Lack of clarity in the recent central government order notifying 10 medical devices including the controversial drug eluting stents as drugs has created 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 licences 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 order 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.

Though the order was notified on October 7, 2005, the central government is yet to come out with operational guidelines for the notified products. DCGI had told Pharmabiz recently that the Centre was in the process of framing the guidelines, though he did not specify any time frame for announcing it.

The confusion starts with whom to license the products. Though the order says that 'licence has to be obtained from the licence approval authority, which is the DCGI's office, the mechanism is perceived to be a joint licensing procedure of state and central drug administration as in the case of blood banks, say sources. At present, DCGI is empowered to licence only import of drugs, and states are the sole authority for issuing manufacturing licences. The order has not specified whom to approach for manufacturing and marketing licences.