Centre Extends Application Deadline For Import, Registration of Medical Devices to June 29

The Union ministry of health and family welfare, which came out with the guidelines for licensing of import and manufacture of medical devices with a deadline of sixty days with effect from March 1, 2006, has now postponed the deadline to June 29, 2006.

The ministry's decision comes in the wake of opposition from the industry and state regulatory officials, who are yet to get clarification on various issues related to the notification. "Representations were received from many associations of medical devices stating that the period of sixty days from March 1 to April 30, 2006 is entirely too brief and may be extended so that the applicants are in a position to comply with the requirement of various documents required to be furnished along with the application. The Government of India after careful consideration has agreed to extend further the period to make application for import and registration of medical devices by another sixty days, coming to an end on June 29, 2006," said the new notification.

As per the guidelines, published on March 1, 2006, the manufacturers and importers of the notified medical devices, now considered as drugs under section 3 (b) (4) of Drugs and Cosmetics Act, were given a time of 60 days to make application with effect from the date of publication of the guidelines.

After a few weeks Pharmabiz had reported that the guidelines for import and manufacture of medical devices have caused confusion to the state drug control administrations and most of the states were reluctant to start implementing the rules. Even after a few weeks after the notification, some of the senior state drug officials had said they were waiting for a few clarifications from the DCGI to accept and process the application.

They pointed out that as per the notification, the state Licensing Authority, after joint inspection and verification, have to forward the manufacturing licence application to the Central Licensing Approval Authority (CLAA) for approval, and the licence have to be issued Form 28 of the said Rules after due approval of CLAA. As per the Drugs & Cosmetics Act, Form 28 is under the jurisdiction of the state licensing authority, and the form even lacks space for joint approval. Further, as per the Drugs & Cosmetic Rules 1945, a licence to manufacture for sale or distribution of drugs specified in Schedule C and C1 other than large volume parenterals, sera and vaccines, drugs specified in Part X-B and Schedule X are licensed in Form 28, and those under Schedule C&C1 and Schedule X are licensed under Form 28-B by the state licensing authorities.

At present, two joint licenses are in vogue, for large volume parenterals, sera and vaccines under Form 28 D and for blood banks under Form 28 C. Ideally, a new form should have been prescribed for medical devices, like 28 S or a similar category Form 28. The officials also had said that most of the states were yet to get a copy of the guidelines, even after two and half week since the rules came into force.

(Ref : Chronicle Pharmabiz Dated May 4, 2006)

Guideline For Medical Devices May Hurt Industry : CII

The new guidelines for import and manufacture of medical devices will affect the medical devices manufacturing sector in India, as some of the stipulations will create bottle-necks to the logistics of medical devices and the new players in the field, observes Confederation of Indian Industry (CII).

The guideline insists that the import of stents or drug eluting stents will not be permitted if the applicant has not sold less than one thousand stents of the particular specification prior to the date of issue of the guidelines, which in result restricts the entry of new players into the devices sector, commented Alok Mishra, Chairman, CII- Medical Equipment Division (MLED), in a press release.

The guidelines also insists that in case of devices, which have not been imported in the country before the date of notification, no import would be permitted without the approval of the competent authority. He said that such stipulations will restrain the import of medical devices including stents and drug eluted stents in the country.

Further, he added that the proposed registration fees of US$ 1000 per device is rather high and could become a burden for smaller manufacturers and also affect the available range of products in India as the sales per device are usually quite small.

(Ref : Chronicle Pharmabiz Dated May 4, 2006)