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.
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.
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.
On February 11, 2020, the Indian Government had gazetted a notification that brought all medical devices and medical equipment sold in India under existing quality and safety regulatory framework by declaring them as “drugs”. However, this notification has exposed all medical devices to India’s drug price control regulation that was put in place to make drugs affordable and accessible as well. So, from April 1, 2020 (i.e. the effective date of the notification), all manufacturers and importers of medical devices and medical equipment sold in India will have to be careful to not increase the maximum retail price of their products by more than 10% within 12 months. They will have to make periodic trade-related filings with the Government in which they will have to submit price information such as price to distributors, price to stockist, price to hospital and price to retailer. And, on top of all this, they will have to operate under constant risk of price fixation at the hands of the Government, like was done in the case of coronary stents and knee implant systems in 2017.
Background
The quality and safety of drugs sold in India is regulated by the Drugs and Cosmetics Act, 1940 (“DCA”). There is no equivalent legislation for medical devices. Therefore, the Indian Government notifies those medical devices whose quality and safety it intends to regulate as ‘drugs’ from time to time.
Prior to February 11, 2020, the Indian Government used to regulate the quality and safety of medical devices in a piecemeal manner. There were only 37 categories of medical devices and medical equipments that had been notified as drugs under DCA (see annexure for this list). However, on February 11, 2020, the Government declared all medical device and medical equipment to be drugs in order to bring them under the fold of quality and safety regulation under DCA, effective April 1, 2020. We have written extensively about it here.
There was a collateral impact of this decision of the Government on price and supply chain of medical devices and medical equipment. India regulates production, control and supply of all essential commodities through a law called the Essential Commodities Act, 1955 (“ECA”). ‘Drugs’ are regulated as an essential commodity under ECA. Therefore, the Government has power to regulate product control and supply of all drugs under ECA. In furtherance of the provision of ECA, the Government has notified a price control order for drugs called the Drugs (Prices Control) Order, 2013 (“DPCO”).
On February 11, 2020, when the Government decided to regulate all medical devices and medical equipment by notifying them as drugs, it automatically subjected them to the provision of DPCO. The authority responsible for the administration of DPCO, the National Pharmaceutical Pricing Authority (NPPA), has already brought out a clarificatory order stating that the provision of DPCO will squarely apply to all medical devices and medical equipment.
Impact on price and supply of medical devices after April 1, 2020
From April 1, 2020, all medical devices and medical equipment manufacturers and importers will have to comply with the provisions of DPCO. The obligations imposed by DPCO on all manufactures and importers of medical devices and medical equipment are as follows:
Retail sale price to be mentioned on all medical devices, including ones for institutional use: The DPCO requires that every SKU of medical device and medical equipment must be labelled with its maximum retail price (“MRP”) that is to be set by the importer/manufacturer/marketer. The said price must be prefixed by the words “Maximum Retail Price” and suffixed by the words “inclusive of all taxes”.
Before April 1, 2020, there was an exemption available for medical devices and medical equipment that weighed more than 25 kg or that were intended for institutional use, from declaration of MRP under the Legal Metrology (Packaged Commodity) Rules, 2011. However, from April 1, 2020, all medical devices and medical equipment, irrespective of their weight and intended use, will have to declare MRP on the label of each SKU in the manner specified above.
% cap on variation of retail sale price: The importers, manufactures and marketers of medical devices will have to be cognizant about variation of the MRP declared on the label of their medical devices. The MRP of the product should not be varied by more than 10% in any 12 month period, else the variation in excess of 10% will be recovered as ‘overcharging’ from the business concerned. For example, if an importer of medical device decides to reduce the MRP by 20%, but after a single quarter decides to return to the original retail price (i.e. increase by around 20%), then it won’t be permitted to do so. It can, at best, increase its MRP by 10% of the reduced price. If it starts selling the product at the original MRP, then the 10% excess will be recovered from the importer on MRP basis i.e. by multiplying the number of units sold with the 10% excess, along with intrest and penalty.
Risk of price fixation: The NPPA has the powers to fix ceiling prices of any drug under extra-ordinary circumstances and in public interest. Now, from April 1, 2020, this power will extend to all medical devices and medical equipment. Once a price is fixed, the importer, manufacturer and marketer of said medical device has to set its MRP either equal to or below the ceiling price. Most of the times, NPPA also fixes the margins that may be offered to the supply chain and makes the concerned importer/manufacturer/marketer liable for any breach of margin by the supply chain.
Risk of being subject to market based pricing: The Ministry of Health and Family welfare brings about a National List of Essential Medicines (“NLEM”) every few years. Medical devices are also included in the said list from time (e.g. coronary stent). The consequence of being included in NLEM from pricing perspective is that the medical device in question automatically becomes subject to a market price based price control i.e. the MRP of the said device must not exceed the average MRP of all importers, manufacturers and marketers who sell the same device and who have more than 1% market share in that particular device market. The said average MRP (referred to as “Ceiling Price”) is decided and set by NPPA. The Ceiling Price may go up or down every year, depending on the wholesale price index of the Government. The MRP of the medical device will have to be adjusted accordingly. A prior permission from NPPA is required to withdraw or to reduce production / import of medical device which are recognized as ‘essential’ by the Government.
Consequences of non-compliance
There are different consequences associated with different violations. Any violation of DPCO is serious because its parent legislation, the Essential Commodities Act, 1955, stipulates that any breach of DPCO may result in imprisonment and fine for the company and person(s) in-charge of the company for conduct of its business. However, undoubtedly, the most draconian provision of DPCO is the liability to deposit any amount ‘overcharged’ by the importer or manufacturer in breach of DPCO in addition to the interest and penalty.
Final comments
It is extremely important for medical devices and medical equipment companies doing business in India to be aware of the compliance requirements and obligation under India’s price control law (i.e. EC Act and DPCO). Since all medical devices and medical equipment are now regulated as drugs, and all drugs are treated as essential commodities, an inadvertent violation of India’s price control laws may have serious consequences for the business of these companies.
