Despite approval accorded by the relevant committees at the Drug Regulatory Authority (DRA), an unnecessary route of summary through the Prime Minister's House is delaying the registration of many life saving drugs of blood pressure, cancer, arthritis, respiratory, and diabetes, Business Recorder has learnt through reliable sources.
The sources said that a meeting of Drug Pricing Committee of Drug Regulatory Authority of Pakistan (DRAP) was held in May last year and its minutes are still to be approved by the PM. Similarly, the minutes of another meeting of DPC held in June 2016 and the recent ones (DPC 21 and 22) held in April and May, respectively, this year are yet to be approved.
"As there is only Minister of State for National Health Services, Regulations and Co-ordination Saira Afzal Tarar and no federal minister, so according to the law only the Prime Minister can make the decisions and give approvals for the ministry affairs which is resulting in inordinate delay due to his commitments," said the sources.
The minutes of all DPC meetings are on hold because the Prime Minister has not given approval to them which is uncalled for the pharmaceutical industry of the country as well as to the poor patients suffering from the above-mentioned diseases. "Due to this issue, around 2,700 drugs including life saving ones are pending for approval and few important therapeutic areas of the said drugs include blood pressure, cancer, arthritis, respiratory, and diabetes," said the source.
A study shows that approximately 40 percent of improvement in mortality is due to innovative medicines alone. In the cardiovascular space, innovative medicines contributed to 28 percent reduction in death rates for cardiovascular disease between 1997 and 2007. Similarly, death rates due to heart failure and heart attack post-hospitalization fell by 45 percent between 1999 and 2005 primarily due to medicines and interventional treatments.
The sources claim that thousands of patients have suffered the miseries of cancer and ultimately loss of their lives. These patients could have been saved if the drugs were made available upon the recommendation of DRAP but the delay in the price approval by the PM has contributed to the loss of thousands of lives.
But the government is still ignorant to this development and is in the habit of delaying general public's access to quality medicines which is evident from this delay in the approval of minutes, leading to the registration of hundreds of drugs, which is aggravating the already fragile situation, the sources added. Analysts believe that providing the right medication to the right patient at the right time, especially for those suffering from chronic diseases can only succeed through a collaborative work with governments, healthcare bodies, regulators, payers, health funds, medical community, advocacy groups and innovation companies.
The DRAP has become a complete failure that has failed to address many serious issues which include substandard and/or counterfeit medicines, no policy making, ill planning, poor enforcement of even distorted law, toll manufacturing issues, and most importantly pricing issues, the sources said.
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