There is no separate definition for the term E-pharmacy, while the term pharmacy has been explained under Rule 64 of the Drugs and Cosmetics Rules, 1945. As per Rule 64-

For the purpose of this rule the term ‘Pharmacy’ shall be held to mean to include every store or shop or other place: (1) where drugs are dispensed, that is, measured or weighed or mode up and supplied: or (2), where prescriptions are compounded; or (3) where.

drugs are prepared; or (4) which has upon it or displayed within it, or affixed to or used in

connection with it, a sign bearing the word or words “Pharmacy”, “Pharmacist,” “Dispensing Chemist” or “Pharmaceutical Chemist”; or (5) which, by sign, symbol or indication within or upon it gives the impression that the operations mentioned at (1), (2) and (3) are carried out in the premises; or (6) which is advertised in terms referred to in (4) above

In accordance with Rule 65 (9) (a) and Rule 65 (10) of the Drugs and Cosmetics Rules, 1945, substances specified under Schedule H and H1 Shall not be sold without the prescription of a registered medical practitioner, one copy of which should be kept with the licensee. The section follows as following:

Rule 65 (9) (a):

(a) Substances specified in Schedule H1, or Schedule X shall not be sold by retail except

on and in accordance with the prescription of a Registered Medical Practitioner and 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.

(b)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

Rule 65 (10): For the purposes of clause (9) a prescription shall –

(a) be in writing and be signed by the person giving it with his usual signature and be

dated by him;

(b) 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;

(c) indicate the total amount of the medicine to be supplied and the dose to be taken.

Further Rule 65 (11) talks with regard of the dispensing of a prescription containing drug specified under Schedule H1, they need to comply with following requirements:

(a) the prescription must not be dispensed more than once unless the prescriber has stated thereon that it may be dispensed more than once;

(b) if the prescription contains a direction that it may be dispensed a stated number of times or at stated intervals it must not be dispensed otherwise than in accordance with the directions;

(c) at the time of dispensing there must be noted on the prescription above the signature of the prescriber, the name and address of the seller and the date on which the prescription is dispensed.

Now there is no specific legislation providing clarity on the guidelines for the delivery of H1 drugs through E-Pharmacy. However, during the times of COVID, there was one notification released by the government providing certain directions to the pro-awaited discussion. As per the notification released by the Ministry of Health and Family Welfare on 26th March 2020, it permitted the doorstep delivery of the drugs specified under Schedule H , except Narcotic drugs, Schedule  H1 and X, subject to the condition that the sale of a drug specified in Schedule H shall be based on receipt of prescription physically or through e-mail and such sale of drugs shall further be subject to the following conditions:

  1. The licensee shall submit an e-mail ID for registration with the licensing authority if prescriptions are to be received through email.
  2. The drugs shall be supplied at the doorstep of the patients located within the same revenue district where the licensee is located.
  • In case of chronic diseases, the prescription shall be dispensed only if it is presented to the licensee within 30 days of its issue, and in acute cases, the prescription shall be dispensed only if it is presented to the licensee within 7 days of its issue.
  1. The bill or cash memo shall be sent by the return email and records of all such transactions shall be maintained by the licensee.

Further, FICCI (Federation of Indian Chambers of Commerce & Industry), released a Self-Regulation Code of Conduct for the e-pharmacy sector in the interest of the consumers. In furtherance with the code, Scheduled medicines must be processed only against a valid copy of the prescription (physical or scanned copy) of a registered medical practitioner.

E pharmacy must ensure that no Schedule X and other sensitive habit-forming medicines are processed from their platform. The list must be updated periodically and shared with all the players. E pharmacy must:

  1. Ensure there are adequate checks and balances in place to prevent sale of any such drugs.
  2. E Pharmacy who wishes to facilitate sale of such medicines would need to procure the physical prescription from the consumer and validate dosage with the doctor with suitable records
  3. E Pharmacy player must work with Government to create an electronic tool for proper surveillance of such medicines – where for every dispensation, the consumer’s name, doctor name and prescribing pharmacy details are recorded and made available to the regulator

CONCLUSION

 

  1. Schedule H drugs except Narcotic drugs, Schedule H1 and X, can be sold only by licensed pharmacies on the basis of valid prescription, the definition of which has been provided above.
  1. The door-to-door service of Schedule H drugs could be continued on the basis of COVID notification released by the Ministry of Health and Family Welfare on 26th March 2020, which is still in force. However, the following for conditions need to be fulfilled:
  2. The licensee shall submit an e-mail ID for registration with the licensing authority if prescriptions are to be received through email.
  3. The drugs shall be supplied at the doorstep of the patients located within the same revenue district where the licensee is located.
  • In case of chronic diseases, the prescription shall be dispensed only if it is presented to the licensee within 30 days of its issue and in acute cases, the prescription shall be dispensed only if it is presented to licensee within 7 days of its issue.
  1. The bill or cash memo shall be sent by the return email and records of all such transactions shall be maintained by the licensee.
  1. The code released by FICCI stands as a voluntary code of conduct, it is upon the discretion of the company that they whether want to comply with the same or not. However, if EMPL is a member of FICCI then we would advise to follow the guidelines.

SCHEDULE H1 AND X DRUGS ARE NOT ALLOWED UNDER THE COVID DOORSTEP DELIVERY NOTIFICATION