DTAB Nod On Medical Device Control On August 2

The Central Government is likely to bring in amendments to Drugs and Cosmetic Rules within three months to arm the Central Drugs Standard Control Organisation (CDSCO) to regulate the entire range of medical devices manufactured or marketed in the country. The Drug Technical Advisory Board (DTAB) is to take up the issue of medical devices in its forthcoming meeting schedule on August 2, 2005. The Drugs Consultative Committee (DCC) has already given its approval for bringing medical devices under the perview of Drugs and Cosmetic Act.

Informing this to Pharmabiz, Ashwini Kumar, Drugs Controller General of India (DCGI) said that the changes were likely to be in place by September end. "We are already working on the list of medical devices that are to be brought under regulatory control. The DTAB approval is to come in the forthcoming meeting," he said.

The amendment would put an end to the confusion prevailing among various state drug regulatory departments with regard to the powers to ensure quality standards of various medical devices.

The question of bringing medical devices under the Drugs and Cosmetics Act has been engaging the attention of the government for sometime. As of now, there is no separate regulation to control the manufacturing and marketing of medical devices in the country. However, under section 3(b) (iv) of Drugs and Cosmetics Act, the central government has scope to regulate medical devices as may be appropriate from time to time. The DTAB, meeting would now endorse the view of DCC to enlarge the regulatory overview on medical devices by bringing all "sterile medical devices" under Section 3(b) (iv) of the Act.

What triggered swift action from the government side was the decision of Maharashtra FDA to mandate quality standards for marketing drug-eluting stents, and to ask companies to obtain prior approval from DCGI to market such products in the state.

(Ref : Chronicle Pharmabiz dated July 21, 2005)

Care To Implant New Cardiac Device In 100 Patients As Part Of Global Study

The Hyderabad based Care Hospitals will soon start screening patients suffering from atrial fibrillation, a condition in which the upper chamber of the heart beat becomes too fast leading to blood clots, for implanting 'Watchman' device among 100 patients free, as part of a worldwide study.

The device, resembling a balloon top, avoids harmful blood clots from entering the blood stream. The device is guided into the heart through a vein in the leg. It soon becomes part of the organ.

Care is the only hospital outside the US and Europe chosen for this US FDA approved study to implant the device. Globally, 40 centres are conducting the study, including 10 from Europe. In the US, the experimental method is employed by hospitals including Mayo Clinic and Cleveland Clinic.

Dr B Somaraju, chairman of Care Hospital said the traditional practice either involved over or under treatment, leaving scope for risks. The hospital is planning to implant the device in 100 patients at free of cost, beginning from September 2005. The device has been so far implanted in 500 patients.

The director of Cooper Vascular Centre at Cooper University Hospital (US), professor Zoltan Turi, said, "Atrial fibrillation can cause blood to stagnate  and from clots in the left atrial appendage area of the heart. When blood enters hearts of such patients and into the blood stream that may leads to strokes and other complications. The problem mostly exists in patients with high blood pressure, diabetes, coronary heart diseases and certain heart valve diseases.

The current practice is to recommend medication to patients. Some of the thinning medications are effective in reducing the risk of stroke. But undesirable side effects including bleeding happen in many cases and the drug has to be taken for several years.

(Ref : Chronicle Pharmabiz dated July 21, 2005)