ANSWER
THE MINISTER OF HEALTH AND FAMILY WELFARE
(SHRI JAGAT PRAKASH NADDA)
(a) to (e): A statement is laid on the Table of the House
STATEMENT REFERRED TO IN REPLY TO LOK SABHA
STARRED QUESTION NO. 430* FOR 16TH DECEMBER, 2016
(a): In terms of the provisions of the Drugs and Cosmetics Rules, 1945, as amended from time to time, drugs specified in Schedules H, H1 and X cannot be sold except on, and in accordance with the prescription of a Registered Medical Practitioner from a licensed premises. Some instances of online sale of medicines had been reported in the media. Wherever any violation is noticed, suitable action is taken by the State Licensing Authorities.
(b): The Government recognises the possible benefits of e-pharmacy, the potential for its misuse, the deficiencies in the existing brick and mortar model of dispensing medicines and the need to leverage ICT for optimising the manner of dispensing medicines including tracking their manufacturers and beneficiaries.
(c): As stated in reply to part (a) above, drugs specified in Schedules H, H1 and X cannot be sold except on, and in accordance with the prescription of a Registered Medical Practitioner from a licensed premises. Therefore, any sale of such drugs other than from a licensed premises is not in conformity with these rules. Further, other requirements such as noting the name and address of seller and date on which medicines are dispensed can also not be met in many cases. Currently, e-pharmacies which do not meet the requirements of Drugs and Cosmetics Rules, 1945 including those relating to sale from a licensed premises and maintaining necessary records, are not permitted.
(d): e-Pharmacies have the potential to optimise the process of dispensing medicines. However, unlike other goods, the sale and distribution of medicines without adhering to the requirement of Drugs and Cosmetics Rules, 1945 could lead to its misuse and avoidable incidence of antimicrobial resistance.
(e): Online pharmacy continues to be regulated as per provisions of the Drugs and Cosmetics Rules, 1945 as amended from time to time.
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