Summary: The
Indian Government has published Telemedicine Practice Guidelines (“Telemedicine
Guidelines”) on March 25, 2020. These guidelines finally clarify India’s
position on the legality of teleconsultation. It is now perfectly legal to provide
teleconsultation by registered medical practitioners (M.B.B.S and above) in
line with the requirements of the Telemedicine Guidelines. It has been
clarified that the first consultation between doctor and patient need not be an
in-person consultation, and doctors in India can provide the first consultation
to patients located in any State remotely through teleconsultation. However,
going forward, all doctors who provide teleconsultation will have to display
their registration number in all communications exchanged with the patient –
for example, in emails or WhatsApp messages, on prescriptions and on fee receipts.
Doctors will also have to be careful while issuing a prescription during teleconsultation.
As a thumb rule, prescribing medicines for chronic diseases (such as asthma, diabetes
or hypertension) should be avoided during teleconsultation, unless it is an
add-on or refill of an earlier prescription obtained during an in-person
consultation less than six months ago. If a prescription for chronic diseases is
to be issued, then the teleconsultation should be done strictly via video. A
prescription can be sent through any electronic medium such as email, WhatsApp
etc. as a photo/scan / digital copy of a signed prescription or an
e-prescription.
3.8.1. Consultation through Telemedicine by the Registered Medical Practitioner under the Indian Medical Council Act, 1956 shall be permissible in accordance with the Telemedicine Practice Guidelines contained in Appendix 5 (of Code of Conduct).
A registered
medical practitioner under Indian Medical Council Act, 1956 is a person who is
enrolled in the State Medical Register or the Indian Medical Register under the
Indian Medical Council Act, 1956 (or National Medical Commission Act, 2019 as
and when it comes into
full force and replaces the Indian Medical Council Act, 1956). Every practising
doctor in India today is required by law to be enrolled in the State Medical
Register or Indian Medical Register before the start of his or her medical practice.
Therefore, the amendment does not add any new requirement of registration for
doctors who want to practice telemedicine and provide teleconsultation to his
or her patients.
Telemedicine is
defined under the Telemedicine Guidelines as:
“The delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities”
Now, doctors who
are providing teleconsultation independently or through such companies can rest
assured that such practice is lawful as long as it is done in compliance with
Telemedicine Guidelines. Doctors can also provide teleconsultations to patients
from any part of India.
In fact, the
Telemedicine Guidelines specifically permit Doctors to provide teleconsultation
for prescribing medicines, providing counselling (e.g. food restrictions, do’s
and don’t’s for a patient on anticancer drugs, proper use of a hearing aid etc.)
and imparting health education (e.g. advice on contagious infections,
immunizations, exercises, hygiene practices, mosquito control etc.).
What
does the amendment mean for patients?
India does
not have a great doctor to patient ratio. This, coupled with the fact that
India is a huge country and that the density of doctors is far higher in cities
than in rural areas where the bulk of India’s population resides, is the reason
why teleconsultation has great demand and potential in India.
Unfortunately, there
were hardly any standards for doctors to follow and patients to expect during a
teleconsultation. For example, Indian patients sometimes felt short-changed
when a doctor was not clear or audible, or the doctor refused to issue a
prescription or did not provide a report of the consultation after the
consultation ended. Some patients feared whether the person on the other end
was, in fact, a doctor or not. A few worried about their privacy, as electronic
communications over mobile application or email, can leave a trail.
Indian patients
now will be able to hold doctors accountable to provide teleconsultation as per
the Telemedicine Guidelines, which provide a clear set of do’s and don’ts for
doctors. A violation of the Telemedicine Guidelines will give patients avenue
to complain against the doctor before appropriate State Medical Council for ‘misconduct’.
Telemedicine
Guidelines – Salient features
Doctor can choose the medium of teleconsultation: A doctor may use any medium for patient consultation, e.g. telephone, mobile or landline phones, chat platforms like WhatsApp, Facebook Messenger etc., other mobile apps or internet-based digital platforms for telemedicine or data transmission systems like Skype/ email/ fax etc. However, before proceeding with the teleconsultation, the doctor should exercise professional judgement to decide whether the teleconsultation is, in fact, appropriate and in the interest of the patient. If the answer is yes, then the doctor should evaluate which medium would be preferred for the teleconsultation. For example, a complaint of appendicitis may require a physical examination and teleconsultation may not be preferred. On the other hand, some common complaints may not require physical examination or even consultation in real-time. For example, a complaint of headache or fever may not always require the doctor to examine the patient physically or audio-visually through a mobile or computer application. However, in certain cases, for example, on presentation of allergy or inflammation (e.g. Conjunctivitis), the doctor may choose to examine the patient in-person or through an audio-visual teleconsultation. Thus, the decision to examine the patient physically or remotely i.e. through teleconsultation, and the medium of teleconsultation, is to be taken by the doctor himself or herself on case to case basis.
Doctor has to maintain the same standard of care during teleconsultation as during in-person consultation: The Telemedicine Guidelines require doctors to maintain the same standard of care towards a patient during a teleconsultation as they would during an in-person consultation. In other words, the fact that the teleconsultation took place over a mobile app or email or telephone cannot be taken as a defence by a doctor against an allegation of medical negligence. Every doctor is expected to know the limitation of teleconsultation and advise or prescribe accordingly.
Patient is responsible for the accuracy of information: During the course of teleconsultation, if the doctor inquires for relevant information from the patient, then the patient is supposed to disclose the right information. The Telemedicine Guidelines have clarified that is the patient who will be responsible for accuracy for the information shared with the doctor, and not the doctor. However, since the standard of care is as high in the case of teleconsultation as in-person consultation, the doctor must make all efforts to gather sufficient medical information about the patient’s condition before deciding on a diagnosis or a treatment. If a patient provides any contradictory information, or if the doctor is not convinced with the information at hand to make a professional decision, he may ask patient to provide such documents or undertake such tests as he/she may feel proper in his/her professional judgement without fear of liability.
Caregiver is deemed to be authorized on behalf of minor or incapacitated patients: If the age of the patient is 16 years or less, or if the patient is incapacitated (due to mental conditions like dementia or physical disability due to an accident), then the caregiver is deemed to be authorized to consult on behalf of the patient. The Telemedicine Guidelines clarify that in such cases, the teleconsultation can take place with the caregiver without the presence of the patient.
