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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

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

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, We are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

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

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GUIDE TO MANDATORY LABELLING REQUIREMENTS FOR COSMETICS IN INDIA

Mandatory Labelling Requirements for Cosmetics in India

Regulatory declarations usually do not receive the same importance as cosmetic product claims and design, but they are essential nonetheless and may invite liability if they are found to be missing from a product package.

The above statement may apply to cosmetics sold all around the word, but is especially true for cosmetics products sold in India because the Indian cosmetics regulator (the State Licensing Authority i.e.  SLA for domestically manufactured cosmetics, and the Central Drugs Standards Control Organization i.e. CDSCO for imported cosmetics) does not approve labels at the time of granting marketing authorization (even though it is mandatory to submit a copy of the label at the time of application). It is up to the importers and manufactures of cosmetics products to ensure that mandatory declarations laid down under the Cosmetics Rules, 2020 (“Cosmetics Rules”) and other laws appear on the product’s label.

Omitting any of the compulsory declarations would render the product ‘misbranded’ under the Drugs and Cosmetics Act, 1940 and may have consequences for the manufacturer or importer, ranging from suspension or cancelation of manufacturing license or import registration to criminal prosecution. It may even have consequences for the whole sellers and retailers, as misbranded products are bound to be confiscated without compensation.

In this article, we have described mandatory labelling requirements for sale of cosmetics in India.

Understanding inner label and outer label

Typically, a cosmetic product would have labels on the container (“inner label”), an outer wrapper or box (“outer label”), and sometimes a leaflet containing instructions or additional information.

The Cosmetics Rules not only prescribe the declarations but also stipulate the label on which those declarations should appear.

As per the Cosmetics Rules the following declarations must appear on the label or labels specified. If the product has only a single label, all declarations must appear on that label.

Mandatory declarations for cosmetics manufactured in India under Cosmetics Rules, 2020

Inner and Outer labels

The following information needs to appear on label on the container as well as any external packaging.

  • Name of the cosmetic
  • Name of legal manufacturer
  • Complete address of the premises where the cosmetic has been manufactured
  • Use before date/date of expiry.
  • List of ingredients, present in concentration of more than one percent, shall be listed in the descending order of weight or volume at the time they are added, followed by those in concentration of less than or equal to one percent, in any order, and preceded by the words “INGREDIENTS”

Inner or Outer labels

The following information needs to appear on either the inner or outer label.

  • Distinctive batch/lot code* [preceded by “Batch No.”, “B. No”, “Batch”, “Lot No.” or “Lot”]
  • Manufacturing License Number* [preceded by “M”, “M.L. No.”, or “Mfg. Lic. No.”]

It is advisable to include the license number and batch code on the both outer and inner label, as most regulatory authorities check the external label for compliance, but most consumers discard the secondary package upon unboxing.

Only on Outer label:

The following information only needs to appear on the outer label:

  • Net contents (weight for solids, fluid measure for liquids, and either for semi-solids)*
  • Number of items, if more than one

Only on Inner Label(s):

If there are any hazards linked to a cosmetic, the following should appear:

  • Adequate directions for use
  • Any warning, caution or special directions
  • Names and quantities of ingredients that are hazardous or poisonous

If not, only the declarations that need to appear on both the inner and outer label must be mentioned on the container.

Mandatory declarations for cosmetics imported into India under Cosmetics Rules, 2020

The Cosmetics Rules stipulate the labelling requirements for all products that are sold in the Indian market, which includes imported cosmetics. All the information that must appear on the domestically produced cosmetics must also appear on imported cosmetics (except to the extent mentioned below). In addition, details of the importer must also be mentioned, so that consumers and the regulators have access to a domestic entity in relation to the imported products. Note that the modifications to the labelling may be effected at a customs bonded warehouse i.e. before clearing Indian customs before after importing into India.

The following additional declarations must appear:

  • Import registration certificate number [preceded by “RC”, “RC No.”, “Reg. Cert. No.”]
  • Name of importer
  • Address of importer
  • If the importer does not wisht to declare the manufacturing site, –then a declaration of country of manufacture as would suffice [“Made in (Country)”].
  • If the cosmetic is imported from a country that does not require that the manufacturing license number be mentioned, manufacturing license number need not be mentioned.

Exemptions for small-size cosmetic packages under Cosmetics Rules, 2020:

Small containers of cosmetics are subject to certain relaxations.

