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Pricing Information of Medical Devices Marketed in India to be Submitted to National Pharmaceutical Pricing Authority (NPPA) by March 10, 2021

India’s medical device price regulator has issued a direction to importers and manufacturers of 24 categories of medical device to submit price-related information, including the price at which they sell medical devices to distributors and hospitals in India, by March 10, 2021.

Background

In India, medical devices are regulated not just for quality, but also for price. The Drug (Price Control) Order 2013 (“DPCO”) regulates prices of all medical devices that are marketed in India. Some medical devices such as coronary stents, drug eluting stents, condoms and intra-uterine devices that are listed in the schedule of DPCO have their ceiling price fixed by the National Pharmaceutical Pricing Authority (“NPPA”), while all other medical devices (i.e. the non-scheduled medical devices) have to abide by a restriction whereby their maximum retail price cannot increase by more than 10 per cent in any given 12-month period.

Direction

In order to ensure that medical device manufacturers and importers are complying with the requirements of DPCO, the NPPA has been given powers under DPCO to issue directions to manufacturers and importers to submit price related information. It is in furtherance of this power that NPPA has directed that the following information be submitted to it:

  • Medical device category as per risk classification published by DCGI
  • Product name or specifications
  • Brand name or description
  • Date of launch in India
  • Minimal unit of sale/retail pack size
  • Price per unit to distributor / stockist
  • Price per unit to hospital
  • Price per unit to retailer
  • Applicable GST percentage
  • Moving Annual Turnover
  • Maximum retail price for unit as on January 1 of the years 2018, 2019, 2020 and 2021 (for a few categories, only the MRP as on January 1, 2021 needs to be submitted)

A copy of the said direction is available at this link.

24 Categories of Medical Devices covered by the Direction

Disposable Hypodermic SyringesDisposable Hypodermic NeedlesDisposable Perfusion SetsIVD devices of HIV, HBsAg and HCV
CathetersIntra Ocular LensesI.V. Cannulae       Bone Cements     
Heart ValvesScalp Vein SetOrthopedic ImplantsInternal Prosthetic Replacements      
Ablation DevicesOrgan Preservative SolutionBlood Grouping SeraLigatures, Sutures and Staplers
Tubal RingsSurgical DressingsUmbilical tapes     Blood/Blood Component Bags
NebulizerBlood Pressure Monitoring DeviceDigital ThermometerGlucometer

Challenges with submitting price for retailer

There may be certain fields for which information has been requested by NPPA, but the information may not be available with the importers or manufacturers. For example, the details of price to retailer sought by NPPA may not be available since importers and manufactures typically sell to a distributor or hospital, and not directly to a retailer. In such cases where the information is not available due to the nature of the manufacturer’s or importer’s business model, the importer or manufacturer may simply submit to NPPA that the information is not available with them. The importer or manufacturer is not expected to retrieve this information from its supply chain and submit to NPPA. Being in possession of such information may in fact result in breach of anti-trust laws, as an attempt to undertake resale price maintenance.

Sale of imported medical devices marketed by marketer

Some importers import and sell directly to a marketer in India. In that case, it is the marketer who is supposed to provide this information as price related information is not available with the importer. However, the importer should ideally endorse and countersign the information submitted by marketer because the primary obligation to submit this information is with the importer. Alternatively, the importer may submit whatever information that it has and give a written undertaking along with the submission that the remainder of the information will be submitted by the marketer because the remaining information is unavailable with the importer.

Requirement of license

The direction also contains a note which states that manufacturers and importers must attach a copy of the licence obtained from the DCGI for each medical device. It may be difficult to furnish the manufacturing licence for Class A and Class B medical devices (such as Glucometer). The said licence is actually issued by State Licencing Authority of the state where the medical device is manufactured. In order to comply with the requirement of the direction, a copy of the licence issued by State Licencing Authority should be annexed in place of copy of license from DCGI.  

