QQ. Where can I find the labelling guidelines for investigational product in India and US FDA?
● Suresh Vaghela Amdavad
The following are the relevant guidelines:
FDA 21 CFR 312.6 Labelling of an investigational new drug.
(a) The immediate package of an investigational new drug intended for human use shall bear a label with the statement ``Caution: New Drug - Limited by Federal (or United States) law to investigational use.''
(b) The label or labelling of an investigational new drug shall not bear any statement that is false or misleading in any particular and shall not represent that the investigational new drug is safe or effective for the purposes for which it is being investigated.
Indian GCP 2.3.1.6.
Handling of the product(s)
a. Measures to be implemented to ensure the safe handling and storage of the pharmaceutical products.
b. System to be followed for labelling of the product(s) (code numbering etc.)
c. The label should necessarily contain the following information: the words - "For Clinical Studies only", the name or a code number of the study, name and contact numbers of the investigator, name of the institution, subject's identification code.
Q. According to GCP, we need an impartial witness for an illiterate subject, can a person who is an impartial witness to one subject, be impartial witness for 10 or group of subjects?
● Dr Sridhar, Bangalore
ICH GCP definition of impartial witness is:
A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
If you can demonstrate that the witness is really impartial, without any involvement in the study, as volunteers/ site person, this would be acceptable. However, if the same person becomes a witness to many subjects, his motive for doing this may be suspect and this may become a critical audit/inspection finding.
Q. For all the solid dosage forms bioequivalence studies are essential? Any special cases are there where no need of bioequivalence studies for the drugs?
● Viresh Kumar,Hyderabad
The BE studies are required during drug development till you finalize the formulation for marketing and later if you make any changes in formulation/ manufacturing or if you are going for ANDA.
For drugs which can not be measured in blood because of little systemic absorption e.g. inhalers, topical or bio-generic, you need to conduct therapeutic equivalence instead of BE.
Q. Could you please clarify whether all clinical research organization can be called as contract research organization?
● Lakhamanan, Bangalore
ICH GCP Contract Research Organization
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.
Indian GCP Clinical Research Organization
An organization to which the sponsor may transfer or delegate some or all of the tasks, duties and/or obligations regarding a Clinical Study. All such contractual transfers of obligations should be defined in writing. A CRO is a scientific body - commercial, academic or other.
If you consider these definitions, a Clinical Research Organization can become a Contract Research Organization if it works contractually for a sponsor.
Q. What is Phase II a, Phase II b study?
● Lakhamanan, Bangalore
Phase II a is clinical pharmacology in patients with target disease (small nos up to 200) to assess pharmacokinetics/ pharmacodynamics and dose/ concentration effect responses for preliminary efficacy and safety, and to validate surrogate endpoints
Phase II b is a larger scale study in several hundred patients to formally assess the dose response relationship, and continue to expand the efficacy and safety databases
Q.What are the regulatory requirements for devices in India?
● S Ganapathi, Chennai
The Ministry of Health and F.W. under Gazette notification S.O. 1468 (E) dated 6/10/2005 declared the following sterile devices to be considered as drugs under Section 3 (b) (iv) of the Act.
1. Cardiac Stents.
2. Drug Eluting Stents.
3. Catheters.
4. Intra Ocular Lenses.
5. I.V. Cannulae.
6. Bone Cements.
7. Heart Valves.
8. Scalp Vein Set.
9. Orthopedic Implants.
10. Internal Prosthetic replacements.
The relevant authority is CDSCO.