To help bring the booming medical equipment industry in the country under the specific regulation of a law, the Health Ministry has sought the Cabinet's nod for a new Drugs and Cosmetics Bill, 2013 to replace the existing Act of 2007.
Sources in the Health Ministry said a note proposing the new Bill has been sent to the Cabinet Secretary for approval of the Union Cabinet.
Health Minister Ghulam Nabi Azad had earlier cleared the proposal for bringing all medical devices and equipment under the proposed new Drugs and Cosmetics Act. If given a go ahead, the Ministry will move the Bill in Parliament for its approval.
The Ministry wants to replace the existing Drugs and Cosmetics (Amentment) Act, 2007 and bring a separate chapter on medical devices and equipment setting standards and regulations for them.
"Till now, medical equipment and devices were treated as drugs under the purview of the existing Drugs and Cosmetic Act," a senior officer said.
The proposed new Bill has been prepared keeping in view the recommendations of the Parliamentary Standing Committee on Health, which had suggested bringing medical equipment and devices under specific regulations of a law and set standards for them.
"The proposal of the new Bill, if approved by the Cabinet, will ensure that there will be separate provisions for regulation of medical devices and equipment. They will not be treated as drugs under the law anymore, once the proposal is cleared. The Health Ministry will then move a new Bill in this regard in Parliament for its passage," the official said.
The need for regulating the medical equipment industry comes in the wake of reports of such equipment being used in an unregulated manner in the country.
The Bill provides for monitoring and setting standards for medical devices. It will also help in strengthening the domestic manufacturing industry.
India's pharmaceutical sector has made rapid strides in the last few years but the medical equipment sector is still unregulated and is functioning without any standards for the equipment used.
The government also proposes to strengthen the country's apex drug regulator - the Central Drugs Standard Control Organization (CDSCO) by adding more skilled manpower in the body to deal with the expanding health sector.