  • Address of manufacturer may be shortened to only principal place of manufacture and the pin code where the cosmetic’s container is less than or equal to 60 ml of liquid and 30g of solids and semi-solids.
  • Batch code need not be mentioned on any cosmetic that are up to 10 grams if in the solid or semi-solid state or 25 ml if in the liquid state.
  • The declaration of net contents need not appear in case of a package of perfume, toilet water or the like, the net content of which does not exceed 60 ml or any package of solid or semi-solid cosmetic the net content of which does not exceed 30 grams
  • The list of ingredients need not appear for cosmetics that are less than or equal to 60 ml of liquid and 30g of solids and semi-solids.

These relaxations have likely been granted to ensure that the vital declarations are still present and readable, while avoiding unnecessary packaging and inserts.

Requirements for Hair Dyes containing dyes, colours and pigments under Cosmetics Rules, 2020:

Hair dyes must contain additional declarations due to their strong chemical composition, and the likelihood of reactions occurring.

The following statements must appear on both the inner and outer labels in English and in local languages:

  • “Caution.﹘ This product contains ingredients which may cause skin irritation in certain cases and so a preliminary test according to the accompanying directions should first be made. This product should not be used for dyeing the eyelashes or eyebrows; as such a use may cause blindness.”
  • “This preparation may cause serious inflammation of the skin in some cases and so a preliminary test should always be carried out to determine whether or not special sensitivity exists. To make the test, cleanse a small area of skin behind the ear or upon the inner surface of the forearm, using either soap and water or alcohol. Apply a small quantity of the hair dye as prepared for use to the area and allow it to dry. After twenty-four hours, wash the area gently with soap and water. If no irritation or inflammation is apparent, it may be assumed that no hypersensitivity to the dye exists. The test should, however, be carried out before each and every application. This preparation should on no account be used for dyeing eyebrows or eyelashes as severe inflammation of the eye or even blindness may result.”

Cosmetics that are subject to any Bureau of Indian Standards (BIS):

The Ninth Schedule to the Cosmetics Rules specifies the BIS Standards that are applicable to a total of 37 categories of cosmetics including skin powders, skin creams, hair oils, shampoos, soaps, lipsticks, foundations, etc. Further, if any new BIS standards are introduced for cosmetics, those would become mandatory after six months from the date of publication.

If any of the standards specify labelling requirements, they must mandatorily be complied with. This requirement applies to both domestically manufactured and imported cosmetics.

Animal Testing Declaration

While most products do include a statement or symbol to signify that the cosmetic product was not tested on animals, the Cosmetics Rules do not require that the declaration be made since animal testing has been outrightly banned for cosmetic products. Should the brand choose to include the declaration, however, care should be taken that they do not use any of the symbols associated with certifications such as the PETA’s ‘Beauty without Bunnies’ or the Cruelty-Free International’s ‘Leaping Bunny’ unless the certification has actually been obtained.

Mandatory declarations for cosmetics imported or manufactured into India under Legal Metrology (Packaged Commodities) Rules, 2011

In addition to the Cosmetics Rules, the label must also contain the declarations required under the Legal Metrology (Packaged Commodities) Rules, 2011 (“Packaged Commodity Rules”).

The additional declarations that would be required are:

  • Generic name of the product
  • Maximum retail price
  • Contact details for customer care
  • Date of import, if applicable

Alteration of Mandatory Declaration on Cosmetics Product Labels:

Caution should be taken while finalising the labels for a cosmetic product, since making any modifications to the label once the product leaves the manufacturing factory premise (in case of manufactured cosmetics) or the Indian customs (in case of imported cosmetics), would require prior approval from the office of Drugs Controller General of India (India), who heads the CDSCO, and, if the modification relates to a mandatory declaration under the Packaged Commodity Rules, the authority thereunder as well.

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Alcohol-Based Hand Rubs and Sanitizers – Regulatory requirements, uncertainties and important considerations for doing businesses in India

Alcohol Based Hand Rubs India Legal Requirements Issues

Summary: Due to the sudden spurt of demand for hygiene products due to COVID-19 virus pandemic,   several manufacturers and marketers in India are now selling hand sanitizers containing ethanol or isopropyl alcohol as an active ingredient.  However, regulatory uncertainties, especially surrounding requirement of drug license for stock and sale and scope of price control are becoming roadblocks for businesses from scaling-up operations. Manufacturers and marketers of hand sanitizers are thus forced to explore alternate options such as manufacturing hand sanitizers as a cosmetic or ayurvedic formulation (Indian medicine) to overcome some of these regulatory challenges. However, these alternatives have their own limitation.

