ISLAMABAD: The drug registration board on Wednesday unanimously decided to register the hepatitis C medicine developed in the United States recently.

However, local manufacturers will have to fulfill certain regulatory requirements before introducing the medicine, says a press release issued by Ministry of National Health Services.

The United States Food and Drug Administration (FDA) introduced the drug molecule Sofosbuvir (brand name Sovaldi) in the US in December 2013 after its approval.

Medical experts say the medicine is reported to have much better cure rate, with minimal side effects, than the current Interferon injections.

Drug said to have much better cure rate than Interferon

The Technical Advisory Group (TAG) for the prevention and control of viral hepatitis last week recommended early registration of this drug for the benefit of huge number of hepatitis C patients in Pakistan.

According to the press release, the decision to register the medicine was taken at a meeting attended by experts from medical and pharmaceutical fields and directors from Drug Regulatory Authority of Pakistan (DRAP).

TAG secretary Dr Huma Qureshi, who participated on special invitation, informed the registration board that the five per cent prevalence of hepatitis C in Pakistan was the second highest in the world after Egypt.

She said TAG had discussed the new therapy and strongly recommended its availability to hepatitis C patients on urgent basis.

Accordingly, the registration board unanimously agreed that Sofosbuvir tablet is registered on priority basis if other regulatory requirements are met.

“Government should complete the process as early as possible to ensure availability of medicine to patients,” Dr Huma said.

Director Quality Assurance A. Q. Javed at DRAP told Dawn that the local manufacturers would have to produce the medicine in white colour in contrast to the yellow colour it is marketed in the United States, but with the same effectiveness.

“The manufacturers have been instructed to complete documentation of the medicine,” he said.

Questioned about the high price of $1,000 for a Sofosbuvir tablet in the US, Mr Javed said it would be available for $20 in Pakistan.

“As many as 27 companies, which have applied for licence to manufacture the medicine locally, have been told to submit a certificate of shelf stability of medicine,” he said.

Published in Dawn, July 24th, 2014