No fixed Format for issuing a prescription: There is no fixed format for issuing a prescription in a teleconsultation. The Telemedicine Guidelines has recommended a format, but following it is not mandatory. However, the doctor must provide photo/scan /digital copy of a signed prescription or e-Prescription to the patient via email or any messaging platform. Please note that a doctor can transfer the prescription to a pharmacy only if he/ she has the explicit consent of the patient.
Invoice for fees: Doctors can charge appropriate fees for teleconsultation. A receipt or invoice should be given to the patient against the fees.
Do’s
and Don’t’s for Doctors
Patient identification is mandatory during first consultation: If the teleconsultation is, in fact, the first consultation of the patient with the doctor, then doctor should confirm the patient’s identity to his/her satisfaction by asking patient’s name or age or address or email I.D. or phone number or any other identification that may be reasonable.
Patient identity confirmation is not mandatory during follow-up consultation, but may be carried out on need basis: It is not mandatory to identify the patient during a follow-up teleconsultation with a known patient, especially if the doctor is communicating through the registered user id, email id or phone number. However, in case of doubt, the doctor should confirm patient identity as during the first consultation.
Caregiver identity and authorization should be checked: If the patient is not a minor or is not incapacitated, then a caregiver cannot consult on behalf of the patient unless he or she has a formal authorization such as a signed authority letter by the patient or his/her legal representatives (family members) or, where the caregiver is a family member himself or herself, if he or she has a document that verifies his or her relationship with the patient such as a government identity proof. The caregiver’s identity and authorization should be checked by the doctor before offering teleconsultation. In the case of minors, the identity of the caregiver should be confirmed.
Doctor should identify himself/herself to the patient before start of every teleconsultation: A doctor should begin any teleconsultation by informing the patient about his/her name and qualification. This may be uncomfortable to be done every time, especially to a known patient. However, this is the requirement of Telemedicine Guidelines at present.
Doctor should display his/her registration number at every touch-point with patient: A doctor who provides teleconsultation is required to display his/her registration number provided by respective State Medical Council on his/her prescription, website, electronic communications (WhatsApp/Message/Email etc.) and fee receipts given to his/her patients.
Doctor should not continue with teleconsultation if it not appropriate: the doctor is not satisfied with the information provided by the patient to provide specific treatment, i.e. prescription or health advice, then he/she should provide limited consultation as appropriate and refer the patient for an in-person consultation.
Doctor should maintain patient records of teleconsultation: For in-person O.P.D. consultations in India, the doctors, in general, do not maintain patient records. Appropriate patient history, observations and findings are recorded on the prescription and it is handed over to the patient. However, for teleconsultation, it is mandatory for doctors to prepare, maintain and preserve the patient’s records (e.g. case history, investigation reports, images, etc.), copy of prescription issued and proof of teleconsultation (e.g. phone call history, email records, chat/ text record, video interaction logs etc.). While no time period is prescribed for how long such records are required to be preserved, it is generally recommended to maintain these records for three years.
Patient’s personal data should not be disclosed or transferred without written consent of the patient: Since teleconsultation happens on an electronic medium, the Indian law that protects personal information, including medical and health-related information of patients, squarely applies to doctors who provide teleconsultation and receive such information from patients. This is in addition to the ethical obligation to protect patient privacy that is recognized in the Code of Conduct. The most important thing to note here is that Doctors who provide teleconsultation should not disclose or transfer any information that may identify the patient without the prior written consent of the patient.
Doctor should not deny emergency teleconsultation, but limit it for immediate assistance or first aid: Emergency teleconsultation should not be provided remotely except when it is the only way to provide timely care.Even then, such emergency teleconsultation should be limited to first aid, life-saving measures, counselling and advice on referral. Every emergency teleconsultation must end with an advise to the patient or his/her carer for in-person interaction with a Doctor at the earliest.
Limitation on prescribing medicines to patients: This is, perhaps, the most significant limitation imposed by Telemedicine Guidelines on the practice of telemedicine in India. Going forward, doctors will not be able to prescribe medicines over teleconsultation freely.
In order to
prevent abuse, the Telemedicine Guidelines require every doctor to “prescribe
medicines via telemedicine ONLY when (the doctor) is satisfied that he/ she has
gathered adequate and relevant information about the patient’s medical
condition and prescribed medicines are in the best interest of the patient.” Prescribing
Medicines without an appropriate diagnosis/provisional diagnosis will amount to
professional misconduct.
Before issuing a prescription
through teleconsultation, every doctor is supposed to inquire about the age of
the patient. If there is any doubt about the age of the patient, then the
doctor should seek age proof. If the patient turns out to be a minor, then further
teleconsultation should be done and prescription should be issued only in the presence
of an adult, whose identity should also be ascertained by the doctor.
If the teleconsultation
with the patient does not take place over video, then the concerned doctor
cannot prescribe drugs to the patient other than common over-the-counter (“O.T.C.”)
medications such as paracetamol, O.R.S. solutions, cough lozenges etc. Such patient
also cannot be prescribed medication for which diagnosis is possible only by
video consultation such as antifungal medications for Tinea Cruris,
Ciprofloxacillin eye drops for Conjunctivitis etc. The doctor may, however,
prescribe ‘add-on’ medication to such patient to optimize the existing
treatment through drugs if such existing treatment was prescribed in an
in-person consultation less than six months ago. Please note that there is no
bar in prescribing emergency medications, even if they are not O.T.C. medicines,
as and when notified by the government, through any form of teleconsultation,
whether video or not.
A list of common O.T.C.
medications that can be prescribed without video teleconsultation is described
in List O, Appendix 5 of the Code of Conduct. A list of ‘add-on’ medications to
optimize existing treatment is described in List B, Appendix 5 of the Code of
Conduct. For the purpose of this list, emergency medications would be included
in the list of O.T.C. medications, i.e. List O.
