DCGI waives Phase III trials for drugs
DCGI waives Phase III trials for drugs, PVChronicle is back with one more regulatory update.
This time for Clinical trials, as we are a lot of approval issues and patient participating in Clinical trials were facing issues during recent times. This update provides good insights for Clinical research Organizations, Pharma Companies and lot of drugs being planned to introduced in Indian market.
These kind of proposals and approach not only supports companies for fasten the process of drugs launch and benefits people being benefited of best drug available in the market.
PVC (PV Chronicle) recently shared, MHRA Compliance Reports regulatory udpate on Safety reporting.
DCGI waives Phase III trials for drugs, shares the recent update from Drug Controller General of India (DCGI), CDSCO
Why should Indians be deprived of the latest drugs that are being developed and marketed in countries where the regulatory system is known to be robust,” Singh said
Phase III clinical trials for drugs will now be an exception rather than the norm, with more emphasis on post-marketing surveillance, Drug Controller General of India Dr G N Singh has said.
“If a drug is approved in the US, Europe, Australia, Canada or Japan, then phase III clinical trials will have to be done only in cases where there is a specific requirement… Phase IV, that is the pharmacovigilance programme, will go on as usual. Earlier, phase III was waived in some cases, now it will have to be done in some cases. Why should Indians be deprived of the latest drugs that are being developed and marketed in countries where the regulatory system is known to be robust,” Singh said.
The best part of CDSCO website is multi lingual it can be viewed in 90 plus languages including local languages Telugu, Tamil and others too.
However the proposal for above news was proposed in February 2015, by India’s Drugs Technical Advisory Board (DTAB) has suggested granting Phase III clinical trial waiver to some drugs approved in “well-regulated” countries like the US or EU.
For full details of proposal : India’s Drugs Technical Advisory Board (DTAB) Proposal
For your understanding of each phase of Clinical trials and DCGI waives Phase III trials for drugs do check the below mentioned 4 Phases :
|Phase 0||Pharmacodynamicsandpharmacokinetics in humans||Phase 0 trials are the first-in-human trials. Single subtherapeutic doses of the study drug or treatment are given to a small number of subjects (10 to 15) to gather preliminary data on the agent’s pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs). For a test drug, the trial documents the absorption, distribution, metabolization, and removal (excretion) of the drug, and the drug’s interactions within the body, to confirm that these appear to be as expected.|
|Phase 1||Screening for safety.||Testing within a small group of people (20–80) to evaluate safety, determine safe dosage ranges, and begin to identify side effects. A drug’s side effects could be subtle or long term, or may only happen with a few people, so phase 1 trials are not expected to identify all side effects.|
|Phase 2||Establishing the efficacy of the drug, usually against a placebo.||Testing with a larger group of people (100–300) to determine efficacy and to further evaluate its safety. The gradual increase in test group size allows for the evocation of less-common side effects.|
|Phase 3||Final confirmation of safety and efficacy.||Testing with large groups of people (1,000–3,000) to confirm its efficacy, evaluate its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.|
|Phase 4||Safety studies during sales.||Postmarketing studies delineate additional information, including the treatment’s risks, benefits, and optimal use. As such, they are ongoing during the drug’s lifetime of active medical use. (Particularly relevant after approval under FDA Accelerated Approval Program)|
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NOTE : This article is intended to provide update available in the media, the official gazette from Government of India is still awaited.
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