Question

Provide a brief explanation of the accrediting or regulatory body you found in week 7; what area of health care does the agency work in, what are their primary aims and what is its brief history? Who accredits the accreditors? J ust think about that one for a moment. Mostly it is the government (state and federal) but are there other quasi-governmental agencies or groups? What is the value of regulation and accreditation? Does regulation help or hinder efficiency? Quality? “Set out to right the world’s wrongs and you will inevitably add to them. The world is often too complicated for the rules we need to keep it ordered”

Answer 1

Central Drugs Standard Control Organisation

The Central Drugs Standard Control Organisation is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency .

The regulation of medical devices in the country is set for an overhaul. The government plans to bring all medical devices under the jurisdiction of the Central Drugs Standard Control Organisation (CDSCO) with an aim to impr

Functions of CDSCO

Approval of new drugs and clinical trials

Import Registration and Licensing

License approving of Blood Banks, LVPS. Vaccines, r-DNA products & some Medical Devices (CLA Scheme)

Amendment to D &C Act and Rules

Banning of drugs and cosmetics

Grant of Test License, Personal License, NOCS for Export

Testing of New Drugs

Oversight and market Surveillance through Inspectorate of Centre Over and above the State Authority

ove their quality as well as safety