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Union health ministry to soon notify e-pharmacy rules based on DTAB recommendation

Shardul Nautiyal, Mumbai
Wednesday, August 21, 2019, 08:00 Hrs  [IST]

Union health ministry is all set to notify online pharmacy rules based on Drug Technical Advisory Board (DTAB) recommendations. It has recommended to finalise draft online pharmacy rules on priority based on suggestions and comments from the stakeholders.
DTAB during its 83rd meet in Delhi on June 11, 2019 was apprised that a large number of comments have been received in response to the online pharmacy rules draft notification.

State drug controllers, representatives from Central Drugs Standard Control Organisation (CDSCO), government analysts from national drug testing laboratories, Member Secretary, DTAB under the chairmanship of S Venkatesh, Director General of Health Services (DGHS) deliberated on the agenda of draft online pharmacy rules based on previous DTAB recommendations.

DTAB was apprised that Department of Health and Family Welfare had issued a draft notification dated August 28 2018 to amend the Drugs and Cosmetics (D&C) Rules, 1945 by incorporating separate part for the regulation of online pharmacies in the country.

However, a number of Public Interest Litigations (PILs) have been filed in various High Courts of the country at Delhi, Madras, Mumbai, Patna etc.

The courts have issued various directives with regards to the regulation of sale of drugs online. Keeping in view the issue of online pharmacy, Central Government had also carried out wider consultations before finalising the draft notification.

Drug Consultative Committee (DCC) in its 56th meet held on June 01, 2019 also had deliberated on the issue of finalisation of draft notification dated August 28, 2018. It had recommended to include the provision for uploading the online prescription in the rules on online pharmacy.

DTAB had in its 81st meeting held on November 29, 2018 deliberated and agreed for amendment of the D & C Rules, 1945 to regulate online sale of drugs. It had asked CDSCO to frame 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 to finalise the draft rules considering the suggestions and comments from the stakeholders.

Case related to delay in notifying online pharmacy rules is also subjudice at Patna High Court (HC). Patna HC has therefore directed the Union Health Secretary to inform why the draft rules remains at the draft stage and what is the impediment in giving it a final shape.

The All India Organisation of Chemists and Druggists (AIOCD) in a recent meeting with Union commerce ministry also discussed the draft online pharmacy policy and raised issues like predatory pricing and other issues like aggregator's role in online pharmacy not being clearly defined and the existing cash on delivery mechanism in online prescription drugs sale.

The meeting was called by the Union commerce ministry to deliberate on AIOCD memorandum on online pharmacy submitted to the government.


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