Format for submission

All the above information has to be certified by a qualified chartered accountant or cost accountant in a physical format, and the same information is also required to be sent in form of an Excel Sheet to the NPPA at the following email ID medicaldevices-nppa@gov.in

What should manufacturers and importers of medical device take this direction very seriously?

Any non-compliance with the direction of NPPA to submit price information may result in criminal prosecution under provisions of Essential Commodities Act of 1955.

The information will also be used to ascertain whether any manufacturer, importer or marketer has fixed the MRP of the medical device in excess of ceiling price or has increased the MRP over the permissible 10 per cent limit in a 12-month period. In both these cases, the NPPA has the power to recover the excess price paid by the end-consumer from the importer or manufacturer, and to levy a penalty for overcharging in certain cases.

That apart, the information will most likely be used by NPPA to track  or validate the market share of various medical devices and medical device manufacturers in terms of moving annual turnover (MAT) of said medical device under the submitted medical device category. If, at any time in future, a medical device is inserted in the schedule of DPCO on the grounds of essentiality to the Indian population, then the market share in terms of MAT will become an important consideration before NPPA in fixing the ceiling price that medical device.

Therefore, manufacturers and importers of the 24 categories of medical devices listed above must take this exercise seriously and submit the requisite data to the NPPA in prescribed form within timelines, both in physical and electronic format.

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Legal Considerations for Awareness Campaigns on Persons with Disabilities in India

Legal Considerations for Awareness Compaigns on Persons with Disabilities in India

Across the world, December 3 is observed as the International Day of Disabled Persons. The United Nations has designated it as a day that “aims to promote the rights and well-being of persons with disabilities in all spheres of society and development, and to increase awareness of the situation of persons with disabilities in every aspect of political, social, economic and cultural life.”  The United Nations Convention on the Rights of Persons with Disabilities (CRPD), which was signed and ratified by India, charts out a tangible path for realising this goal.

India enacted the Rights of Persons with Disabilities Act in the year 2016 pursuant to its obligations under the CRPD. The Act defines person with disability as “a person with long term physical, mental, intellectual or sensory impairment which, in interaction with barriers, hinders his full and effective participation in society equally with others” and specifies a total of 21 physical, intellectual and mental disabilities as well as disabilities due to chronic neurological conditions and blood disorders.

Amongst other things, the law calls for greater public awareness in a bid to break the stigma, discrimination and ostracization faced by people with disabilities. In recent years, there has been a spurt in campaigns – largely digital – aimed at a establishing a more inclusive society. While these should, without a doubt, be encouraged, there are certain legal considerations that should be kept in mind.

Web Accessibility

While this requirement is not yet embedded in the law, it seems counterintuitive to have campaigns that the primary beneficiaries do not have access to. Nonetheless, web accessibility is still in its formative stages in India. The Rights of Persons with Disabilities Rules, 2017 requires that every establishment (government and private) maintains a website that is accessible to the disabled. This mandate was scheduled to come into effect on June 15, 2019, but as of date, the Government has only released the standards for government websites, and it yet to notify the standards applicable to private entities’ websites. In addition to complying with the standards, the documents on the website must be in a text-to-speech compatible Electronic Publisher or Optical Character Reader based PDF format.

As a matter of good practice, businesses should move towards accessible websites. There are plenty of resources online, most notably the Web Content Accessibility Guidelines. If not entirely, businesses may choose to incorporate at least a few of the tools and tactics to make their websites more accessible.

It should also be noted that all organisations are required to have an Equal Opportunity Policy, which outlines the measures that the organisation has taken to implement the provisions under this law. It should, inter alia, contain a statement verifying that it has the requisite barrier-free accessibility, facilities, amenities and assistive devices that are required for a person with disability to be able to discharge their duties, thereby making it an inclusive organisation. This policy should be displayed on the business’ website, or, if they do not have a website, in a conspicuous location within the premises.

