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AV recording of ICP mandatory for vulnerable subject in trials

Thursday, October 5, 2017, 08:00 Hrs  [IST]

I am a PhD scholar and my research topic is on curcumin and its effect on the human lipid profile primarily the HDL levels. I have submitted my synopsis for approval to the scientific committee. I Have following doubts and would appreciate if you can clarify them.

1. Since the project involves hyperlipidaemic human patients, do I require any regulatory clearance?

2. Do I need to give any compensation to participants? As this is an academic trial for PhD purpose.

Dr. Pankaj Bablani
As curcumin is herbal drug, which you wish to try in an allopathic indication, you need to consider whether curcumin falls in category of new drug/ phytopharmaceutical. If so, you need regulatory approval. Compensation rules are applicable to all trials approved by regulatory authorities.

Relevant regulations and guidelines are given below:

The definition of new drug as per Schedule Y is

122E. Definition of new drug
  • A drug, as defined in the Act including bulk drug substance which has not been used in the country to any significant extent under the conditions prescribed, recommended, or suggested in the labelling thereof and has not been recognized as effective and safe by the licensing authority
  • A drug already approved by the Licensing Authority for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration.
New Chemical Entity
  • As per G.S.R. 826(E), dated 30th October 2015 “New Chemical Entity” means an active substance in developmental stage which may be specified as a drug under the Act, after undergoing any clinical trial.
Phytopharmaceutical drug
  • Phytopharmaceutical drug is defined as purified and standardized fraction with defined minimum four bioactive or phytochemical compounds (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals for diagnosis, treatment, mitigation, or prevention of any disease or disorder but does not include administration by parenteral route.
Your clinical trial with curcumin can qualify as an academic trial for new drug if the data generated is not intended for submission to licensing authority. In such a case, EC approval would be adequate to conduct the clinical trial.

Recently we were approached by a company for a medical device, which is not regulated by DCGI. Please advice what regulation should be followed for testing/validation/trial.
Gajjela Praveen
I assume you are aware of CDSCO Gazette of 17 Oct 16 on Medical Devices. This contains requirements for validation.

I feel you can use the principles/ processes recommended in CDSCO rule or any international guidance – EMA/US FDA – for this purpose or the regulation of the country where the device will be marketed.

If any drug is approved for one indication and we wish to conduct trial of the drug for different indication, will AV recording of informed consent be required?  
Vishal nakrani
Definition of new drug definition as per 122E includes
  • New chemical entity (NCE)
  • New indication/dosage form/route
As per G.S.R. 611 (E), Dated 31st July 2015: Audio-Visual (AV) recording of Informed Consent Process (ICP) is mandatory for vulnerable subject in clinical trials of NCE/New Molecular Entity (NME).

As per G.S.R. 826(E), dated 30th October 2015 “New Chemical Entity” means an active substance in developmental stage which may be specified as a drug under the Act, after undergoing any clinical trial.’As per the definition your trial is for a new drug for a new indication and not for New Chemical Entity. Hence, Audio-Visual (AV) recording of Informed Consent is not applicable.

Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com


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