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