LAHORE: Highlighting blunders which led to waste of 1.2 million interferon injections, a commission appointed by the Lahore High Court has strongly recommended local production of interferon without further delay to protect the lives of millions of people suffering from hepatitis C.

The commission was appointed on June 6 last on the order of the LHC to inspect the cold storage of the Centre of Excellence in Molecular Biology (CEMB) and ascertain the availability of manufactured injections and raw material. It has submitted its report to the LHC for further action.

The commission conducted detailed inspection of the CEMB and its stock, and interviewed the officials involved in the whole process of manufacturing of the local interferon injections.

“After going through the stock of injections, the respondents were dismayed that a lot of precious material has been wasted when hepatitis patients are dying every day for want of injections,” the commission laments in the report.

It said this detailed inspection proved to the hilt that 99,804 interferon injections manufactured in 2008 at M/s Cirin Pharmaceuticals (Pvt) Ltd, Hattar, NWFP under licence from the Ministry of Health, physically existed and were in the storage at CEMB labs.

It was further observed that 14 batches of interferon production were completed before closure of production facilities, yielding an amount of 1.2 gms of purified interferon protein, as evidenced from the record of “interferon production batches”. This material could have been used to formulate an additional 1.2 million interferon injections.

The commission noted that local production of interferon ceased since 2010 and had not yet restarted despite a clear directive by the Public Accounts Committee/National Assembly in February 2013 conveyed through letter No 8(10)/2012-ASA(p&c) on June 18, 2013.During probe it has been confirmed that there is not a single interferon production/manufacturing facility in Pakistan and all the existing companies which are selling injections in the market are “formulation companies” which manufacture interferon injections by mixing the “active ingredient” being imported from China, Argentina etc., with stabilising material.

“The local production facility at CEMB is indeed the only interferon active ingredient production facility in the country and thus it is complimentary to and not competing with the existing companies.

“All members of a meeting convened by the commission unanimously voiced that the number of hepatitis patients in the country is steadily increasing as is the number of deaths by the killer disease, mainly due to inaccessibility of the therapeutic interferon to the poor public.

“The cost of treatment from interferon injection in the market is undoubtedly beyond the reach of a common man as envisaged by the Public Accounts Committee/National Assembly.”

The representative of Allama Iqbal Medical College/Jinnah Hospital pointed out that every hepatitis patient needed about 64 injections and on that basis, 100,000 injections would have helped more than 1,440 patients. Needless to mention, continued production would have helped many more needy patients.

It was further highlighted that the incidence of hepatitis was gradually increasing because of a lack of preventive measures and vaccine, and inadequate supply/accessibility of interferon.

“During further discussions, it was identified that the lowest market price for an interferon injection is around Rs300, however, the quality of the medicine is questionable,” the report said. It further said the quality of injections from M/s Rosch was acceptable and it was sold at Rs900 and above per injection.

The report said international efforts to produce a vaccine against this dreadful virus had so far been unsuccessful. “The only therapy available, if detected in earlier stages, is a six-month treatment with a therapeutic protein called “interferon alfa” at a cost that varies from Rs35,000 to Rs400,000 per patient. It is estimated that less than 5pc patients in Pakistan are able to afford such expensive therapeutic treatment,” it said.

The prevalence of hepatitis, the report said, was high in poor people and treatment costs were unaffordable. As a consequence, this had become a part of social reforms agenda of various political parties.

In 2005, ECNEC approved a five-year development project at a cost of nearly Rs2 billion with the main goal to reduce the incidence of hepatitis to 50pc by 2010. Nine years had passed and there’s no evidence that the incidence of hepatitis had come down, said the report.

In 2007, it said, then Punjab governor Khalid Maqbool launched a campaign to make “free supply of interferon” in different hospitals in Punjab, including Jinnah Hospital, Mayo Hospital and Nishtar Hospital, Multan.

“The present Punjab government is working to further expand the programme of free interferon supply. The Sindh government is pursuing the same policy, and recently opened a tender for Rs1.3 million, for one year supply of interferon.”

An accurate diagnosis and monitoring was not being done, said the report that pointed out that there were several kinds of hepatitis C virus such as 1a, 1b, 2a, 2b, 3a, 3b etc and only two kinds 3a and 3b were treatable with interferon (if detected in very early stages).

It pointed out that in most hospitals in Pakistan the liver histology sections were strong, however, experience and infrastructure for determining viral genotype and concentration were weak.

Published in Dawn, July 11th, 2014