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.

Indian government may reconsider its decision of prohibiting manufacture of drugs and nutraceuticals, health supplements in same facility
The Indian government is reportedly reconsidering its decision to act against pharmaceutical companies who are manufacturing nutraceuticals, health supplements and drugs in the same facility, due to objections raised by small scale manufacturers. The previous Good Manufacturing Practices (Schedule M) for drugs gave some concession to manufacturers of drugs to manufacture nutraceuticals and health supplements in the same facility. However, no such concession exists under revised Good Manufacturing Practices (Schedule M) published in December 2023.
Source: bit.ly/3x59lQo

Exporters of Indian farm produce are facing phytosanitary challenges
Indian agricultural exports, including fruits and vegetables, are reportedly finding it difficult to enter regions like Europe, Australia, and the US due to tough phytosanitary requirements and thresholds such as high pesticide content. In response, India’s Commerce Ministry is reportedly creating a data set on export consignments of agricultural exports that were refused by European countries and other nations on grounds of phytosanitary non-compliances, resulting in significant trade hurdles regardless of duty relaxations. A phytosanitary certificate is required for the export of agricultural products to ensure that the produce is pest-free, disease-free, and meets other health requirements such as traceability at the farm level.
Source: bit.ly/4ctvxnB

Indian government has established Fact Check Units to check spread of fake news
The Indian Ministry of Electronics and Information Technology has appointed the Press Information Bureau of the Ministry of Information and Broadcasting as Fact Check Unit to address fake and misleading news against Central Government. The fact check unit of the central government is expected to vet all the online content related to the business of the central government. Any content identified as fake by the unit will be taken down from the internet.
Source: bit.ly/3Px3Yj8

The Centre gives more time to states to establish Allied Healthcare Councils
India’s Ministry of Health and Family Welfare has extended the timeline for states to establish state allied and healthcare councils by six months. State Governments have to setup State Councils for Allied Healthcare by November 2024. The National Commission for Allied and Healthcare Professions Act 2021, which regulates quality of allied and other healthcare professionals in India, will be operationalized once the State Councils have been established.
Sourve : bit.ly/3PxeZ4d

Integrated Veterinary Health Certificates (VHC) mandatory after 30th June,2024 for import of milk and milk products into India
The Food Safety and Standards Authority of India (FSSAI) has extended the deadline for implementing its decision to require imported food consignment of milk and milk products to be supported by an integrated veterinary health certificate. The requirement will take effect on July 1, 2024. From that date, only those milk and milk products that are supported by integrated veterinary health certificates will be allowed importation into India. The Integrated Veterinary Health Certificate must demonstrate that imported milk and milk products meet both the FSSAI’s food safety standards and the Department of Animal Husbandry and Dairying’s (DAHD) sanitary criteria.
Source: bit.ly/3TIh53F

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.

Panel of auditors to audit the promotional expenses of pharma and medical device companies will be appointed soon: Government
The Secretary, Department of Pharmaceuticals, has reportedly said that the government will appoint a panel of auditors who can undertake risk-based audits from time to time, to evaluate whether the promotional expenses, especially towards conferences and workshops, have been incurred in an ethical manner as per the Uniform Code for Pharmaceutical Marketing Practices 2024. Any discrepancy will be reported to the appropriate government agency or authority.
Source: bit.ly/49SNs5f

Industry welcomes the new Uniform Code for Pharmaceutical Marketing Practices
The pharmaceutical industry has reportedly welcomed the new Uniform Code for Pharmaceutical Marketing Practices (UCPMP). According to news reports, the industry feels that the new code is a step ahead towards the advancement of the industry as it ensures ethical and healthy engagement between the pharmaceutical industry and medical professionals.
Source: bit.ly/4a6SZWd

Nutraceutical and food supplement regulations are to be tightened further
The Food Safety and Standards Authority of India (FSSAI) is in the process of tightening the regulations for nutraceuticals and health supplements. This move was prompted by the receipt of several complaints by the FSSAI about the presence of non-compliant health supplements on the market and the fact that the over-the-counter availability of nutraceuticals and health supplements is resulting in people consuming supplements along with drugs, which increases the risk of adverse effects.
Source: bit.ly/3wXMsOU

A major e-commerce entity was fined Rs 25 lakh due to its inaction to remove counterfeit products from the marketplace
A State Consumer Commission in India has imposed a fine of Rs. 25 lakhs on a major e-commerce entity on the grounds that the e-commerce entity failed to correct the listing of a product, which it was aware was a counterfeit product. By failing to remove the listing, the Commission held that the e-commerce entity had engaged in dark patterns and unjust enrichment.
Source: bit.ly/3IBUsaH

EU to extend regulatory data protection for innovator drugs to 7.5 years
The European Union is set to extend regulatory data protection for innovator drugs to 7.5 years, with one extra year of incentives if the drug meets an unmet medical need and clinical trials are conducted in the EU. There is a proposal to grant an additional 3 years of protection from generics, taking the total protection to a maximum of 11.5 years.
Source: bit.ly/3IxEIWl

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

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

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.

