India’s largest domestic firm Cipla Ltd is planning to launch low-priced misoprostol pills to control severe blood loss during pregnancy in India, reports said.
Cipla has developed misoprostol pills in 600-microgram strengths for postpartum hemorrhage (PPR).
Postpartum hemorrhage results from an increased loss of blood – greater than 500 ml of blood following vaginal delivery, or 1,000 ml of blood following cesarean. Postpartum hemorrhage is the leading cause of death among pregnant women in India.
Death rate of mothers following child birth is still too high in India.The Maternal Mortality Rate (MMR) in India is pegged at about about 350 out of one lakh pregnancies.
The low-priced 600-microgram misoprostol (MisoProst) tablets could help significantly reduce such deaths, especially in hospitals in rural areas where the people oftent find affordability of such drugs a problem.
Cipla’s 600 mg misoprostol tablets branded as MisoProst will be priced Rs 52 per pill, reports said quoting senior officials from the company.
Currently, anti-post-partum hemorrhage drugs are available as gels and injections in the market. They need to be stored in refrigerators and hence their availability is limited in rural areas.
Misoprostol is an E1 prostaglandin analogue which has been approved in more than 85 countries since its first marketing in 1985.
So far misoprostol is approved only for the treatment of gastric ulcer (although France, Brazil, Taiwan and Egypt have licensed dedicated products for gynaecological or obstetrical use).
Misoprostol, which is the sold in the brand name Cytotec by Pfizer, is used off label in most countries.
A study by Richard Derman and colleagues conducted in rural India (Lancet 2006; 368:1248-1253) has revealed the efficacy of misoprostol tablets for prevention of postpartum hemorrhage.
Over 1600 low risk women were randomised to receive oral misoprostol (600 microgrammes) or placebo at the time of delivery. Blood was collected for the first hour post-partum. In the misoprostol group, the risk of PPH (>500mls) was halved, and the risk of severe PPH was reduced by 80%.
Misoprostol is effective for women with postpartum hemorrhage, but has little effect on normal bleeding (in contrast to oxytocin). Oral misoprostol is absorbed more slowly than intramuscular oxytocin, and by the time it reaches its peak at 20 minutes the third stage is over for most women. Thus, the more prolonged the bleeding (i.e. the PPH), the more effective misoprostol is, the study authors noted.
The World Health Organization announced the inclusion of misoprostol to its Model List of Essential Medicines based on its proven safety and efficacy for the treatment of incomplete abortion and miscarriage. The judgment was made by an expert committee that evaluated available evidence, which includes several guidelines and numerous randomized and comparative clinical trials for this indication.
Misoprostol is currently distributed throughout hospitals and clinics in Uganda, Nigeria and Ethiopia for the prevention and treatment of post-partum hemorrhage.
The approved dosages misoprostol are 600 microgrammes orally for prevention and 1000 microgrammes rectally for treatment.
Cipla, which has pioneered the low-cost HIV/AIDS treatment globally by offering generic drug cocktails, has also developed a new blood pressure drug branded as Cresar AM, a combination of hypertension drugs telmisartan and amoldipine and a nasal spray for allergic rhinitis, named Furamist Aze, the drug combines anti-inflammatory drug fluticasone furoate with Azelastine.
Recently, Cipla has launched a generic version of kidney cancer drug sorafenib (Nexavar) at one tenth of Bayer’s selling price in India pending court case.
Cipla, which has branded its generic sorafenib as Soranib, will price the drug at less than Rs 28,000 a months treatment, report said quoting Cipla’s chief executive officer Amar Lulla.
Bayer is currently selling Nexavar for a price of Rs 2,80,000 for a month’s treatment.
At present, Cipla’s Soranib will be the only generic competitor for Bayer’s Nexavar.
In March, Indian Supreme Court rejected a plea from German drug giant Bayer AG seeking to block the marketing approval of a generic version of its patented kidney cancer drug Nexavar (sorafenib) by Cipla, reports said.
Bayer AG moved India’s Supreme Court following the Delhi High Court’s latest verdict upholding an earlier judgment in the case.
Cipla has also launched its generic versions of anti-cancer drug erlotinib, patented by Roche and branded Tarceva, even after the Swiss company was granted product patent in India.