Any new drug, which is to be marketed in India, needs to undergo a battery of tests according to the "New Drugs and Clinical Trials Rules, 2019." These rules are enforced by Central Drugs Standards Control Organization (CDSCO). These tests are to be carried out to prove that the drug ...
These new regulations, along with the New Drugs and Clinical Trials Rules, 2019 issued by the Central Drugs Standard Control Organization (CDSCO), will ensure more transparency and expedition in new drug approvals, especially orphan drugs for rare diseases, as well as new innovative medicines that...
The New Drugs and Clinical Trials Rules, 2019 was released on March 19, 2019 by the Central Drugs Standard Control Organisation (CDSCO) to promote ethical clinical research in India. This is also required as concerns have been raised regarding requirement of such laboratory testing of new drugs ...
The Central Drugs Standard Control Organisation (CDSCO) has introduced a system of formal Pre-submission Meetings (PSM) of applicants with CDSCO officers and subject experts to discuss regulatory pathway in respect of specific application for approval of clinical trial, new drug, medical devices, etc...
deemed approval for clinical trials in 30 working days, if no communication is otherwise received from the Central Licensing Authority, for drugs discovered in India or for drugs whose R&D is done in India and proposed to be manufactured and marketed in India. This is a huge push towards encou...
(PPH) and the drug manufacturer, Ferring Pharmaceuticals, is getting ready to approach the Central Drugs Standard Control Organisation (CDSCO) for necessary regulatory clearances to market the product, it is learnt.A recent global clinical trial has unequivocally proven the new medication's potential ...
GMPANDcGMPCONSIDERATIONSDr.BasavarajK.NanjwadeM.Pharm.,Ph.D.AssociateProfessorDepartmentofPharmaceuticsKLEUniversityBELGAUM-5..
The present review provides an insight about history of OTFs, definitions, types of classification, mandatory characteristics, formulation aspects, manufacturing and evaluation methodologies, stability, approvals by regulatory authorities (CDSCO of India), key players in the domain, notable patent battle ...
The present review provides insight into the history of OTFs, definitions, types of classification, mandatory characteristics, formulation aspects, manufacturing and evaluation methodologies, stability, approvals by regulatory authorities (CDSCO of India), key players in the domain, notable patent battle ...
of new drugs which were earlier approved based on the recommendation of the multidisciplinary committee of experts, the same are again placed before the Committee for subsequent application since the market based data is not available even after approval of the retail price of the formulations ...