The detailed Central Government notification on the guidelines for import and manufacture of medical devices with effect from March, 1 2006 has added more confusion to the state drug control administrations and most of the states are yet to start implementing the rules.

Senior regulatory officials note that as per the notification, the State Licensing Authority, after joint inspection and verification, would forward the manufacturing licence application to the Central Licensing Approval Authority (CLAA) for approval, and the licence shall be issued in 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 a joint approval.

As per the Drugs & Cosmetic Rules 1945, a license to manufacture for sale or distribution of drugs specified in Schedule C & C1 other than large volume perenterals, 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, than allowing the same under a general category Form 28, note sources.

They said most of the states are yet to get a copy of the guideline, even after two and a half week since the rules came into force, and are awaiting for the same to seek clarification on this from the Central authority. As per the guideline, the importers, stockists and retail sellers of medical devices have to obtain appropriate sale licences from the State Licensing Authorities within a period of 3 months form the issue of the guidelines and the manufacturers have to get their licenses within six months.

As per the guideline, application for the grant of licence for manufacture of the notified sterile Devices in the country shall be made in Form 27 to the State Licensing Authority, accompanied by the requisite fee in the Form and manner as prescribed in the said Rules, along with a copy to the office of DCG(I). In case of devices belonging to the notified categories, which have not been manufactured in the country before the date of notification, no manufacture would be permitted without the approval of the competent authority as per norms.

Among a list of conditions, the guideline states that details of the standards followed by the company for Good Manufacturing Practices and product evaluation have to be provided during the application. Sources cite GMP is yet to be made mandatory in the case of medical device manufacturing in the country and manufacturers could challenge this.

Further, for the purpose of evaluation of Medical Devices which are new or do not have any benchmark certification, expert committees have to be set up to examine in detail the information provided by the applicant for the assessment of the device. The committee after completing their assessment will forward the opinion regarding suitability of the device to the competent authority for the purpose of grant of permission for placing the device in the market. Sources cite that such an arrangement would cause inordinate delay for the manufacturer to get the licenses and approval for manufacturing.

As reported earlier, the Centre was forced to come up with a hasty notification on medical devices on 7th October 2005, 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. Though the notification was made, none of the state drug controllers issued 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, due to lack of proper rules and guidelines.