LAHORE: The government continues to turn a deaf ear to the plight of the hepatitis C patients by delaying registration of miracle drug Sovaldi.

At least 10 million people in Pakistan infected with HCV are awaiting this life-saving medicine.

Since interferon therapy is very painful and risky mode of treatment for the patients of HCV, the drug in tablet form had recently been introduced as an effective, safe and easy to use product. Physicians at both public and private hospitals are prescribing Sovaldi (sofosbuvir) daily to many patients with other antiviral medicines to treat chronic hepatitis C genotype 1, 2, 3, and 4 infection in adults.

The number of pending applications the DRAP had received from all over the country for the drug had touched 6,000, a senior official told Dawn. He said a file pertaining to the drug was circulating in the office of the Ministry of National Health Services Regulations and Coordination (NHSR&C) for final approval.

After fixing its price at the Drug Price Committee of the Drug Regulatory Authority Pakistan (DRAP) held on Nov 21 last, the Authority had sent it to the ministry. Ferozsons Laboratories was the sole company which was granted rights to sell and market this much-awaited drug in Pakistan at Rs1,940 each tablet. The company was supposed to make available a pack of 28 tablets for Rs55,000 after final approval by the federal government.

The official said the file was moving from one department to another for the last three months or so though the process required a maximum of two weeks for approval as the DRAP had already completed workup before processing it.

This drug was already facing a delay of more than a year and a half after the developed states had made it an integral part of their respective drugs control lists.

He said the ministry had already been briefed on the significance, perspective and historic background of the liver diseases in Pakistan and number of patients who were depending upon it when the case was processed for the approval of the drug. The purpose was to sensitise the ministry for speedy process of this drug for approval.

He quoted a report which shared alarming statistics about the liver diseases’ impact in Pakistan. “Pakistan is the 6th most populous country in the world with significantly higher HCV infection prevalence of about 2.2-14 per cent.”

The official said approximately 10 million people in Pakistan were infected with HCV and this number was growing continuously. “Within Pakistan, the HCV prevalence rate reported in Punjab is 6.7 per cent, the highest one followed by Sindh 5 per cent, Balochistan 1.5 per cent and in Khyber Pakhtunkhwa is the lowest one which is 1.1 per cent,” according to the data.

He said unfortunately the country also lacked facilities for surgical treatment of those recommended for liver transplant. “In people with cirrhosis, in case of deterioration and liver failure, liver transplant is the last option although this is a very major operation and is done only in people who are very unwell,” he said. However, the percentage of success in the surgeries was reported between 60-80 per cent only which further increased importance of its timely treatment through the available drugs.

According to the official, many parliamentarians and other top officials have also been pressuring the ministry to promptly approve the drug as many of them are HCV patients.

NHSR&C Secretary Ayub Sheikh was not available for comments.

DRAP Pricing Director Amanullah told Dawn that the Minister for NHSR&C last week had asked the secretary to expedite the process for the approval of Sovaldi. He said the ministry was already aware of the issue, saying the drug was likely to be approved next week.

Asked about the delay in approval of the drug, Amanullah said it was perhaps due to the new drug pricing policy in which the DRAP had proposed cut on the medicines.

Published in Dawn February 11th , 2015

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