If the patient is
examined through video, then the doctor may prescribe medications other than O.T.C.
medicines described in List A of Appendix 5 of Code of Conduct. Some examples
of such medicines are:
Ointments/Lotion for skin
ailments: Ointments Clotrimazole, Mupirocin, Calamine Lotion, Benzyl Benzoate
Lotion etc.
Local Ophthalmological
drops such as: Ciprofloxacillin for Conjunctivitis, etc
Local Ear Drops such as:
Clotrimazole ear drops, drops for ear wax etc.
The doctor may
also prescribe a ‘refill’ of medication already prescribed during an in-person consultation
for chronic illnesses (hypertension, diabetes, asthma etc.) or an ‘add-on’ medication
to optimize the existing treatment (like in the case of non-video consultation).
Please note,
however, that no doctor is permitted to prescribe habit forming drugs (i.e.
drugs in Schedule X of Drugs and Cosmetics Rules, 1945) or narcotic or
psychotropic drug (i.e. drugs regulated by Narcotic Drugs and Psychotropic
Substances Act, 1985) through any medium of teleconsultation.
For details on restrictions
on the ability of doctors to issue prescriptions during teleconsultation,
please refer to the table below:
Type
I (Non-video consultation)
Prior in-person consultation
Scope and limitation of prescription
List of drugs that may be prescribed
No prior in-person consultation
+ Can prescribe only O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids
– Cannot prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc.
– Cannot prescribe ‘add-on’ medication which are used to optimize an existing condition
– Cannot prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc.
– Cannot prescribe habit forming, narcotic or psychotropic drug
As provided in List O, Appendix V of Code of Conduct
Prior in-person consultation for same health condition in last six months
+ Can prescribe O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids
+ Can prescribe ‘add-on’ medications which are used to optimize an existing condition – e.g. if the patient is already on Atenolol for hypertension and the blood pressure is not controlled, an A.C.E. inhibitor such as Enalapril may be prescribed as an add-on.
– Cannot prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc.
– Cannot prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc
– Cannot prescribe habit forming, narcotic or psychotropic drug
As provided in List O & List B of Appendix V of Code of Conduct
Type
II (Video consultation)
Prior in-person consultation
Scope and limitation of prescription
List of drugs that may be prescribed
No prior in-person consultation
+ Can prescribe O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids
+ Can prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc.
– Cannot prescribe ‘add-on’ medication which are used to optimize an existing condition
– Cannot prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc – Cannot prescribe habit forming, narcotic or psychotropic drug
As provided in List O & List A of Appendix V of Code of Conduct
Prior in-person consultation for same health condition in last six months
+ Can prescribe O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids
+ Can prescribe ‘add-on’ medications which are used to optimize an existing condition – e.g. if the patient is already on Atenolol for hypertension and the blood pressure is not controlled, an A.C.E. inhibitor such as Enalapril may be prescribed as an add-on.
+ Can prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc.
+ Can prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc
– Cannot prescribe habit forming, narcotic or psychotropic drug
As provided in List O, List A & List B of Appendix V of Code of Conduct
Mandatory
training in telemedicine
At some point of time in future, the Board of Governors in supersession of Medical Council or National Medical Commission would introduce training programs in telemedicine. It will be mandatory to participate in those training programs for all doctors who intend to offer teleconsultations to patients. However, until those training programs are developed, there is no restriction in terms of prior training or qualification for registered doctors to engage in teleconsultation.
Do
Telemedicine Practice Guidelines apply to doctors who are practising Indian
medicine?
The Telemedicine
Guidelines do not apply to practitioners of Ayurveda, Yoga, Homeopathy, Unani
or Siddha.
What
happens to the Telemedicine Guidelines when the National Medical Commission is
set-up?
The Board of Governors in supersession of Medical Council of India will soon make way for the National Medical Commission. However, this transition will not impact the Telemedicine Guidelines and the practice of telemedicine in India. The National Medical Commission Act, 2019 has a savings clause, which will allow the Code of Conduct and Telemedicine Guidelines to survive and remain enforceable until new regulations are made.
Impact of 2018 judgement of Deepa Sanjeev Pawaskar and Anr. v. State of Maharashtra on Telemedicine Practice Guidelines
In 2018, a judgement
of High Court of Bombay caused panic amongst doctors who offered
teleconsultation. In that case, two gynaecologists were denied anticipatory
bail on the grounds that, prima facie, they were criminally negligent towards their
patient who unfortunately died while under their care. The material facts of
the case are that the deceased patient had presented herself with a complaint
of fever and severe vomiting. She was admitted to the nursing home of the
accused doctors by the hospital staff without examination, as the doctors were
out of town. One of the doctors started treatment for the patient
telephonically, by instructing the on duty nurse. Unfortunately, the patient
died. The Court held that the patient died because, amongst other things, she
was prescribed treatment over telephone without appropriate diagnosis, and
found such practice to be an act of criminal negligence. The application of the
doctors for bail in anticipation of arrest was rejected. However, the doctors
were successful in receiving the bail in appeal and were not arrested.
This judgement was
interpreted
by some doctors as deeming the practice of telemedicine and teleconsultation itself
illegal. However, such an interpretation is without basis and incorrect.
The Court was only concerned failure of the doctor to diagnose the patient. The
fact that the drugs for treatment of patient were communicated by the doctor through
telephone is only incidental to the outcome of the judgement. It is not the
basis of the judgement. In other words, had the doctor communicated the same
drugs to the nurse orally while being physically present but without examining
the patient, and then patient would have died, the Court would have come to the
same conclusion. Thus, the judgement should not be extrapolated to state that
the practice of telemedicine and teleconsultation itself is illegal.
Therefore, the above
judgement of Bombay High Court does not interfere with the Telemedicine
Guidelines at all. In fact, it supports it. The Telemedicine Guidelines require
doctors who provide teleconsultation to start patient treatment only if the
doctor is satisfied that he/ she has gathered adequate and relevant information
about the patient’s medical condition and prescription of medicines which are
in the best interest of the patient. Else, the doctor should not prescribe
medication to the patient. If the doctor prescribes patient in violation of the
Telemedicine Guidelines, he/she risks losing his/her registration with
respective State Medical Council i.e. the license to practice medicine on
grounds of professional misconduct.
