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ASSURING QUALITY OF DEVICES

P A Francis
Wednesday, May 31, 2017, 08:00 Hrs  [IST]

Gujarat has emerged as a medical devices hub of the country over the years with the mushrooming of hundreds of medium and small scale units producing a wide range of these life saving products. Most of these are low value products used regularly for different kinds of surgical procedures while high value items like pace makers, bare stents, drug eluting stents, etc. are still being imported. Although medical devices are life saving products, stringent regulatory control on their manufacturing and marketing practices was never exercised for many years. This has given rise to questionable practices in their manufacture and pricing causing avoidable harm to the patient community. With no strict monitoring of quality and efficacy of medical devices, product failures in this sector often go undetected and unreported. Some of the causes for the rising number of product failures in the medical device industry are on account of indifferent attitude towards quality of products, lack of focus on continuous improvement and the ever-increasing complexity of medical devices. Various departments of the government never realized the need for laying specific standards for manufacturing practices and quality of materials required for production of devices. And the first regulatory control was introduced in this sector by placing 14 medical devices under Drugs & Cosmetics Act some years ago. Then only in October 2014, the Health Ministry came out with a notification making labelling of medical devices mandatory. Although labels of some of these products do contain a few details, many key information never used to be printed on the packs.

Establishing adequate number of testing facilities for medical devices is perhaps a vital requirement that has been missing in the country despite the growth of this sector. Medical devices are not tested properly in India in the absence of reliable and advanced medical device testing labs. Gujarat government’s decision to set up a device testing lab at state’s Food and Drug Control Administration office at Vadodara recently is a welcome move. The lab, first of its kind in India, planned to be developed in partnership with technical support from Healthcare Technology Division of National Health Systems Resource Centre. Now, National Institute for Pharmaceutical Education and Research, Ahmedabad is also planning to develop itself as a testing hub for medical device industry in the country. Creating a strong skilled workforce to meet the requirements of testing labs is a big challenge in this regard. NHSRC needs to take up this task with utmost urgency. Without a strong medical devices testing infrastructure a high tech industry like this cannot survive and grow. Another area of concern for the regulatory authorities is monitoring of adverse reactions of medical devices as many of these products are implanted in the human body. As in the case of medicines a string of adverse reaction monitoring centres needs to be developed across the country. For the success of this programme, the Health Ministry has to seek support and cooperation of the state governments.

 

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Oly Anise May 31, 2017 12:26 PM
Congratulations to Gujarat! At Andaman Medical we did several regulatory and quality projects with medical devices in India as well as rest of Asia Pacific. We also provide regulatory training and support. Will be happy to work with you www.andamanmed.com
 
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