Suggestion on bio-equivalence studies under Rule 122 DAA

Last Updated on June 29, 2021 by The Health Master

Suggestion on report of bio-equivalence studies under Rule 122 DAA

Amendment in the following rules in Drugs and Cosmetics Rules (DCR) are suggested for proper implementation of report of bio-equivalence studies in respect of BCS Category II and IV drugs after introduction of Rule 122 DAA in New Drugs and Clinical Trails Rule 2019 and non applicability of Part XA and Schedule Y.

1. Rule 74(q)- The applicant shall submit the result of the bio-equivalence study referred to in CHAPTER VIII of New Drugs and Clinical Trials Rules 2019, with application for grant of license of oral dosage form of drugs specified under Category II and Category IV of the BCS.

• Rule 76(10)- The applicant shall submit the result of the bio-equivalence study referred to in CHAPTER VIII of New Drugs and Clinical Trials Rules 2019, with application for grant of license of oral dosage form of drugs specified under Category II and Category IV of the BCS.

Also read: Suggestion: G.S.R No. 223 (E) 18-03-2019, Form 39(A)

• Rule 78(r)- The applicant shall submit the result of the bio-equivalence study referred to in CHAPTER VIII of New Drugs and Clinical Trials Rules 2019, with application for grant of license of oral dosage form of drugs specified under Category II and Category IV of the BCS.

• Rule 78-A(9)- The applicant shall submit the result of the bio-equivalence study referred to in CHAPTER VIII of New Drugs and Clinical Trials Rules 2019, with application for grant of license of oral dosage form of drugs specified under Category II and Category IV of the BCS.

Disclaimer: This is the personal opinion of the writer and anyone may have a different opinion.

Also read: Suggestions for amendment of Rule 64 & Sch-N

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