Enforcement
of the Telemedicine Guidelines
The Telemedicine
Guidelines have been published in form of an amendment to the Code of Conduct. Therefore,
any violation of the Telemedicine Guidelines will be looked at as a
‘misconduct’ at hands of the concerned doctor under the Code of Conduct. A
patient, who suffers due to misconduct, has the right to complain to the
respective State Medical Council with whom the doctor is registered about the
misconduct. If the doctor is found guilty of the misconduct, he or she may be
reprimanded, or his/her registration may be suspended or cancelled. A
suspension or cancellation of registration would effectively stop the doctor from
carrying on his/her medical practice.
Conclusion
The notification
of the Telemedicine Guidelines marks the dawn of a new era in the practice of
modern medicine. The law has finally caught up with the reality and necessity of
modern times.
The Telemedicine
Guidelines enable doctors to confidently provide teleconsultation via any
medium (such as email, phone call, message, fax, WhatsApp, other mobile and
computer applications such as Skype, Google Hangouts etc.) to the
patients.
At the same time, they
protect patient interest by mandating doctors to identify themselves before
consultations, disclose their registration number, offer the same standard of
care to patients as during in-person consultation and limit medicines that can be
prescribed through a teleconsultation.
Indians will now
be able to enjoy access to quality healthcare remotely, and doctors will be
able to extend their services to many more needy patients.
The Indian law that regulates quality and
safety of medical devices has been amended and it will now apply to all medical
devices, effective April 1, 2020. Prior to the amendment, only 37 categories of
medical devices were regulated or were notified to be regulated in near future in
India.
The immediate consequence of the amendment in
law is as follows:
Before October 1, 2021, all presently unregulated medical devices will have to be registered by respective importers or manufacturers with the Drugs Controller General of India. However, those medical devices which are already regulated or have been notified to to be regulated are exempted from the requirement of registration (see list of 37 categories of medical devices at the end of this article which are exempt from registration).
Before October 1, 2022, importers, manufacturers, distributors, whole sellers and retailers of presently unregulated Class A (low-risk) and Class B (low-medium risk) medical devices sold in India will have to compulsorily obtain a license.
Before October 1, 2023, importers and manufacturers, distributors, whole sellers and retailers of presently unregulated Class C (medium-high risk) and Class D (high risk) medical devices sold in India will have to compulsorily obtain a license.
In order to obtain registration for medical
devices, the importers and manufacturers of the medical devices have to be certified
as compliant with ISO-13485 (Medical Devices – Quality Management Systems –
Requirements for Regulatory Purposes).
What actually happened?
On February 11, 2020, the Government of
India gazetted two notifications – a
new definition of medical devices and The
Medical Devices (Amendment) Rules, 2020. The cumulative effect of these two
notifications is that all medical devices will be brought under the fold of
quality and safety regulation from the effective date of both notifications – April
1, 2020.
India’s medical device quality
regulation
The standards of quality and safety of
medical devices are regulated in India by a law called The
Drugs and Cosmetics Act, 1940 (“DCA”). The scope of DCA is restricted to
only those medical devices which are notified by the Government from time to
time as “drugs” (commonly referred to as “notified medical devices”).
The Medical
Devices Rules, 2017 (“MDR”) have been framed under DCA. These rules lay
down comprehensive quality requirements to be followed by marketers / importers
/ manufacturers / sellers of notified medical devices.
The way DCA and MDR ensure quality and
safety of notified medical devices at all levels of the supply chain is by enforcing
a mandatory license requirement. All importers / manufacturers / sellers of
notified medical devices must obtain a license from the appropriate licensing
authority before undertaking any commerce in notified medical devices. A
license is issued only after quality checks. The license holder’s business premise
is subject to periodic inspection. A license holder is also required to
maintain detailed records of the sale-purchase undertaken in relation to
notified medical devices and ensure traceability in the event of a quality or
safety-related failure or complaint.
New Definition of Medical Devices
Until February 11, 2020, the Government had
regulated or notified 37 categories of medical devices as drugs (see list of
these 37 categories of medical devices at the end of the article). On February
11, 2020, the government exercised its powers to notify one or more categories
of medical devices as “drug” to actually notify a new definition of medical
devices.
As per the notification, effective April 1,
2020, the medical devices that fall under the following definition will be
regulated as “drug” under the DCA and MDR:
All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ― (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) disinfection of medical devices; and (vi) control of conception.
For the purpose of this article, all
medical devices which were not notified until February 11, 2020 (i.e. other
than the list of 37 categories of medical devices listed at the end of this
article), and will now be covered by the new definition of medical devices will
be referred to as “Newly Notified Medical Devices”.
The Medical Device (Amendment) Rules,
2020
On February 11, 2020, the government also
notified The Medical Device (Amendment) Rules, 2020 (“MDR Amendment”).
The MDR Amendment introduces two changes to MDR. The first is introduction of a
new chapter for registration of Newly Notified Medical Devices by their
respective manufacturers and importers. The second is an exemption for the 37
categories of already regulated or notified medical devices from the requirement
of registration introduced by the new chapter.
Requirement of registration
The manufacturers or importers of Newly
Notified Medical Devices will be required to compulsorily register their
medical devices with the Drugs Controller General of India (“DCGI”) before October
1, 2021. The DCGI will start accepting applications for registration through a
dedicated online portal called “Online System for Medical Devices” from April
1, 2020 (or from such later date by when the online portal to ready to accept
applications). There is no time-frame prescribed as of now for processing of the
application for registration by DCGI. It appears that the registration will be
done instantly after submission of all information and documents on the online
portal i.e. without any examination of the information and documents submitted
by the applicant at the hands of DCGI.
The registration process is relatively
simpler and should not be equated to a full-fledged marketing registration or authorization.
