NPPA panel fixes the retail price of uncoated sustained-release tablets containing Medroxyprogesterone Acetate, details

In addition to this, the NPPA has fixed the retail price of uncoated sustained release tablet containing Medroxyprogesterone Acetate IP 30 mg manufactured by Synokem Pharmaceuticals and marketed by Torrent Pharmaceuticals.

The retail price of each uncoated sustained-release tablet containing Medroxyprogesterone Acetate IP 30 mg has been set at Rs 14.04 per tablet excluding GST.

Medroxyprogesterone is a progestin (a form of progesterone), a female hormone, that helps regulate ovulation and menstrual periods. Ovulation is the process of the release of an egg from an ovary.

Medroxyprogesterone is used to treat conditions such as irregular or absent menstrual periods, or abnormal uterine bleeding. It is also used to decrease the risk of endometrial hyperplasia (a condition that may lead to uterine cancer) while taking estrogens.

Medroxyprogesterone is also used as part of combination hormone replacement therapy with estrogens to reduce menopause symptoms (such as hot flashes). Medroxyprogesterone is added to estrogen replacement therapy to reduce the risk of cancer of the uterus.

This drug is not recommended during pregnancy as it causes birth defects. The drug is also not recommended during breastfeeding as it passes through breast milk.

Medroxyprogesterone acetate inhibits gonadotropin production, reduces nuclear estrogen receptors and DNA synthesis in epithelial cells of the endometrium, and induces p53 dependant apoptosis in cancer cell lines. These oral tablets have a half-life of 40-60 hours.

Medroxyprogesterone acetate inhibits the production of gonadotropin, thus preventing follicular maturation and ovulation, which is responsible for its ability to prevent pregnancy. This action also thins the endometrium.

This recommendation came during the 40th meeting of the Multidisciplinary Committee of Experts, held on March 14, 2022, under the convenorship of Shri Manmohan Sachdeva, Advisor(cost), through video-conferencing.

After detailed deliberation, the Committee recommended the retail price of each uncoated sustained release tablet containing Medroxyprogesterone Acetate IP 30 mg, for Synokem Pharmaceuticals Limited (manufacturer) and Serum Institute of India Limited ( marketer) at Rs 14.04 per tablet excluding GST as detailed below.

Note 1

Derived retail price as per recommended of pronabsen committee:

P(s)=P*[1+a{(s-s^*)/s*}]

Where :P(s)=Price ceiling of strengths

P*=pricing ceiling for reference strengths

S=strength in terms of API content

s^*=reference strength

a=0.8for tablets/capsule and 0.7 for injections

Similarly, the Committee deliberated upon the matter in detail and recommended the retail price of each uncoated sustained release tablet contains Medroxyprogesterone Acetate IP 30 mg for Synokem Pharmaceuticals (manufacturer) and Torrent Pharmaceuticals (marketer) at Rs. 14.04 per tablet excluding GST as detailed below:

Note 1. Derived retail price as per recommendation of pronabsen commit tee : P(s) = P*.[1+a.{(s-s*)/ s*}]

Where : P(s) =Price ceiling of the strengths

P* = price ceiling for reference strength s* s = strength in terms of API content

s* = reference strength

a= 0.8 for tablet / capsule and 0. 7 for injectibles