India: Telemedicine In India - Legal Analysis

Last Updated: 12 February 2013
Article by Vijay Pal Dalmia, Partner

Article by Vijay Pal Dalmia, Advocate Delhi High Court and Supreme Court of India
Partner, Vaish Associates Advocates, New Delhi, India, vpdalmia@vaishlaw.com

The concept of telemedicine and web based medical services are derived from the exchange or transmission of medical knowledge or information through electronic formats and mediums, so as to cut across time and space across the world for the benefit of medical advancement. Medical information is communicated through electronic media in interactive formats such as audiovisual media, telephonic conferences, satellite communication, internet etc. for medical consultation, examination or remote monitoring / medical procedure purposes. The model has popularized since it links isolated communities to advanced medical services and provides speedy delivery of medical expertise. Certified medical practitioners world over have started taking advantage of the telemedicine concept, expanding their services. The United States licensure laws promote the model while requiring a practitioner following the format to obtain a full license across states to deliver telemedicine healthcare services across state lines. In India practitioners and medical societies have been tele-transmitting medical information and remote monitoring health services since as early as 1975. The medium of tele applications and web-interface based systems linking patients and medical practitioners through telemedicine services may use wireless diagnostics tools like stethoscopes; blood pressure, temperature and insulin monitors, and ultrasounds enabling remote diagnosis, treatment, advanced healthcare and medical services.

The Medical Council of India regulates uniform standards of higher qualifications in medicine and recognition of medical qualifications in India and abroad. Official registration of doctors with recognized medical qualifications is controlled by the council, and procedures have been laid out under the Indian Medical Council Act 1956 and Indian Medical Degree Act 1916. Although there are no legal constraints specifically dealing with methodology of executing or dispensing medical services in India, various laws including the Drugs and Cosmetics Act, 1940 define negligence; criminal intent; sale, manufacture and distribution of drugs etc., while judicial precedent and case laws determine medical negligence on a case by case basis. The healthcare service provider adopting telemedicine methods of medical practice must ensure that medical consultation, prescriptions, treatment and drugs are dispensed only in accordance with legal provisions and guidelines regulating the medical and healthcare sector in India.

Under the present laws relating to the above in India, a fully automated process solely based on an artificial intelligence program may not be legally feasible, as it is a basic requirement that only medical practitioners registered before the Medical Council of India and other relevant lawsare allowed to provide medical consultation,prescriptions and treatment. For understanding the legal proposition in regard to the telemedicine in India, one has to understand the implications of some important legal provisions relating to medical healthcare and drugs in India, as under:

A *"Registered medical practitioner" has been defined under Section 2 (ee) of the Drugs and Cosmetics Rules, 1945 of India as a person-

  1. holding a qualification granted by an authority specified or notified under Section 3 of the Indian Medical Degrees Act, 1916 (7 of 1916), or specified In the Schedules to the Indian Medical Council Act, 1956 (102 of 1956); or
  2. registered or eligible for registration in a medical register of a State meant for the registration of persons practicing the modern scientific system of medicine excluding the Homoeopathic system of medicine; or
  3. registered in a medical register, other than a register for the registration of Homoeopathic practitioner, of a State, who although not falling within subclause (i) or sub-clause (ii) declared by a general or special order made by the State Government in this behalf as a person practicing the modern scientific system of medicine for the purposes of this Act; or
  4. registered or eligible for registration in the register of dentists for a State under the Dentists Act, 1948 (16 of 1948); or
  5. who is engaged in the practice of veterinary medicine and who possesses qualification approved by the State Government.

A "Drug" has been defined under Section 3 (b) of the Drugs and Cosmetics Act, 1940 and includes-

  1. all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;
  2. such substances (other than food) intended to affect the structure or any function of human body or intended to be used for the destruction of (vermin) or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;
  3. all substances intended for use as components of a drug including empty gelatin capsules; and
  4. such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.

The term "prescribed" as per Section 3 [(i)] of the Drugs and Cosmetics Act, 1940 means prescribed by rules made under the Act.

Prescriptions made against medical consultation and diagnosis services under telemedicine formats should satisfy legal requirements given below so as to be a valid legal prescriptionunder the laws of India. The Drugs and Cosmetics Rules, 1945 specify the type of drugs that require valid medical prescriptions for retail purchase, classifying them under Schedules appended to the Rules.

"Prescription only drugs" are defined under Section 65(9) of the Drugs and Cosmetics Rules, 1945, which states that –

  1. Substances specified in Schedule H or Schedule X shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner only.

    Further, in the case of substances specified in schedule X, the prescriptions shall be in duplicate, one copy of which shall be retained by the licensee for a period of two years.
  2. The supply of drugs specified in Schedule H or Schedule X to Registered Medical Practitioners, Hospitals, Dispensaries and Nursing Homes shall be made only against the signed order in writing which shall be preserved by the licensee for a period of two years;

The above provision deals only with the dispensing of medicine and supply of a certain category of medicine. However, irrespective of the schedule in which a medicine may fall, prescription of a medicine can be made only by a registered medical professional as per the Rules. Since there are no legal provisions describing the manner of treating a patient, prescriptions instructing a patient to consume any drugs are very important documentary evidence of negligence or lack of it on the part of a medical practitioner while treating a patient. The Rules have defined the important components that constitute a valid legal prescription, for all medical practice purposes.