Any importer or manufacturer of Newly Notified Medical Device will be able to
obtain registration on the submission of the following information:
Name of the company or firm or
any other entity
Name and address of
manufacturing site (for devices manufactured in India only)
Specification and standards of
medical device (for imported devices only)
Details of medical devices (Generic
Name, Model No., Intended Use, Class of Medical Device, Material of Construction,
Dimensions (if applicable), Shelf Life, Sterile or Non-sterile status, Brand
name only if registered under India’s trade mark law)
Certificate of compliance with
respect to ISO 13485 standard accredited by National Accreditation Board for
Certification Bodies or International Accreditation Forum in respect of such
medical device
Free sale certificate from
country of origin (for imported devices only)
A duly signed undertaking
stating that the information furnished by the applicant is true and authentic
The registration will be complete only upon
generation of a registration number.
If an importer or manufacturer is unable to
obtain registration for its Newly Notified Medical Device before October 1, 2021, then it will not be
able to market and sell its medical device in India until a registration is
obtained.
The importer or manufacturer of a medical
device which belongs to one of the 37 categories of medical device regulated or
notified prior to February 11, 2020 (see list at the end of this article) are
exempt from the requirement to obtain registration for its medical device and
therefore can continue to carry on their business on the strength of the
license issued by appropriate licensing authority.
Label declaration of registration number
Every importer and importer who obtains a
registration number for its medical device will have to display the
registration number on its label. The requirement to declare registration
number is not tied to the deadline for registration (October 1, 2021). Rather
it is an immediate requirement and will trigger from the time the registration
number is issued, unless otherwise mandated by DCGI.
Consequence of obtaining registration
A certificate of compliance with ISO-13485 (Medical
Devices – Quality Management Systems – Requirements for Regulatory Purposes) is
mandatory for registration of Newly Notified Medical Device. Therefore, an importer
or manufacturer of a registered medical device will have to ensure that the
requirements of ISO 13485 are met at all times. Broadly speaking, ISO 13485
requires creation, documentation and implementation of a quality management
system which is to be supplemented by an independent audit from time to time.
Once an importer or manufacturer registers
its medical devices, it will have to strictly conform to its documented quality
management system.
If any gap is found in the implementation
of quality management system by DCGI, it will have the right to suspend or
cancel the registration of the medical device.
An order of suspension or cancellation of registration for medical
device will prevent the importer or manufacturer of said medical device to further
import or manufacture said medical device.
Consequences of registration on supply
chain
There is no consequence of registration of
medical device on its supply chain. The
supply chain will not be required to obtain registration or license to sell registered
medical devices.
Requirement to obtain a license
In addition to registration, importers and manufacturers
of Newly Notified Medical Devices will have to obtain a license under MDR before
the prescribed deadline (see table for deadlines).
In the table below, we have listed the name
of the authority who will issue the license to importers and manufacturers
along with prescribed deadlines.
Class of medical device
Licensing Authority
Stipulated timeline for processing application
Deadline for obtaining license
Class A and B (import)
DCGI
Up to 9 months from the date of application
September 30, 2022
Class C and D (import)
DCGI
Up to 9 months from the date of application
September 30, 2023
Class A (manufacture)
State-level Licensing Authority
Up to 45 days from the date of application
September 30, 2022
Class B (manufacture)
State-level Licensing Authority
Up to 140 days from the date of application
September 30, 2022
Class C and D (manufacture)
DCGI
120 – 180 days (estimated)
September 30, 2023
It is important to note that it is not
mandatory to have a registration number in order to obtain a license.
Therefore, the application for license can be made anytime after April 1, 2020
(or such other date that DCGI may specify in future).
If a license is obtained much in advance before the deadline gets over, it will not obligate the manufacturer or importer to comply with the requirements of MDR only on the grounds that a license has been obtained. For example, if a Class C or Class D medical device importer or manufacturer obtains a license before the deadline of September 30, 2023, the said importer or manufacturer will not have to declare the import license number on the label. The supply chain of the said device also will not require a license just because the medical device importer or manufacturer has applied for and received a license. However, after the deadline gets over, all the compliances stipulated under MDR including the requirement to obtain license by the entire supply chain will have to be met. The routine inspections of warehouses or manufacturing premises should also begin only after the prescribed deadline gets over.
The risk-classification of all medical
devices (Class A, B, C, D) will be done by the DCGI. It is expected that the DCGI
will come out with a list of classification of medical devices on or before
April 1, 2020. However, in the meanwhile, anybody interested in knowing the
potential classification of medical device can refer either refer to parameters
of classification of medical devices described in the first schedule to MDR or
to its classification in a GHTF country (EU, Australia, Canada, Japan, USA etc.) because India largely follows GHTF principles of
classification of medical devices.
Therefore, it may not hurt importers and
manufactures of Newly Notified Medical Devices to make an application to obtain
a license sufficiently in advance of the expiry of deadline.
Supply chain to obtain license
The supply chain of Newly Notified Medical
Devices (including marketers) will also have to obtain appropriate license for
distribution (i.e.Wholesale ) or retail sale before the deadline for obtaining a
license for respective class of devices expires. See table below for the name
of the authority who will issue the license and for prescribed deadlines.
Class of medical device
Licensing Authority
Stipulated timeline for processing application
Deadline for obtaining license
Class A and B (imported or manufactured)
State-level Licensing Authority
Up to 3 months (estimated)
September 30, 2022
Class C and D (imported or manufactured)
State-level Licensing Authority
Up to 3 months (estimated)
September 30, 2023
Relaxation to obtain registration and
license
The government has given time to the
medical device industry to transition into the regulatory framework and to obtain
ISO 13485 certification, if not already obtained.
The government has relaxed the requirement
to obtain registration and license for Newly Notified Medical Devices for the
following period:
April 1, 2020 to September 30, 2021 – No registration or license will be required to manufacture, import, distribute or sell Newly Notified Medical Devices;
October 1, 2021 to September 30, 2022 – Registration will be required to import or manufacture such medical devices, but no license will be required;
October 1, 2022 to September 30, 2023 – License will be required to manufacture, import, distribute or sell Class A or Class B medical devices, but no license will be required to manufacture, import, distribute or sell Class C or Class D medical devices; and
After October 1, 2023 – License will be required to manufacture, import, distribute or sell Class C and Class D medical devices as well.
