В Индии зарегистрирован препарат для лечения гепатита С "Софосбувир"
The country's drug regulatory agency has approved for marketing a medicine called sofosbuvir to treat hepatitis C virus infections.
The medicine is produced by a US company whose patent claim on the drug has been denied by India's regulators.
The biopharmaceutical company Gilead Sciences said its drug - which the company has pledged to sell in India and other developing countries for $900 (Rs 56,000) for a 12-week course of treatment - had received regulatory approval in India earlier this week.
The company also said it would appeal against the decision by India's patents regulators earlier this week to deny a patent on sofosbuvir, citing Section 3(d) of India's patent law that does not allow granting patents on minor variations of known drug molecules.
"Gilead strongly defends its intellectual property. The company will be appealing the decision as well as exploring additional procedural options," the company's executive vice-president Greg Alton said in a statement on Friday.
The patent proceedings, he said, do not impact the company's commitment to enabling access to the hepatitis C medicine in India and other developing countries. "We welcome the regulatory approval in an unprecedented four months," Alton said.
India is the first country in Asia to approve sofosbuvir, a product that has been marketed in North America, European Union and Australia, among other countries where it is used as first-line therapy for patients with hepatitis C infections.
Patients' rights activists have welcomed the approval. "Patients with advanced liver disease caused by hepatitis C infections are desperate for this - they have no other option," said Leena Menghaney, of Medicins Sans Frontieres, the international humanitarian agency which hopes to procure low-cost generic versions of the drug.
The company says about 80,000 patients have so far received sofosbuvir, an oral medication that has been described as more effective than the current standard therapy for hepatitis C which involves a combination of an injected drug called pegylated interferon and an anti-viral called ribavarin.
Two government panels had recommended that sofosbuvir be approved in India without clinical trials saying "its efficacy... is higher than the current drugs used in India," and that it is the "only drug" that can be used in patients with advanced liver fibrosis, cirrhosis and those who cannot tolerate interferon.
Public health experts estimate that about 12 million people in India have chronic infections with the hepatitis C virus.
The denial of a patent on the drug would also allow other generic companies to produce the drug. Menghaney said she expects some generic versions of the drug to be available in India by the end of 2015.