Why in News:

• In order to counter fake, sub-standard and expired drugs, the Union Health Ministry has said Hindi and regional language will be used in the tendering process.

Background:

• The Drugs Technical Advisory Board (DTAB) recently recommended that government procurement agencies should take necessary steps in the tendering process to include the regional language, along with English, on the label of iron tablets and polio drops in government programmes.

DTAB:

• DTAB is highest statutory decision-making body on technical matters related to drugs in the country.
• It is constituted as per the Drugs and Cosmetics Act, 1940.
• It is part of Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare.

functions of DTAB:

• The Board (DTAB) deliberated the matter and agreed for the proposal to amend the provisions in Rule 64, making it identical for waiver of clinical performance evaluation of In-vitro Diagnostic medical devices in line with waiver given for medical devices under Rule 63 of the Medical Device Rules, 2017.
• The Board recommended that in case a medical device which already exists in the Indian market for use is brought in future under regulation, then such device shall not be a new medical device with condition that the applicant need to provide evidences of safety, performance & effectiveness.
• The Board deliberated the matter and agreed for the proposal for enabling NABL accredited laboratories or any hospital accredited by national accreditation board for hospitals and health care providers (NABH) for issuing performance evaluation report under Medical Devices Rules, 2017, to harmonize the requirements at par with the  international rules and accordingly, the requirements specified in sub-clause (h) of clause  of Part II of the Fourth Schedule may be The Board deliberated the matter and agreed for the proposal to include the following medical devices and other high end equipments under the purview of Section 3(b) (iv) of the Drugs and Cosmetics Act, 1940:
• All implantable medical devices
• CT scan equipment
• MRI equipment
• Defibrillators
• Dialysis Machine
• PET equipment
• X-Ray Machine
• The Board deliberated the matter and agreed for the proposal to incorporate pharmacy degree/ post-graduation as a qualification in Medical Devices Rules, 2017.
• The Board deliberated the matter and agreed for the proposal to accept the eIFU (electronic Instructions for Use) as an option in place of traditional paper IFU (Instructions for Use).
• The Board recommended the sale of Invitro Diagnostic products shall be undertaken by a valid, whole license holder to Hospitals, Pathology Laboratories, Blood Banks & other such institutions, based on requisition for such products, & the records of which shall be maintained. In case an In-vitro Diagnostic product is to be sold directly to the consumer, it shall be supplied through a valid license holder, for retail sale for such products.
• The Board deliberated the matter and agreed for the proposal for notification of bone marrow cell separator as a medical device under Section 3(b) (iv) of the Drugs and Cosmetics Act, 1940.
• The Board deliberated the matter and agreed for the proposal for inclusion of medical devices approved by Licensing Authority under Drugs & Cosmetics Rules, 1945, to bear CDSCO logo on its labels.