Medical devices to be treated as drugs

  1. The Health Ministry has announced certain medical devices such as all implantable devices, CT / PET / MRI equipments, dialysis machines, will be now treated as a “drugs” as defined in Drugs and Cosmetics Act with effect from 1st April 2020.
  2. Drug & Cosmetics Act, 1940 regulates the import, manufacture and distribution of drugs in India.
  3. Currently, only 23 medical devices are regulated under it by the Central Drug Standards Control Organization (CDSCO) – the apex drug regulator.
  4. The recent announcement is significant for patient’s safety as all implantable and diagnostic devices will come under the regulatory framework. The quality and efficacy of majority medical devices largely remains unregulated in India.