India: Breaking Down ‘Prabhat Steel Traders Pvt. Ltd v Excel Metal Processors Pvt. Ltd'

Newspapers and the Electronic Media carry daily advertisements of online pharmacies inducing the reader to purchase medicines by uploading the doctor's prescriptions. While this certainly saves time, most users of these online pharmacies may be mindful of the genuineness, storage conditions, and source of the medicines so dispensed.

Presently, these online pharmacies or e-pharmacy portals operate on the marketplace or inventory model in compliance with The Information Technology Act, 2000 and the e-commerce guidelines of the Government of India, with registered pharmacies or chemists as channel partners of these portals and the source of the medicines.

While the brick and mortar "Chemist" as we generally refer to these shops, are regulated by The Drugs and Cosmetics Act, 1940 and the Rules framed thereunder (the "Act"), the Act does not explicitly regulate the online pharmacies. The Government of India has by Notification dated August 28, 2018 proposed the Draft Drugs and Cosmetics Amendment Rules, 2018 (Draft Rules) to include provisions for regulation of the online pharmacies/e-pharmacies, by including a new Part VIB in the extant Drugs and Cosmetics Rules, 1945.

A brick and mortar Chemist is required to have a drug license issued by the Licensing Authority, for dispensation of drugs with the mandatory requirement of a Registered Pharmacist who is a person registered under the Pharmacy Act, 1948, or a matriculate or equivalent with four years' experience of selling drugs, or a degree holder form a recognized University who has one year's experience of dealing in drugs. The need of a Registered Pharmacist arises only when the Chemist is a pharmacy engaged in compounding medicines against a prescription. The Draft Rules purport to impose similar conditions on the E-pharmacies.

Under the Draft Rules, an E-pharmacy means the business of distribution or sale, stock, exhibit or offer for sale of drugs through web portal or any other electronic mode. E-pharmacy portal is defined as a web or electronic portal established and maintained by the E-pharmacy registration holder to conduct the business of e-pharmacy.

The E-pharmacy portal is to be established in India and the data generated or mirrored through the portal is prohibited from being sent or stored by any means outside India.

Every person who intends to operate the E-pharmacy, including an individual, HUF, Company, Partnership, LLP is required to apply for registration with the Licensing Authority to sell, stock, exhibit, or offer for sale drugs through E-pharmacy. The conditions for registration are:

  1. Compliance with the provisions of The Information Technology Act,2000.
  2. Cash or credit memo to be generated through the portal and should reflect:
  3. serial number and date,
  4. the name, address and sale license number of the licensee dispensing the drugs,
  5. the name, quantity, batch no., date of expiry and name of manufacturer of the drug dispensed.
  6. name and address of the e-pharmacy registration holder along with signature/digital signature of the Registered Pharmacist Incharge.

The registration would be for a period of three years, renewable within three months of expiry.

The E-pharmacy is prohibited from dealing with narcotic and psychotropic drugs referred to in the Narcotic Drugs and Psychotropic Substances Act, 1985, Tranquilizers and Drugs specified in Schedule 10 of the Drugs & Cosmetics Rules, 1945.

The obligations of the E-pharmacy registration holder for operating the E-pharmacy portal are:

  1. Orders for retail sale received through e-pharmacy portal.
  2. Dispensation of drugs against prescription of a registered medical practitioner received from the customer through the portal.
  3. Details of drugs dispensed including patient details to be maintained on the portal.
  4. Portal to disclose:
  5. registration certificate.
  6. constitution of the registration holder.
  7. logo, if any, of the portal.
  8. types of drugs offered for sale and availability.
  9. supply channels or vendor lists.
  10. details of registered medical practitioner, if any.
  11. name and registration details of Registered Pharmacist who validates the prescription before dispensing the drugs.
  12. details of the logistic service provider.
  13. return policy of dispensed drugs.
  14. Contact details of the E-pharmacy – email, landline and mobile numbers, address.
  15. Procedure for submitting grievances on the portal and redressal mechanism
  16. Facility for customer support and grievances redressal available for at least 12 hours every day for all 7 days of the week.
  17. Details of the patient to be kept confidential and not disclosed to any other person except the Central or State Government.

The Registered Pharmacist is under an obligation to verify the details of the patients, registered medical practitioner issuing the prescription and then to arrange to dispense the drugs in accordance with the prescriptions.

The E-pharmacy registration holder who has received the prescription on the portal shall dispense and make arrangements for supply of drugs from any retail or wholesale licensed premises under the Drugs & Cosmetics Act, 1940.

The Licensing Authority shall have powers to monitor the information on the E-pharmacy portal periodically as well as physically inspect every two years, the premises from where the E-pharmacy business is being conducted.

The Draft Rules have given the public a forty five days window for objections/suggestions which would be considered by the Central Government, after which the same would be re-notified in the Official Gazette and become effective.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Sign Up
Gain free access to lawyers expertise from more than 250 countries.
 
Email Address
Company Name
Password
Confirm Password
Position
Industry
Mondaq Newsalert
Select Topics
Select Regions
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