hair electrical appliances to obtain an Indian Standard Mark (IS mark) from Bureau of Indian Standards (BIS) in order to be able to sell in India. BIS grants rights to use IS Mark after testing and inspection of products and manufacturing facilities, both in India and abroad, and charges a fee on the products sold.
Source: bit.ly/4c8wSzW

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.

India takes baby steps in regulation of Artificial Intelligence, puts in place prior consent requirement before deployment of AI
India’s Ministry of Electronic & Information Technology has reportedly advised platforms and intermediaries which employ artificial intelligence (“AI”) models or generative AI software, algorithms to mandatorily obtain government approval before offering their services. Additionally, platforms or intermediaries using unreliable AI models or algorithms should label themselves as “under testing” and take explicit consent from users, making them aware of potential errors in the technology.
Source: bit.ly/430rwT8

Indian Government to hold discussions with private hospitals on capping of medical treatment rates
India’s Ministry of Health and Family Welfare is reportedly in discussion with major corporate hospitals on the possibility of capping of medical treatment rates. India’s Supreme Court last week had directed the Ministry to exercise its powers under Clinical Establishment Rules for prescribing ceiling prices of medical treatments, and threatened that if it did not do so, the Court will itself direct the Ministry to notify Central Government Health Scheme (CGHS) rates as ceiling prices for medical treatments across the country.
Source: bit.ly/3wGw6di

Eye drops in India may soon have to be sold in transparent bottles to detect contamination
India’s central drug regulator, the Drugs Controller General of India, has called a meeting with pharmaceutical manufacturer associations to propose the use of transparent bottles in packaging eye drops. It is expected that use of transparent bottles will help detect contamination and particulate matter, so that any damage to the eye due to contaminated or spurious eye drops may be avoided. Most eye drops are currently sold in opaque bottles.
Source: bit.ly/3UX4Lxv

Yogurt makers may lawfully claim that it can reduce the risk of type 2 diabetes: US FDA
The U.S. Food and Drug Administration has reportedly allowed dairy-based yogurt makers to claim that Yogurt may reduce the risk of type 2 diabetes. However, the US FDA has recommended that the claim may be used carefully in yogurts that contain high levels of added sugar.
Source: bit.ly/3STFDF2

Legal validity of US Medicare drug price negotiation program upheld
A federal judge in Delaware in US has upheld the legal validity of U.S government’s condition that manufacturers of Top 10 drugs which are used in Medicare health insurance program will have to reduce prices or stop supplying to the program. This is the third positive court ruling in favour of US Government in the last few weeks on the subject of price negotiations.
Source: bit.ly/4bZbOM8

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.

Major Indian Ayurvedic Medicine Manufacturer to be tried for Contempt of Court for publishing misleading drug advertisements
India’s Supreme Court is reportedly set to issue a Contempt Notice to a major Ayurvedic medicines manufacturer in India after it found out that the manufacturer had published a misleading advertisement claiming permanent relief for certain chronic conditions such as Diabetes and Liver Cirrhosis. In November 2023, the manufacturer had given an undertaking to the Supreme Court that it will not publish misleading advertisements or disparage allopathy. The Supreme Court has also questioned the Indian government for its inaction over publication of misleading advertisements by the manufacturer despite existence of a law which makes publication of misleading advertisement punishable with imprisonment.
Source: bit.ly/42U33yI

Doctors will have to obtain registration with State Medical Council of every State where they practice: Delhi HC
The High Court of Delhi has upheld the legality of a notice issued by Delhi Medical Council which made it mandatory for Doctors to register with the Council if they wanted to practice in the State of Delhi. The Doctors argued that it was an onerous requirement which would require them to register in every State they practice in. However, the Court held that the intent of the law is to require Doctors to register in every State that they practice in, and that Doctors have the option to register with multiple State Medical Councils in India.
Source: bit.ly/3TgHANw

