APPLICATION TO MARKET NEW CHEMICAL ENTITIES (NCEs)
The Expert Committee decided that if India participates in GCT for NCE's to be used for diseases prevalent in our population, approval should be sought from CDSCO for marketing these NCEs in India after approval for marketing in the innovator country or in regulated markets.
Read MoreAPPLICATION TO MARKET NEW CHEMICAL ENTITIES (NCEs)
The Expert Committee decided that if India participates in GCT for NCE's to be used for diseases prevalent in our population, approval should be sought from CDSCO for marketing these NCEs in India after approval for marketing in the innovator country or in regulated markets.
Read MoreANCILLARY CARE TO THE CLINICAL TRIAL SUBJECTS
Decided by the Expert Committee that there should be provision for providing ancillary care to patients suffering from any other illness during the trial.
Read MoreImport NOC for import of small quantity of cosmetics
CliniExperts Services can assist the wholesale traders or manufacturers interested in importing small quantity of cosmetics into India for R&D and testing purpose
Read MoreLabeling of Cautionary Note under Rule of 97 of Drug & Cosmetic Act – (No. DCGI/MISC/572012)
Rule 97 of Drug & Cosmetics Act 1945, provides for printing caution/ Warning in respect of drugs covered under Schedule H, Schedule G and substance covered under the purview of Narcotic & Psychotropic drugs Act, 1985 for the information of patients, doctors pharmacists and others so that there is no misuse of these drugs.
Read MoreGovt forms panels to frame guidelines & SOPs for approval of new drugs, trials, banning drugs
The Union health ministry has constituted two expert committees to formulate policy guidelines and standard operating procedures (SOPs) for approval of new drugs, clinical trials, banning of drugs and Fixed Dose Combinations (FDCs).
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State FDA & Zonal CDSCO
Zonal Licences (East, West, North and South Zone), State Licenses
Feature
Consultation on Medical Device and Diagnostic Kit for India Market
Import and Registration of Medical Devices, Registration certificate of Critical / Notified Diagnostic Kits, Test licence for Medical Device and Diagnostic Kits, Import License for Diagnostic Kits, Manufacturing licence for medical device, Clinical Trial Approval for Medical Devices and Diagnostic Kits
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CLINICAL TRIAL ON MEDICAL DEVICE
Decided by the Expert Committee, the procedures for Clinical Trial approval, accreditations of investigators, sites, Ethics Committee and other conditions would be similar to the clinical trials of New Drug/ Vaccines.