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Medical Device Industry Needs To Develop Products Indigenously At Affordable Costs

Shri Dinesh Trivedi
Minister of State
Ministry of Health and Family Welfare

Address by Hon’ble Minister, Shri Dinesh Trivedi, minister of state for health and family welfare in a national workshop on Medical Devices jointly organized by CDSCO and the Federation of Indian Chambers of Commerce and Industry in New Delhi On June 11-12, 2010. Hon. Minister, Shri Dinesh Trivedi addressed delegates representatives from Industry, Regulators and eminent speakers. It also included regulators from USFDA and European Commission.

The health care sector is currently valued at approximately $35 billion and is one of the largest & fastest growing sectors in India with a 10-12% annual growth rate. Of this $35 billion, medical devices, diagnostics and equipment contribute only 6%. The use of Medical Devices is increasing day by day in the field of Healthcare. Technological advancements in Medical Devices have resulted in more precise system of treatment, less invasive surgeries and this in turn has resulted in shortened stay of the patients in the hospitals with better quality of treatment.

Increasing population with greater awareness and transforming disease profile of the country has resulted in an increased demand for healthcare services. Variety of Medical Devices provide means for complex diagnosis and life saving supports systems. In view of their extensive use, it is necessary to have a proper regulatory control over the Medical Devices so that patients are provided with safe, affordable and effective tools of Healthcare.

India has a large scientific talent and medical expertise for manufacture and use of medical devices in the country. However high cost of Medical Devices raises the cost of the Healthcare and the objective of providing Healthcare to the poor and needy patients by the Government through the Government Hospitals gets retarded. It is therefore essential that the Medical Device industry in the country grows at a faster rate and Medical Devices are developed indigenously at affordable costs.

The present regulatory control over Medical Devices is being exercised in the country under the provision of the Drugs and Cosmetics Act. At present, only 14 notified Medical Devices are being regulated under the said Act. It is however being proposed to establish a bill on the Medical Devices Regulatory Authority to bring a comprehensive legislation to ensure standards, safety, quality and effectiveness of devices in this July. This act is under the active consideration of the Ministry. The government’s effort would also be to ensure that the medical records of all citizens are electronically stored and digitized for ease of access by pathologists and doctors for diagnosis and treatment of patients.

The ministry had signed a MoU with the railway ministry for acquiring railway land for setting up diagnostic centers and hospitals at or near railway stations.

Shri Trivedi underlined the need to address basic issues of healthcare and education if GDP was to grow at a sustainable 9 per cent per annum.


Dr. Surinder Singh
Drugs Controller General of India

Dr Surinder Singh, Drugs Controller General of India, said that the proposed law to regulate medical devices would be specific to India to cater to the country’s socio-economic conditions. The role of the government would be to enforce the law and facilitate the growth of the indigenous industry.

 

On the second day of the workshop, Dr. S. Eswara Reddy, Assistant Drugs Controller General of India, briefed on the Proposed Comprehensive regulatory framework for Medical Devices.

Dr. S. Eswara Reddy
Asst. Drugs Controller General of India

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