Cosmetic Importers asked to provide sales details in a bid to curb import of counterfeit cosmetics
In an effort to curb the import of counterfeit cosmetic products, India’s Central Cosmetics Regulator, Drugs Controller General of India, has directed importers of cosmetics who import cosmetics already registered by authorized importers, to furnish annual sales details such as number of consignments, imported quantity, total cost of imported cosmetics of each consignment, along with warehouse details.
Source: bit.ly/42T2IMR

Central Government has to fix ceiling prices of medical treatment within 2 months: Supreme Court
The Supreme Court has directed the Central Government publish ceiling prices for medical treatments offered by Hospitals all over the country within 2 months. If the Central Government fails to do so, the Supreme Court has said that it will direct Central Government to fix medical treatment costs stipulated under Central Government Health Scheme as ceiling price of medical treatment offered by Hospitals for the whole country.
Source: bit.ly/3wsyHHs

India Seeks to delay implementation of EU Carbon Emissions Limits
India is set to conduct negotiation with the European Union regarding the implementation of the Carbon Control Regime, seeking a complete elimination of the Carbon Border Adjustment Mechanism, failing which India will seek an extension of timelines for reduction of emissions. It is expected that in order to comply with requirements under EU Carbon Control Regime, Indian exporters will have to make significant capital investment will increase cost of production.
Source: bit.ly/42S7DxH

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.

India’s new criminal law regime to take effect from July 1, 2024
The three criminal laws, namely, Bhartiya Nyaya Sanhita, Bhartiya Nagrik Suraksha Sanhita, Bharatiya Sakshya Adhiniyam that will replace the erstwhile the Indian Penal Code, 1860; Code of Criminal Procedure, 1898; and the Indian Evidence Act, 1872, respectively, will take effect from July 1, 2024. However, Section 106 (2) of the Bharatiya Nyaya Sanhita, 2023 which provides for punishment of “0-10 years” in “hit and run” cases, has been put on hold.
Source: bit.ly/3P13RMz
Source: bit.ly/3TbqvUU
Source: bit.ly/3wxhexO

Cosmetic Importers in India who are not directly authorized by foreign manufacturer must submit annual statement of import to Cosmetics Regulator
The Central Drugs Standard Control Organisation (CDSCO) has issued a circular reminding cosmetics importers who have obtained Import Registration Number (IRN) in Form Cos-4A, that is on the strength of prior import registration issued to an importer authorized by the foreign manufacturer, to provide annual statement of cosmetics imported in India from date of grant of IRN. The importers have also been advised to furnish details such as number of consignments, imported quantity, total cost of imported cosmetics of each consignment, along with warehouse details.
Source: bit.ly/49L6bzl

Timeline for obtaining Standard Mark for sanitary napkins, baby diapers and reusable sanitary pad/napkins extended to 1st October.
India’s Ministry of Textiles has extended the date of enforcement of Medical Textiles (Quality Control) Order, 2023 from 1st April to 1st October 2024. The said order requires that Foreign as well as Indian manufacturers of sanitary napkins, baby diapers and reusable sanitary pad/napkins to obtain a standard mark and label the products with a standard mark before the products are sold in India.
Source: bit.ly/3IjAWiV

Inspection of food manufacturers/processors in non-mandatory classes should be completed within 15 days: India’s food regulator
The Food Safety and Standards Authority of India (FSSAI) has issued an advisory to State Food Licensing Authorities for processing licensing applications of manufacturers of food categories which do not warrant mandatory inspection such as prepared foods, Indian sweets, egg and egg products, foodstuff intended for nutritional supplements. The FSSAI has advised that such applications should ideally be cleared without inspection, but if for some reason an inspection is deemed to be warranted, then such inspection should be concluded within 15 days from date when the application is marked for inspection.
Source: bit.ly/3wwHNTN

Germany legalises private cultivation and recreational use of cannabis
Germany has passed a law legalizing cultivation of up to three cannabis plants and for owning 25 grams of cannabis for private consumption. The law also permits establishment of cannabis clubs to facilitate consumption with a cap of 500 members. Germany has become ninth country to legalise private recreational use of cannabis.
Source: bit.ly/3OSK6a3

Posted on

TOP 5 HEALTH LAWS & 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.

