Question : Distribution of Drugs through e-pharmacies

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

(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, whether 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
THE 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 stringent action against violation of provisions of the Act and Rules.

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

In order to regulate the online sale of medicines comprehensively, the Government has published draft rules vide G.S.R. 817 (E) dated 28th August 2018 for 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.


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