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Current Affairs 19 April 2021 – IAS Current Affairs

Current Affairs 19 April 2021 – IAS Current Affairs

Current Affairs 19 April 2021  focuses on Prelims-Mains perspective. Major events are :

  1. New Regulatory Regime for 8 Medical Items under Drugs and Cosmetics Act

New Regulatory Regime for 8 Medical Items under Drugs and Cosmetics Act

Why in News ?

The Union Ministry of Health & Family Welfare has taken a significant decision for ensuring continued access of eight regulated medical devices. 

All Implantable Medical Devices , CT scan equipment, MRI equipment, Defibrillators, PET Equipment, Dialysis Machine, X-Ray Machine, Bone marrow cell separator are regulated under the Drugs and Cosmetics Act.

About the Order

  • The importers/manufacturers are required to take import or manufacturing licence from Central Licencing Authority or State Licencing Authority
  • As of now the license is applicable only for import/manufacture of above devices, w.e.f. 1st April, 2021.

What is the aim of Regulation ?

  • To ensure supply chain continuity and access to these Medical Devices.
  • The application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said devices up to 6 months from issue of this order.
  • there is no specific legislation that regulates the manufacture, import, export and sale of medical devices.

Current system of Regulation

  • The standards of quality and safety of medical devices are regulated in India by a law called The Drugs and Cosmetics Act, 1940.
  • The scope is restricted to the items that are notified by the government by time to time. 

Need to regulate medical devices

  • No pre-market control to assess the safety, performance and quality of medical devices.
  • No formal post-market surveillance system including adverse incident reporting.
  • Inadequate product information for the public and operators.

Drugs and Cosmetics Act

  • Regulates the import, manufacture and distribution of drugs in India.
  • To ensure that the drugs and cosmetics sold in India are safe, effective, quality and standards.
  • The Act lacks specific penalties for violating provisions relating to clinical trials.
  • Drug is defined and includes a wide variety of substance, diagnostic and medical devices.
  • Latest Amendment was in 2017. 

Source : PIB

GS II : Development processes and the development industry- the role of NGOs, SHGs, various groups and associations, donors, charities, institutional and other stakeholders


For Pelims Fact Click Here : 19 April 2021

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