The Drug Regulatory Authority of Pakistan (DRAP) has started preparing a code of conduct for pharmaceutical companies and medical practitioners to safeguard the interest of patients, who are fleeced by both medicine manufacturers and doctors to satisfy their greed, DRAP chief Dr Muhammad Aslam said on Wednesday.
“The nexus of some of the black sheep in the pharmaceutical industry and the medical practitioners is seriously hurting the interest of patients and a code of conduct to regulate the sale of drugs has become inevitable now,” he told The News when asked what DRAP was doing to curb unethical practices of the pharmaceutical industry.
Pharmaceutical companies all over the world are often accused of using bribes, both in the form of cash and kind, to influence doctors, consultants and medical practitioners to prescribe unnecessary drugs, in some cases causing serious health issues and repercussions for patients instead of curing their illnesses.
Recently a pharmaceutical giant was fined around 37 million sterling pounds for “illegal and unethical” practices while the US Food and Drug Authority (FDA) also fined the company millions for bribing doctors to prescribe its antibiotics unnecessarily but no such action has ever been taken against any company in Pakistan.
Pakistan’s chief drug regulator said some of the pharmaceutical companies were in the practice of “offering cash” to medical practitioners in exchange for prescribing their drugs, which was an illegal and criminal act as these companies had no regard for the care of patients’ health and wellbeing.
“Both the companies and medical practitioners are equally responsible in this act and action would be initiated against both once a comprehensive code of ethics for the pharma industry and medical practitioners is finalised,” Dr Aslam vowed, adding that the code of ethics would be applied to medical practitioners also and, in this regard, the Pakistan Medical and Dental Council (PMDC) would be taken on board.
He further revealed that pharmaceutical companies were arranging local and foreign tours, providing cars and decorating offices of doctors, spending money on their family marriages, sending them on shopping tours with all expenses paid and offering many other incentives, which were not only unethical practices but could also be declared illegal acts.
“In return, doctors prescribe unnecessary and low-quality drugs to return the favours. They sometime prescribe antibiotics, vitamins, food supplements and other drugs, which are extremely expensive and of no use to a patient,” he disclosed.
Some doctors event ask the patients to purchase medicine from a particular medical store and in order to ensure that drugs prescribed by them have been purchased by the patients, they direct their patients to come back and show them if “original” drugs had been bought or not.
The DRAP chief said some small pharmaceutical companies, which were buying cheap raw material, lack qualified and trained pharmacists and staff and had invested very little in production, were in the habit of using such tactics while top 20 to 30 Pakistani pharmaceutical companies did not indulge in such nefarious practices.
Responding to a query, he said a panel of experts comprising experts from the government, pharmacists, doctors, representatives of the pharmaceutical industry, civil society and even from consumer councils would be formed to frame the code of ethics and once it was approved by the competent authority, it would be implemented in letter and spirit.
He claimed that DRAP had already fined up to 70 pharmaceutical companies through a drug court for indulging in illegal practices, while NAB recently recovered Rs380 million from another pharmaceutical company, which had wrongly acquired higher prices for two of its drugs from the previous drug regulators.
WHO prequalification
The DRAP chief further claimed that efforts were underway to get Central Drub Laboratory (CDL) of Pakistan prequalified from the World Health Organisation (WHO) so that it could certify Pakistani drugs for exports to high-price market of Europe, instead of Africa and Asia.
“US Food and Drug Authority and WHO are assisting DRAP for upgradation of our CDL in Karachi to become a WHO-certified lab so that it could test and verify drugs produced by our local pharmaceutical companies.”
Dr Aslam said that in order to get the CDL certified from WHO, two levels of the QMS (Quality Management System) had been achieved while work on achieving the third level was underway, after which DRAP would request WHO to inspect and declare the CDL a certified lab for testing drugs in the region.
Highly skilled and trained staff were being hired by DRAP in this regard, he said, adding that USFDA was providing financial and technical assistance to DRAP to achieve its targets.