New Departmental Guidelines for sampling of Spurious Drugs, Medical Devices and Cosmetics Published
India’s apex regulatory body for drugs, medical devices and cosmetics, the Central Drugs Standards Control Organization, has published revised sampling guidelines for inspectors to follow in various states. All inspectors are required to collect at least 9 samples of drugs, and 1 sample of cosmetic or medical device in each month. The inspectors are supposed to be alert about feedback received from citizens and doctors in deciding which drugs, cosmetics and medical device brands they ought to sample and test for compliance with laws.
Source: bit.ly/3SDnLym

Social Media companies asked by High Court to handover details of persons who fraudulently operated certain accounts and channels
The Delhi High Court has ordered major social media companies including Facebook and Telegram to disclose identities of users accused of misusing trademark of major venture capital firm to cheat users by soliciting bogus investments. The court has also ordered concerned social media companies to provide details on action they will take to prevent further violation.
Source: bit.ly/3HXkxAP

WhatsApp and emails may be used to send legal notices for demanding unpaid amounts: High Court
The Allahabad High Court has reiterated that notice in cheque bounce case sent by WhatsApp or e-mail will be considered valid notice for the purposes of recovery under The Negotiable Instruments Act, 1881, and it will be presumed to have been dispatched and served on the same day.
Source: bit.ly/48f8Xf6

Popular Party Drugs added to list of Psychotropic Substances
The Indian Government has added popular synthetic party drugs, ADB-BUTINACA, Alpha-PiHP and 3 Methylmethcathinone (3-MMC), to list of psychotropic substances and notified small and commercial quantity of these substances for the purpose of fixing quantum of punishment for unlawful possession. Possessing psychotropic substances without permission or prescription is an offence under Narcotic Drugs and Psychotropic Substances Act, 1985.
Source: bit.ly/48ghuhM

WHO recommends antibiotics which should be exclusively put to human use to reduce chance of antimicrobial resistance
The World Health Organization (WHO) has updated its Medically Important Antimicrobials for Human Use (WHO MIA List), and reclassified antimicrobial drugs on basis of potential impact on human heath to limit the use of identified antimicrobials in other populations such as in plants and animals. The WHO hopes that reducing use of critical antimicrobial drugs in other population will reduce pace of antimicrobial resistance.
Source: bit.ly/49eVll9

Posted on

Top 5 Health Laws & 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.

Innovator Pharma Company questions biosimilar trial on ground of non-procurement of comparator drug from authorized sources
A multinational pharmaceutical company has questioned the veracity of a biosimilar drug trial before India’s clinical trial regulator, The Drugs Controller General of India (DCGI), on grounds that the comparator drug, a biologic, was not procured from authorized sources, thereby putting clinical trial subjects at risk and casting shadow over appropriateness of the clinical trial.
Source: bit.ly/49tJmjj

Indian IPR regime well-equipped to handle AI generated works and there is no proposal to amend the law in context of AI generated content: Ministry of Commerce & Industry
India’s Minister of Commerce & Industry, while replying to a question in India’s parliament, has clarified that user of Generative AI should obtain permissions of owner of original copyrighted work processed by Generative AI technology before using the AI generated content for commercial purposes. The Minister further clarified that there is neither any proposal to create any separate right nor to amend the law in the context of AI-generated content.
Source: bit.ly/48cK4R8

Guidelines to distinguish nutraceuticals and drugs which have same or similar composition soon
The Indian Government has reportedly formed a high-level committee to address complaints that products which have identical or similar compositions are being approved as nutraceuticals, drugs or ayurvedic formulations, depending on the regulatory pathway chosen by the manufacturer. Under the current law, nutraceuticals are not permitted to make claims of treatment or cure on the label, however there are reports of non-compliance with this requirement.
Source: bit.ly/49bvaMb

