While the Central Government is yet to come up with operational guidelines for issuing licenses for the recently notified medical devices as drugs, the custom officials at various ports and airports are raising objections for importing these products into the country, it is learnt.

The Mumbai port authorities confiscated a large consignment of notified medical devices imported by the leading medical device supplier in the country - Johnson & Johnson Medical, two weeks ago, for importing drugs without a valid import license. When the company authorities contacted the DCGI for help, an embarrassed DCGI’s office had to talk to the Mumbai custom officials to detail the situation and release the products, informed sources.

When contacted by Pharmabiz, Alok Mishra, managing director, Johnson & Johnson Medical confirmed the development. “Since I was abroad at that time, I am yet to get more details of the products that were withheld by the custom officials in Mumbai. It is a substantial volume as majority of the fast moving and most wanted medical devices have been notified as drugs, including stents,” he said.

Mishra noted that it was only a temporary phase and medical devices could be imported without much problem once licensing authorities start issuing licenses, as J&J’s products conform to the best international quality certifications.

However, when Pharmabiz contacted a few other medical device distributors, they said they were yet to face any difficulty in importing the products.

As Pharmabiz reported two weeks ago, lack of clarity in the recent Central Government order notifying 10 medical devices including the controversial drug eluting stents as drugs is still causing confusion among the state drug control authorities to implement the rules.

As a result, none of the state drug controllers have started issuing either manufacturing or trade licenses for the notified products - cardiac stents, drug eluting stents, catheters, intra ocular lenses, IV Cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements. This is despite manufacturers and traders approaching the authorities for legalising their business activity following the notification.

The hasty notification, dated 7th October 2005, was necessitated following the 18th September 2005 directive of the division bench of Mumbai High Court to the DCGI to notify sterile medical devices for external or internal use in human beings as drugs with immediate effect within three weeks.