As the medical tourism and healthcare sector are witnessing a phenomenal growth in the country, senior medicos in the state are concerned over the quality of medical devices received by both the corporate and government hospitals in the state. And the hospitals in the state are mulling over a proposal to be submitted to the regulatory authorities in the state to ascertain quality-manufacturing practices while approving the marketing of medical devices.
The adherence to sterility norms by medical device manufacturers for catheters, IV infusion sets, bone cements and prosthetic replacements are not sufficient for gauging the quality of the products. The manufacturers need to ensure good production practices and provide safety operational data for approvals from the regulatory authorities in the country, said hospital officials in Karnataka.
Although there have been no particular instances of a poor quality product by medical device manufacturers from Karnataka, yet there is always an element of apprehension among medical specialists and surgeons when these are utilized, sources from the government-run Bowring and Lady Curzon Hospital and Victoria Hospital said.
According to a section of orthopaedic surgeons from the Sanjay Gandhi Research and Accident Hospital, (government owned), implants are critical and there are cases reported in hospitals outside Karnataka where patients have had problems after using it, bringing quality of the product coming under the scanner.
The hospitals expressed that catheters and some surgical items only follow the Bureau of Indian Standards (BIS) and this was inadequate because these items enter the body and complications could arise if they lacked product quality.
Karnataka Drugs Controller Dr B Sripathy Rao said, that medical device manufactures in the state have been adhering to only the standards recommended under the Drugs & Cosmetics Act Schedule M III which calls for sterility test compliance of products. The sterility tests reports are submitted to the state drug control department for inspection. The manufacturers either maintain product sterility using gamma rays or through the ETO sterilization.
"It is therefore vital to have a set of guidelines in the manufacturing practices and product safety of medical devices along with qualified personnel handling the products," added Dr Rao.
In Karnataka, there are only four companies which manufacture medical devices, Vascular Concepts which manufacture drug eluting stents and catheters at its facility in Doddaballapur near Bangalore, Windsor Medicals in Bangalore which deals with IV sets, Finic Infusions and Pharmaceuticals at Manipal in Dakshina Kannada district deals with disposable sets and Mansel Infusion, Bangalore.
There are no specifications for manufacture and these companies have been maintaining their own in-house good manufacturing practices and we have to ensure that the standards are according to the DCGI notification, informed Dr Rao.
Until two years ago, approvals were sought from the state drugs control department only for single use medical devices and these included sterile perfusion sets, sterile disposable needles and syringes listed under Schedule R of the Drugs and Cosmetics Act. Now with the notification of 10 medical devices, there are still no clear-cut guidelines on the production processes and quality standards, stated Dr Rao.
Medical devices companies stated that so far there have been no rejection of products which prove the high quality standards. Yet, the companies unanimously called for guidelines from the regulatory authorities so that they could increase their reach in global markets. Currently, sterile perfusion sets, disposable needles and syringe manufacturers restricted their product marketing only to southern states.
Hospital officials stated that in the wake of medical tourism growth and healthcare boom in the country, medical devices per se needed stringent set of standards. Devices like stents were all imported but syringes, needles and catheters used for general purposes were from the domestic units. Quality of these devices are always a major concern. Therefore all medical devices produced in India needed manufacturing licenses, they pointed out.