Drug manufacturing facility cannot manufacture food products: Central Drugs Regulator
India’s Central Drug Regulator, The Drugs Controller General of India (DCGI), has directed the state drug licensing authorities to take action against the drug manufacturers who are also manufacturing nutraceuticals and health supplements in the same facility. Under Indian law, a drug manufacturing facility cannot be used to manufacture food products. Nutraceuticals and health supplements are regulated as food products in India.
Source: bit.ly/4bUWpwg

Methodology to calculate Green Credit against Tree Plantations notified
India’s Ministry of Environment, Climate and Forest Change, has notified the methodology for calculating green credit in respect of tree plantation under Green Credit Rules, 2023 which were notified under The Environment Protection Act, 1986. A person desirous of purchasing green credits will have to make an application to the Administrator. 1 tree planted will be equal to 1 green credit.
Source: bit.ly/3wGJgqo

A person cannot be prosecuted for food related offence under Food Safety Law and Indian Penal Code simultaneously: Supreme Court
The Supreme Court of India has held that, since The Food Safety and Standards Act, 2006 (FSSA) has effect notwithstanding any other law, a food related offence will have to be pursued under FSSA and not under a general law such as the Indian Penal Code, 1860 (IPC).
Source: bit.ly/48whOZJ

Period Safety Update Reports (PSURs) of new drugs will have to be submitted online, physical submissions will not be accepted
The Indian Central Drug Regulator, Central Drugs Standard Control Organization (CDSCO), will accept PSURs of new drugs, subsequent new drugs (SND), fixed dose combinations (FDC), biologicals and veterinary drugs only through online medium from 11th March 2024. A PSUR is required to be submitted for a period of four years after receipt of marketing permission.
Source: bit.ly/3wDqZKE

Indian Government is incentivizing domestic drug manufacturers to develop cost effective treatment for rare health conditions
India’s medical research body, Indian Council of Medical Research (ICMR), has reportedly invited domestic drug companies to develop localized treatments for “priority rare genetic disorders” and has offered assistance in pre-clinical, clinical research and regulatory approvals. The aim for this initiative is to encourage domestic drug companies to develop cost-effective treatments for rare health conditions by offering assistance in clinical research.
Source: bit.ly/4bQQ3y4

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.

Drug manufacturing facility cannot manufacture food products: Central Drugs Regulator
India’s Central Drug Regulator, The Drugs Controller General of India (DCGI), has directed the state drug licensing authorities to take action against the drug manufacturers who are also manufacturing nutraceuticals and health supplements in the same facility. Under Indian law, a drug manufacturing facility cannot be used to manufacture food products. Nutraceuticals and health supplements are regulated as food products in India.
Source: bit.ly/4bUWpwg

Methodology to calculate Green Credit against Tree Plantations notified
India’s Ministry of Environment, Climate and Forest Change, has notified the methodology for calculating green credit in respect of tree plantation under Green Credit Rules, 2023 which were notified under The Environment Protection Act, 1986. A person desirous of purchasing green credits will have to make an application to the Administrator. 1 tree planted will be equal to 1 green credit.
Source: bit.ly/3wGJgqo

A person cannot be prosecuted for food related offence under Food Safety Law and Indian Penal Code simultaneously: Supreme Court
The Supreme Court of India has held that, since The Food Safety and Standards Act, 2006 (FSSA) has effect notwithstanding any other law, a food related offence will have to be pursued under FSSA and not under a general law such as the Indian Penal Code, 1860 (IPC).
Source: bit.ly/48whOZJ

Period Safety Update Reports (PSURs) of new drugs will have to be submitted online, physical submissions will not be accepted
The Indian Central Drug Regulator, Central Drugs Standard Control Organization (CDSCO), will accept PSURs of new drugs, subsequent new drugs (SND), fixed dose combinations (FDC), biologicals and veterinary drugs only through online medium from 11th March 2024. A PSUR is required to be submitted for a period of four years after receipt of marketing permission.
Source: bit.ly/3wDqZKE

Indian Government is incentivizing domestic drug manufacturers to develop cost effective treatment for rare health conditions
India’s medical research body, Indian Council of Medical Research (ICMR), has reportedly invited domestic drug companies to develop localized treatments for “priority rare genetic disorders” and has offered assistance in pre-clinical, clinical research and regulatory approvals. The aim for this initiative is to encourage domestic drug companies to develop cost-effective treatments for rare health conditions by offering assistance in clinical research.
Source: bit.ly/4bQQ3y4

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

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.

