In India, There is no special provision or act present that can describe, regulate and specify E-Pharmacy. At present E-Pharmacy business in India is regulated through Drug and Cosmetic Act and Rules in its current state. Department of Health & Family welfare has published a draft to amend Drug and Cosmetic Rules, 1945 to regulate E-pharmacy business in India. Along with Drug and Cosmetic Act & Rules, E-Pharmacy business also require to follow the rule and regulation mentioned under Information Technology Act.
You will require a pharmacist at your online pharmacy for receiving and processing prescription uploaded by patient or his care taker. Offline Pharmacy set-up is mandatory for selling medicine online with complete documents and procedure.
Here we take a short look at documents and necessities for starting Offline Store First and then sell medicine online.
- Retail Drug License
- GST number
Retail Drug License:
Retail drug license is issued by District Drug Control Officer who provide drug license as per guidelines issued by State Drug Control Officer. You need to visit district drug control office for applying retail drug license number. Procedure for applying retail drug license may be online or offline as per state policy, you are going to apply.
Requirement and documents for Setting UP Online Pharmacy:
- Area required: Minimum of 100 square feet
- Registered Pharmacist: All related documents photocopy will be attached along with Drug License application form
- Rent agreement or ownership proof of premises
- Blue print of premises (3 copies)
- Address Proof of Premises
- Refrigerator and Air conditional Purchase Bill
The Department of Health & Family Welfare had published draft vide G.S.R. 817(E) dated 28.08.2018 further to amend the Drugs and Cosmetics Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by Section12 and Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board.
The new set of rules/Forms mainly consists of the following sub:
67 I: Definitions
67J: Registration of e-pharmacy
67K: Disclosure of information generated through e-pharmacy portal 67L Application for registration of e-pharmacy
67M: Conditions of registration of e-pharmacy
67N Grant of registration of e-pharmacy
67O Periodic Inspection of e-pharmacy
67P Procedure for distribution or sale, of drugs through ePharmacy
67Q Validity of registration of e-pharmacy
67R Renewal of Registration of e-pharmacy
67S Prohibition of advertisement of drugs through e-pharmacy
67T Suspension or cancellation of registration
67U Complaint Redressal mechanism
67V Monitoring of e-pharmacy
67W Mode of payment of fee
Form 18AA Application for grant of Registration or Renewal to distribute and sell, stock or exhibit or offer for sale, drugs through epharmacy
Form 21AA Registration to distribute and sell, stock or exhibit or offer for sale, drugs through e-pharmacy
Highlights of Draft published related to sale of drugs by E-Pharmacy:
Registration of e-pharmacy:
(1) With effect from the commencement of PART VIB of these rules, no person shall distribute or sell, stock, exhibit or offer for sale of drugs through e-pharmacy portal unless registered under rule 67N.
(2) The e-pharmacy registration holder shall receive the orders for retail sale through e-pharmacy portal.
(3) e-pharmacy registration holder shall arrange or provide the drugs, as per the prescription received from the customer, within the period specified by the e-pharmacy registration holder at the time of placement of the order through e-pharmacy portal
(4) The e-pharmacy registration holder shall have a facility for customer support and grievance redressal of all stakeholders which shall run not less than twelve hours for all seven days of a week:
Provided, that the facility for customer support shall have registered pharmacist in place to answer the queries of customers through such customer helpline.
Application for registration of e-pharmacy:
(1) Any person who intends to conduct business of e-pharmacy shall apply for the grant of registration to the Central Licensing Authority in Form 18AA through the online portal of the Central Government.
(2) The information furnished above shall be supported by the duly notarised affidavit from the applicant
(3) Any application for the grant of e-pharmacy registration of e-pharmacy made in Form 18AA to the Central Licensing Authority shall be accompanied with a fee of fifty thousand rupees and the information and documents as specified in Form 18AA.
Conditions of registration of e-pharmacy:
(1) An e-pharmacy registration holder shall comply with provisions of Information Technology Act, 2000 (21 of 2000) and rules made thereunder
(2) The details of patient shall be kept confidential and shall not be disclosed to any person other than the Central Government or the State Government concerned, as the case may be.
(3) The supply of any drug shall be made against a cash or credit memo generated through the epharmacy portal and such memos shall be maintained by the e-pharmacy registration holder as record which shall contain the following particulars: –
(i) name, address and sale licence number of the licencee who is dispensing the drugs mentioned in prescription uploaded on the e-pharmacy portal;
(ii) serial number and date of the cash/credit memo; and
(iii) the name of the drug, quantity, batch number or lot number, date of expiry and name of the manufacturer;
(iv) name and address of e-pharmacy registration holder with Registration Number along with signature/ digital signature of Registered Pharmacist in-charge.
(4) The e-pharmacy registration holder shall inform the Central Licensing Authority `in writing in the event of any change in the constitution of the firm operating under the registration. Where any change in the constitution of the firm takes place, the current registration shall be deemed to be valid for a maximum period of three months from the date on which change takes place unless, in the meantime, a fresh registration has been taken from Licencing Authority in the name of the firm with the changed constitution.
(5) The e-pharmacy registration holder shall not carry out e-pharmacy with respect to the drugs covered under the categories of the Narcotic and psychotropic as referred to in the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985), tranquilizers and the drugs as specified in the Schedule X of Drugs and Cosmetics Rules, 1945
(6) The e-pharmacy shall mention the following details on its e-pharmacy portal, –
(i) registration issued in Form 21AA;
(ii) constitution of the firm including details of the Directors, partners or persons having ownership of the E-pharmacy;
(iii)official logo of the e-pharmacy portal, if any
(iv)details of the logistic service provider;
(v) return policy of dispensed drugs;
(vi) name of the registered pharmacist, with the Regd. No. and name of Pharmacy Council where the pharmacist has been registered, who validates the prescription prior to forward it to dispense the drugs;
(vii) contact details of e-pharmacy including telephone number, mobile number, e-mail, address;
(viii) procedure for lodging grievances, complaints etc.