Delay in clearing imports hits Indian medical industry

MANUFACTURERS HAVE ASKED FOR PERMISSION TO IMPORT ESSENTIAL COMPONENTS ON VALID MD-9 CERTIFICATION TEMPORARILY

- Rhythma Kaul

Prolonged delays in clearing imports of essential components has resulted in disruptions in the manufacture of medical devices, people in the business said, adding that this could affect the government's Make-in-India scheme in the long run.

"Despite full regulatory compliance, a lack of policy clarity among regulatory authorities has led to stalled shipments, severely affecting production timelines and jeopardising health care services," said a manufacturer of X-ray device, requesting anonymity.

According to the manufacturers of critical devices such as X-ray and C-Arm machines, even though they are equipped with valid so-called MD-9 certifications as required under India's Medical Devices Rules, they are encountering unexpected demands for additional import licences.

"It is being sought for components such as flat panel detectors (FPDs), which is contrary to the certification's established scope as these components are integral to manufacturing and not standalone devices," said the manufacturer cited above.