CT, MRI will become cheaper if brought under Drug and Cosmetic Act 1940
In order to curb the increasing costs of the medical devices in India, the state government have taken an initiative to bring all the testing and imaging devices such as magnet resonance imaging (MRI), CT scan and X-ray machines under the Drug and Cosmetic (D&C) Act 1940.
The Central Drugs Standard Control Organisation (CDSCO), an arm of the Ministry, has proposed to notify eight medical devices — all implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machines, PET equipment, X-Ray machines and bone-marrow cell separator as ‘drugs,’ under Section 3 of Drugs and Cosmetics Act.
“The proposed notification will be finalised in 21 days, after inviting comments and suggestions from all stake holders,” said official.
The notice issued by the CDSCO stated “In pursuance of sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), Drugs Technical Advisory Board (DTAB) in its 79th meeting held on May16 deliberated and recommended for the proposal to specify the following medical devices under the definition of drug.”
A senior official from the Food and Drugs Administration (FDA) said the Drug Controller General of India (DCGI) has taken a good decision of bringing all the imaging devices under Drug and Cosmetic Act 1940.
“DCGI should make it mandatory for all stakeholders to follow the standard procedure and if they don’t a strict action should be taken against them. Also, they should divide the standard practices and content right from the stage of sourcing the raw material to manufacturing and distribution,” official added.
The health workers and the Non-Governmental Organisations (NGOs) said bringing these machines under the ambit of the law, will certainly bring down the prices of the tests and will prove to be beneficial for the poor.
President of the Society for Awareness of Civil Rights, YP Rao said for the past two years they are demanding to curb the rampant profiteering in the healthcare sector. “It is first step taken by the government for price fixation and now the National Pharmaceutical Pricing Authority (NPPA) should fix the prices as soon as possible,” added Rao.
The health workers and the Non-Governmental Organisations (NGOs) said bringing these machines under the ambit of the law, will certainly bring down the prices of the tests and will prove to be beneficial for the poor