Regulation to ensure safe, good quality medical devices

The regulation, however, may take long in coming as states do not respond in time

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Sonal Matharu | June 11, 2010



To ensure that the medical device in the market are of good quality, the health ministry will soon introduce Central Drug Authority bill in the parliament under which all the medical device will have to be registered with the ministry, said minister of state for health Dinesh Trivedi here on Friday.

“There is a need for regulation, implementation and monitoring in India for the benefit of all. Medical device is a very important element in healthcare. The new legislation will regulate the industry manufacturing these devices since the standards will be universal. The definition of medical device will change under this act. The idea is to empower the consumer,” said Trivedi.

He was speaking at the two-day workshop on medical device regulations in India organised by Federation of Indian Chambers of Commerce and Industry (FICCI) and central Drugs Standard Control Organisation (CDSCO). Drug Controller General of India, health ministry, Surinder Singh was also present at the workshop and said that the device under the Act would be divided under four categories – A, B, C and D – with D being the high risk category. All the life-saving drugs like pace-makers will fall under this and each category will have different set of standards.

The medical devices at present come under the purview of the Drug and Cosmetics Act and only 14 notified devices are regulated under it. With the coming of the Central Drug Authority Act, all medical devices will have to be registered before they are available in the market.

Rakesh Sharma, Head, regulatory affairs at Becton Dickinson India Private Limited, a US-based company manufacturing medical devices, said, “With these standards in place, the quality of equipments will be ensured. Some companies manufacturing medical devices are working very hard but they end up competing with the cottage industries without any regulatory body. With a proper monitoring mechanism, the quality of the products and the companies’ manufacturing them would come on the forefront and this will add credibility to the company.”

However, some states are not responding to centre’s this proposal of introducing regulation on medical devices. This is the reason the health ministry is not able to go ahead with the bill.

“Health is a state subject and centre government cannot take action without taking concurrence from the states. We have already given all inputs to the state governments. Now they have to get back to us. We are prepared with the bill,” said Trivedi.

The healthcare sector in India is valued at Rs 35 billion and it is the largest and the fastest growing sector with a 10 to 12 percent growth every year. Out of the Rs 35 billion, only six percent is the contribution of medical devices in India. The prices of the medical devices would not be monitored by the health ministry. Apart from that, the devices and equipments which are already in use in various clinical establishments in the country will not fall under this Act. A transition period of one year will be given to all the clinical establishments and they will have to upgrade the devices to meet the new standards in this period.

“We need safe, affordable and effective tools to be provided to the patients. High cost of devices also raises the cost of the treatment,” added Trivedi.

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