Data Protection

The extent to which data protection is an applicable varies largely depending on the nature of the campaign. If it’s an entirely social- or programmatic-based campaign, the entity organising the campaign gets access to only aggregated and anonymised data, which does not demand a high level of compliance. If the campaign directs the user to a website where they need to register, however, it is far more onerous. The website must contain a detailed privacy policy – ideally optimised to be accessible for persons with disabilities – outlining the data that is being collected, the purpose of its collection, who it will be shared with and why, how it will be protected, and how the person may withdraw their consent for the collection, processing and storage of such data. Given the sensitive nature of the data, strong security systems should be implemented.

Community Guidelines

Social media has come to be synonymous with the freedom of speech and expression, which has made it a catalyst for change. In the last few years alone, a number of movements have been waged and amplified over the internet. However, most platforms have strict policies which specify the type of content that is permitted and prohibited on the platform. Most policies unequivocally prevent any type of content that can be viewed as or that promotes bullying and harassment, hate speech, or discrimination against protected classes, which includes persons with disabilities. Content that can be considered triggering is also generally discouraged. We recommend going through the relevant platform’s community guidelines and tailoring the content to ensure that it does not violate or promote violations, since that may diminish the reach of the post.

Targeting Content

While targeting a campaign specifically at relevant stakeholders is one of the biggest USPs of digital campaigns, there are certain restrictions in place that would hamper a campaign with persons with disabilities as their target group.

Google’s (and YouTube’s) policy states that “Advertisers can’t use personal hardship categories to target ads to users or to promote advertisers’ products or services” and clarifies that this includes disabilities, even when content is oriented toward the user’s primary caretaker.

 Similarly, Facebook’s policy states that “Ads must not contain content that asserts or implies personal attributes. This includes direct or indirect assertions or implications about a person’s race, ethnic origin, religion, beliefs, age, sexual orientation or practices, gender identity, disability, medical condition (including physical or mental health), financial status, voting status, membership in a trade union, criminal record, or name.”

Unintended Consequences of the Comment Section 

The comment section for posts about social justice issues like disability are often filled with an overwhelming amount of compassion, with complete strangers bonding over their struggles and experiences. While fostering a strong sense of community is aspirational, it is not without risk. The most obvious is the strong likelihood of hate speech erupting: which is not only undesirable on a humane level, but also a violation of platform policies and the law. Secondly, it results in the somewhat inadvertent collection and sharing of highly sensitive personal data, that can be misused by absolutely anyone to discriminate against persons with disabilities. While these issues may not have direct legal ramifications for the campaign organiser or poster specifically, they are highly undesirable. We would recommend seriously considering the pros and cons of keeping the comments section disabled (no pun intended whatsoever).

Testimonials

A great deal of caution must be used while using testimonials from persons with disabilities, their family, friends or caretakers, or medical and allied healthcare professions. Waivers should be obtained, in writing, prior to using such content. Personal information of persons with disabilities should not be disclosed unless explicitly consented to, and even then, should be avoided. While collaborating with medical or allied healthcare professionals, ensure that the content is not positioned as medical advice, a diagnosis or a tool for self-diagnosis. Encourage viewers to seek professional help if required. Most importantly, ensure that persons with disabilities are not shown in a bad light.

Conclusion

To conclude, it would be unpragmatic to not use the platforms that we have access to today to spread awareness about the many issues that plague society, and to work towards a better tomorrow. However, exercise caution while doing so to avoid inadvertently violating the law.

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The use of cannabis leaves in Indian ayurvedic medicine – legalities and limitations

In India, the use of cannabis and cannabis leaves in medicines has caught public imagination. Contrary to popular perception, the use and consumption of cannabis and cannabis leaves is not entirely prohibited in India. It is permitted for medical and scientific purposes, subject to compliance with applicable laws. In this article, we have discussed the legality of use of cannabis leaves in pharmaceutical and ayurvedic medicines.

What are the laws that regulate use of cannabis leaves in medicines in India?

