Registration of Generic version of new molecule, a breakthrough treatment drug for Hepatitis-C

February 11, 2016

Islamabad, the February 11, 2016:- Minister of State, Saira Afzal Tarar said that Drug Regulatory Authority of Pakistan has 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 done another break through 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. While she was addressing the press conference today in Islamabad

Siara Afzal Tarar said that it is pertinent to mention that prevalence of Hepatitis C in Pakistan is 2nd highest in the world. Keeping in view public health urgency, 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 process for registration of Sofosbuvir. Innovator drug was approved in August, 2014 @ MRP Rs.55000/- for 28 tablets. Later on, through mutual efforts of M/o NHRS&C, and DRAP M.R.P. was reduced and notified to Rs.38,000/- for 28 tablets. However, to further facilitate patients local distributor is directly selling to patient at the trade price (Rs.32,300), which is 15% less than the re-notified MRP. It is pertinent to mention that same therapy is being sold USA @ USD 1000 per tablet.

She further said that Local manufacturers were also advised to complete their registration applications in terms of safety, efficacy and quality parameters. 16 manufacturers who submitted their registration dossiers and provided data regarding manufacturing and quality control of drug. Keeping in view importance of drug, sensitivity of disease, risk to patient and to address the complaints about submission of fake data, it was decided to confirm quality and authenticity of data and drug (API; Active Pharmaceutical ingredient) submitted by local manufacturers through on site inspection. This process was done on very urgent and transparent manner and was completed in about 2 weeks time. Registration Board considered these panel reports and approved 09 manufacturers for registration of Sofosbuvir while registration applications for rest of manufacturers whose inspection reports were un-satisfactory / un-verifiable and after being given an opportunity of hearing in next Registration Board meeting were rejected as they could not satisfy the Board about their data and inspection.  

The Minister said 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 Rs.26,600. But keeping in view international trend about price of material and to give maximum benefit to patient, it was decided to approve 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 @ 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.  After fixation of MRP, DRAP issued registration letters to 11 firms (09 local manufacturers and 02 imported products) on 10.02.2016.

Minister said that the false impression given earlier at various forums that any focused importance was given to a particular company due to political influence has been totally nullified today by granting the most economical price in the world today for the generic version of this new drug molecule. She further responded in regard to earliest availability of these drugs that some pharmaceutical companies have assured that within 2 weeks drug will be available for patient use.

The Minister said that it may be added 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 in the patient interest. It may be inferred from the above that utmost care has been exercised to ensure that the entire process is transparent, fair and meets the interests of patients with regard to quality, availability and affordability of the medicine.