E-Cigarette and ENDS ban in India: Analysis of laws, consequences and challenges

Last updated: June, 2019

May 31 is observed every year as the World Anti-Tobacco Day. On May 31 of 2019, The Indian Council of Medical Research (ICMR), the apex bio-medical research body of the Indian government, issued a  formal recommendation to ban the sale of e-cigarettes and electronic nicotine delivery systems (ENDS) through-out India. The ICMR recommendation has come at an opportune time since, very recently, the Delhi High Court has stayed the operation of a Central Government circular imploring various Indian States to ban ENDS. 

In this post, we have analyzed the current regulatory framework for the regulation of e-cigarettes and ENDS (hereinafter referred collectively as ENDS for convenience) to evaluate its scope and limitations, as well as decode the method of current regulation of ENDS under Indian law. We have also highlighted the consequences of violation of the ban, if any.

Legal and regulatory framework

Under Indian law, there are five distinct regulatory buckets in which ENDS may fall:

  1. ENDS as a combination product of drug and medical device
  2. ENDS as a tobacco product
  3. ENDS (nicotine) as food
  4. ENDS (nicotine) as a poison
  5. ENDS (nicotine) as an insecticide

We will deal with each regulatory bucket in the paragraphs below.

Combination of Drug and Medical Device

Preparations of nicotine are regulated as a drug in India. In fact, the sale of gums and lozenges containing more than 2 mg of nicotine requires a retail drug license.

As per a survey carried by the author, most States in India have regulated ENDS as a drug (since substances and devices are deemed to be drugs in India). Under the Drugs and Cosmetics Act, 1940 and its rules (“Drug Laws“), a license is required to import, manufacture and sell drugs. Wherever State Governments have banned ENDS, they have done so by refusing to issue a license to undertake any commercial activity related to ENDS on the grounds that ENDS is not approved for sale as a drug. This position has been endorsed by the Central Government as well, who had released in advisory for all States in India to that effect in August 2018.

Import, manufacture or sale of ENDS in violation of Drug Laws could result in confiscation, fine and imprisonment for the company involved as well as the person in charge of the operations of the company. 

However, two separate Delhi High Court orders have raised serious questions over the legal basis of the ban on ENDS. In Piush Ahulawalia v. Union of India, the Delhi High Court clarified that the Central Government’s advisory was not binding, and therefore the State Governments were free to chart their own course in terms of banning (or not banning) ENDS. In Focus Brand Trading India Pvt. Ltd. and Anr  v. DGHS and Ors., the Delhi High Court went a step ahead and questioned whether ENDS could be regulated as the drug in the first place. The March 2019 order passed in this matter effectively brings into question any ban enforced on ENDS on the assumption that ENDS is a drug.  A Customs notification released in November 2018 had made it mandatory that import consignments of ENDS would require prior approval of Additional Drugs Controller, Customs. The said notification has also been stayed by the March 2019 order. 

In the author’s own considered opinion, however, the government is well within its powers to regulate ENDS as a drug. It is a fact that nicotine is a drug. As per the current construct of Drug Laws, a drug when consumed for non-medicinal purpose would remain a drug and be regulated as one. Therefore, what is actually left to be established whether the system i.e. ENDS is drug or not. As most readers are aware, ENDS is just a system that delivers nicotine. Therefore, it is not a chemical but a device. Drug Laws do not regulate all devices. They regulate notified devices only and ENDS is not a notified device. Therefore, ENDS sans nicotine cannot be said to be regulated under the Drug Laws. But a combination of ENDS with nicotine (i.e. refill) should certainly qualify as a drug. There are enough instances where such combination products have been regulated as drugs in India in the past. For instance, a Glucometer by itself is not a drug (at least not until January 1, 2020). But a Glucometer when sold along with glucose strips is regulated as a drug, because glucose strips are regulated as drugs. This analogy squarely applies to ENDS sold with nicotine refills.

Having said that, what is important to remember that the Drugs Laws do not ban ENDS with nicotine refills. Therefore, it is possible to structure business operations in a manner that it would be lawful to carry out the business of ENDS with nicotine refills under a drug license in India. 