Background

The World Health Organization (WHO) has said that hand hygiene is extremely important to prevent the spread of COVID-19 virus. As part of hand hygiene guidelines, WHO  has recommended the use of an alcohol-based hand rub for 20-30 seconds using appropriate technique when hands are not visibly dirty. In line with these guidelines, various governments around the world have promoted the use of ethyl alcohol or isopropyl alcohol-based hand rubs for hand hygiene. India is no exception.

The WHO endorsement and government recommendations for alcohol-based hand sanitizers have resulted in high public demand for these products in India. Due to the heightened public demand, there is a race to manufacture and market alcohol-based hand sanitizers (gel) and hand rubs (liquid) (together referred to as “ABHRs”). The Drug Licensing Authorities have also started granting a license to manufacture ABHRs in a record time of three (3) days to drug manufacturers, even to alcohol distilleries and cosmetic manufacturers to ensure steady and sufficient supply of hand sanitizers and hand rubs.

However, manufacturers and marketers of ABHRs are now faced with some legal and regulatory challenges, which they must overcome in order to scale the business of ABHRs. In this article, we have discussed these challenges in detail.

Stock and sale drug license

The Drugs and Cosmetics Act, 1940 (DCA) mandates that every drug stocked or sold in India must be sold under a license unless the drug, or the person stocking or selling the drug, is exempt by law from this requirement.

There is no such exemption for ABHRs. Therefore, the entire supply chain, including retailers of ABHRs, are required to sell them under a stock and sale license under DCA.

However, due to COVID-19 (Corona) virus, it is not possible to meet the current demand for ABHRs through existing distribution and retail channels that have stock and sell license for drugs. Therefore, there is a widespread expectation that ABHRs should be sold through general FMCG distribution and retail channels.

The only way to legally do so is by positioning ABHRs as disinfectants. There is an exemption under DCA for disinfectants that allows disinfectants to be stocked and sold without a drug license. Such an exemption from stock and sale drug license is not unique to disinfectants. Several other drugs presently enjoy such exemptions as well, for example, oral rehydration salts, medicated dressings, condoms etc.

Some courts in India have, in the past, recognized the disinfectant properties of specific formulations of antiseptic liquids containing alcohol and validated their ability to avail exemption from drug stock and sale license otherwise available only to disinfectants. However, the courts are yet to specifically opine on exemption of ABHRs in general from the requirement of stock and sale license.

The industry is awaiting an official clarification on this issue. The central drug regulator, the Drugs Controller General of India (DCGI), is currently reviewing the regulatory positioning of hand sanitizers, including ABHRs, as ‘disinfectants’ and availability of exemption from drug stock and sale license to them. Until DCGI takes a final position, some State-level Drug Licensing Authorities may accept ABHR’s claim of disinfectants and allow them to be stocked and sold by the distributors and retailers without drug license. But Some State-level Drug Licensing Authorities some may not do the same, and the overall objective to scale ABHRs business to meet demand may not be met.

It is our view that such an exemption should be available to ABHRs, especially since the US Pharmacopeia, which is one of the pharmacopoeias recognized under Indian law for drug quality standards, explicitly acknowledges disinfectant properties of ABHRs.

Meanwhile, with a view to improve access to ABHRs, the Government has notified them as an essential commodity (discussed in next paragraph in detail). However, notification of ABHRs as an essential commodity does not automatically exempt them from the requirement to be sold under a stock and sale drug license either at distributor or retail level. All drugs sold in India are, in fact, essential commodities.

To overcome the limitation imposed by requirement of drug stock and sale license on distribution of ABHRs, some manufacturers and marketers are manufacturing ABHRs under as an ayurvedic drug that is made under an ayurvedic drug manufacturing license, or as cosmetic that is made under a cosmetic manufacturing license. Both ayurvedic drugs and cosmetics do not require any regulatory license for stock and sale and therefore may be distributed via a supply chain that does not have a drug stock and sale license.

