ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has authorised 11 pharmaceutical companies for sale of generic version of new drug Sofosbuvir which will be available for Rs5,868 for Hepatitis C patients in the country.Minister of National Health Services, Regulation and Coordination (NHSRC) Saira Afzal Tarar said this while addressing a press conference here on Thursday.She said that 16 manufacturers had submitted their registration dossiers and provided data regarding manufacturing and quality control. She added that the drug and registration board (DRB) considered panel reports and approved 9 manufacturers for registration of Sofosbuvir while registration applications for the rest of the manufacturers were rejected as they could not satisfy the board about their data and inspection.
The minister said those rejected were given another opportunity of hearing in next registration board meeting. She added that keeping in view the importance of drug, sensitivity of disease, risk to patient and to address the complaints about submission of fake data, it was decided to confirm the quality and authenticity of data and drug Active Pharmaceutical Ingredient (API) submitted by local manufacturers through on-site inspection.She said that Drug Regulatory Authority of Pakistan (DRAP) had been encouraging manufacturers to produce generic drugs in the country to ensure availability of safe, efficacious and quality drugs at an affordable price to the patients.
“In this regard, DRAP has made another breakthrough by approving 11 new companies for sale of generic version of a new miracle drug namely Sofosbuvir, which is the latest therapy available in the world for Hepatitis C,” she said.The minister said that according to Drug Pricing Policy 2015, price for the new generic would be 30% less than the innovator brand; thus as per this formula the generic version of this new molecule would be Rs26,600. But keeping in view the international trend about the price of material and to give maximum benefit to the patient, it was decided to approve the price of generic version of this new molecule at the minimum within standards of quality & required regulatory compliances.
Accordingly, the federal government decided to fix price Rs5,868 for 28 tablets on a cost-plus formula basis in partial modification of the provisions of the Drugs Pricing Policy-2015 after approval by the prime minister. After fixation of MRP, DRAP issued registration letters to 11 firms (nine local manufacturers and two imported products) on February 10.She said that DRAP has granted approval to a local company for manufacturing of raw material (API) for this drug and Pakistan has become 5th raw material producing country as this will bring the prices further down, benefiting the patient.