Central Drugs Standard Control Organization Current Affairs - 2019
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The government has notified the following eight medical equipments as Drugs after consultation with the Drugs Technical Advisory Board:
- All implantable devices.
- CT scan.
- PET equipment.
- MRI equipment.
- Dialysis machines.
- Bone marrow separators.
- X-ray machine.
The notification has been made under Section 3 of the Drugs and Cosmetics Act, with effect from April 1, 2020. The notification brings all the implantable and diagnostic devices will come under the regulatory framework. This is a big step forward as the majority of the medical devices were unregulated in India.
Drugs Technical Advisory Board (DTAB)
DTAB is the highest statutory decision-making body on technical matters related to drugs in India. It was constituted under the provisions of the Drugs and Cosmetics Act, 1940. DTAB is part of the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.
Tags: all implantable devices • bone marrow separators • CDSCO • Central Drugs Standard Control Organization • CT Scan • defibrillators • dialysis machines • Drugs • Drugs and Cosmetics Act 1940 • Drugs Technical Advisory Board • MRI equipment. • PET equipment • X-ray machine
The 22nd conference of Asian Harmonization Working Party (AHWP) was recently held New Delhi. It was inaugurated by Minister of State (MoS) Health & Family Welfare Anupriya Patel.
The five day conference was organised by Central Drugs Standard Control Organization (CDSCO) and National Drug Regulatory Authority (NDRA) of India in collaboration with Union Ministry of Health & Family Welfare.
The key objective of the conference was to develop and recommend approaches for convergence and harmonization of medical device regulations in Asia and beyond. It also aimed at facilitating exchange of knowledge and expertise amongst regulators and industry.
Asian Harmonization Working Party (AHWP)
AHWP is voluntary non-profit organization that aims to promote regulatory harmonization on medical device regulations in Asia and other regions in accordance with the guidance issued by International Medical Device Regulators Forums (IMDRF). It was established in 1999 by of 30 national regulators of member countries and industry members. It works in collaboration with related international organizations such as IMDRF, International Organization for Standardization (ISO), World Health Organisation (WHO) etc.