The Drug Controller General of India (DCGI) is planning to make and issue guidance documents for regulation of in-vitro diagnostic devices and regents for grant of manufacturing licences by state licencing authority with a view to bring uniformity in the sector.

The office of the DCGI is planning such a document following the request for such guidance and guidelines by the industry at a meeting with the DCGI here recently.   The meeting, which examined the current issues of the IVD industry, was attended by representatives of associations like FICCI and CII, Association of Diagnostic Manufacturers of India, apart from the senior officials from the CDSCO.

The meeting decided that the submission of performance evaluation reports (PER) of notified diagnostic devices may be exempted at the time of submission of application for re-registration of the manufacturing site and products till December 31.

The industry-regulatory interaction also decided that for grant of import licence for cancer markers, an application may be accepted along with one batch performance evaluation report with a condition that the applicant should submit legal undertaking along with the application stating that the PER of the remaining batches would be submitted before sale or distribution of the products.

The DCGI Dr G N Singh informed the industry that all kits for identification/screening/diagnostic/monitoring of hepatitis B virus are regulated as notified diagnostic devices under the Drugs and Cosmetic Act. He also said no exemption would be granted for the import of diagnostic kits/reagents having less than 60 per cent residual shelf-life period as on the date of import. “However, in exceptional cases, the licencing authority may allow the import of such kits as per Rule 31 of the Drugs and Cosmetic Rules,” he said.

The industry members requested attention of CDSCO to the constraints and bottlenecks faced in testing of closed systems IVD products at National Institute of Biological, Noida.