CDSCO lays down the Timeline for testing of various classes of New drugs
New Delhi: To streamline the process of testing for approval of all categories of drugs, the Central Drugs Standard Control Organization(CDSCO), Directorate General of Health Services has now specified particular timelines for testing by Central Government Laboratories
The timeline was released in a notice by Dr V G Somani, Drugs Controller General (India) (DCGI) to all Government Laboratories.
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 the requirement of such laboratory testing of new drugs which are pharmacopoeial products or which are additional strengths of an already approved new drug," the notice stated
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 |
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