Preparing a list of unvaccinated employees does not amount to violation of privacy: Madras High Court
India’s Madras High Court has held that the action of preparation of list of employees who have not received COVID-19 vaccinations and subsequent circulation of such list amongst employees of company would not amount to violation of privacy. The High Court was hearing a criminal complaint filed by an employee of the Company under Information Technology Act, 2000 on grounds that the Company had breached the said law sharing his personal information as part of list of unvaccinated employees.
Source: bit.ly/42yExmP

Couples seeking surrogacy on medical grounds are able to use donor sperm or egg, in spite of law to the contrary, by approaching a High Court
Following the precedent set by Supreme Court, the Bombay High Court has permitted two couples to use donor eggs for surrogacy owing to medical issues faced by the Couple. The development is important because The Surrogacy (Regulation) Rules, 2022 explicitly prohibits the use of donor gametes for surrogacy. In the past, Karnataka High Court has also granted similar reliefs to a couple facing medical challenges to conceive using own gametes while seeking a surrogate to deliver the baby.
Source: bit.ly/42yczHP

Posted on

Frequently Asked Questions on the New Menu Labelling Requirement for Food Service Establishments in India

FAQs on Food menu labelling

The packaging and labelling of food items served in a food service establishment in India is regulated by The Food Safety and Standards (Packaging and Labelling) Regulations, 2011 (“Regulations”). The Regulations were amended in August 2020 to introduce the concept of menu labelling for the first time in India. Menu labelling means the process of declaring the nutritional information, calorific value per serving, information about allergens, and the logo exhibition for vegetarian or non-vegetarian, as applicable, on the menu cards/boards/booklets of restaurants and hotels. The menu labelling directives have been in force since January 01, 2022. However, the food regulator had relaxed its stringent implementation till June 30, 2022 in order to grant some additional time to the food business operators to adopt to the menu labelling mandates. In order to ensure compliance to the Regulations, the food regulator will commence verification of the declarations by sampling food items listed on the menu cards/boards/booklets of the food business operators from July 01, 2022 onwards. Since, the date is approaching, we have put together a list of frequently asked questions (FAQs) with our responses in this article to facilitate the food business operators to adopt the practice of menu labelling in a self-compliant manner.

Please note that these FAQs are based on our understanding of the law, and under no circumstances should they be regarded as legal or professional advice or an endorsement of any industry practice.

Q. What is the new menu labelling requirement?

A. Owing to an amendment to The Food Safety and Standards (Packaging and Labelling) Regulations, 2011 in August 2020, a new sub-regulation (2.4.6.), i.e., ‘Display of information in food service establishments’ was inserted to the existing regulation 2.4 enlisting specific requirements/restrictions on the manner of labelling. This sub-regulation mandates declaration of calorie information of food items amongst other specific labelling proclamations. This sub-regulation has introduced India to the concept of menu labelling in line with the emerging global trend towards reshaping the conventional food systems.

Q. Who does the menu labelling requirement apply to?

A. The menu labelling requirement is applicable to food service establishments either having central license or outlets at 10 or more locations. However, food service premises operating for a period of less than sixty days in a calendar year (consecutively or non-consecutively) are exempt from the menu labelling mandate irrespective of whether they possess a central license or have outlets at 10 or more locations.

Q. Which restaurants are covered by the menu labelling requirement?

A. Restaurants having a turnover of more than Rs. 20 Crores per annum or outlets at 10 or more locations have to ensure compliance with the menu labelling requirement.

Q. Do caterers also have to comply with the menu labelling requirement?

A. Yes. Caterers having a turnover of more than Rs. 20 Crores per annum or outlets at 10 or more locations have to comply with the menu labelling requirement. However, event caterers operating for a period of less than sixty days in a calendar year (consecutively or non-consecutively) are exempt from the labelling requirement.

