DTAB Gives Nod To Bring Medical Imaging Equipment Under Regulation

New Delhi, 27 Feb 2018: The Drugs Technical Advisory Board (DTAB), India's highest drug advisory body, has decided to include medical imaging equipment under the Drugs and Cosmetics Act with an aim to regulate the manufacture and sale of these devices.

“The members of DTAB deliberated the matter and agreed to include organ preservative solution, ultrasound equipments and similar imaging equipments under the purview of section 3(b) (iv) of the Drugs and Cosmetics Act, 1940 as medical devices, with a aim to regulate its import, manufacturing, distribution and sale,” according to the minutes of the 78th meeting of DTAB, held on February 12.

The advisory body that approves changes in drug administration rules is chaired by BD Athani of Director General Health Services (DGHS).

The inclusion of imaging equipment in the Drug and Cosmetics Act allows the India's drug regulator the Central Drugs Standard Control Organization (CDSCO) to regulate devices, including Ultrasound, X-ray, CT, MRI and Endoscopic equipment.

"Until we have a separate Medical Devices Law we will need to bear with this item by item decision to be regulated rather than all medical devices at one go," said Rajiv Nath, forum coordinator of Association of Indian Medical Device Industry.

The Indian government has brought the Medical Device Rules, 2017 to regulate medical devices, but it's yet to be passed by Parliament.

The DTAB rejected a proposal to label ex-factory prices and import prices on medicines.

At the moment maximum retail price (MRP) including taxes is printed on all medicine packs. To bring in transparency and rein high trade margins,  CDSCO was proposing to label ex-factory and import or landed prices along with MRP.

The industry was highly critical of the proposal as ex-factory and import prices keep changing based on market dynamics.

In a move to promote generic drugs, the DTAB also recommended pharmacies to maintain a separate rack reserved solely for the storage of generic medicines visible to consumers.

DTAB also proposed raising minimum experience required for Licensing Authority or the third party laboratories employed by state regulators that certify manufacturing and sale of drugs to minimum of 10 years instead of existing 5 years.

DTAB members also opined that there should be stringent and uniform licensing procedures among various State Licensing Authorities. Moneycontrol