Thursday September 23, 2021

Price of Hepatitis-C drug fixed at Rs5,868

February 12, 2016


The government Thursday announced the registration of 11 companies (9 of them local manufacturers) for sale of the generic version of Sofosbuvir, the new miracle therapy for the treatment of Hepatitis-C. The price of the drug has been fixed at Rs5,868 (for 28 tablets) on cost plus formula basis, in partial modification of the provisions of the Drugs Pricing Policy 2015, and upon approval of the Prime Minister.

Minister of state for health Saira Afzal made this announcement at a press briefing. She said, “The Drug Regulatory Authority of Pakistan (DRAP) has been encouraging manufacturers to produce generic drugs in the country to ensure availability of safe, efficacious and quality drugs at affordable prices.”

Saira said, DRAP initially permitted import of innovator drug Sovaldi (400 mg) from M/s. Gilead Sciences inc., USA on patient basis from USA, and at the same time, started the process for registration of Sofosbuvir. The innovator drug was approved in August 2014 at the rate of Rs55,000 (for 28 tablets). Later on, the price was brought down to Rs38,000 (for 28 tablets). “However, to further facilitate patients, local distributor was directly selling the drug to patients at the trade price (Rs32,300), which was 15 per cent less than the re-notified manufacturing retail price,” she said.

The minister of state said, according to the Drug Pricing Policy 2015, the price of the new generic would be 30 per cent less than the innovator brand; thus as per this formula, the generic version of this new molecule would be Rs26,600. “But in view of the international trend governing the prices of material and to give maximum benefit to patients, we decided to approve the minimum possible price of the generic version of this new molecule while conforming to standards of quality and required regulatory compliances. Accordingly, the government decided to fix the price at Rs5,868 for 28 tablets, and issued registration letters to 11 firms (09 local manufacturers and 02 imported products) on February 10.

Saira said, local manufacturers were advised to complete their registration applications in terms of safety, efficacy and quality parameters. Sixteen manufacturers submitted their registration dossiers and provided data regarding manufacturing and quality control of drugs. “Keeping in view the importance of the drug, the sensitivity of the disease, risk to patients, and to address complaints about submission of fake data, we decided to confirm quality and authenticity of data and drug (Active Pharmaceutical Ingredient) submitted by local manufacturers through on-site inspection. This process was done in a transparent manner and was completed in two weeks. The Registration Board considered these panel reports and approved 9 manufacturers for registration of Sofosbuvir; registration applications of the rest of manufacturers whose inspection reports were un-satisfactory were rejected as they could not satisfy the Board about their data and inspection in the hearing that followed.

Saira claimed that the false impression of focused importance being given to a particular company due to political influence has been totally nullified as the government has granted the most economical price in the world for the generic version of this new drug molecule. 

This claim was contested by Muhammad Usman, a representative of Everest Pharma, who accused the Ministry of Health of approving 233 per cent excess price. “Hepatitis C is a disease of the poor. And the poor cannot afford to buy the drug at the price approved by the government, that too in the presence of a more affordable alternative. We had offered Rs90 per tablet for Sofosbuvir (Rs2,520 per pack), Rs140 per tablet for Sofosbuvir+Lidepasvir (Rs3,920 per pack), Rs70 per tablet for Simepravin (Rs1,960 per pack), and Rs32 per tablet for Daclatasvir (Rs896 per pack).”

Usman appealed to the Prime Minister, the President, the Chief Justice, and the Chief Ministers to further reduce the prices of the Hepatitis drug to save the lives of 20 million Hepatitis C patients in Pakistan.

Going back to the press conference, the minister of state assured earliest possible availability of the drug. She said, some pharmaceutical companies have assured availability of the drug within the next two weeks. She also stated that DRAP has granted approval to a local company for manufacturing of raw material (API) for this drug, making Pakistan the 5th raw material producing country. “This will bring the prices further down,” she concluded.