Q. Do departmental canteens at the premises of central government institutions also have to declare information on their menu?

A. Yes. Departmental canteens at the premises of central government institutions having a turnover of more than Rs. 12 Lacs per annum are mandated to comply with the menu labelling requirement.

Q. Do food service establishments involved in preparation and serving of food at airports/seaports also have to comply with the menu labelling requirement?

A. Yes. Food service establishments involved in preparation and serving of food at airports/seaports have to comply with the menu labelling requirement.

Q. Do Restaurants/Caterers/Canteens at the premises of Railway Stations also have to comply with the menu labelling requirement?

A. Yes. Restaurants/Caterers/Canteens at the premises of Railway Stations serving food items through a menu card/board/booklet and having a turnover of more than Rs. 12 Lacs per annum have to comply with the menu labelling requirement.

Q. Are the food delivery platforms also required to comply with the menu labelling requirement?

A. Yes. The menu labelling requirement is applicable to all e-commerce food business operators to the extent it is applicable to physical food establishments, i.e., e-commerce food business operators have to display the mandated declarations on their website/platform only for food items from those establishments which have a central license or outlets at 10 or more locations. The e-commerce food business operator can either get this information directly from the respective food business operators and update it on their online platforms or implement a feature on their web and/mobile applications that allows such restaurant chains to upload and exhibit the same information for every food that is offered for sale by the restaurant on the platform of the e-commerce food business operator.

Q. Is the menu labelling requirement also applicable to food items not listed on the menu of the food service establishment?

A. No. The menu labelling mandate is not applicable to special-order items or modified meals not listed on the menu of the food service establishments. The menu labelling mandate is also not applicable to self-serve condiments that are free of charge and not listed on the menu. In addition, the menu items prepared as per the request of the customer will also not attract a menu label irrespective of the mode and manner of sale.

Q. What declarations have to be mentioned against the food items on the menu card as per the menu labelling requirement?

A. The following information has to be declared against the food items displayed on the menu cards/boards/booklets of the food service establishments in a manner compliant to the provisions of the Regulations:

  • Calorific value (in kcal per serving and serving size) including the reference information on calorie requirements to be specified verbatim as “an average active adult requires 2,000 kcal energy per day, however, calorie needs may vary”
  • Information relating to allergens
  • Logo for vegetarian or non-vegetarian
  • Nutritional information
  • Information relating to organic food or ingredients, if claimed
  • Specific labelling requirements mandated under the Regulations relating to food products containing added monosodium glutamate, artificial sweeteners, caffeine, polyols, polydextrose, and plant stanol esters

Q. How can a food business operator determine the nutritive value of the food items displayed on their menu?

A. The calorie and nutrition information for food items can be determined by the food service establishments either by a laboratory testing and a nutrient analysis method or by manual calculation using the nutritive/calorific values of each of the ingredients provided by a credible scientifically-backed source. In the latter case, the food business operator will be required to retain physical or soft copy documentation/records of all such sources relied by him for determining the nutritive value of food items for the purposes of verification by the food safety officers, as and when required. On the other hand, the laboratory testing and nutrient analysis method is usually adopted by restaurant chains preparing standardized food items with standardized ingredients and recipes across their outlets.

Q. What if the nutritive value determined by a food business operator is not entirely accurate?

A. A deviation of up to twenty-five per cent is allowed by the regulator.

Q. What is the objective behind mandating the menu labelling requirement?

A. The objective behind introduction of the menu labelling mandate is to enable the consumers to make informed choices about their food purchases and promote public health.

Q. Is there any penalty for non-compliance with the menu labelling requirement?

A. Yes. Any non-compliance with the menu labelling requirement may initially attract an improvement notice from the designated officer under Section 32 of The Food Safety and Standards Act, 2006 directing compliance. If the food business operator fails to comply with an improvement notice, his licence may be suspended and even cancelled if the non-compliance with the improvement notice continues.