Sovaldi tablet available for Hepatitis C treatment: NA told

ISLAMABAD: State Minister for National Health Services Saira Afzal Tarar Friday informed the National Assembly that original brand of Sovaldi tablet was available for treatment of Hepatitis C, manufactured by Ferozsons, costing Rs 38,000 per 28 tablets.

Replying to a question during Question Hour, the minister said some nine local companies were allowed to manufacture tablets for treatment of Hepatitis at affordable cost. Five out of nine companies started manufacturing the tablets and the remaining companies would also start delivery soon, she added.

She said Sofosbuvir 400mg tablet is indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. The therapy was approved by United States FDA in December, 2013 for M/s. Gilead Sciences inc., USA. The company appointed M/s Ferozsons Laboratories Ltd. as distribution partner for Pakistan, she said.

The minister said keeping in view public health urgency, DRAP and M/o National Health Services and Regulation took the initiative for urgent availability of the drug for the needy patients.

Technical Advisory Group (TAG) on Viral Hepatitis also strongly recommended that this new treatment be made available to Hepatitis C patients on urgent basis in the country, she said.

Saira Tarar said permission was given for import of Sovaldi tablets from Gilead Sciences inc., USA for patient use only, under Drugs (Import and Export) Rules, 1976.

DRAP also granted No objection certificates/permission for import of Sovaldi (Sofosbuvir) 400mg tablets for about 25232 packs (28's tablets) for 8871 patients at price of Rs.56,000/- for pack of 28 tablets, she said.

She said registration of Sofosbuvir 400mg tablet was processed on priority keeping in view public health urgency. M/s Ferozsons Laboratories Limited, one of the applicants viz Sovaldi Tablet 400mg (innovator drug brand from M/s Gilead, USA completed the registration application which was approved by Registration Board.

She said later on through mutual efforts of the ministry, DRAP, M/s Ferozsons MRP was reduced to Rs. 32300/- for 28 tablets through Gilead Patient Access Programme for Pakistan, Egypt and India.

The minister said the government decided to fix price @ Rs. 5,868 for 28 tablets on cost plus formula basis in partial modification of the provisions of the Drugs Pricing Policy-2015 after approval by the Prime Minister of Pakistan. The price was notified vide S.R.O No. 101(1)/2016 dated 9th February, 2016 for generic versions of this new molecule.