There are two sets of laws that regulate the use of cannabis leaves in medicines – The first set of laws treat cannabis leaves as a potential narcotic drug, and the second set of laws treat cannabis leaves as an intoxicant and a taxable item, i.e. as a source of revenue for the Government.

Narcotic drugs

The Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act) regulates the use of narcotic drugs in medicines India. In context of cannabis, it identifies three things as narcotic drugs: 1. The cannabis plant as a whole, including its parts such as leaves; 2. Cannabis, i.e. the flowering or fruiting top of cannabis plant when separated or not from the cannabis plant; and 3. Resin of the cannabis plant, when separated from the cannabis plant (popularly known as Charas or Hashish).

The NDPS Act treats cannabis leaves as ‘narcotic drug’ only when: 1. They are attached to the cannabis plant; 2. When they are separated from the cannabis plant but are not separated from its flowering or fruiting tops; and 3. If they contain resin from the cannabis plant.

So, leaves of cannabis plant are not regulated as narcotic drugs in India under the NDPS Act. They are regulated as narcotic drug only when they are associated with a narcotic drug, i.e. when they are attached to the cannabis plant or its flowering or fruiting tops or when they contain resin from the cannabis plant. This legal position has been upheld by Indian courts and accepted by the Indian Government.

Intoxicant

Each State in India has an excise law, for example, the Madhya Pradesh Excise Act, 1915. These laws are also sometimes referred to as prohibition laws, for example, the Maharashtra Prohibition Act, 1949. The purpose of these laws is to control access to intoxicants, and to give powers to the State Government to charge a duty on the manufacture and supply of intoxicants.

Almost all state laws in India identify cannabis leaves as an intoxicant, like they identify alcohol as an intoxicant. This means that cannabis leaves cannot be produced (i.e. separated from the cannabis plant) or used for commercial purposes without a license. For example, if a manufacturer of medicine wishes to use cannabis leaves in its medicines, it ought to have an appropriate license to procure cannabis leaves and to use it for medicinal purposes. Needless to say, the manufacturer will also have to pay a ‘duty’ (or tax) for procurement of cannabis leaves.

Why is the use of cannabis leaves more prevalent in ayurvedic medicines than in pharmaceutical medicines?

The marketing of medicines in India is regulated by Drugs and Cosmetics Act, 1940 (DCA). At present, there is no pharmaceutical medicine containing cannabis or cannabis leaf (or cannabinoids) that is approved under DCA for sale in India. If any pharmaceutical manufacturer were to introduce a cannabis or cannabis leaf based medicine in India, it would have to first undertake clinical trial of such medicine and establish its safety and efficacy.  Undertaking clinical trials is an expensive and time-consuming process. To add to that, cannabis is hardly cultivated officially in India. So, it is difficult to procure standard quality cannabis or cannabis leaf that may be required in the manufacture of pharmaceuticals containing cannabis or cannabis leaf or their extracts.

However, Ayurveda as a branch of medicine explicitly recognizes use of cannabis and cannabis leaves in manufacture of ayurvedic medicines. This means that if a standard ayurvedic medicine is to be manufactured which contains cannabis or cannabis leaves, then no clinical trials have to be undertaken prior to its commercial launch. This makes ayurvedic system of medicines an obvious choice to manufacture and sell cannabis and cannabis based medicines.

Why manufacturers choose to use cannabis leaves over cannabis in ayurvedic medicines?

There are chemicals in cannabis that have medical properties. These chemicals are commonly referred to as cannabinoids. Of the many cannabinoids, cannabidiol (CBD) and tetrahydrocannabinol (THC) are the most sought after for their medicinal properties.

Both CBD and THC are found in significant quantity in the flower and the bud of the cannabis plant. Their percentage in leaves of the cannabis plant is relatively insignificant.

