Drug Regulatory Authority of Pakistan in a strongly worded statement issued in the backdrop of vilification campaign by certain elements has said Hepatitis C medicine of 19 pharmaceutical companies were registered and the drugs were available freely in the market. The authority cautioned against misleading the public on matters that relate to health and well being of the people.
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 Ministry have taken on priority for availability of economical version of the new treatment for Hepatitis C. Due to these efforts, now 19 pharmaceutical companies have been already been granted registration and their products are now freely available at the lowest prices in the world complying to quality specifications and requirements, across the board.
Hepatitis C drugs produced in the country are mostly generics while Multinational companies only brought the new drug in the past. In November 2013, DRAP first time decided to allow local manufacturers to apply for new drugs 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 the local manufacturers were able to manufacture new drug generic versions in the country so as to bring economical generic versions of new drugs for the benefit of the poor and non-affording. Since this approach required due care and caution, to ensure avoidance of risk to the local patients, the Registration Board in its 240th meeting held on dated 7th November, 2013 specified numerous requirements to ensure safety and quality of such new drugs. Among these, one of the requirements was the stability studies according to International Council for Harmonization (ICH) which was later found difficult to meet by many of the local manufacturers. The firms were not able to arrange the large quantities of raw material before registration to provide this required data, hence processing of these deficient and incomplete applications of local manufacturers was not possible. Therefore, to remove this difficulty, the DRAP after discussion with the stakeholders in 2015, made a new initiative and proposed revised requirements for the local manufacturers for data submission including the stability studies based on scientifically rational laboratory scale batches instead of larger pilot scale batches.
This approach was approved by the Registration Board in its 251st meeting held on dated 12-13thAugust, 2015 as a procedure to be followed in future for all new drug generic versions. This was practically feasible under the local circumstances. The local firms, thus became able to complete the required data and their registration application. Under this policy, the cases pertaining to the registration of the newly invented treatments / drugs for Hepatitis and Cancer like ailments were considered on urgent basis in the best public interest. In order to ensure the transparency in the registration procedure of new drugs generic version. On the directions of the Minister of State for National Health Services, Regulations and Coordination, to ensure quality of new drugs generic versions and to conduct on-site inspections for verification and authentication of submitted data through confirmation of quality, specification, test analysis, facilities, API source authenticity and especially for the stability data of all the applicant firms, across the board, before grant and issuance and of registration letters so that risk to patients is avoided. These panels of experts are approved by the Registration Board. In case of registration of generic versions of Sofosbuvir tablet, the panel inspected 16 applicants at that time, out of which only 9 could be verified for authenticity of their submitted data while 7 were deferred and called for hearing as their data could not be verified for authenticity. As a result generic versions of Sovaldi (Sofosbuvir) were registered with highly economical prices in public interest, for those companies who met the quality requirements. Some companies claimed to offer low cost medicines but they could not qualify for want of authenticity of their submitted data and failed to confirm product quality that they would manufacture and thus misleading the public and media for their vested interests.
This practice of data verification and authentication through onsite inspection proved that many companies have submitted fake and incomplete data which could not be verified / authenticated at the time of onsite inspection by the panel of experts. Therefore, the claim of so called associations that as soon as they submit the application, the Registration Board should grant approval is not rational, unscientific and against the law and it is not practiced anywhere in the world without proper evaluation and confirmation. Authorities only grant registrations through proper legislation to ensure quality, safety and efficacy of drug products at affordable prices. The above experience proves the requirement of proper evaluation and confirmation as done in case of Sofosbuvir. This has now caused an additional responsibility to DRAP officers to take care of such false data submission possibility.
Further, 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 by the Registration Board through similar onsite inspection, verification and authentication of submitted data. Their price fixation is now under process. Thus after completing all codal formalities, the registration letters will be issued.
It may also be added that 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. The DRAP has gone in appeal and also seeking opinion of law division to enable the Federal Government to fix prices of essential drugs as soon as possible.
Regarding prices of stents in Pakistan, it is pertinent to mention that the prices of medical devices are not regulated in the world even in countries where the drug prices are controlled. However, India has recently fixed prices of cardiac stents only in February, 2017. After the national consultative meetings, the government has already issued directions for a pricing mechanism for printing of MRP on the sale pack of stents and to place price list of stents in the cath lab premises by the firms for clear public information. Government is further working for the pricing mechanism of stents and medical devices as submitted in the Honorable Supreme Court of Pakistan. DRAP has given an advertisement on 5thApril, 2017 for expression of interest for consultancy services to study / research for data for determination of landed cost, components of operating expenses in storage, distribution, marketing & sale, expenses and margin / mark-up in percentage term in supply chain of imported medical devices including cardiac stents, defibrillations, pacemakers, prosthetic heart valves and cardiac balloon catheters and suggesting for reasonable rate of profit/rate of return on investment to importers. This shows consistent progress by the DRAP and Ministry of NHSR&C in this regard.
It is further added that any unregistered drug under patient need basis can be imported by the institutions, directly or through indenters and DRAP always allows patient or hospital to import such medicine on prescription / institutional basis as per S.R.O.28(I)/2013. Under Section 6 of the Drugs Act, 1976, the storage and sale of drugs in the market is regulated by the Provincial Governments, therefore, DRAP has advised the Provincial Health Authorities to take action under the law against the companies who violate provisions of the Drugs Act, 1976 and rules frame there under.
DRAP will continue with its Pro-poor policy and make every endeavour to provide economical quality drugs to the masses. We will not be deterred by tactics of elements out to serve vested interests and frustrate our efforts aimed at saving lives and upholding merit and fairplay, concluded the statement.
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