If any patient had been withdrawn due to pharmacokinetic reason e.g. emesis, will such an adverse event be considered a significant adverse event or not?
Bhumi Vyas
Please see ICH guidance: ICH E2 A
Medical and scientific judgement should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the patient or may require intervention to prevent one of the other outcomes listed in the definition above. These should also usually be considered serious.
The decision whether an event is serious or not is governed by medical/scientific judgement of the investigator.
For clinical trials of herbal medicines, is it essential to 1) obtain DCGI approval 2) obtain EC approval and 3) register the trial in CTRI?
Ajay Vijay
As per Indian GCP, an NCE from herbal should undergo all regulatory requirements before being evaluated clinically. For the herbal remedies and medicinal plants that are to be clinically evaluated for use in the Allopathic System and which may later be used in allopathic hospitals, the procedures laid down by the office of the DCG (I) for allopathic drugs should be followed. It is advisable to obtain DCGI approval.
The EC approval is mandatory for all trials including herbal medicines. The CTRI registration is mandatory for all trials approved by DCGI office. For other trials it is voluntary. However, most journals are willing to accept a clinical trial for publication only if the trial has been registered in a public registry.
What data are essential before planning a trial of herbal medicines?
Dr Anand Virkar
Indian GCP 7.5.2. recommends
● It is important that plants and herbal remedies currently in use or mentioned in literature of recognized Traditional System of Medicine is prepared strictly in the same way as described in the literature while incorporating GMP norms for standardization.
● Before conducting phase II toxicity studies will be required if there are reports suggesting toxicity or when the herbal preparation is to be used for more than 3 months. It should be necessary to undertake 4-6 weeks toxicity study in 2 species of animals in the circumstances pointed out or when a larger multicentric phase III trial is subsequently planned based on results of phase II study.
● Clinical trials with herbal preparations should be carried out only after these have been standardized and markers identified to ensure that the substances being evaluated are always the same. be approved by the appropriate scientific and ethical committees of the concerned Institutes.
● It is essential that such clinical trials be carried out only when a competent Ayurvedic, Siddha or Unani physician is a co-investigator in such a clinical trial.
What are fees for regulatory department in India?
Balaji K
The Drugs and Cosmetics Act 122DA. – Application for permission to conduct clinical trials for New Drug/Investigational New Drug.- cover the fees.
● For human clinical trials (Phase-I) on a new drug shall be made to the Licensing Authority in Form 44 accompanied by a fee of Rs 50,000
● For exploratory clinical trials (Phase-II) on a new drug fee of Rs 25,000
● For confirmatory clinical trials (Phase-III) on a new drug fee of Rs 25,000
Can a nutritional supplement be tested in a comparative study in pregnant women to get the supplement approved for marketing in India even if the same supplement can tested in other patient population (non pregnant subjects) for its desired therapeutic effect?
Nitin Chandurkar
Guidelines for nutritional supplements are undergoing revision. Please see the Food Safety and Standard Act 2006 and consult Food Safety and Standards Authority of India in Delhi. They have a website www.fssai.gov.in
Pregnancy is an important medical condition. Studies in pregnancy will have to follow Indian GCP guidelines.
2.4.6.1.Pregnant or nursing women :
2.4.6.2. Pregnant or nursing women should in no circumstances be the subject of any research unless the research carries no more than minimal risk to the foetus or nursing infant and the object of the research is to obtain new knowledge about the foetus, pregnancy and lactation. As a general rule, pregnant or nursing women should not be subjects of any clinical trial except such trials as are designed to protect or advance the health of pregnant or nursing women or foetuses or nursing infants, and for which women who are not pregnant or nursing would not be suitable subjects.
Dr Arun Bhatt is currently,
president, ClinInvent,
Research Pvt Ltd, Mumbai.
Readers can send their queries
at: arunbhatt@clininvent.com