However, there are significant challenges in selling ABHRs as ayurvedic drugs or cosmetics. For example, ayurvedic drugs containing alcohol have a long history of litigations with excise department for their potential to be abused as intoxicating liquor. Some State Governments in India have prescribed a limit on alcohol content, stating that alcohol used in the manufacture of antiseptic solutions should not contain alcohol in excess than is necessary for the preservation of (ayurvedic) ingredients. As ABHRs typically have 60%+ alcohol content, manufacturers and marketers of ABHRs must ensure that their product passes the above test.

When ABHRs are sold as cosmetics, it is not possible to make any ‘drug’ claim on it. For example, it is not possible to claim on the label that the ABHR ‘kills’ germs, as it would mean that the product is not for cosmetic application but for medicinal application. The definition of ‘drug’ under DCA is broad and covers all substances that are intended to be used in the prevention of disease in human beings. If any such ‘drug’ claim is made on the label of a cosmetic, then it may invite strict regulatory action under DCA.

Status as new drugs in India

The two ABHR formulations recommended by WHO are: Ethanol 80% (v/v) or Isopropyl alcohol 75% (v/v), Glycerol 1.45% (v/v) and Hydrogen peroxide 0.125% (v/v). As per the records released by central drug regulator, DCGI, both these formulations were first approved for sale in India in 2017. These formulations now preferred by most manufacturers and marketers due to the WHO endorsement and constitute the bulk of new ABHRs being launched in India.

Under New Drugs and Clinical Trial Rules, 2019 (NDCTR), a formulation is deemed to be a “new drug” for four years from the date of its first approval. Therefore, both WHO recommended formulations are to be currently treated as ‘new drugs’ for regulatory purposes in India until 2021.

When any drug is classified as a ‘new drug’, it has two consequences for the manufacturer of the drug. Firstly, a prior permission from the central drug regulator, DCGI, is required to be obtained in addition to a manufacturing license. Secondly, after the manufacturing license is granted, the manufacturer is supposed to undertake post marketing surveillance and submit periodic safety update reports (PSURs) to DCGI.

The manufacturers of ABHRs as per WHO recommended formula must ensure that DCGI permission is in place for their products, in addition to the manufacturing license, and must make periodic submissions of PSURs to DCGI as per the format specified under NDCTR.

Price control of hand sanitizers

ABHRs manufactured under a drug manufacturing license have always been under some or the other form of price control. The Drug (Prices Control) Order, 2013 (“DPCO”) regulates the prices and distribution of ABHRs containing ethyl alcohol 70% (v/v) since 2013. The current price ceiling on 70% ethyl alcohol solution is 0.56 Rupees per ml, which translates into 112 Rupees for 200 ml. All other ABHRs are restricted from increasing their maximum retail price by more than 10% in between twelve months.

However, as described earlier, it is possible to manufacture “hand sanitizers” as an Indian medicine (ayurvedic drug) or cosmetic as well. Ayurvedic formulations are not regulated for price by DPCO to a great extent and cosmetics are not regulated for price at all. Thus, the price cap of 112 Rupees for 200 ml will not apply to ayurvedic or cosmetic hand sanitizers. Furthermore, DPCO does not regulate cost of raw materials of drugs, in this case methylated industrial alcohol / denatured ethyl alcohol / isopropyl alcohol. The DPCO also does not empower State Governments to direct manufacturers of drugs to enhance production capacity and increase their availability. This power is vested only with the Central Government.

In order to overcome these challenges, the Indian Government has notified The Essential Commodities Order, 2020, thereby classifying “hand sanitizers” as essential commodity until June 30th, 2020. Due to this, all hand sanitizers (drug, ayuvedic medicine, cosmetic) and the raw material used in them have come under the purview of price control and have become amenable to jurisdiction of respective State Governments. The Indian Government has also notified The Fixation of Prices of Masks (2 ply and 3 ply), Melt Brown Non-Woven Fabric and Hand Sanitizers Order, 2020 (“Hand Sanitizer Price Control Order”). As a consequence, all hand sanitizers (drug, ayurvedic, cosmetic) cannot be sold for price higher than 100 Rupees for 200 ml until June 30, 2020. Needless to say, after expiry of the aforesaid order, hand sanitizers will be regulated as per DPCO (to the extent applicable to them).

