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DCGI approval not required for clinical trial of herbal products

Dr Arun Bhatt
Wednesday, April 6, 2016, 08:00 Hrs  [IST]

How do you consent an illiterate patient for a clinical study as per ICH GCP and Schedule Y? Can a relative sign as a witness?
Shilpa Raut

As per ICH GCP,  impartial witness (IW) is person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
One can consider different types of IW – a relative of patient or a hospital staff member. Both of these could be independent of trial. However, hospital staff is likely to be influenced by people involved with the trial, as he/she is known the site staff. Hence, in Indian setting it would be desirable to request a relative to be an impartial witness.  

We plan to conduct clinical trial of an herbal preparation. Do we need approval of clinical trial from DCGI?
Dr. Vrajesh Udani

In Indian regulations, the major class of herbal products are:  
a)     Classical Ayurveda drugs as mentioned in the authoritative books of Ayurveda system, which are manufactured and named in accordance with the formulations described in the authoritative texts,
b)    Patent or Proprietary medicine makes use of ingredients referred in the formulations of authoritative texts but with intellectual intervention, innovation or invention to manufacture products different from the classical medicine.
None of these classes of herbal medicines come under purview of DCGI as they are not new drug as per Indian regulations. Hence, DCGI approval is not required for clinical trial of herbal products.
In 2015, regulatory requirements Central Drugs Standards Control Organization (CDSCO) prescribed regulatory provisions for phytopharmaceuticals.  Phytopharmaceutical drug is defined as purified and standardised fraction with defined minimum four bio-active or phyto-chemical 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. Clinical trials of phytopharmaceutical drug would require DCGI approval.

Is it must to have Indian nationality to become member in Ethics Committee (EC) in India?
Tarak Desai

In Ethics Committee function, the most important responsibilities of members are to comply with ethical and regulatory requirements for EC function. You need to consider whether there would be violation of ethical norms of behaviour in case someone who is not an Indian national becomes an EC member. Some difficult situations could be:
Regulatory scrutiny during registration / accreditation
Participation on in EC meetings physically
Any potential legal issues due to participation e.g. chairperson has to give an undertaking to CDSCO as part of registration requirements.
Availability during EC inspection
Response of non-Indian national regulatory/media/legal situations

Can husband and wife become member of two different ECs?
Tarak Desai

122DD EC Registration mandates that there should be no conflict of interest. Also, EC should have policy to monitor or prevent the conflict of interest along with standard operating procedures.

In addition EC members have to maintain confidentiality. Please consider whether a couple participating in 2 different ECs would be able to comply with these regulatory and ethical requirements.

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


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Dr. Shankar G Lokhande Dec 20, 2017 6:14 PM
Is there any need of clinical trials for formulation (patent) , if only name of ingredients is mentioned in textual reference but for another use,?
P.L.Chatterji Jul 6, 2017 7:41 PM
are clinical trials on human beings mandatory for ayurvedic medicines?
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