DCGI [Regulatives / Guidelines]

posted by bharat narnavar – India, 2014-01-23 12:08 (4539 d 21:21 ago) – Posting: # 12239
Views: 6,252

Dear All
I have following questions
  1. Bioequivalence study for Anticancer drugs is suggested on healthy volunteers as per USFDA Recommendation and various regulatory so we are applying for BENOC application for export purpose with study design on healthy volunteers but from your kind office we have received the letter for either do the study on patients or it is recommended for the NDAC so, we need clarification regarding same can we proceed for BENOC application with study design for every anticancer drug on the patients instead of the healthy volunteers.
    Eg:
    1. Bexarotene
    2. Erlotinib Hydrochloride
    3. Abiraterone Acetate
  2. what about the antipsychotic drugs, for antipsychotic drugs also we have to apply with patients only or it will be case to case basis.
  3. On which basis DCGI office decided the category of the drugs whether drug below to category of new drug, approved less than 1 year, approved between1 to 4 year or old drug, because the list given on the website is not enough to chose the category to which drug belong?
    The given list on website for some of the drugs only name is given without any information of the strength and dosage form.
    Eg: In Year 1999 only drug names mentioned without information of dosage form and strength.
  4. The notification or amendment if any is it necessary to take the approval from DCGI office or acknowledgement copy received from your office is sufficient to commence the study.
  5. Typographical error occurs from DCGI office on BENOC, query letter etc is it necessary to notify you the same?
  6. Typographical error occurs from applicant side is it necessary to notify DCGI?
Thanks in advance
Regards
Bharat Narnavar

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