There has been a collateral impact of the Hand Sanitizer Price Control Order on non-alcohol based hand sanitizers. There are currently at least twenty-four (24) formulations of hand sanitizers approved for sale in India, some of which are not alcohol-based. The Hand Sanitizer Price Control Order does not clarify whether it applies only to alcohol-based hand sanitizers or other hand sanitizers as well. The expression “hand sanitizer” is not defined under law, and has been interpreted loosely by the central drugs regulator, DCGI. The DCGI has in fact put out a list of all hand sanitizers approved by it which includes both alcohol-based and non-alcohol based hand sanitizers. Therefore, there is a risk that the Hand Sanitizer Price Control Order may be interpreted broadly and cover non-alcohol based hand sanitizers as well.

On a separate note, manufacturers who have been selling formulation of ethyl alcohol 70% (v/v) will have to obtain a prior price approval from central price regulator, National Pharmaceutical Pricing Authority (NPPA), before manufacturing ABHR containing ethyl alcohol as per the procedure prescribed under DPCO.

Making Corona related Claim

There is scientific laboratory data now in place to support the claim that WHO recommended formulae for ABHRs, or ethyl alcohol or isopropyl alcohol in concentration of more than 30% v/v, can inactivate COVID-19 virus in thirty (30) seconds.

However, such scientific laboratory data has not been endorsed by India’s central drug regulator, DCGI, and is very specific to WHO formulations when used under laboratory conditions. If any manufacturer or marketer wishes to put a generic COVID-19 virus related claim on its label, it may need to first obtain prior permission from DCGI who may decide to treat the ABHR as a untested ‘new drug’ and require the manufacturer to submit supporting laboratory data for its own formulation before it is permitted to make any COVID-19 virus related claim.

Needless to say, in absence of the permission from DCGI, any such claim may make the manufacturer liable for prosecution under DCA.

Making “WHO recommended formula” claim

There is an expectation in some quarters of the industry that the if an ABHR is manufactured as per the WHO recommended formulae (described in earlier paragraphs), then it should be launched with a supporting claim of ‘WHO recommended formula’ on its label. However, it may not be ethical to commercially exploit the WHO brand name since the WHO formulae were originally recommended as an alternative when suitable commercial products were either unavailable or too costly. The actual recommendation from WHO for ABHRs is, in fact, for any effective alcohol-based hand rub product that contains between 60% and 80% of alcohol.

For context, the WHO recommended formula even today is intended for local production by pharmacies and WHO has permitted use of its brand name by them in order to (most likely) lend credibility to the end product.

On the same note, it is an offence in India to put the name of World Health Organization or its abbreviation (WHO) without prior permission of the Central Government under the Emblems and Names (Prevention of Improper Use) Act, 1950. Therefore, even if a manufacturer is able to manufacture the exact formulation as recommended by WHO, it should not claim that it is manufactured “as per WHO recommended formula” without prior permission of the Central Government.

Putting Government Logo for endorsement in fight against Covid-19 virus

Like World Health Organization, putting the name or official seal or emblem of the Government of India or of any State or of a Department of any Government without prior permission of the Central Government is an offence under the Emblems and Names (Prevention of Improper Use) Act, 1950.

Getting the labelling right

Apart from alcohol, there may be other active ingredients in ABHRs such as hydrogen peroxide which kill or limit the growth of harmful microorganisms. Such ABHRs with more than one active ingredients fall in the category of ‘fixed dose combinations’ (“FDCs”). Every FDC is required by law to state the composition on the label first, followed by its brand name. For instance, in case of the WHO recommended formulae described earlier, the name of the active ingredients must appear prominently on the label and simply writing “hand sanitizer” or “hand rub“ may not be enough.

Further, due to the high alcohol content in the ABHRs, there are specific declarations that ought to appear on their label. Each label must specify that ABHR contains denatured alcohol (in case of use of methylated spirit) and that it is for external use only. If the ABHR is making a disinfectant claim, then it must specify the mode of use. The content of the alcohol in the ABHR must be stated in terms of average percentage of absolute alcohol.

It is also advisable to write about storage conditions and appropriate warnings, in view of the high concentration of alcohol in ABHRs.

Same brand name, different drug

Some marketers of ABHRs are selling two or more formulations of ABHRs under the common / umbrella branding of ‘Hand Sanitizer’. This strategy should be revisited, since different formulations of ABHRs are different drugs, and selling different drugs under a common / umbrella branding of ‘Hand Sanitizer’ may be misleading.

