Lok Sabha Question No. 1134 (UNSTARRED), answered on 2020-02-07
Subject: Distribution of Drugs through e-pharmacies
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Sunil Kumar Mondal, Sudhakar Tukaram Shrangre, P.R. Natarajan, Vincent H Pala, Devji Mansingram Patel, Pratima Bhoumik, Sunil Kumar Singh

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

## LOK SABHA UNSTARRED QUESTION NO. 1134 TO BE ANSWERED ON 7 th FEBRUARY, 2020

## DISTRIBUTION OF DRUG S THROUGH E -PHARMACIES

## 1134. SHRI SUNIL KUMAR MONDAL:

SHRI SUDHAKAR TUKARAM SHRANGARE:

SHRI NATARAJAN P.R.:

SHRI VINCENT H. PALA:

SHRI DEVJI M. PATEL:

MS. PRATIMA BHOUMIK:

SHRI SUNIL KUMAR SINGH:

Will the Minister of HEALTH AND FAMILY WELFARE

- (a) the current status of online sale of medicines;
- (b)  whether  any  complaints  have  been  received  from the  Organisation  of  chemists  and druggists and individuals across the country with regard to illegal sale of medicines through online trade, if so, the details thereof along with the action taken thereon;
- (c)  whether  the  Government  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, w hether the Government has finalized the guidelines for sale and distribution of drugs through e- pharmacies; and
- (e) if so, the salient features thereof along with the date by which the e -pharmacy rules are likely to be finalized and implemented?

## ANSWER T HE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

- (a) to (e): Sale  of  drugs  in  the  country  is regulated  under  the  provisions  of  Drugs  & Cosmetics Act, 1940 and Rules, 1945 thereunder by the State Licensing Authorities (SLAs) through a system of licensing and inspection. SLAs are legally empowered to take stri action against violation of provisions of the Act and Rules.

It has been noted that there are certain online portals selling medicines. Some o cerns have been raised by certain stakeholders, including All India Organisation of Chemist Druggists (AIOCD), against online sale of medicines.

be pleased to state:

In order to regulate the online sale of medicines comprehensively, t he Government has published draft rules vide G.S.R. 817 (E) dated 28th August 2018 for inviting commen from  public/stakeholders  for  amendment  to  the  Drugs  and  Cosmetics  Rules,  1945  fo incorporating provisions relating to regulation of sale and distribution of drugs th -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 redressa l mechanism, monitoring of e- pharmacy, etc.

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

The Hon'ble Madras High Court vide order dated 17.12.2018 has ordered that as the draft  rules  are  f ramed  by  the  Central  Government,  after  deliberations  including  th 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  o 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 direc to ensure that the same is prohibited forthwith until further orders.

Accordingly, Central Drugs Standard Control Organisation (CDSCO) vide letters date 08.05.2019 & 28.11.2019 has requested State Drug Control Authorities to comply with order of the Hon'ble High Court of Delhi.