Thermometers, blood pressure measuring equipments, glucometers and X-ray films - You might have been using at least any one of these equipment throughout your lives, but would be surprised to know that only 14 such medical devices are registered for use in India.
According to the Drug Controller General of India, the reason behind this is, in the country, medical devices were still considered a part of drugs and fall under the ambit of the Drugs and Cosmetics Regulation Act.
Thus though 321 applications have been received for registration till September 2009, only 14 are officially registered, DCGI Surinder Singh said.
To rectify the disparity, the Union Health Ministry is soon to come out with a new Act for regulation of medical devices which will facilitate their registration at par with the global standards.
The move to frame a new law came following a directive from the PMO after it was approached by the US Food and Drug Administration (USFDA) with complaints of complexities in getting medical equipment registered in India, where only 14 such devices are registered till date.
The PMO then called Health Secretary Sujatha Rao, the DCGI and other senior officials of the ministry to discuss the matter and a decision was taken to simplify the process, the DCGI said on Sunday.
“A core group including members from the medical devices industry has been formed and a draft of the Act would be ready by next month,” Singh said.
Once the draft is ready, a national seminar would be held in January for consultations on the document after which it would be sent to the Law Ministry for vetting.
The need to have a separate Act for registering medical devices was felt because currently, the registration of medical devices is done under the Drugs and Cosmetics Act, which makes the process cumbersome due to lack of uniform standards between the drugs and the devices, Singh said.
Minister of State for Health, Dinesh Trivedi said the seminar would be funded by the FICCI.
“There has to be a legislation to move the process forward and the final notification can be expected to come out around June 2010,” Singh said.
Under the Act to be named ‘Central Devices Act’, devices would be divided into four categories according to their usage and requirements, he added.
Equipment for regular use like thermometers and X-ray films would be classified as category A which will have to undergo conformity assessment by the manufacturer.
Medical devices under category B, C and D will have to assessed by the notified bodies and undergo joint inspection by the DCGI respectively.
The new regulation is expected to make way for the foreign companies in the medical device sector. However, many in the medical devices industry - both foreign and domestic - are pushing for even broader reforms that would create an independent authority to regulate medical devices. Several such proposals are pending with the Centre.
