Conduct Bioequivalence Study: CDSCO panel tells Abbott India on Dydrogesterone MR Tablets
New Delhi: Responding to the proposal for manufacturing and marketing synthetic progesterone, Dydrogesterone Modified-release (MR) Tablets presented by Abbott India, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm to conduct the bioequivalence (BE) study as per the protocol and submit the report along with the clinical trial protocol.
This came after the drug major Abbott India presented the proposal for manufacturing and marketing of Dydrogesterone MR tablet 30 mg along with BE study protocol and clinical trial protocol before the committee.
Dydrogesterone is a synthetic progesterone for menstrual cycle regulation, infertility treatment, prevention of miscarriage, and other conditions.
It is used to treat irregular duration of cycles and irregular occurrence and duration of periods caused by progesterone deficiency and also used to prevent natural abortion in patients who have a history of habitual abortions.
Dydrogesterone is a progestogen that works by regulating the healthy growth and normal shedding of the womb lining by acting on progesterone receptors in the uterus.
At the recent SEC meeting for Reproductive and Urology held on 20th July 2023, the expert panel reviewed the proposal presented by drug major Abbott India to manufacture and market the Dydrogesterone MR tablet 30 mg along with BE study protocol and clinical trial protocol.
After detailed deliberation, the committee recommended the conduct of BE study as per the protocol presented.
In addition, the expert panel suggested that the firm should submit BE study report along with the clinical trial protocol for further consideration of the proposal.
