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A change in inclusion/exclusion criteria will require approval from DCGI

Is it necessary to obtain DCGI/EC approval for clinical trial of nutraceutical and register the trial in CTRI? Is it essential to carry out toxicity studies? Binu Kuruvilla DCGI approval is not required unless the indication claim is as per definition of a new drug as per Drugs & Cosmetics Rules.  

The definition of drug is as follows: All medicines for internal or external use of human beings and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings.

In addition, you should consider new drug definition as per Rule 122E.

A drug is considered a new drug if
1) it is a new chemical, biological or recombinant bio-technological or such devices or delivery systems
2) a drug already approved for certain claims is now being considered for modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration
3) fixed dose combination of two or more approved drugs, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of individual drugs already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration EC approval is essential. Registration of clinical trial in CTRI is voluntary. The requirement of toxicity depends on the available human safety data of nutraceutical and duration of the treatment with the nutraceutical in the clinical trial.  

What is the current situation of investigator initiated trials in India - applicable regulations, investigators keenness, funds?  

Shilpi Ray The regulations do not describe investigator initiated trials. However, in light of current MCI Code and CDSCO approach, these are treated like any other trial i.e. investigator IND. If the trial is industry sponsored, it is treated like a typical regulatory approval trial. However, if the trial is an investigator's personal research, requirements are less stringent e.g. a protocol and publication supporting the objectives may suffice. In my experience, very few investigators are keen on such trials. Usually they expect industry to fund and take care of all issues - regulatory/ethics approval etc.  

What is a registry study? Dr Nitin Kulkarni Registry is one approach in Phase IV post-marketing stage. Registries are conducted in a real world setting with the objective of measuring a product’s effectiveness, and are useful in validating the safety and efficacy of interventions seen in controlled clinical trials into everyday practice. The patient registries allow large-scale/long-term data collection without high cost of traditional Phase IV studies. The patient registries also provide an opportunity to collect relevant information relating to interventions, such as: physician experience, patient-reported outcomes, and burden of illness.  

Is BE study of new oncology molecule allowed in Indian patients, if the drug is not available in the Indian market? Is the new liposomal formulation of an old drug considered new medical entity? Is Phase I trial for new formulation of a European sponsor allowed?
Chirag Shah Yes, you can get approval for BE study from DCGI for a new drug. As per Drugs and Cosmetics Act 122 E a new formulation is considered a new drug. If the Phase I is for a new medicinal entity discovered outside India, Phase I will not be allowed.  

If the protocol version is changed due to some minor changes in inclusion and exclusion criteria, do we need DCGI approval or notification is enough?  
Rashmi A change in inclusion/exclusion criteria will require approval from DCGI office. Please see the CDSCO guidance on protocol amendment.
■ Those amendments which do not require notification to or permission of the licensing authority
● Administrative and logistic changes
● Minor protocol amendments and additional safety assessments in case the institutional ethics committee has already approved these changes
● Those amendments which require notification to the licensing authority but need not wait for permission
● Additional investigator sites
● Change in investigator with the consent to withdraw from the earlier investigator
● Amended investigators brochure, amended informed consent
■ Those amendments which require prior permission of the licensing authority
● Additional patients to be recruited
● Major changes in protocol with respect to study design, dose and treatment options
● Any change in inclusion or exclusion criteria.

Dr Arun Bhatt is currently, president, ClinInvent, Research Pvt Ltd, Mumbai. Readers can send their queries at:

Source: Pharmabiz


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