Lok Sabha Question No. 3778 (UNSTARRED), answered on 2017-03-24
Subject: E-pharmacy
Ministry: HEALTH AND FAMILY WELFARE
Asked by: BAIJAYANT "JAY" PANDA, A.P. JITHENDER REDDY, DUSHYANT SINGH

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO. 3778 TO BE ANSWERED ON 24 th MARCH, 2017

## E - PHARMACY

## 3778. SHRI BAIJAYANT JAY PANDA: SHRI A.P. JITHENDER REDDY: SHRI DUSHYANT SINGH:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

(a)  whether  the  Government  has  any proposal to establish separate guidelines for the sale of medicines online in order to outline a legal framework for e - pharmacy businesses and if so, the details thereof;

- (b)  whether  the  Government proposes  to  amend  the  Drugs  and Cosmetics  Act,  1940  to differentiate between online and offline pharmacies and if so, the details thereof;
- (c) whether the Government proposes to take necessary steps to address the issue of validity of prescriptions in e - pharmacy businesses and if so, the details thereof;
- (d) the details of modalities and difficulties being faced by start - ups in the e- pharmacy business; and
- (e) if so, the corrective s teps taken by the Government in this regard?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI FAGGAN SINGH KULASTE)

- (a) & (b): In  view  of  the  concerns  raised  on  the  sale  of  drugs  over  internet,  the Drugs Consultative Committee (DCC)in its 48 th meeting held on 24 th July, 2015, constituted a sub -committee  to  examine  the  issue  of  sale  of  drugs  on  internet. The  Sub- Committee,  in  its report, has interalia recommended: -
- Creation of a National Portal to act as the nodal pl atform for transacting and monitoring online sale of drugs.
- Necessity of evolving a mechanism to register e -pharmacies.
- Geographical restrictions for operation of e - pharmacies.
- Mechanism for verification of authenticity through a link to the National Portal.
- Existing licensees carrying out retail sale of drugs would also be able to register on t Portal for carrying out online sale of drugs.
- As certain categories of drugs viz. the Narcotic and Psychotropic drugs, tranquilizer forming drugs and Schedule X drugs that are prone to being abused or misused to be excl from sale through e - pharmacies.
- Amendment  of  Drugs  &  Cosmetics  Rules,  1945  for  effective  monitoring  and  proper enforcement of the Drugs & Cosmetics Act, 1940 for achieving its aims and objectives.

(c) to (e): Any sale of medicine in the country continues isbe regulated as per provisions of the Drugs and Cosmetics Rules, 1945 as amended from time to time. In terms of the provisions of the said Rules, drugs speci f ed in Schedules H, H1 and X cannot be sold except on, and in accordance with the prescription of a Registered Medical Practitioner from a licenced pr The pharmacies are also required to maintain the record of medicines dispensed in accor withthe provisions of Drugs & Cosmetics Rules, 1945. Therefore, any sale of such drugs o than  from  a  licensed  premises  is  not  in  conformity  with  these  rules.  Currently,  e - pharmaci s which do not meet the requirements of Drugs and Cosmetics Rules, 1945 inc luding those relating to sale from a licensed premises and maintaining necessary records, are not permitted.