Enforce medical devices standards strictly
A year ago, the Drugs Controller General Of India’s office, the frontline regulatory outfit of the Central Drug Standard Control Organisation (CDCSO), issued fresh guidelines for manufacture and import of medical devices, a category of healthcare ...
By KG Narendranath, TNN |
NEW DELHI: A year ago, the Drugs Controller General Of India’s office, the frontline regulatory outfit of the Central Drug Standard Control Organisation (CDCSO), issued fresh guidelines for manufacture and import of medical devices, a category of healthcare products which had largely escaped intent regulatory gaze all through the years.
Considering that use of many medical devices such as the ones which go into the body parts or are in touch with the body, involve life-or-death situations, the regulatory norms also included mandatory registration and import licensing for such products.
The DCGI’s decision was triggered by a legal battle which the Maharashtra Food and Drug Administration (FDA) had waged with an importer of such devices who protested the FDA’s “pro-active” posture regarding quality control of the devices.
Subsequently, the drugs technical advisory board (DTAB) decided to give actions such as what the FDA had taken, sufficient legal backing through amendments to the Drugs and Cosmetics Act. The fact that devices were originally included in the definition of “drugs” came in handy for the centre, as it brought 10 categories of sterile devices under its mandatory registration/approval for import and/or manufacture and marketing.
The products which were thus brought under stricter regulatory control are: Cardiac stents, drug eluting stents, catheters, intra-ocular lenses, IV Cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements.
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Most of these products continue to be fully or largely imported from Europe and the US. The guidelines for import of these medical devices said: “In case of stents or drug eluting stents, the import will not be permitted if the applicant has sold less than 1,000 stents of the particular specification prior to the issuance of the guidelines.” Obviously, the government was taking prevalence as justification for continuance of the products whose safety was not otherwise regulated till the introduction of the new guidelines. One guideline was that separate committees consisting of experts would be set up for evaluation of specific categories of devices. The expert committees would set benchmarks for evaluation of the devices.
Sources say that compliance with the EU’s CE certification and the US-FDA norms, which are ascertained among other things for import registration/licensing, is practically the norm for approval in most cases even now, rather than independent evaluation by DCGI’s own expert committees.
The seriousness of this lapse could be gauged from the fact that experts continue to be divided over the desirability of using some of these devices such as the drug eluting stents, use of which could allegedly lead to sudden death of patients due to late stent thrombosis
“Many Indian firms which manufacture critical medical devices have got the EU’s CE certification for export to other countries ,including the EU countries. There are identified auditing agencies who evaluate the products for the EU authorities,” said Ashwini Kumar, former DCGI.
Another justification which the regulators give for taking foreign certifications for granted is the fact that surgeons are well aware of the procedures of using these devices, and their compatibility with individual patients.
In fact, it was said at the time of introducing the guidelines last year that the list of product categories that need mandatory approvals from the DCGI would be gradually expanded. There has however been no such move thereafter.
Medical devices market in India is estimated to have a size of over $13 billion at present, with overall growth of an average 4.5%, and particular products showing double digit growth. With the expansion of the healthcare infrastructure in the private sector, the rising income of the middle class and the increase in government spending for heathcare, the growth could be accelerated in the coming years.
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