MRI, CT, X-ray machines to be brought under Drugs act?

The Central Drug Standard Control Organisation (CDSCO) has issued a notice on June 22. The CDSCO has asked all the stakeholders to send their suggestions and comments before 21 days after the notice has been issued

MRI, CT, X-ray machines to be brought under Drugs act?

In yet another move to curb the rising costs of the medical services in India, the government has decided to bring testing and imaging devices such as MRI, CT, and X-ray machines under the ambit of the Drug and Cosmetic Act 1940.

Health workers say 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.

The notice issued by the CDSCO states,

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 16.05.2018, deliberated and recommended for the proposal to specify the following medical devices under the definition of drug.

All implantable medical devices

  • CT scan equipment
  • MRI equipment
  • Defibrillators
  • Dialysis machine
  • PET equipment
  • X-Ray machines
  • Bone marrow cell separator

MRI, CT, X-ray machines to be brought under Drugs act?

While speaking to My Medical Mantra, Mahesh Zagade, Former Commissioner of Maharashtra, Food and Drugs Administration said, “This is a very good decision taken by the Drugs Controller General of India. But, appropriate action should be taken against those who are not following the standard. Also, the DGCI should divide the standard practices and content right from the stage of sourcing the raw material to manufacturing and distribution.”

NGO’s which are working in the healthcare sector have welcomed the central government’s move.

President of the Society for Awareness of Civil Rights, YP Yajurvedi Rao said, “This is indeed a very good decision. We have been demanding this for over two years now. This will curb the rampant profiteering in the healthcare sector. By issuing the notice to bring the testing and imaging devices under the ambit of the Drugs and Cosmetic Act, the government has taken a step forward for price fixation. Now, the NPPA should fix the prices as soon as possible.”