Exemption for devices regulated or
proposed to be regulated but notified before February 11, 2020
As indicated earlier, the 37 categories of
medical devices regulated or notified before the date of MDR Amendment i.e.
February 11, 2020, will not be affected by the MDR Amendment and therefore will
not be required to obtain registration. The list of 37 categories of medical devices
is reproduced at the end of this article.
However, being exempted from application of
the MDR Amendment does not mean that they are exempted from MDR itself. These
devices and their importers, manufactures and the entire supply chain will have
to obtain a license and observe other compliances stipulated under MDR at all
times.
Consequences of non-registration or of not
obtaining license before deadline
If an importer or manufacturer of a Newly
Notified Medical Device fails to obtain a registration until October 1, 2021,
then it will have to cease import or manufacture of said medical device until
such time the registration is obtained. It will be easy for the DCGI or
State-level Licensing Authority to know whether a medical device is
manufactured or imported without registration. Under the Legal Metrology
(Packaged Commodity) Rules, 2011, every importer and manufacturer of any
medical device (whether regulated or unregulated) is required to declare the
date of import of medical device or date of manufacture of medical device on
its label. Therefore, if a declaration exists on the label of a medical device that
the medical device has been imported or
manufactured on or after October 1, 2021, but the label does not show a DCGI registration
number, then it will be confiscated by DCGI or appropriate State-level
Licensing Authorities and action will be taken against the importer or
manufacturer.
Any violation of MDR including failure to
obtain registration or license before stipulated deadline may result in
criminal prosecution resulting in imprisonment and fine. Any stock of medical device
that is sold without registration or license could also be confiscated.
In our view, the notification of the new (and
comprehensive) definition of medical device has brought finality to the issue
of regulation of all medical devices that has haunted the government and Indian
consumers for a long time. The Government has now given sufficient time for the
industry to adopt ISO 13485 and obtain registration for hitherto unregulated medical
devices. Now, the onus is on the industry to do its part and reinforce the belief
of the Indian consumer and the international community in the quality and
safety of medical devices sold in India.
List of 37 categories of medical devices
regulated or proposed to be regulated but notified before February 11, 2020,
and therefore not affected by the amendment
1. Disposable Hypodermic Syringes;
2. Disposable Hypodermic Needles;
3. Disposable Perfusion Sets;
4. Substances used for in vitro diagnosis including
Blood Grouping Sera;
5. Cardiac Stents;
6. Drug Eluting Stents;
7. Catheters;
8. Intra Ocular Lenses;
9. I.V. Cannulae;
10. Bone Cements;
11. Heart Valves;
12. Scalp Vein Set;
13. Orthopedic Implants;
14. Internal Prosthetic Replacements;
15. Ablation Devices;
16. Ligatures, Sutures and Staplers;
17. Intra Uterine Devices (Cu-T)
18. Condoms;
19. Tubal Rings;
20. Surgical Dressings;
21. Umbilical tapes;
22. Blood/Blood Component Bags;
23. Organ Preservative Solution;
24. Nebulizer (effective from 1 Jan.2021);
25. Blood Pressure Monitoring Device (effective from
1 Jan.2021);
26. Glucometer (effective from 1 Jan.2021);
27. Digital Thermometer (effective from 1 Jan.2021);
28. All implantable medical devices Equipment
(effective from 1, April,2021);
29. CT Scan Equipment (effective from 1,
April,2021);
30. MRI Equipment (effective from 1, April,2021);
31. Defibrillators (effective from 1, April,2021);
32. PET Equipment(effective from 1, April,2021);
33. X-Ray Machine (effective from 1, April,2021);
34. Dialysis Machine (effective from 1, April,2021);
35. Bone marrow cell separator (effective from 1,
April,2021);
36. Disinfectants and insecticide specified in
Medical Devices Rules, 2017;
37. Ultrasound equipment (effective from 1,
November, 2020)
The Ministry of Health and Family
Welfare in India has notified the Draft Medical
Devices (… Amendment) Rules, 2019 (Draft Rules) for public comments on
October 18, 2019. By notifying these rules, the Indian Government has made its
intention clear to regulate all medical devices in a phased manner. As of date,
only twenty-three categories of medical devices are regulated by the Indian
Government. Thirteen categories of medical devices will be regulated from the
year 2020.
Highlights
Amendment to Medical Devices Rules,
2017: The Draft Rules will be incorporated within the existing
Medical Devices Rules, 2017 (MDR). This is an important fact considering some
news reports had indicated that the Union Government was planning to completely
overhaul the medical device regulatory framework which would have affected the
medical devices that are currently regulated, as well. Thus, medical devices
which are presently regulated should not be impacted upon formalization of the
Draft Rules.
New registration requirement:
All medical device manufacturers and importers will have to register themselves
and their medical devices with the Central Licensing Authority (i.e. the Drugs
Controller General of India).
Key requirements for registration in
case of manufacturers: In order to register, a manufacturer
will have to submit a) name and address of the manufacturer and the
manufacturing site, b) details of medical devices, including shelf life and c)
certificate of compliance with ISO 13485.
Key requirements for registration in
case of importers: In order to register, an importer
will have to submit a) name and address of the importer, b) specification and
standards of the medical device, c) details of medical devices, including shelf
life, c) certificate of compliance with ISO 13485 and e) free sale certificate
from country of origin.
Grace period for registration: It will be voluntary for manufacturers and
importers to register themselves until the expiry of eighteen months from the
date of notification of the final rules (“Grace Period”).
Registration to be mandatory:
After expiry of Grace Period, it will be unlawful for manufacturers and
importers to market the medical device in India without a registration issued
by the Central Licensing Authority.
License requirement:
Manufacturers and importers of Class A (low risk) and Class B (low medium risk)
medical devices will have to obtain a license under MDR from the appropriate
authority within 12 months of the expiry of the Grace Period. Manufacturers and
importers of Class C (medium-high risk) and Class D (high risk) medical devices
will have to obtain a license under MDR from the appropriate authority within
24 months of the expiry of the Grace Period.
Labelling requirement:
Once registered, both manufacturers and importers will have to mention their
registration number on the label of the medical device.
