ISLAMABAD: The government has deferred a request of seven pharmaceutical companies to manufacture the drugs used to treat fatal diseases like Hepatitis C on unsatisfactory data verification.

A report submitted by the Drugs Regulatory Authority of Pakistan before the Supreme Court through Deputy Attorney General Sajid Ilyas Bhatti stated that the registration board of the regulatory authority had also allowed registration and manufacture of Sofosbuvir 400mg tablets to nine pharmaceutical companies after verifying that the medicine they produced were up to the satisfactory level.

The information was presented before a Supreme Court bench consisting of Justice Ejaz Afzal Khan and Justice Faisal Arab that had on a suo motu taken up the disturbing nature of deaths of children, especially in the rural areas, because of pneumonia and diarrhoea as well as the alarming growth of Hepatitis C patients.

The notice was taken on an application of Sheraz Mehmood Qureshi, a resident of Mansehra, inviting the attention of the apex court towards the worrying state of affairs in the health sector. The applicant had also enclosed two newspaper columns published in November last year – by Orya Maqbool Jan and Javed Chaudhry.

During the proceedings, the court observed that it had been informed that a son-in-law of a federal minister was creating impediments in the registration of medicines that were less expensive for treatment of Hepatitis C.

Justice Khan regretted that vaccines and syringes for treatment of pneumonia were openly sold in the wholesale market and as a result the citizens, especially the children suffered.

“If a child dies of pneumonia, it will be the State that will be responsible,” the judge observed and cited the example of the Second Khalifa of Islam who had said that even if a dog dies at the bank of River Nile, Umar (RA) will be held responsible for that.

The court ordered Advocate Khawaja Mohammad Farooq, who represents Everest Pharmaceuticals which had applied for registration of the same medicine at less price of Rs116 per tablet, to submit a concise statement highlighting the alleged impediment in the manufacture of the medicine.

The same directions were issued to Mian Aftab Ahmed and Mehfoozur Rehman, who wanted to bring certain information to the knowledge of the court regarding registration of drugs coupled with suggestions to facilitate manufacture of medicines which were less expensive but equally effective in the treatment of Hepatitis C.

The court directed the deputy attorney general to go through all these reports when filed to assist it in arriving at a just conclusion so that official impediment created in registration of medicines for treatment of Hepatitis C, be taken care of.

The deputy attorney general pleaded before the court that the regulatory authority had been exercising utmost care to ensure that the entire process of registration of drugs was transparent, fair and meets the interest of patients with regard to availability and affordability of the medicine. According to the price mechanism, the cost of 28 tablets for Hepatitis C would be Rs9,999, he added.

He said the registration board deferred applications of the seven companies for registration because safety, efficacy, purity and quality of drugs were not verifiable but all these companies which could not qualify or provide the data authenticity requirements have been given an opportunity of hearing and had been asked to appear in the next meeting of the registration board to explain and defend their position.

He said products of manufacturers that were approved initially and their data also verified and the registration board finally approved their registration and the process for fixation of their prices was under way.

The deputy attorney general said a meeting with Minister for National Health Services Saira Afzal Tarar was also held which recommended to give maximum benefit to patients because it was a public health matter in view of prevalence of Hepatitis C in the country, therefore the price of generic version of this new molecule should be considered at the minimum within standards of quality and required regulatory compliances.

The case will again be taken up in the third week of February.

Published in Dawn, January 21st, 2016