If a marketer is selling ABHRs manufactured under pharmaceutical drug license and ayurvedic drug license under a common / umbrella branding such as ‘Hand Sanitizer’, then the regulatory risk identified above may increase since pharmaceutical drug and ayurvedic drug are two very different products though with the same end-application.

The law does not want consumers to be misled while buying drugs. Therefore, every manufacturer who wishes to sell ABHR under a brand name is required to file a declaration at the time of applying for drug manufacturing license. The declaration states that the brand name under which the drug is proposed to be sold is not used by  any other manufacturer. This declaration should be submitted by manufacturers of ABHRs before obtaining the manufacturing license for ABHR.

Getting quality aspects right

The manufacturers of ABHRs is obligated by law to ensure that its products are of standard quality. The WHO has recommended that the efficacy of any ABHR should be proven according to European (EN 1500) or American (ASTM E-1174) standards. Considering these are foreign standards and may not be enforceable in India, manufacturers of ABHRs must ensure that the hand sanitizers at least satisfy requirements of quality and efficacy as per applicable Indian standards.

As of date, in case a drug is found to be not of standard quality (NSQ), the liability lies with the manufacturer and not the marketer. However, this will change in future. From March 1, 2021, the marketers of drugs themselves will be responsible for the quality of the drug and the agreement between marketers and manufacturers will play an important role in the determination of liability. Therefore, the meeting of applicable Indian quality standards by ABHRs will be important for both the marketer and the manufacturer.

Conclusion

Hand Sanitizers, specifically ABHRs, are more relevant and in-demand in India than ever before. However, manufacturers and marketers of ABHRs should be careful about compliance with laws and regulations, because any oversight today may invite strict regulatory action in future.

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New Compliances for Health Research on Drugs, Medical Devices and Cosmetics in India

Woman sitting in laboratory

From September 16, 2019, all research conducted in India which focuses on human diseases or conditions in the context of a drug, medical device or cosmetics will have to be reviewed and overseen by a non-governmental body known as Ethics Committee.

More specifically, from that date, the Drugs and Cosmetics Act, 1940 (DCA) will begin to apply to “biomedical and health research”, which is defined as “research including studies on basic, applied and operational research or clinical research, designed primarily to increase scientific knowledge about diseases and conditions (physical or socio-behavioral); their detection and cause; and evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation”. The New Drugs and Clinical Trials Rules, 2019 (NDCTR), notified under the DCA, will make it mandatory for any person, company or institution involved in biomedical and health research regulated by NDCTR to ensure that a registered Ethics Committee reviews and oversees the conduct of the research.

Background

Prior to notification of NDCTR on March 19, 2019, there was no law as such that regulated biomedical and health research carried out on human participants other than such clinical research which involved a ‘new drug’. The Indian Council of Medical Research, India’s apex medical research and scientific body, had published The National Ethical Guidelines for Biomedical and Health Research on Human Subjects but there was no law that could enforce these guidelines on sponsors, professionals and institutions involved in the research. This lacuna in the law has been addressed by NDCTR.  The provisions in NDCTR that relate to biomedical and health research were to take effect after 180 days from March 19, 2019 (i.e. the date of its notification). This time was sought, perhaps, to put the administrative machinery in place, such as the National Ethics Committee Registry for Biomedical and Health Research.

Who will be impacted

Any legal person, whether an individual or company, undertaking any biomedical or health research regulated by NDCTR for academic or business purposes, will have to approach a registered Ethics Committee for approval of the research proposal.

A laundry list of those who may be impacted the most is described below for convenience –

Pharma Companies – Pharma companies usually undertake non-interventional research to evaluate patient behaviour, adoption and outcomes. Pharma companies also undertake non-mandatory post-marketing surveillance of pharmaceutical drugs. To the extent that such research concerns the health of the patient, it would have to be approved and overseen by a registered Ethics Committee.

Medical Device Companies – Like pharma companies, medical device companies undertake non-interventional research to evaluate patient behaviour, adoption and outcomes. Medical device companies also commission research to analyse secondary health data in patient registries. Such research would have to be approved and overseen by a registered ethics committee.

Cosmetics Companies – Cosmetics companies commission health-related studies from time to time. For example, cosmetic companies pay market research companies to assess the impact of the product from a psychological perspective (e.g. increase in confidence, reduction in stigma related to pimples or scars etc.). Such studies would henceforth be required to be approved and overseen by a registered Ethics Committee.

Diagnostic Companies – Diagnostic companies, especially those operating in the field of precision diagnostics, commission studies on existence and determination of various biological markers that aid in the diagnosis of diseases and conditions prevalent in the Indian market. Such studies would henceforth be required to be overseen by a registered Ethics Committee.

Technology Companies – Some technology companies, such as IBM, offer products and services that help clinicians in making better decisions with respect to the choice of medicines by analyzing a database of patient records (e.g. IBM Watson). Such technology companies, before deploying their products and services that analyze patient data with reference to pharmaceutical drugs, notified medical devices or cosmetics, would require the approval of a registered Ethics Committee.

Contract Research Organizations – There are numerous contract research organizations that undertake comparative Bio-availability and Bio-equivalence studies in India for pharmaceutical drugs that have been in the market for some time (i.e. drugs other than new drugs). Such comparative studies would henceforth be required to be approved and overseen by a registered Ethics Committee.

Market Research Organizations – Many market research organizations collect health data or undertake health-related primary research (e.g. patient interviews) and secondary research (e.g. prescription analysis) to reach certain conclusions for its clients (e.g. distinctive health-related product claims).  Such marketing research organization would also have to submit their research to a registered Ethics Committee for review and approval.

Who will not be impacted

Companies undertaking health research on traditional medicinal products (Ayurvedic, homoeopathic medicines etc.) – The NDCTR have been framed under powers that the Central Government has with respect to pharmaceutical drugs, notified medical devices and cosmetics. Therefore, logically, it does not apply to all other categories of drugs such as ayurvedic medicines and homoeopathic medicines. Since the obligations with respect to biomedical and health research are provided under the NDCTR, these logically cannot apply such other category of drugs due to the inherent limitations of NDCTR.

Companies undertaking health research on non-notified medical devices – The DCA applies to a very small number of notified medical devices at present. Any bio-medical and health research that concerns non-notified medical devices should not be covered by NDCTR.

Food & Beverage companies – The DCA does not apply to food or beverages. A separate legislation, called Food Safety and Standards Act, 2006 (FSSA), regulates the quality of food and beverages sold in India. There is no requirement to obtain an Ethics Committee permission to undertake biomedical and health research related to food products under FSSA.

Educational institutions – Students, academicians and professionals in numerous educational institutions undertake epidemiological research i.e. biomedical and health research that is related to diseases and conditions in general and not related to any particular medicine, notified medical device or cosmetics. Such research should not fall in the scope of NDCTR.

Challenges

Shortage of registered ethics committees – Almost all major research institutions in India have a registered ethics committee that they have formed themselves. Some research institutions who don’t have a registered ‘institutional’ ethics committee of their own seek services of a registered ‘independent’ ethics committee. These ethics committees are registered to review clinical trials on new drugs and investigational notified medical devices. The challenge, however, is that a separate registration is required for ethics committees which will review biomedical and health research proposals. In fact, the authority which will grant such registration to ethics committees was designated only a few days ago by the government (i.e. on September 12, 2019). Therefore, at the time of commissioning biomedical and health research, the sponsor of such must carefully evaluate the ‘registered’ status of the ethics committee who has offered its services.

Lack of clarity in definition – The definition of “biomedical and health research” is very broad, so much that it could arguably extend to research on how a medicine “tastes” or a medical device “feels”. Further, the definition by itself does not restrict the application of NDCTR to research that involves medicines, notified medical device and cosmetics only. It is broad enough to cover “basic research” as well, which is not connected any medicine, medical device or cosmetic but instead concerns research on human body and its constituents. Such expansive interpretation of the scope of the definition is not correct, because the parent law to NDCTR, that is the DCA, is applicable only to drugs, notified medical devices and cosmetics. Therefore, rules made under it, cannot go beyond the scope of DCA.  

Conclusion

In light of the application of NDCTR to biomedical and health research, sponsors of any research that concerns human participants and involves a pharmaceutical drug, notified medical device or cosmetic must be careful to not inadvertently violate NDCTR. A good practice would be to refer all such studies for approval of a duly registered Ethics Committee who may, after review of the study design, itself come to a conclusion that it is within the scope of NDCTR or not. Needless to say, all eligible biomedical and health research should under undertaken after review, and under supervision, of a duly registered Ethics Committee only.