A "prescription" has been defined under Section 65(10) of the Drugs and Cosmetics Rules, 1945 so as to have the following components-

  1. be in writing** and be signed*** by the person giving it with his usual signature and be dated by him;
  2. specify the name and address of the person for whose treatment it is given, or the name and address of the owner of the animal if the drug is meant for veterinary use;
  3. indicate the total amount of the medicine to be supplied and the dose to be taken.

For all medical treatments through telemedicine or web-interface format, it is important to ensure that the prescriptions must satisfy the above requirements of being in writing and signed by a registered medical practitioner, without which the prescription will be invalid in the eyes of the law.

Due to the recognition of electronic documents under the Information Technology Act, 2000, a prescription in an electronic format may be validated as a legal prescription if it is a secure electronic record affixed with a secure digital signature as prescribed under the Information Technology Act, 2000 of India. The Information Technology Act, 2000 provides for authentication of secure electronic records and affixing of digital signatures so as to ensure the legal validity of the same. Section 4, mentioned herein below, of the Information Technology Act, 2000 which recognizes electronic records is important for understanding above:-

"where any law provides that information or any other matter shall be in writing or in the typewritten or printed form, then, notwithstanding anything contained in such law, such requirement shall be deemed to have been satisfied if such information or matter is –

  1. Rendered or made available in electronic form, and
  2. Accessible so as to be usable for subsequent reference."

Section 3 of the Information Technology Act, 2000 deals with authentication of electronic records as under:-

  1. Subject to the provisions of the section any subscriber may authenticate an electronic record by affixing his digital signature.
  2. The authentication of the electronic record shall be effected by the use of asymmetric crypto system and hash function which envelop and transform the initial electronic record into another electronic record.

Digital signatures are legally recognized under Section 5 of the Information Technology Act, 2000, which states as under:-

"where any law provides that information or any other matter shall be authenticated by affixing the signature or any document shall be signed or bear the signature of any person then; notwithstanding anything contained in such law, such requirement shall be deemed to have been satisfied, if such information or matter is authenticated by means of digital signature affixed in such manner as may be prescribed by the Central Government."

Automated artificial intelligence based telemedicine formats controlled by a registered medical practitioner can formulate legal prescriptions in the form of an electronic record, provided the same can be attributed, under Section 11 of the Information Technology Act, 2000, to the originator-

  1. if it was sent by the originator himself;
  2. by a person who had the authority to act on behalf of the originator in respect of that electronic record; or
  3. by an information system programmed by or on behalf of the originator to operate automatically.

Section 14 of the Information Technology Act, 2000, defines a secure electronic record, wherein any security procedure has been applied to it at a specific point of time, after which such record shall be deemed to be a secure electronic record from such point of time to the time of verification.

Under Section 15 of the Information Technology Act, 2000, a secure digital signature by application of a security procedure agreed to by the parties concerned, can be verified to be a digital signature, at the time it was affixed, if it was—

  1. unique to the subscriber affixing it;
  2. capable of identifying such subscriber;
  3. created in a manner or using a means under the exclusive control of the subscriber and is linked to the electronic record to which it relates in such a manner that if the electronic record was altered the digital signature would be invalidated.

Since telemedicine formats of medical practice are essentially based on mediums of technology, the medical practice model may use the above legal provisions to their advantage with respect to preparation of valid legal electronic prescriptions.

'OTC Drugs' (Over The Counter drugs) are drugs legally allowed to be sold 'Over The Counter', i.e. without the prescription of a Registered Medical Practitioner. In India, though the phrase has no legal recognition, all drugs not included in the list of 'prescription only drugs' under the Drugs and Cosmetics Act, 1940 may be considered as non-prescription drugs (or OTC drugs). A proposal for a list of over the counter (OTC) drugs has been under the government's consideration and a committee appointed for the purpose has been working on it. The Drug Controller General of India is expected to lay down a separate set of rules or guidelines for OTC marketing once the list is official.

In a scenario where advice is provided electronically through a telemedicine interface, which is manned by certified medical practitioners and/ or an artificial intelligence system validated by medical practitioners entitled to practice medicine in India, the guidelines issued by the Medical Council of India under the Code of Ethics Regulations, 2002 also apply. Some guidelines, which may apply to a telemedicine system are listed below:-

Section 1.4 of the Code of Ethics Regulations, 2002 states that registration numbers of medical practitioners/ doctors accorded by the State Medical Council / Medical Council of India must be displayed in the clinic and in all prescriptions, certificates, money receipts given to patients.

Under Section 6.1.1 of the Code of Ethics Regulations, 2002 the act of soliciting patients directly or indirectly is unethical, by a physician or a group of physicians, institutions or organizations. Although no legal provision deals with the manner of communication between a medical practitioner and patient with respect to diagnosis and treatment, there are numerous legal provisions dealing with ethical conduct to be followed by medical practitioners while dispensing specialized medical services.

© 2013, Vaish Associates, Advocates,
All rights reserved with Vaish Associates, Advocates, 10, Hailey Road, Flat No. 5-7, New Delhi-110001, India.

The content of this article is intended to provide a general guide to the subject matter. Specialist professional advice should be sought about your specific circumstances. The views expressed in this article are solely of the authors of this article.



To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Vijay Pal Dalmia, Partner
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions