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F.No. 12-01/19-DC(PT-195)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
Office of Drugs Controller General (India)
(New Drugs Division)
FDA Bhawan, Kotla Road,
New Delhi-110002
Date: '''31~/~
NOTICE
Subject: Testing of all categories of new drugs for their approval - reg.
Under the New Drugs and Clinical Trials Rules, 2019, CDSCO grants
permission for import/manufacture of new drugs for sale and distribution. One of the
requirements is testing of the new drugs in the Central Government Laboratories
before their approval.
Concerns have been raised regarding requirement of such laboratory testing
of new drugs which are pharmacopoeial products or which are additional strengths of
already approved new drug.
In this regard, to streamline the new drug approval process, it has been
decided that, testing will be carried out by the Central Government Laboratories as
per the following timelines unless otherwise, there is any specific issue involved
relating to testing of the drug.
Categories of new drug Timeline
New drugs already approved 4 weeks
New drugs which are pharmacopoeial 6 weeks
Other new drugs 8 weeks
Yours faithfully,
~.~{..
V
(Dr. V.G. Somani)
Drugs Controller General (India)
To,
1. All Government Laboratories.
2. All Stakeholders.