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Plant-based extracts are not considered as new drugs


Wednesday, February 3, 2021, 08:00 Hrs  [IST]

We are working on a new composite formulation which is a combination of an already approved drug chlorhexidine and the other one is a plant-based extract, which is otherwise a commonly used OTC product. We plan to use this formulation as mouth wash for gum diseases. Do we require DCGI approval for this clinical study?
Prof  Ashish Jain
You need to consider the following aspects to take appropriate decisions. 

Is the formulation a new drug as per definition of New Drugs in Rules 2019? New drug means - a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licensing Authority with respect to its claims; or a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licensing Authority with respect to its claims; or the drugs shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licensing Authority.

Based on these definitions, chlorhexidine and plant-based extract, are not likely to be considered new drugs. Hence, this formulation does not need approval of clinical trials from DCGI office. However, you will need Ethics Committee approval for this clinical trial.

We are conducting a trial on rare disease. We have a patient who can read/write in Bangla. His son can understand both Bangla, English. But we don’t have an ICF in Bangla. Can we recruit this patient in trial by requesting his son to act as legally acceptable representative?
Dr Srikrishna Mehta 
Recruitment of the patient requires (1) obtaining informed consent and (2) screening process. For informed consent process, Indian GCP mandates:
Prior to the beginning of the study the investigator(s) should obtain the Ethics Committee’s approval for the written informed consent form and all information being provided to the subjects and/or their legal representatives or guardians as well as an impartial witness.

The information should be given to the subjects and/or their legal representatives or guardians in a language and at a level of complexity that is understandable to the subject(s) in both written and oral form, whenever possible.

Before requesting an individual's consent to participate in research, the investigator must provide the individual with the information in the language he or she is able to understand which should not only be scientifically accurate but should also be sensitive to their social and cultural context.
As the patient can read/write Bangla, he is capable of giving consent. Legal representatives cannot give consent for a patient who is literate. For compliance to these GCP requirements, you should get a Bangla translation of ICF approved by the Ethics Committee before the screening process. In addition, the person designated to explain consent document, should be able to converse with the patient in Bangla.

Do regulatory authorities accept to modifications electronic medical source records?
Priyanka Kulkarni
The US FDA recommends that audit trails would be essential if the electronic medical records/data elements can easily be modified or altered at any time to misrepresent information, without evidence that a change was made, and in a manner that destroys the original information. US FDA advises that for an electronic audit trail, each data element should have an authorized data originator - a person, system, device, or instrument. There also should be data element identifiers, such as the date and time, and that along with the data originator should be attached to each data element. Modified and/or corrected data elements must have data element identifiers that reflect the date, time, originator, and reason for the change, and must not obscure previous entries. A field should be provided allowing originators to describe the reason for the change (e.g., transcription error).

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

 

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