In a notification dated August 28, 2018, the Ministry of Health and Family Welfare (“Ministry”) has issued the Draft Amendment Rules (“Draft Rules”) which proposes to further amend the Drugs and Cosmetics Rules, 1945. The Draft Rules proposes to insert PART VI-B after Rule 67H and before Part VII, aimed at regulating ‘Sale of drugs by E-Pharmacy’.

The Ministry has invited objections and suggestions, if any, on the Draft Rules, which may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in within October 12, 2018.

“e-pharmacy” means business of distribution or sale, stock, exhibit or offer for sale of drugs through web portal or any other electronic mode; and

“e-pharmacy portal” means a web or electronic portal or any other electronic mode established and maintained by the e-pharmacy registration holder to conduct business of e-pharmacy.

Key Highlights:

Registration of e-pharmacy

• Any person who intends to conduct business of e-pharmacies will have to mandatorily apply for registration to the Central Licensing Authority (“CLA”) in Form 18AA along with a fee of Rs. 50,000 and the requisite documents through the online portal of the Central Government.  Registration would be made compulsorily for the purposes of selling, distributing, stocking, exhibiting or offering for sale of drugs through e-pharmacy portal by any person.
• Registration issued to any person will remain valid for 3 years from the date of its issue.
• An e-pharmacy registration holder will be required to make an application for renewal before its expiry or 3 months before expiry in Form 18AA along with a fee of Rs. 50,000 with the requisite documents as specified in Form 18AA.
• The registration will be deemed to have expired if application for its renewal is not made within six months after its expiry.
• The e-pharmacy registration holder must have a facility for customer support and grievance redressal of all stakeholders which shall run not less than 12 hours in a week. Such facility for customer support must have registered pharmacist in place to answer the queries of customers through such customer helpline.

Confidentiality of information generated through e-pharmacy portal

• The e-pharmacies will be required to keep all its customer’s information confidential but will be duty bound to disclose any information to the State or the Central Government whenever required for public health purposes.
• The e-pharmacy portal must to be established in India and all the data generated are to be kept localised. The data generated or mirrored through e-pharmacy portal cannot be sent or stored, by any means, outside India.

Maintenance of e-portal

The e-pharmacies must mention the following details on their e-pharmacy portal:

• Registration issued in Form 21AA
• Constitution of the firm (details of Directors, partners having ownership)
• Official logo of the e-pharmacy portal, if any
• Details of the logistic service provider
• Return policy of dispensed drugs
• Name of the registered Pharmacist with Registration Number
• Contact details of e-pharmacy (telephone number, mobile number, email)
• Procedure for lodging grievances and complaints on the e-portal

Other Requirements

• The e-pharmacy registration holder must not deal in drugs that are covered under the categories of the Narcotic and psychotropic as referred to in the Narcotic Drugs and Psychotropic Substances Act, 1985
• The e-pharmacy registration holder needs to inform the Central Licensing Authority in writing upon any change in the constitution of the firm operating under the registration.
• The e-pharmacy registration holder must keep his place of open for periodic inspection, every two years, by an authorised team of the CLA.
• The registered pharmacist must verify the details of the patient, Registered Medical Practitioner and arrange for the dispense of the drugs as per the instructions of the Registered Medical Practitioner and the details of the drugs dispensed along with the patient details is to be maintained on the e-pharmacy portal.
• E-pharmacy are prohibited to advertise any drug on radio, television, internet, print or any media for any purpose.

Source: Ministry of Health and Welfare

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