Regulation of E-Pharmacies: DTAB calls for finalization of rules to regulate online sale, distribution of drugs
New Delhi: In light of concerns raised in various forums, the Drugs Technical Advisory Board (DTAB) has recently recommended for finalization of the draft rules to regulate the sale and distribution of drugs over the internet (E-pharmacy).
DTAB was apprised that, the Department of Health and Family Welfare has issued a draft notification proposing to amend the Drugs and Cosmetics Rules, 1945 by incorporating separate part for the regulation of e Pharmacies in the Country.
In response to the draft notification, a large number of comments have been received. However, a number of PILs have been filed in various Hon'ble High Courts of the country in Delhi, Madras, Mumbai, etc. The Hon'ble High Courts have issued various directions with regards to the regulation of the sale of drugs over the internet. Keeping in view of the above matter, the Central Government has also decided to carry out wider consultations before finalizing the draft notification.
DCC in its 56th meeting held on 01.06.2019 deliberated the issue of finalization draft notification and recommended to include the provision for uploading the e-prescription in the rules on e-pharmacy which is to be finalized.
DTAB in its 81st meeting again deliberated and agreed for the amendment of the Drugs and Cosmetics Rules, 1945 for the regulation of the sale of drugs by E-Pharmacy and asked CDSCO to bring the final version of the notification to DTAB for review.
Accordingly, the draft for final notification, as available with CDSCO, was placed before the DTAB. DTAB after detailed deliberations recommended for finalization of the draft rules considering the suggestions/ comments of stakeholders.