The amendment, named as the NDCT (Amendment) Rules, has brought in a change in the Rule 2, in sub-rule (1) in clause (g) of the Rules 2019. In order to bring clarity in the definition of ...
CDSCO implements prior intimation system for certain drugs under amended NDCT Rules: Gireesh Babu, New Delhi Thursday, April ...
The NDCT Rules are today applicable to all new drugs, investigational new drugs for human use, clinical trial, BE study and Ethics Committee. The Union health ministry has issued draft notification on ...
The Union ministry of health has initiated efforts to include specific norms related to reporting of post approval changes to the licensed new drugs, both imported and manufactured in the country, to ...
India's pharmaceutical research ecosystem is set for a major regulatory overhaul with the Union Ministry of Health and Family Welfare notifying key amendments to the New Drugs and Clinical Trials ...
Regulatory Grey Zone Sparks Controversy: Are India's New Drug Approval Rules Being Applied Unevenly?
New Delhi [India], April 9 (ANI): Questions are being raised over how India's new drug approval framework is being interpreted, with experts pointing to a possible gap between the written provisions ...
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