CDSCOCentral Drugs Standard Control Organization (India)
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In 2015 the CDSCO published the largest and arguably most comprehensive study of medicine quality any country has ever undertaken.
Delineating the roles and responsibilities of regulatory authorities including CDSCO, PvPI at IPC, it recommends that Pharmacovigilance System Master File (PvMF), which will contain all the information pertaining to PV system, shall be located at the site in India where the PV activities are performed.
Ask industry insiders and the general opinion is that instead of moving the CDSCO to the chemicals and fertilisers ministry, it will make more sense to shift the Department of Pharmaceuticals and the NPPA to the health ministry, which should continue to retain the CDSCO (See Table The Web of Governing Structures).
Moreover, alerts would get reflected on the CDSCO website if a particular prescription was used more than once for buying medicines from a particular echemist, said the official, adding that all e- pharmacists would be centrally linked to CDSCO.
At the time of conducting the study, the CDSCO did not qualify as a "stringent regulatory authority" in accordance with global norms (Interviews, WHO official, NTP official, state-level drug control official, state-level TB control official).
There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts," the report said.
All documentation and communication records are required to be dated, filed and preserved for five years after the completion of the study, or submission of data to CDSCO.
Tenders are invited for Rate Contract Of Drugs And Medicines To Chhattisgarh Medical Services Corporation Limited Eligibility Criteria : Manufacturing firms with valid product license are eligible to participate in the tender provided, they have : (i) Tenderer shall be a manufacturer having valid Own manufacturing /Loan license issued by State Drugs Controller or direct importer holding valid import license issued by CDSCO.
CDSCO guidelines on clinical trials dictate that if a drug gains approval internationally but not in India, additional phase III clinical trials and bio-equivalence studies must be completed to prove its safety and effectiveness.
2012" formulated by CDSCO was used to identify the API used in FDCs which are already banned.
At one level, CDSCO has embarked on a process to streamline the activities of various state and central regulatory agencies.