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Judgement of investigator is final on SAE/AE

Wednesday, May 4, 2016, 08:00 Hrs  [IST]

We are developing herbal extract based product for vaginal application. What is the regulatory scenario for such product in India?
Yogesh Bhide

In India, Ayurveda, Yoga & Naturopathy, Siddha or Unani (ASU) drugs have been under purview of Department of Ayush.
Herbal extracts are covered under Ayurvedic formulations.
In Indian regulations, the major class of Ayurveda, Siddha or Unani (ASU) drugs included are:

a)Classical ASU drugs as mentioned in the authoritative books of ASU system drugs, which are manufactured and named in accordance with the formulations described in the authoritative texts, For this category, issue of license to manufacture is based on citation in authoritative books and published literature, unless the drug is meant for a new indication, when proof of effectiveness is required.

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. For this category issue of license to manufacture requires proof of effectiveness, based on pilot study as per relevant protocol for ASU drugs.

In 2010, Department of Ayurveda, Unani, Siddha and Homeopathy (Ayush), introduced Rule 158(B) which made requirement of proof of effectiveness for licensing of patent or proprietary ASU medicine. This was followed by release of GCP guidelines for voluntary use by the researchers interested in taking up clinical trials by using ASU medicine

Herbal extract based product which you have referred would be classified as Patent or Proprietary medicine, for which you will need manufacturing license from ayurvedic FDA of the state in which the product is manufactured.

Can a person serve on 2 ethics committees?
Dr Santha Devi T

There is no regulation preventing a person from serving on 2 ECs. However, as you are aware, the registration of EC requires EC to fulfill its regulatory obligations of
Need to remain conversant with current regulations and ethical guidance
No conflict of interest (This could be an important question when someone is part of 2 ECs) The members need to declare this to EC that they are part of another EC)
Initial review
Ongoing review
SAE assessment and compensation review
Readiness for regulatory inspection
Maintenance of records
Undertaking by chairperson

The new requirements for accreditation of ECs are quite exhaustive.
Hence, the ethical questions to be considered in this scenario are:

  • With such regulatory/ethics demands, most people are not keen to serve even on 1 EC. Then why do some want to work for 2 ECs? Is there any personal gain?
  • How will they devote time for the above responsibilities? Or are they just following opinions of other experts in the meetings?
  • Are they aware of their regulatory responsibilities? Will they be able to face a regulatory inspector who may ask them such questions?
  • These issues are critical for the chairperson, who is involved in all EC functions and is responsible for regulatory/GCP compliance.

During BA-BE study a subject encountered AE and referred to hospital for further treatment. The medical expert advised hospitalization as per consultant opinion but subject to refused to get admitted to a hospital? Is this an SAE?
Tarun Goswami

In assessing the seriousness of AE, judgment of the investigator is final. The AE required hospitalization as per the consultant. Hence, this is an SAE.

We intend to harvest/(collection, storage and processing) blank human blood/plasma from healthy volunteers for the purpose of BA method development, validation and analysis for biosimilar at our CDSCO approved BE study centre. What is the regulatory scenario for this process in India?
Yuvraj chopra

There is no specific mention of bio-analytical (BA) method development issues in biosimilar regulation. The new draft Indian guidelines for biosimilars do discuss the need for PK studies. However, they do not refer to the lab aspects of bio-analytical method development.
There are guidelines for blood banks in India, which are relevant when blood/components/cells are used as therapy. However, there are no Indian guidelines for harvesting the blood/blood plasma from healthy volunteers for bio-analytical method development/validation.

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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