However, the use of cannabis leaves in medicines is preferable to cannabis in general. There are two reasons for it. First, it is relatively easy to procure cannabis leaves as they are not regulated as ‘narcotic drugs’. Second, cannabis leaf-based medicines do not require license to sell in each state under the NDPS Act as cannabis-based medicines do.

Are there any specific labelling declarations that are applicable to manufacturers of ayurvedic medicines made out of cannabis leaves?

Manufacturers of ayurvedic medicines containing cannabis leaves or extracts must put the following declaration “Caution: to be used taken medical supervision” in English and Hindi on the label of the medicine, if the medicine is for internal use. As per an advisory issued by Ministry of AYUSH, these medicines should be sold under a prescription of a registered medical practitioner. They are not required to be labelled as “NRx”, however, since these medicines are not narcotic drugs.

What is the limitations of use of cannabis leaves in ayurvedic medicines?

The manufacturers of ayurvedic medicines containing cannabis leaves or its extracts must be careful to not use resin that may be deposited on the leaves of the cannabis plant for preparation of medicines. The resin found on any part of the cannabis plant (including leaves) is considered narcotic, and its use in ayurvedic medicine will make the ayurvedic medicine a narcotic drug, which in-turn will invite several additional compliances such as manufacturing quota, mandatory sale license and record-keeping.

The manufacturers should also be careful to not disturb the natural balance of cannabinoids as found in leaves of cannabis plant, while using cannabis leaves or its extract in the medicine. One of the cannabinoids, THC, is known for its psychoactive properties and is regulated as a psychotropic substance under NDPS Act. If the cannabis leaves are used specifically to extract THC out of cannabis leaves for subsequent use in ayurvedic medicines, then there is a risk that the ayurvedic medicine may be regulated as a psychotropic substance under NDPS Act, thereby inviting additional compliances.

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Legality of use of CBD Oil in India, and why NDPS Act does not apply to it

CBD Oil Legality India

Recreational use of Cannabis (Ganja) and its resin (Charas or Hashish) was outlawed in India in 1985 by the Narcotic Drugs and Psychotropic Substances Act, 1985 (“NDPS Act”). The NDPS Act itself was the result of India’s commitment under the Single Convention on Narcotic Drugs, 1961 (“Single Convention”). Interestingly, neither the NDPS Act nor the Single Convention outlawed the medical use of cannabis. Nevertheless, medical use of cannabis is almost non-existent in India.

The ground reality is that most State Governments in India are reluctant to issue a license to cultivate and grow cannabis, even though the NDPS Act empowers them to do so. Therefore, almost all cannabis that manufacturers of cannabis-based medicines have access to grows in the wild. Because the cannabis plant grows in the wild with little to no human intervention, there is very little scope for quality control and standardization of the cannabis, which is essential to manufacture a cannabis-based medicine. This poses a big challenge for manufacturers and discourages them from manufacturing cannabis-based medicines at a meaningful scale.

The NDPS Act, however, does not apply to the leaves and seeds of cannabis plant when they are separated from the flowering or fruiting tops of the plant, which are its most intoxicating parts. This is why Bhang (cannabis plant leaf) is sold freely in most States in India, subject of course to Excise Control, since it is still an intoxicant.

As the leaves of cannabis plant are relatively easy to access, there is massive potential for its use in medicine. One of the key chemicals (or cannabinoids) present in cannabis, including in its leaves, is CBD or Cannabidiol. CBD possesses medicinal properties, but not narcotic properties. The World Health Organization (WHO) itself has recommended its exclusion from Single Convention because it “does not have psychoactive properties and has no potential for abuse and no potential to produce dependence”.

Most CBD Oils sold in India (including over internet) are in fact made out of full-spectrum extracts of the leaves of the cannabis plant, meaning they contain all the cannabinoids, including CBD, that are present in the leaves. Since the leaves of cannabis plant are not considered to be a narcotic drug, CBD Oil made out of extract of the leaves should also not be treated as narcotic drug. In other words, consumption of CBD Oil manufactured from leaves of the cannabis plant should not attract provisions of the NDPS Act.   