ENDS as a Tobacco product

Most jurisdictions around the world, including the US and Europe, regulate ENDS as a tobacco product. In India, tobacco products are regulated by law, but in a limited manner. The Cigarette and Other Tobacco Products Act, 2003 and its rules (“Tobacco Laws”) regulate advertisement, sale to minors and labelling of cigarettes and tobacco products, but stop short of giving power to the government to ban a tobacco product in India. In other words, the Tobacco Laws in India impose compliance requirements for cigarettes and tobacco products, but the government cannot use it to ban import, manufacture or sale of tobacco product in India so long as the tobacco products are compliant to the requirements stipulated by law. Interestingly, the definition of ‘tobacco product’ under Tobacco Laws is exhaustive, and it means any product that is listed in the Schedule to the main Act. ENDS is not listed in that Schedule yet. Therefore, it is strongly arguable that Tobacco Laws in India do not apply to ENDS at all. 

Suffice it is to say that the Tobacco Laws, as they exist today, do not (read cannot) ban the sale of ENDS with nicotine refills.

ENDS as food

Food in India is regulated by the Food Safety and Standards Act, 2006 and the rules and regulations made under it (“Food Laws”). The definition of “food” under India’s Food Laws extends to substances in the form of liquid, gas or vapour. Therefore, nicotine, when consumed in form of gas or vapour, may qualify as food. The consumption of nicotine as a food ingredient has been specifically banned under Food Laws. States such as Tamil Nadu and Union Territories like New Delhi have also issued notifications (1, 2) banning “all food products chewable or otherwise… containing tobacco and/or nicotine as ingredients” in public interest for successive periods of one year.

This makes it unequivocally clear that any food containing nicotine cannot be sold in India. It is but natural to conclude that the language of the ban would engulf ENDS with nicotine refills as well. A violation of Food Laws could result in confiscation, fine and imprisonment for the company involved as well as the person in charge of the operations of the company. 

However, the ban on products containing nicotine imposed through food laws is not without controversy. Over the last few years, different High Courts have given contrary decisions on whether tobacco products should be regulated exclusively under Tobacco Laws or both Tobacco and Food Laws. A February 2019 Madras High Court judgement has highlighted this contrarian position as well. Therefore, until the Supreme Court of India decides on this issue, it is possible to argue today that ENDS with nicotine refills should not be regulated as food, but rather as a tobacco product and be governed exclusively by the Tobacco Laws (which incidentally does not give power to the government to ban ENDS). This means that the ban on nicotine as food or food ingredient may have no bearing on ENDS with nicotine refills. 

ENDS as a poison

India regulates import and sale of poisons, in the same manner as drugs. A license is required to import or sell poisons. The difference between drug regulation and poison regulation is that every state has the power to notify any chemical as a poison and regulate it (this legal position has been upheld by Supreme Court as well). Thus, given the ambiguity surrounding the application of drug regulation to ENDS, some states in India have decided to notify nicotine as a poison under the Poisons Act, 1919 and thus regulate ENDS. For instance, Punjab has regulated nicotine as a poison since 2014.

A violation of the Poisons Act, 1919 could result in confiscation, fine and imprisonment.

Again, like drug regulations, the Poisons Act, 1919 does not ban the sale of ENDS with nicotine refills. Therefore, it is possible to structure business operations in a manner that it would be lawful to carry out the business of ENDS with nicotine refills under a poisons license in India.

ENDS (nicotine) as an insecticide

The chemical, Nicotine Sulphate, and preparations made out of it, have been identified as insecticide under the Insecticides Act, 1968. Any person desiring to import or manufacture or sell an insecticide requires regulatory clearance from the government.

However, Insecticides Act, 1968 itself exempts “Any substance specified or included in the schedule or any preparation containing any one or more such substances, if such substance or preparation is intended for purposes other than preventing, destroying, repelling or mitigating any insects, rodents, fungi, weeds and other forms of plant or animal life not useful to human beings“. Due to the said exemption, the fact that nicotine sulphate and its preparations are insecticides has no bearing for ENDS with nicotine refills, because it not intended to be used as an insecticide.

Takeaways

On the strength of the above analysis, it is difficult to say that trade in ENDS has been conclusively or comprehensively banned in India. It is true that some states such as PunjabTamil Nadu and Karnataka have banned the trade of ENDS within their territory, but such a ban does not appear to have a very strong backing of a statute. This becomes more evident as one peruses the actual text of the administrative orders through which the ban has been imposed, because there is hardly, if any, statutory provision cited in those orders to support the ban and the government appears to be relying solely on “public interest” to support its stance. Numerous media reports (12) have also indicated that the government is struggling to find a way to ban ENDS. Therefore, it appears that the stage is set for the courts, especially the Supreme Court, to clarify the position on the so-called ban on ENDS in India. Until then, it cannot be said that it is not possible to do the business of ENDS in India.