Indian GCP not recommends duration for retention of samples

What is retention quantity and retention period of investigational products (IPs) as per Indian guidelines?
A D Asam

Neither ICH nor Indian GCP recommend any duration for retention of samples. See below. However, as per Drugs and Cosmetics Act, for a manufactured batch, the duration is maximum of 3 years the date of manufacture

ICH GCP 5.14.5(b) Maintain sufficient quantities of the investigational products used in the trials to reconfirm specifications, should this become necessary, and maintain records of batch sample analyses and characteristics. To the extent stability permits, samples should be retained either until the analyses of the trial data are completed or as required by the applicable regulatory requirements, whichever represents the longer retention period.
 
Indian GCP 3.1.9.  Supply, storage and handling of pharmaceutical products
The sponsor should maintain sufficient samples from each batch and keep the record of their analyses and characteristics for reference, so that if necessary an independent laboratory may be able to recheck the same.
 
Drugs and Cosmetics Act Conditions of license in Form 25

(l) the licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label, the reference samples shall be maintained for a period of three months beyond the date of expiry or potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture.

Can a person play dual role in the EC quorum e.g. a legal expert can also represent lay person? Can an EC member (required for quorum), who could not attend the meeting, be sent documents for review and opinion collected?
Rohit Prasad

Lay person by definition is someone who is not an expert in any field. A lawyer cannot serve as lay person. Most ECs take a graduate / 12 standard pass person as lay person.
 
Quorum requires physical presence of all members. An opinion sent by a member will not fulfill quorum.

Which guideline should be followed for the conduct of observational and registry trials?
Dr. Yashodha Madhu

Volume 9A of the Rules governing medicinal products in the European Union guidelines on Pharmacovigilance for medicinal products for human use 7 company-sponsored post-authorisation safety studies covers non-interventional clinical studies. There are no specific guidelines for such studies.

For epidemiology studies, ICMR 2006 ethical guidelines provide some guidance.

Indian GCP recommends as follows:

Phase IV

Studies performed after marketing of the pharmaceutical product. Trials in phase IV are carried out on the basis of the product characteristics on which the marketing authorization was granted and are normally in the form of post-marketing surveillance, assessment of therapeutic value, treatment strategies used and safety profile. Phase IV studies should use the same scientific and ethical standards as applied in pre-marketing studies.
 
After a product has been placed on the market, clinical trials designed to explore new indications, new methods of administration or new combinations, etc. are normally considered as trials for new pharmaceutical products.
However, it is expected that the studies follow all scientific and ethical standards applicable to any human study.

Can the chairperson of an EC play a dual role e.g. example chairperson as well as legal expert?
Garima Singh

Yes. A chair person could serve as legal person. In fact some ECs select a retired judge to serve as the chairperson.

For doing a patch test study of a cosmeceutical, do we need approval of local regulatory authorities. In case the cosmeceutical is a US based product, and the sponsor wants to conduct the test on Indian volunteers, what will be the regulatory scenario in that case?
Deepti Goel

It would depend on what is the final indication for cosmeceutical. If the indication overlaps with definition of a drug, you need DCGI permission.
As per Drugs and Cosmetics Act, drug includes all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings.
 
Even if it does not meet definition of drug/new drug, in the current scenario, it is advisable to take DCGI permission for such studies.

Kindly let me know if a person, who is graduate in arts and working in the hospital as an administrator and even assisting nursing staff, can he/she be assigned as site coordinator for clinical research?
Dr. Manoj Yadav

The role of clinical research coordinator covers several tasks which require background of medicine/pharmacy/other life sciences e.g. consent process, screening of subjects, completion of CRF, entries in SD, communication with subjects, coordination with EC and labs, facilitation of monitoring.
 
GCP requires documentation of qualifications and training for all these functions.

An arts graduate cannot do all these functions.