Union health ministry to notify surgical gowns, surgical drapes and incision drapes under D&C Act
The Union health ministry will soon notify the medical devices like surgical gowns, surgical drapes and incision drapes as 'drugs' under Section 3(b)(iv) of the Drugs & Cosmetics (D&C) Act, 1940. Medical devices are defined as ‘drugs’ under the D&C Act for the purpose of regulating prices and quality control and also for regulating under the Medical Device (MD) Rules 2017. The proposal to add these devices to the notified list was approved by the 82nd Drugs Technical Advisory Board (DTAB) at its meet recently. Once a medical device is notified, manufacturers and importers will have to get the regulatory body’s nod to sell these products in the domestic market. In this connection, a public notice was uploaded on Central Drugs Standard Control Organisation (CDSCO) website dated 27 November 2018 for stakeholders review/suggestions within 45 days of the issue of the notice. This was followed by DTAB approval in March this year for the regulation of surgical drapes...