Lok Sabha Question No. 245 (STARRED), answered on 2023-03-17
Subject: Online Sale of Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Subhash Ramrao Bhamre, Sunil Dattatray Tatkare

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

## LOK SABHA STARRED QUESTION NO. 245 TO BE ANSWERED ON THE 17 TH  MARCH, 2023

## ONLINE SALE OF MEDICINES

## *245. DR. SUBHASH RAMRAO BHAMRE: SHRI SUNIL DATTATRAY TATKARE:

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

- (a) whether Drugs Act, Pharmacy Act and other drug related rules do not permit the sale of medicines on the internet and if so, the details thereof;
- (b)  whether  online  pharmacies  and  online  platform  are  indulging  in  illegal  sale  of drugs and there is sudden increase in sale of duplicate and spurious drugs, if so, the details thereof;
- (c)  whether the Government also plans to completely ban online sale of medicines especially  abortion  pills  in  the  near  future,  if  so,  the  details  thereof  and  action taken/likely to be taken thereon;
- (d)  if  not,  whether  the  Government  has  finalized  the  guidelines  for  sale  and distribution of drugs through e-Pharmacies;
- (e) whether illegal e-Pharmacies are also creating their own health data on their portal which is also a threat  to  personal  health  data  and  also  against  the  PM  Health  data policy of NHRM; and
- (f) if so, the corrective steps taken by the Government in this regard?

## ANSWER

## THE MINISTER OF HEALTH AND FAMILY WELFARE (DR MANSUKH MANDAVIYA)

- (a) to (  f) A Statement is laid on the Table of the House.

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 245 FOR 17 TH  MARCH, 2023

(a)  to  (d):  In  order  to  regulate  the  online  sale  of  medicines  comprehensively,  the Government had published draft rules vide G.S.R. 817 (E) dated 28th August 2018 inviting  comments  from  public/stakeholders  for  amendment  to  the  Drugs  and Cosmetics Rules, 1945 for incorporating provisions relating to regulation of sale and distribution of drugs through e- pharmacy.

The  draft  rules  contain  provisions  for  registration  of  e-pharmacy,  periodic inspection  of  e-pharmacy,  procedure  for  distribution  or  sale  of  drugs  through e-pharmacy,  prohibition  of  advertisement  of  drugs  through  e-pharmacy,  complaint redressal mechanism, monitoring of e-pharmacy, etc.

Several court cases are pending in various High Courts in the country on online sale of drugs.

The Hon'ble Madras High Court, vide order dated 17.12.2018, has ordered that as the draft rules are framed by the Central Government, after deliberations including the stakeholders, till the aforesaid rules are notified, the on-line traders are bound not to  proceed  with  their  on-line  business  in  drugs  and  cosmetics.  Thereafter,  Madras High  Court  on  02.01.2019  stayed  the  paragraph  containing  the  above  order  dated 17.12.2018.

In  another  case,  the  Hon'ble  High  Court  of  Delhi  passed  the  order  that respondents  are  injuncted  from  online  sale  of  medicines  without  licence  and  the respondents are directed to ensure that the same is prohibited forthwith until further orders.

The  said  order  of  the  Hon'ble  High  Court  of  Delhi  was  forwarded  to  all States/UTs  Drug  Controllers  by  Central  Drugs  Standard  Control  Organisation (CDSCO)  on  08.05.2019,  28.11.2019  and  03.02.2023  for  necessary  action  and compliance.

Further, show cause notices were issued by CDSCO to various firms engaged in online/ internet sale of drugs on 08.02.2023 & 09.02.2023.

(e) & (f): CDSCO  has  informed  that  no  such  specific  report  has  been  received regarding creation of their own health data by E-Pharmacies on their portal.

*******