In fact, CBD Oil manufactured under a license issued under the Drugs and Cosmetics Act, 1940 may be legitimately used by individuals for medical purposes in India.

It is easy to confuse CBD oil with cannabis or hash oil, but the two are vastly different, both in terms of pharmacology and legal treatment: cannabis or hash oil, unlike CBD oil, is 100% narcotic and is subject to strict monitoring and control in India as per provisions of NDPS Act. Its consumption may also attract provisions of NDPS Act and may result in imprisonment.

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Indian Law on advertisement of brand extensions of alcohol and tobacco products and how it poised to become tougher

India’s Ministry of Information & Broadcasting (MIB) recently put out an advisory for private satellite TV channels to ensure that liquor, tobacco and other intoxicants are not advertised directly or indirectly on their channels in violation of existing law, i.e. the Cable Television Network Rules, 1995 (CTNR). Under CTNR, satellite TV channels are prohibited from carrying out an advertisement that directly or indirectly promotes sale or consumption of liquor, wine, cigarettes and tobacco products.

However, advertisement of brand extensions of liquor and tobacco products is permitted under CTNR, provided the product sold under the brand extension does not make direct or indirect references to the prohibited product, it is distributed in reasonable quantity and is available in a substantial number of outlets, and the proposed expenditure on the advertisement of the brand extension product is not disproportionate to the actual sales turn-over of that product.

The enforcement of the provisions of CTNR has been indirectly delegated to a self-regulated industry body called Advertisement Standards Council of India (ASCI) by way of an amendment to CTNR that prohibits TV channels from running any advertisement that violates ASCI’s Code of Self-Regulation in Advertising (ASCI Code). The ASCI Code has a section titled “Guidelines for Qualification of Brand Extension Product or Service”, which as the name suggests, sets out the standards for what would pass as a brand extension and what would not.

As per the ASCI Code, for an advertisement to qualify as a genuine brand extension advertisement (i.e., by implication, not a surrogate advertisement), the in-store availability of the product sold under the brand extension must be at least 10% of the leading brand in the product category OR sales turn-over of the product must exceed INR 5 Crore (50 million) annually or INR 1 Crore (10 million) in the state where the product is distributed. This is a fairly high threshold by Indian standards and many leading brands, including those that put out Music CDs, have been unable to achieve them.

Consequently, some advertisers of liquor and tobacco products have turned to the internet as a media to advertise brand extensions. This is primarily because the CTNR does not apply to advertisements over the internet, there are no clear guidelines for content regulation over the internet, and until very recently, ASCI did not actively track advertisements over the internet.

This is set to change soon. Under the newly notified Consumer Protection Act, 2019 (CPA), the Central Consumer Protection Authority (CCPA) has the power to investigate manufacturers and services providers for misleading advertisement and impose a penalty up to INR 10 lakh (1 million) for the first violation and up to 50 lakh (5 million) for a subsequent violation. The scope of advertisement coved by CPA extends to advertisements over the internet, including in the electronic media, and therefore would cover misleading advertisements made over the internet or electronic media. The CCPA has recently published a draft of Central Consumer Protection Authority (Prevention of Misleading Advertisements and Necessary Due Diligence for Endorsement of Advertisements) Guidelines, 2020 (Draft Guidelines) to discuss what it would consider to be a misleading advertisement. Surrogate advertisements are deemed to be misleading advertisement under the Draft Guidelines, and therefore will be prohibited once the Draft Guidelines are finalized.

The Draft Guidelines do make an exception for brand extension. An advertisement of brand extension will be permitted only if “the advertisement is produced and distributed in reasonable quantities, having regard to the scale of the advertising in question, the media used, and the markets targeted”. In absence of any specification on what would constitute “reasonable quantity”, it is quite likely that CCPA may refer to the ASCI Code to determine what is “reasonable” for the industry, after all, ASCI is a self-regulatory body of the industry. In the event that happens, the high current thresholds for ‘genuineness’ of brand extension advertisement under ASCI Code will be extended for determination of “misleading advertisement” under Consumer Protection Act, 2019, and that may make advertisement of brand extensions more difficult in India than it already is.

