LAHORE, Nov 7 A large batch of interferon injection --- produced indigenously for the poor hepatitis patients after getting the manufacturing process patented in 2008 --- will expire in December due to an indifferent attitude of the federal ministries of health and science and technology, Dawn has learnt.
Research work was undertaken at the Centre of Excellence in Molecular Biology (CEMB) of the Centre of Applied Molecular Biology (CAMB) and Allama Iqbal Medical College (AIMC), where interferon was replicated to reduce the cost of treatment of hepatitis, sources said.
About four years ago, a group of scientists and medical experts led by a former director of the CEMB, Prof Riazuddin, and the principal of the AIMC, Prof Javed Akram, chalked out a programme for producing proteins indigenously and began working on the project to rid the country of dependence on proteins produced abroad.
After three years of hard work, the group succeeded in cloning 18 human pharmaceutical protein genes. The proteins cloned by the experts included insulin for diabetics, erythropoietin for use in kidney transplantation, interferon injections of four types for hepatitis patients, interleukin of four types to develop immunity in patients, myosin of three types and connexin of four types to heal bone fracture and HPOF for hearing. The scientists termed it a breakthrough in the bio-pharma field.
The group analysed the effects of various diseases and on the basis of reports and data available concluded that hepatitis C was the “number one killer disease” in Pakistan, which infected predominantly, if not exclusively, the poor and middle-class people.
The group cloned interferon injection to make it available in the local market at a price far lower than that of imported vials of the injection.
Discussing the importance of the project, a senior researcher told Dawn that in 2005 the Musharraf government initiated a five-year programme at a cost of Rs2 billion to eradicate hepatitis from the country.
He said the import bill for interferon was Rs1.1 billion in 2005, Rs1.4 billion in 2006, Rs1.87 billion in 2007, Rs2.3 billion in 2008 and over Rs3 billion in 2009.
Despite the massive spending, only five per cent of the hepatitis patients got properly diagnosed and treated, while 90 per cent died an untimely and accelerated death without getting any curative treatment, he said.
At present, he said, some 70 brands of interferon were being imported from various countries. All these brands were beyond the reach of the poor patients suffering from hepatitis C.
“We developed procedures for the production of interferon to ensure a reliable supply at an affordable price of Rs70,” he said.
A source said the federal health ministry initially lauded the efforts of the group and in 2008 gave it the permission to produce 100,000 vials of interferon injection for clinical trials among humans.
But later on some senior officials in the two ministries started creating hurdles, he said. The experts visited Islamabad a number of times to convince the authorities of the importance of the project but to no avail.
The proposal for indigenous production of interferon has been pending with the federal ministry of health and the Pakistan Medical Research Council (PMRC) since then. The vials of locally produced interferon injection have been stored below 4 degrees centigrade in the CEMB.
Finally, the frustrated researchers stopped their work on 17 other proteins for an indefinite period when a senior health ministry official told them “Initiate clinical trials on healthy volunteers, otherwise wait for a miracle.”
When contacted, Dr Riazuddin said low-cost interferon injections were a longstanding demand of the poor hepatitis patients in Pakistan. “If the delay persists, 100,000 interferon injections produced a couple of years ago will expire next month, resulting in the wastage of research effort and material resources,” he said.
He said a hepatitis C patient had to take three injections per week and the treatment continued for six to 18 months, depending on the intensity of the virus. On an average, the diagnosis and follow-ups cost more than Rs50,000 per patient, with the total cost of treatment often amounting to Rs150,000.
The situation was quite alarming as hepatitis B and C were the common cause of liver diseases in Pakistan, he said.
Dr Riazuddin said locally produced interferon compared well with the imported brands sold in the market, as evidenced by the results of safety and bioactivity tests and the results of bio-equivalence tests carried out at a German laboratory.
“The local product was also found safe in experiments on rats and rabbits, comparable to standard interferon as approved by the World Health Organisation,” he said.
Prof Javed Akram said bureaucratic red-tape motivated by “vested interests” was creating hurdles in the clinical trials of the locally manufactured interferon.
He added that if and when their research, which led to the indigenous production of 18 important pharmaceutical proteins, was allowed to reach the poor patient, Pakistan would benefit greatly in the shape of foreign exchange savings and minimising the suffering of millions. “This (bureaucratic red-tapism) has certainly discouraged me and my able researchers. The research remains confined to laboratories and the applicability of such hard work remains a dream,” said Prof Akram.
Federal Health Secretary Khushnood Lashari told Dawn that a few months back his ministry had forwarded the case to the PMRC for ethical evaluation after giving a formal approval.
He said there were certain ethical guidelines to ensure that the drug had no harmful effects on humans.
When reminded that the ethics committee of the AIMC had already approved the drug, he said the decision held good for just one institution.
“It should again be evaluated by experts at the national level,” he said and added that the PMRC had been requested to evaluate the drug at the bioethics committee level.
“Since then the matter is pending with the PMRC,” Mr Lashari said.
He added that his ministry had not only approved the CEMB interferon but also sanctioned an amount of Rs8 million for the purpose.
Asked about the expiry next month of a large batch of interferon injections, he said the PMRC officials could throw a “light on the subject”.
A PMRC member said the council was a part of the health ministry and headed by the secretary himself. “The health secretary can tell you why the project is being delayed,” he said.
A deputy chairman of the Public Accounts Committee of the National Assembly and member of National Assembly's Standing Committees on Commerce, Health, Human Rights and Environment, Yasmeen Rehman, told Dawn that the issue had already been discussed at a higher forum and the government would be pressurised to resolve the matter.
She said the chairman of the NA Standing Committee on Health, Nadeem Ihsan, had briefed the members about the breakthrough.
The committee would discuss the issue after Eidul Azha, she added.