The Gujarat Food and Drug Control Administration (FDCA) is planning to set up a new laboratory dedicated for testing quality of medical devices in the premises of its existing drug testing laboratory at Baroda.
The laboratory is claimed to be the first dedicated facility set up by a state drug regulatory office in the country to monitor the standard of the latest medical devices approved by the Drug Controller General of India (DCGI) under the category of drugs.
The administration has already received nod from the state government to set up the laboratory along with a primary fund allocation of Rs 25 lakh. At present, the officials are comprehending a list of machinery and equipment, including X-ray machines, required to be established in the new facility to test the latest medical devices, said H G Koshia, commissioner, FDCA, Gujarat.
"The new medical devices included in the list of drugs by the DCGI has to be tested with sophisticated equipments as they have metal and plastic contents. We are expecting more funds to flow from the next state annual budget for the project and our target is to complete the works and start operations by the end of 2011," said Koshia.
Gujarat FDCA has already approved six cardiac stent products for marketing since last two years. The state has almost 70 units producing medical devices and the existing drug testing laboratory under the FDCA is equipped to handle basic devices for quality.
The new laboratory will have its importance in near future as the central government has sanctioned projects to set up a medical devices industry cluster along with a training institution for medical devices in the state.
As reported, the Planning Commission is expected to give the in-principle approval soon for the proposal by the Department of Pharmaceuticals to set up a dedicated greenfield Medical Devices and Equipment Park worth around Rs 350 crore near Sanand in Gujarat. The project is to assist the upcoming medical devices industry in the country, which is facing various difficulties in growth, like poor access to high end-technology, lack of adequate infrastructure and limited availability of skilled manpower.
Similarly, the Ahmedabad chapter of the National Institute of Pharmaceutical Education and Research (NIPER), is all set to initiate courses to develop human resources to enhance the performance of medical devices industry in the country. The institute will be one of the first to introduce a dedicated course for medical devices technology.
With the ongoing developments in this area, the state is expected to turn into a hub for medical devices industry in the near future and the drug regulatory mechanism is trying to keep up the growth in the industry and to maintain strict vigilance, said Koshia.