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Draft risk classification of all yet-to-be regulated medical devices and IVDs in India published, comments invited until Oct. 2

In February of this year, India’s Health Ministry had notified a new definition of medical devices with an intent to bring all medical devices under the purview of Medical Devices Rules, 2017 (MDR). Prior to such notification, only 37 categories of medical devices that it had notified were regulated by MDR. The new definition took effect from April 1, 2020, which means that MDR started applying to all medical devices from April 1, 2020. However, an exemption from applicability of MDR was added until August 11, 2022 for Class A (low risk) and Class B (low-medium risk) medical devices, and until August 11, 2023 for Class C (medium-high risk) and Class D (high risk) medical devices, in order give time to industry to acclimatize itself to the new regulatory framework of MDR and to obtain appropriate medical device quality certification such as ISO 13485 from designated certifying bodies.

After the development in February, since MDR regulates medical devices on the basis of their risk classification, there was always a question as to how will these yet-to-be regulated or (more appropriately) newly regulated medical devices will be classified. Unlike most countries, risk classification of medical devices is determined in India by the regulator, Drugs Controller General of India (DCGI), itself as per parameters of risk classification stipulated in First Schedule of MDR, and there is no room for dialogue or consultation with the regulator once the risk classification has been concluded.

The DCGI has now done its preliminary assessment and published a draft of medical device risk classification covering all medical devices for public comments. Medical devices have been split into 24 categories (Anethesiology, Pain Management, Cardiovascular, Dental, ENT, Gastroenterlogical, Urological, General Hospital, Operation Theatre, Respiratory, Neurological, Personnel Use, Obstetrical and Gynecological, Ophthalmic, Rehabilitation, Physical support, Interventional and Radiology, Rheumatology, Dermatology, Plastic Surgery, Pediatric and Neonatology Medical, Oncology, Radiotherapy, Nephrology and Renal care and Software). IVD devices have been split into 3 categories (IVD Analyzer, IVD Instrument and IVD Software).

There are some surprises in the risk classification. Sanitary pads, menstrual cups and tampons are sought to be regulated as medical devices. Fertility and conception software are sought to be regulated as medical devices. Birthing bath and new-born infant bed are also sought to be regulated as medical devices.

It is extremely important that the impacted companies review the draft risk classification and provide comments to DCGI before October 2, 2020 regarding either the inapplicability of law i.e. MDR to their products, or the inappropriateness of risk classification assigned by DCGI. Once the risk classification is finalized, it may not be revised for some time. Also, once MDR starts applying to a medical device, other laws such as Drugs (Prices Control) Order, 2013 will also start applying to such medical device.

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Dedicated portal for online filing of consumer grievances under new consumer protection law in India now live

The Consumer Protection Act, 2019 (CPA) was enforced on July 20, 2020 and it replaced the decades old The Consumer Protection Act, 1986. One of the key features of the CPA is the option with consumers to file a complaint electronically. The portal where consumers can file their complaint electronically is now live at the following URL: https://edaakhil.nic.in/ and will be formally inaugurated on September 18, 2020.

It has step-by-step instructional manuals for consumers on how to register, file a consumer complaint, file written response (as opposite party), file a rejoinder to a complaint, file first appeal and so on. There is no need for consumers to file brief of written arguments if consumers are representing themselves. The said portal will initially accept filing for matters before the State Commissions and the National Commission and not for matters before District Commission, meaning that it will only accept complaints where the consideration for good or services paid exceeds one crore (Rupees 10 million), or where an appeal has been preferred against an order of District Commission.

Needless to mention, the portal will accept filing from advocates who represent consumers before a consumer commission as well.

