CDSCO panel rejects Mankind Pharma's Proposal to Study Dydrogesterone Tablets Kit

This came after Mankind Pharma presented the Phase III clinical trial waiver justification and bioequivalence (BE) Study protocol before the committee for Dydrogesterone Tablets Kit.

Each Dydrogesterone Tablets Kit contains Part (A) 1 Dydrogesterone Tablets 40mg + Part (B) 14 Dydrogesterone Tablets 10mg.

Dydrogesterone is a synthetic progestogen that works similarly to progesterone (female hormone). It's used to treat menstrual disorders caused by a lack of hormones in women. It's also used to help prevent miscarriages and abortions. The drug is used mainly to relieve pain and menstrual cramps.

Dydrogesterone is an orally active progestogen that acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, dydrogesterone has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum.

At the recent SEC meeting for Reproduction and Urology held on 30th August 2023, the expert panel reviewed the Phase III clinical trial waiver justification and BE study protocol for the Dydrogesterone Tablets Kit (Each kit contains; Part (A) 1 Dydrogesterone Tablets 40mg plus Part (B) 14 Dydrogesterone Tablets 10mg ) presented by Mankind Pharma.

After detailed deliberation, the committee is of the opinion that the Dydrogesterone Tablets Kit (Each kit contains; Part (A) 1 Dydrogesterone Tablets 40mg + Part (B) 14 Dydrogesterone Tablets 10mg) is not approved anywhere in the world.

In addition to the above, the expert panel noted that the proposed dose is very high and may lead to intolerance, adverse drug reaction (ADR), and serious adverse events (SAEs).

Furthermore, the committee highlighted, "Patients with threatened abortion may develop an absent cardiac activity or may get aborted anytime."

"Clinicians may want to change/titrate the dose regimen based on the patient's response/condition. As 10 mg tablets of dydrogesterone are available, the clinician should have the discretion to change or titrate of dose." the panel added.

In line with the above, the committee did not recommend approval of the subject kit at this stage without any safety and supporting data.

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