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The Gujarat Food and Drug Control Administration(FDCA) is contemplating to set up a medical device testing laboratory in the state, soon, if things go as planned. The state drug regulator is currently in discussion with the Centre and the state governments over the possibility of establishing a state-of-the-art, exclusive laboratory dedicated for the testing of medical devices to tap the ever growing needs of the industry.
The aim behind this move is to curb the use of substandard medical devices in the market and to ensure proper representation of the sector's requirements for testing, as per the globally accepted standard. It is understood that the Gujarat FDCA has already submitted a proposal, which is being analysed and deliberated over. If approved, this move will have a huge impact on the development of the domestic medical device sector that has been striving to get separate identity from that of drugs. Sources informed that owing to the strong presence of medical device industry in the state, the regulators are considering to scout for a location in and around Ahmedabad for the new testing laboratory, wherein they will be able to utilise the expertise of the best in the industry.
Dr H G Koshia, commissioner, Gujarat FDCA, informed that right now everything is at a very initial stage of discussion but expressed hope that the Centre will approve the plan for setting up a testing lab for the medical devices industry. He believes that this will not only help in addressing industry's demand towards strong regulation, but will also help the country to leverage this opportunity to boost the sector further. However he stressed, “We strongly feel that like drugs even medical devices play an important part in a patient's life as they act as critical life-saving products, when implanted directly into the human body for critical care. Implanting low quality or defective device can endanger the life of the patient and that necessitates the need for separate minimum testings for these products that are different from the regulatory standards and testing procedures as prescribed for the pharma industry.”
Experts forecast exponential growth for the medical device sector, including medical packaging, in the coming years, which would further get a positive push through this kind of initiative. A highly placed source informed that usually it is the consumer and government who drive the regulations, however in India it is the manufacturers who have been time and again requesting for regulations as per expected standards, thus this step even in the conceptual stage comes as a welcome move for the industry.
As of now, the centre has notified 14 categories of medical devices as drug under the Drugs & Cosmetics Act, they are disposable hypodermic syringes; disposable hypodermic needles; disposable perfusion sets; in vitro diagnostic devices for HIV, HBsAg and HCV; cardiac stents; drug eluting stents; catheters; intra ocular lenses; I.V. cannulae; bone cements; heart valves; scalp vein set; orthopaedic implants and internal prosthetic replacements.
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