EU Model Systems For Medical Devices With BIS Fixing Approval Standards

The Central Government is likely to come out with a European Union model regulatory system for medical devices that are manufactured or marketed in the country. The highlight of the proposed system is that it will entrust Bureau of Indian Standards (BIS) to fix the quality standards for the medical devices. The Central drugs regulatory authority will, however, continue as the inspection and licensing agency but the approvals will not be under them.

The sub committee on medical devices set up by the Drugs Consultative Committee of the Centre is known to have favoured the EU model rather than the US model and is in the process of preparing the guidelines.

According to reliable sources, the health ministry is to ask BIS to set up a separate committee consisting of both internal and external experts to approve each and every medical device in the country. The representatives from the central drug regulatory authority would also be part of this committee. The committee would classify the medical devices into various classes depending on the nature of the device. Some categories would be considered as safe, others will have to go through rigorous approval procedures before being cleared for marketing. As per the current plan, the Central Drugs Standard Control Organisation (CDSCO) may be the licensing and inspecting agency for the approvals given by the BIS. There would be a BIS quality certification with specific class mentioned for every product.

The health ministry officials said that the proposal is being worked out and would take minimum one year to get finalised.

The lack of proper regulatory control over most of the medical devices came to the lime light recently after the Maharashtra FDA banned the use of some of the drug coated stents due to doubtful quality. The DCGI later clarified that the approval of drug coated stents comes outside the purview of the existing rules and regulations. He had also suggested the need for changes to bring in strict regulations in this segment.

Sterile Devices To Be Notified Soon

The union health ministry will soon notify sterile medical devices as drugs as part of the move to bring in medical devices under the regulatory ambit of the central drugs control department.

Disclosing this to Pharmabiz, Ashwinin Kumar, Drugs Controller General of India (DCGI), said the department has started collecting data on sterile medical devices and a list will be notified soon.

"So far we have not looked into the regulatory aspect of medical devices marketed and manufactured in India. Bringing all the medical devices under the regulatory framework is an elaborate process and requires some time. To begin with, we will notify sterile medical devices. The Drug Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB) have to study this for notification" said the DCGI.

Sources said the government's move is in the wake of Maharashtra FDA's decision to mandate quality standards for marketing drugs eluting stents, and to obtain prior approval from DCGI to market such products in the state. The DCGI had informed Pharmabiz that the present rules do not empower his office to regulate the quality of medical devices like drug eluting stents and granting of marketing permissions.

Sources said sterile medical devices must be free from live bacteria or other microorganisms and their spores, and undergoes the sterilization process. Hundreds of such products are freely manufactured, imported and marketed in the country, and so far no mandatory quality standards are laid down.

So far the government has notified only disposable hypodermic syringes, disposable hypodermic needles, disposable perfusion sets, intrauterine devices like Copper T and Condoms and they are classified as drugs.

Sources said the US FDA and Australian TGA have enforced strict and elaborate guidelines for regulating medical devices, since many decades ago.

Talking to Pharmabiz, Joseph X Phillips, former US FDA official and advisor to ISPE on international regulatory affairs said the US FDA started regulating medical devices, way back in 1938. The guidelines were changed from time to time, and during the 1980's and 1990's elaborate revamping of the regulations were done.

Australia also has enforced guidelines for regulating medical devices, and its many year old Therapeutic Goods (Medical Devices) Regulations Act was amended during October 2002 to strengthen its medical devices regulatory framework.

Senior regulatory officials pointed out that a comprehensive Medical Devices Act, something similar to the Drugs and Cosmetics Act, needs to be in place or at least a schedule has to be brought under the Drugs & Cosmetics Act to regulate medical devices. Thousands of medical devices like stethoscope, thermometer, spectacles or contact lens, placemakers or steel rods used for implants are currently outside the purview of regulations.

Even analytical regents, which are used in determining the quality of drugs in laboratory tests, are now outside the purview of the regulatory framework, noted sources.

(Ref : Chronicle Pharmabiz dated June 23, 2005)