Registered Hepatitis C drugs available at lowest prices in the world: DRAP

Islamabad: The Drug Regulatory Authority of Pakistan (DRAP), in a statement issued in the backdrop of a recent press conference organised by the Pakistan Young Pharmacists Association and Pakistan Drug Lawyers Forum, has asserted that Hepatitis C medicines of 19 pharmaceutical companies were registered and the said drugs are freely available in the market.

Sofosbuvir (400mg tablet), indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen, was approved by United States FDA in December, 2013 for M/s. Gilead Sciences inc., USA. “DRAP and the Ministry of Health have taken on priority for availability of an economical version of the new treatment for Hepatitis C. Due to these efforts, 19 pharmaceutical companies have already been granted registrations and their products are available at lowest prices in the world,” the statement says.

The statement adds that the Hepatitis C drugs produced in Pakistan are mostly generics, while multinational companies only brought the new drug in the past. For the first time in November 2013, DRAP decided to allow local manufacturers to apply for new drug generic version by giving these applications “out of queue status” and considering these cases as public health urgency without compromising safety, efficacy and quality.

As a result, local manufacturers were able to manufacture new drug generic versions so as to bring economical generic versions of new drugs for the benefit of the non-affording. Since this approach required due caution, the Registration Board, in its 240th meeting held November 7, 2013, specified numerous requirements to ensure safety and quality of such new drugs. One of these requirements pertained to stability studies which many of the local manufacturers later found difficult to meet. The firms were not able to arrange large quantities of raw material before registration to provide the required data, hence processing of these deficient applications of local manufacturers was not possible.

To remove this difficulty, DRAP proposed revised requirements for data submission including stability studies based on scientifically rational laboratory scale batches instead of larger pilot scale batches.

The Registration Board approved this approach on August 13, 2015 as a procedure to be followed in future for all new drug generic versions. Local firms thus were able to complete the required data and their registration application.

“Under this policy, cases pertaining to registration of newly invented treatments/drugs for ailments like hepatitis and cancer were considered on urgent basis. The Minister of State for Health directed DRAP to ensure quality of new drug generic versions and to conduct on-site inspections for verification and authentication of submitted data before grant and issuance of registration letters. In case of registration of generic versions of Sofosbuvir tablet, the panel inspected 16 applicants, of which only 9 could be verified for authenticity of submitted data while 7 were deferred and called for hearing. As a result, generic versions of Sovaldi (Sofosbuvir) were registered on economical prices for companies who met the quality requirements. Some companies claimed to offer low-cost medicines but could not qualify for want of authenticity of submitted data and failed to confirm product quality,” the statement points out.

DRAp has stated that the practice of data verification and authentication through onsite inspection proved that many companies had submitted fake and incomplete data which could not be authenticated. Therefore, the demand that the Registration Board should grant approval soon after submission of the application is unscientific and against the law.

The statement also adds that three breakthrough new chemical entities namely, Daclatasvir, Ledipasvir and Velpatasvir, new drug generic versions for the treatment of Hepatitis C, have already been approved for registration through similar onsite inspection, verification and authentication of submitted data. Their price fixation is now under process, and after completion of codal formalities, registration letters will be issued. “Due to court orders of not to set prices of essential drugs unless flexibilities under Section 58 of the Patents Ordinance 2001 have been fully exhausted in a transparent manner, DRAP has gone in appeal and is seeking opinion of the law division to enable the federal government to fix prices of essential drugs as soon as possible,” it adds.

Regarding prices of stents in Pakistan, DRAP has stated that the prices of medical devices are not regulated anywhere in the world, not even in countries where drug prices are controlled. However, the government has already issued directions for a pricing mechanism for printing of MRP on the sale pack of stents and placement of price list of stents in the cath lab premises by firms for public information. The government is also working on pricing mechanism of stents and medical devices as submitted in the Supreme Court.

DRAP has clarified that any unregistered drug can be imported by institutions, directly or through indenters and DRAP, under patient need basis as per SRO 28(I)/2013. “DRAP will continue to provide economical quality drugs to the masses as part of its pro-poor policy. We will not be deterred by tactics of vested elements out to frustrate our efforts to save lives and uphold fairplay,” the statement concludes.