Drug regulators ease red-tapism on pharma imports

NEW DELHI, NOVEMBER 2017:

In a move to facilitate ease of doing business, the drug regulator’s office has intervened to smoothen processes and clearances at ports to allow imported pharmaceutical consignments including those of medical devices to enter the Indian market.

In a memorandum issued recently to all the port offices, the Central Drug Standard Control Organisation has clarified that products must not be held back for minor confusions or mistakes in paper work if importers are holding valid registration certificate and import licenses.

The move comes in the wake of several complaints from importers, mainly from medical device manufacturers, about ports holding back consignments for a long time without clarity, which impacts supplies as well as shelf life of such products in the market.

The move assumes significance as India is a major importer of medical devices with 80 per cent of the devices used in the country being imported. Medical devices market in India is estimated at around $7 billion. The country also imports around 70 per cent of the active pharmaceutical ingredients used in medicines and a substantial amount of reagents and kits used in diagnostics from outside.

Companies have raised concerns that of late some medical devices and diagnostic consignments were withheld at various port offices on slight confusions in name of the product or because applications were in process during mergers and acquisitions or because of varying shelf life in case of multi-component kits – where one of the components may have expired even as the overall kit remains valid.

To facilitate importers, the regulator has directed the port offices to clear consignments in case of such minor confusions based on undertakings from the importers that the products are registered and have import permissions. “The undertakings along with other documents can then be sent to the regulator for further verification,” an official said.

“These clarifications are issued for better patient safety & enforcement compliances in line with the actions for ease of doing business,” the memorandum said.

Of late, pharmaceutical companies as well as medical device firms have been under immense pressure in India with the government coming heavily on them with stringent price regulations as well as quality checks. The latest move may provide some relief to firms importing products to India as they may not have to face delay in clearances at ports.