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 and surgical gowns under the D&C Act, 1940 wherein stakeholders agreed for the regulation of the said products.
The Central Government under the chairmanship of Director General Health Services (DGHS) with respect to the implementation of the decisions taken by Committee of Secretaries on Technical Textiles, it was proposed that surgical gowns, surgical drapes can be considered for notification under the D&C Act in the meeting convened by the South India Textile Research Association (SITRA) on October 5, 2018 in New Delhi.
Central Government after consultation with the DTAB has also notified all implantable medical devices like CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator for use in human beings as drugs with effect from April 1, 2020. Earlier this year, CDSCO had proposed to regulate these medical devices under the D&C Act to enhance reliability.
Union health ministry has notified the Medical Devices Rules 2017 through a notification dated January 31, 2017 under the provisions of the D&C Act, 1940. As of today, 23 notified medical devices are regulated under the said act.
In pursuance of sub-clause (iv) of clause (b) of Section 3 of the D&C Act, 1940 (23 of 1940), the Government in consultation with the DTAB has also notified nebulizer, blood pressure monitoring devices, digital thermometer and glucometer for use in human beings as drugs with effect from January 1, 2020.
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 and surgical gowns under the D&C Act, 1940 wherein stakeholders agreed for the regulation of the said products.
The Central Government under the chairmanship of Director General Health Services (DGHS) with respect to the implementation of the decisions taken by Committee of Secretaries on Technical Textiles, it was proposed that surgical gowns, surgical drapes can be considered for notification under the D&C Act in the meeting convened by the South India Textile Research Association (SITRA) on October 5, 2018 in New Delhi.
Central Government after consultation with the DTAB has also notified all implantable medical devices like CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator for use in human beings as drugs with effect from April 1, 2020. Earlier this year, CDSCO had proposed to regulate these medical devices under the D&C Act to enhance reliability.
Union health ministry has notified the Medical Devices Rules 2017 through a notification dated January 31, 2017 under the provisions of the D&C Act, 1940. As of today, 23 notified medical devices are regulated under the said act.
In pursuance of sub-clause (iv) of clause (b) of Section 3 of the D&C Act, 1940 (23 of 1940), the Government in consultation with the DTAB has also notified nebulizer, blood pressure monitoring devices, digital thermometer and glucometer for use in human beings as drugs with effect from January 1, 2020.
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