Research, innovation in pharmaceutical sector: Rs3 bn lying unutilised for last nine years, say officials

ISLAMABAD: For the first time since the establishment of Drug Regulatory Authority of Pakistan (DRAP), the federal government is likely to notify a ‘Committee of Experts on Drug Research’ within the next few days to finally utilise billions of rupees that have been collected from the pharmaceutical companies of Pakistan for research and innovation but are lying unutilized for the last nine years, officials told The News on Monday.

Around three billion rupees have so far been collected by the Drug Regulatory Authority of Pakistan (DRAP) from the pharmaceutical companies, which are bound to contribute one percent of their gross profit to the Central Research Fund (CRF) under the Drug Research Rules 1978.

“The federal cabinet is likely to notify an eight-member committee of experts on drug research for utilisation of around three billion rupees within the next few days.

This amount collected from the pharmaceutical companies in the Central Research Funds (CRF) is lying unutilised for the last nine years,” an official of the National Health Services, Regulations and Coordination (NHS, R&C) said while talking to The News.

The federal health authorities often ask the pharmaceutical industry in Pakistan to spend more on research and innovation in the area of drugs manufacturing but it has itself failed to utilise billions of rupees, contributed by the pharmaceutical industry since 1978 for the research and development. “But the present government has finally decided to utilise the funds for research and innovation in the area of clinical trials, discovery of new molecules and establishment of research and development centers in the area of medicine,” the federal government official said, adding that “the eight-member committee would start receiving applications for the grant in aid for research on drugs.”

The official, who requested not to be named, said the process to constitute the committee of experts on drug research was initiated by former Special Assistant to Prime Minister (SAPM) on Health Dr Zafar Mirza, but the process was so lengthy and cumbersome that it took around three years for completion and in the meanwhile, Dr Zafar Mirza quit his position and Dr Faisal Sultan was appointed as the SAPM on Health.

Comprising the Director Pharmacy Services as its ex-officio chairman, the expert committee would also include Deputy Drug Controller, Pharmacy Services of DRAP, Chairman of Pakistan Council of Scientific and Industrial Research (PCSIR) or his nominee, Chairman Higher Education Commission (HEC) or his nominee, one professor of pharmacy from each province, an expert in biotechnology and a co-opted expert nominated by the chairman of the expert committee as its members.

Terming the constitution of expert committee on drug research as a welcoming move, former SAPM Dr Zafar Mirza hoped that the committee would utilise the funds available with the DRAP for research in the area of pharmaceutical sector as well as promotion of ethical marketing practices and irrational use of medicines. “This fund, which has never been utilised for the purpose it was created, can be used in many innovative ways. The pharmaceutical industry is also calling for its utilization for the purpose of research and development,” Dr Mirza said, adding that it is hoped that the expert committee would make the maximum use of the funds at its disposal for funding research projects and facilitate young researchers who are unable to conduct research due to unavailability of finances.

Meanwhile, DRAP officials claimed that the funds collected under CRF were utilised prior to establishment of DRAP in 2012 but more for personal or institutional research interest, instead of public. “Unfortunately, some universities, medical institutions and even pharmaceutical companies used this fund inappropriately, which led to an investigation by the FIA and then it was stopped because all were afraid to approve any projects or ask for funds,” an official of the DRAP told The News on condition of anonymity.

“When DRAP came into being, it took up this case too and made new regulations and defined relevant research fields where this (fund) would be utilised and it also adopted very strict rules in line with the HEC rules, with high accountability and all well maintained recorded funding, its proper utilisation with a mechanism of monitoring and result-oriented approach,” the official added.

He maintained that this fund is for research on development of new, indigenous molecules and indigenous medical and pharmaceutical research with outcome in patients’ direct advantage. “Approval of these new rules were delayed and no one took interest or even any advantage. These rules were finally approved recently and now funds are open,” he added.

The DRAP official further claimed that pharmaceutical companies wish to utilize money in the CRF for ‘their own company projects and works”. “This is not for their own or routine company research which is their own responsibility, and not direct interest to public research requirements. Purpose now clearly defined, it should be in public interest, not private interest. A merger is possible for both private and public interest, if these companies agree to share the profit of this research with public. If this is agreeable than this can make a common interest. Of course this will have to pass the test of public accountability too,” the official added.