Q. Is it mandatory to conduct BA/BE studies only in healthy human volunteers? Why don't we carry the same research in patients?
● Arulsingh Jayaraman
A BA/BE is a comparison of 2 generics. When we use volunteers, they have healthy body systems. Hence, the differences between the 2 formulations are due to pharmaceutical differences and not differences in the functions of different body systems e.g. liver and kidney. If we use patients, their organs are not healthy and this may affect the pharmacokinetic processes. Hence, the BA/BE will be influenced by the disturbances in the patient's body functions.

However, during the drug development, when you need information about effect of disturbed body functions e.g. effect of abnormal liver function on BA, the studies are done in patients.


Q.Can an IEC of a medical college supervise a clinical research proposed by a local practitioner?
● Darshan Bhatt
This can be done provided 1) IEC's SOPs permit this 2) IEC is willing to all its GCP, ethical and legal responsibilities for the external site e.g. safety monitoring, progress reports, patient related ethical issues etc and 3) the external site accepts in writing that they accept the authority of IEC for ethical oversight of the trial at the external site.

Relevant extract from Schedule Y is given below:
The trial site(s) may accept the approval granted to the protocol by the ethics committee of another trial site or the approval granted by an independent ethics committee (constituted as per Appendix VIII), provided that the approving ethics committee(s) is/are willing to accept their responsibilities for the study at such trial site(s) and the trial site(s) is/are willing to accept such an arrangement and that the protocol version is same at all trial sites.

Q.Can we conduct the BA/BE studies and phase 1 clinical trial in the same facility?
● Darshan Bhatt
I am not aware of any guidelines on location of phase I and BA/BE. However, as the objectives of the phase I and BA/BE are different, most companies keep the clinical beds separate. The focus of phase I is safety. Hence, the clinic requires special cardiac monitors for each volunteers and competent and adequate medical staff to look after volunteer safety. In case of BA/BE, the objective focuses on timed blood collections for PK study. Hence, the there are no special equipments required. Most CROs keep separate clinics for Phase I and BA/BE study. These types of arrangements are critical to assure the auditors and regulatory inspectors about human volunteer safety and protection.

Q. What type of drugs need DCGI approval for clinical trials?
● D. Senthil Rajan
All drugs require permission from DCGI office.

The definition of new drug as per Schedule Y is
122E. Definition of new drug - for the purpose of this Part, new drug shall mean and include:
2[(a) A drug, as defined in the Act including bulk drug substance which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims;

(b) A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration;

(c) A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration.

For the purpose of this rule
(i) all vaccines shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21;

(ii) a new drug shall continue to be considered as new drug for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia, whichever is earlier.