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Legality of making COVID-19 defence or immunity claims in India

India’s central drug regulator, the Drugs Controller General of India, has reportedly served a notice on a major FMCG company in India to explain why action should not be taken against it for making a misleading claim that its hand sanitizer is a “immunity booster” and that it “kills inactive coronavirus”. This points to an increasing trend amongst FMCG Companies who are making COVID-19 or corona virus related claims to capture the hygiene market. The basis for these claims are various World Health Organization (WHO) and scientific reports that have found that ethyl alcohol or isopropyl alcohol is effective in killing the viruses of corona virus family (including SARS-CoV-2) when used over a certain concentration. However, these tests are done in strict laboratory condition and the viruses are exposed to the active ingredients over a period of time to yield result, which does not typically happen in everyday usage of the product. More importantly, it may not be proper to “logically” extend the findings of external scientific reports to any formulation that carries the same active ingredient as the laboratory drug, for the simple reason that in the event of an inquiry, it will be almost impossible for a company to actually test its product for “immunity” or “killing” properties against corona viruses as these viruses are not available in private labs for testing and are generally considered as health and environmental hazards. Therefore, a very clear assessment of risks versus benefit must be done before making a COVID-19 or corona virus related claim for a formulation. In fact, India’s regulator for alternative systems of medicine (Ministry of AYUSH) has expressly prohibited advertisement for COVID-19 treatment by alternative system of medicines (such as Ayurveda and Homeopathy). And, as such, even for making claims such as “kills upto 99.99% germs”, a company must first check whether its formulation is able to satisfy the claim by testing its formulation in a recognized laboratory as per prescribed international standards

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New Consumer Protection law in India: A Simple Overview (Seller Beware!)

Consumer Protection Act 2019

On July 20th, 2020, the new Consumer Protection Act, 2019 came into force in India, replacing the previous enactment of 1986. The new Act overhauls the administration and settlement of consumer disputes in India. It provides for strict penalties, including jail terms for adulteration and for misleading advertisements. More importantly, it now prescribes rules for the sale of goods through e-commerce. The consumer is now truly the king!

Here are some of the highlights:

  • An aggrieved consumer can file complaints about a defect in goods or deficiency in services from where she lives, instead of the place of business or residence of the seller or service provider. The new law provides for e-filing of consumer complaint as well.
  • No fees are required to be paid if the claim is within Rupees 5 lakhs (approximately 3500 USD).
  • A consumer can conduct her own case via video conferencing. Engaging a lawyer is optional.
  • A concept of product liability has been introduced by the new law, thereby allowing aggrieved consumers to claim significant compensation as a relief due to the negligence of the manufacturer or service provider.
  • A group of aggrieved consumers can join hands and file a class action suit (like in the US) to reduce costs and improve chances of redressal or settlement.
  • Producers of spurious goods may be punished with imprisonment.
  • Misleading advertisements may be punished with imprisonment. Celebrities endorsing a product may not be punished but can be barred from endorsing if the advertisement is misleading.
  • E-commerce is now tightly regulated, and e-commerce companies are now expected to disclose all relevant product information, including country of origin, and respond to the grievance of consumers withing prescribed timelines.
  • Settlement of consumer disputes through mediation i.e. with the help of a neutral intermediary outside the consumer court is encouraged under the new law, thus saving time and resources of disputing parties which would otherwise have been spent on dispute resolution through a formal mechanism.
  • Consumers now have several protected rights, including the right to safety, information, choice, redressal as well as right to be heard, to be educated as a consumer, and to a mediated settlement.

Corporates entities that cater to consumers will have to exercise greater care and caution in terms of quality, quantity, and product safety. The boards of corporates that manufacture or trade consumer goods must create a Consumer Affairs Committee to periodically review consumer complaints and address the need to proactively offer mediated settlements by holding online mediation and save themselves the expenses of defending a matter in Consumer Courts, in some remote part of India besides incurring the collateral damage to reputation.