The sub committee under the Union health ministry to set rules for 10 medical devices, notified as drugs, will plan a working strategy to cover all the related issues at its premier meeting at Chandigarh, on April 4, 2007.
The first meeting, to be held in presence of Drug Controller General of India (DCGI), will mainly discuss the strategies to be adopted for incorporating procedures in licensing the 10 notified medical devices as drugs. The aim is to set up a fresh set of indigenous rules, on a par with the major foreign drug regulatory systems, according to sources.
"In the first meeting, we will discuss each and every matters related to the licensing of medical devices. The focus will be more on the manufacturing and testing of these products in India, as the imported devices have almost all the records to prove its safety," according to a source from the sub committee.
The committee has to define the word 'implant' and to discuss the issues like setting standards for the date of expiry of these devices, efficient labs to test the quality of devices, quality assurance of automated labs, depicting standards for accreditation of testing labs and the basic requirements of personnel lab experts to work in these labs. The drug control authority is also planning to include dental implants in the drug list, to control it as an internal prosthetic implant, according to sources.
In order to address the details in micro level, the committee will seek help of scientists including experts in testing quality of plastics and metals. The sub committee is also planning to invite opinions and views from doctors who are using these devices as the part of specialisation.
As Pharmabiz reported earlier, the sub-committee constituted by December 2006 with officials from Central Drugs Standard Control Organisation (CDSCO) and various state drug control offices, will have to set standard Good Manufacturing Practices for each notified devices, and to take care of setting rules for testing and qualification of technical staffs both in production and testing process.
The committee will also have to decide whether the new products in the sector should undergo clinical trial to obtain product license, and the standards of references to be followed if it is needed. The experts in the sub-committee also have plans to visit various hospitals in the country to study the basic critical factors involved in the nature of implanting the devices.