During a site visit, a monitor finds that the CRFs are not completed by the investigator, even after informing him prior to the visit. What action should he take?
● Vite

The monitor should also explain to the investigator about his GCP responsibilities as per the legal agreement and Schedule Y. This information - CRFs not completed - should be described in the monitoring report and follow-up letter and informed to project leader. The monitor should check whether the investigator has adequate staff to complete CRFs. If not, he should recommend to the project leader need for a clinical research coordinator who can assist the investigator in completion of CRFs.


Q. A monitor finds that the investigator does not follow protocol even after an explanation. What action can monitor take?
● Vite

This information - that the investigator does not follow the protocol - should be described in the monitoring report and follow-up letter and informed to project leader. The monitor should explain to the investigator his GCP compliance responsibilities and remind him about the investigator undertaking. Even after these actions, if the investigator does not follow the protocol, the monitor has to inform the project leader about the following Indian GCP actions:

3.1.14 sponsor should initiate prompt action in case it is discovered that any party involved has not entirely complied with the GCP, SOPs, protocol and / or any applicable regulatory requirements. If monitoring / auditing identifies serious and / or persistent non-compliance - the sponsor should terminate the defaulting party's participation in the study and promptly notify to the regulatory authority.

3.2.2 (d) the monitor should promptly inform the sponsor and the ethics committee in case any unwarranted deviation from the protocol or any transgression of the principles embodied in GCP is noted

Q. What are the steps/procedures that are required for conducting a cosmetic trial in India? What makes a study drug "cosmetic" in India?
● S. Lakshmanan

Definitions in the Drugs and Cosmetic Act are as follows:

Cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic

Drug includes:
(i) 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 or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;
(ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;
(iii) all substances intended for use as components of a drug including empty gelatin capsules; and
(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals.

You need to decide in which category your product falls. If you are certain that you will not make any claims which can classify under the category of a drug, you can conduct the trials without following any regulatory requirements for drug e.g. DCGI permission. However, as the trials are human experiments, you have to follow all GCP ethical requirements of human protection.

Q. We have amended the protocol. Do we need re-approval from DCGI office?
● D. Senthil Rajan

A Schedule Y recommends:
Protocol amendments, if become necessary before initiation or during the course of a clinical trial, all such amendments should be notified to the Licensing Authority in writing along with the approval by the ethics committee which has granted the approval for the study.

The notification means that you have to send a letter describing the need of amendments, the amended protocol and ethics committee approval of the protocol to DCGI office. You need to obtain an acknowledgement on the covering letter.