Dedicated portal for registration:
There will be a dedicated portal called ‘Online System for Medical Devices’
that will be set-up for registration of medical devices.
Open for comments:
The Draft Rules are open for comments for thirty days from the date of
notification, i.e. until November 17, 2019.
Background
India is one of the few countries
which currently does not regulate all medical devices, including some of the
ones that are put on or inside the human body. The objective of the Draft Rules
is to bring all medical devices within the purview of the regulatory framework.
The ultimate objective, of course, is to set a scientific benchmark for safety,
quality and performance of all medical devices and ensure that every medical
device sold in India conforms to this benchmark. On a separate note, it was
important for the Indian Government to take strong steps to ensure safety and
quality of all medical devices manufactured in India to give a boost to its
flagship Make in India programme, especially since the reduction of import
dependence on medical devices is high up on the Government’s agenda.
Issues
The current language of the Draft
Rules is not without shortcomings. Some of the key shortcomings that we have
identified are:
The lack of clear definition of
medical device: The Draft Rules will be effective only
when the Ministry of Health and Family Welfare notifies that all medical devices
will be regulated as drugs under Section 3(b)(iv) of The Drugs and Cosmetics
Act, 1940. Currently, only thirty-six categories of medical devices have been
notified as drugs, as discussed in the introductory part of this article. It is
expected that such a notification will soon follow the notification of the
Draft Rules once they are finalized. However, the current definition of medical
devices under MDR is a very limited definition. It does not lay down a uniform
set of criteria to determine when any substance or article can be called a
medical device for the purposes of MDR. It is expected that the Ministry of
Health and Family welfare will notify another amendment to MDR and amend the
definition of medical devices to lay down certain objective criteria for classification
as a medical device. Without a uniform set of criteria, it will be very
difficult for manufacturers and importers to assess whether their product falls
under the category of medical device or not.
Discretion to choose class of medical
devices for registration: In most countries around the world,
it is up to the manufacturer or importer of medical devices to select a risk categorization
for its medical device and justify it to the national regulatory agency.
However, in India, as per Rule 4(3) of MDR, the Central Licensing Authority
itself determines the risk classification of the medical devices. There is no
formal avenue to justify or review the risk classification of medical devices
once it is determined by the Central Licensing Authority. Interestingly, for
the purpose of registration, the Central Licensing Authority has allowed
importers and manufacturers to declare a risk classification as they deem fit.
The current text of the Rules does not empower the Central Licensing Authority
to review the risk classification before the grant of registration. This may
result in a situation where two manufacturers of the same generic medical
device may declare different risk classifications. The proper determination of
risk classification is especially relevant since it may have an impact on
quality management system adopted by the manufacturers (and importers, as the
case may be).
Time-frame to adopt ISO 13485:
The ISO 13485 is essentially a quality management system for medical devices.
In order to obtain a certificate of compliance with ISO 13485, a
manufacturer/importer has to not just show that the required documentation and
processes that assure quality are in place, but also demonstrate that the
quality management system is functional. There are many manufacturers /
importers / marketers in India who have a portfolio of numerous medical
devices. It could be an onerous task for them to put in place a functional
quality management system for all medical devices in their portfolio and obtain
a registration from the Central Licensing Authority within 18 months (i.e.
within the Grace Period). As per some industry estimates, it may easily take up
to a year or more for mid-size businesses to put in place a functional quality
management system that complies with the requirements of ISO 13485.
Adverse consequences of ‘voluntary’
registration: If a manufacturer or importer
already has a certificate of compliance with ISO 13485, it does not make
commercial sense for it to obtain registration from Central Licensing Authority
until shortly before expiry of the Grace Period (i.e. eighteen months from the
date of notification). This is because immediately upon receipt of
registration, it will have to start declaring the registration number on the
label. Typically, any change to packaging, including to the label, requires
months of advanced planning from a product continuity perspective. Further,
once registered, the manufacturer or importer would be liable to be
investigated by the Central Licensing Authority for quality and safety. This
rationale is also applicable to manufacturers and importers of medical devices
who do not have certificate of compliance with ISO 13485 yet, but can obtain it
in short time. Instead, it would have been pragmatic for Central Licensing
Authority to take some time and set-up a system for registration that is
exhaustive and fool-proof, so that it could gather greater quantity and quality
of information from registrations.
Potential supply chain disruption:
Though the Draft Rules put in place a registration requirement, please note
that a license requirement will also be applicable for such medical devices in
due course, as highlighted earlier. It is quite likely that the supply chain
(i.e. super stockists, distributors, third-party logistics providers) of most
of the currently unregulated medical devices does not have a license to sell a
medical device. When the license requirement becomes applicable for medical
device manufacturers and importers, it will also become applicable for the
entire supply chain (i.e. they will have to obtain a license to sell a medical
device by wholesale or retail from appropriate licensing authority). If the
entire supply chain does not obtain a license by then, it could result in
supply chain disruption.
Price control:
Once medical devices come within the regulatory framework of MDR, they will
automatically come within the price control framework of Drugs (Prices Control)
Order, 2013 (DPCO). In fact, unregulated medical devices will come within the
price control framework from the date of notification of the final rules. This
is because DPCO applies to all drugs, and the definition of drugs is the same
as that under Drugs and Cosmetics Act, 1940 (DCA). Since MDR has been framed
under DCA by creating a deeming fiction that medical devices are drugs, the
currently unregulated devices will also come under the ambit of DPCO. The
immediate consequence of application of DPCO would be that the marketers of the
medical device will not be able to increase its MRP by more than 10% in any
continuous 12 month period. Under certain circumstances, their prices may also
be fixed by the Government.
Comment
The regulation of all medical devices
is a welcome change that is expected to level the playing field. More
importantly, it is expected to give assurance of quality and safety to the
common man who gets exposed to one or the other medical device at some stage of
his/her life. It is hoped that the Central Drugs Standards Control Organization
would consider some of the issues highlighted herein and address them before
notifying the final rules. In the meanwhile, the medical device industry should
prepare itself for the reality of impending future regulation.
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