DRAP finalises code of ethics draft

KARACHI: The Drug Regulatory Authority of Pakistan has finalised the draft of a code of ethics on the relationship between pharmaceutical Industry and doctors practicing in Pakistan and after completion of consultation on the draft code, it would be enforced as a law to curb unethical practices by the pharma industry, doctors and to safeguard the interest of patients. “We have prepared a code of ethics to regulate the relationship between pharmaceutical industry and doctors and in this regard, Pakistan Medical and Dental Council (PMDC) is also being involved to take action against doctors who are found indulging in unethical practices, which include acquiring monetary benefits from the pharmaceutical industry”, Chief Executive Officer (CEO) of the Drug Regulatory Authority of Pakistan (DRAP) Dr. Muhammad Aslam told a group of journalists in Karachi on Wednesday. Doctors are often accused of prescribing unnecessary medicines to patients in exchange for monetary benefits, cash, foreign and local tours besides several other incentives while some doctors also sell medicines of particular pharmaceutical companies at their clinics and obtain commissions on the sale of such medicines. DRAP Chief said under the new code of ethics for doctors and pharmaceutical industry being prepared by the DRAP, doctors serving at public and private hospitals would not be contacted by the pharmaceutical companies directly for foreign tours and instead of that, managements of the hospitals would decide to send doctors for international conferences, seminars and trainings. Penalties and criminal cases would be lodged against pharmaceutical companies and their managements for bribing doctors, involvement in unethical practices and tax evasion if they are found to be indulging in unethical practices, Dr. Aslam maintained. According to him, so far in the current year, they had cancelled the licenses of 13 pharmaceutical companies for producing spurious and substandard drugs and halted the production of 23 companies on similar charges while heavy fines were being imposed on the pharmaceutical sector, retailors, medical store owners and distributors for selling spurious drugs. “In 2015, DRAP imposed a combined fine of Rs 75 million, lodged hundreds of FIRs and sealed 33 pharmaceutical units for producing substandard and spurious drugs. In 2016, we imposed a collective fine of Rs 105 million and lodged over 600 FIRs against producers of spurious and substandard drugs,” he informed. Similarly, for the first time in the history of Pakistan, doctors, pharmacists and nurses were penalised and criminal cases were lodged against them for giving fake and spurious drugs to patients at their private clinics and workplaces, he claimed. WHO Pre-qualification for Karachi Lab: Central Drug Testing Laboratory in Karachi is in the final stages of getting the World Health Organization (WHO) pre-qualification status and by the end of this year, CDL of Drug Regulatory Authority of Pakistan would become accredited from WHO, Dr. Muhammad Aslam informed, saying this would help in improving quality of local drugs and enhance their exports. “Not a single drug testing lab in Pakistan is pre-qualified by the WHO in Pakistan but after getting this status, it would help Pakistan in saving precious foreign exchange and exporting our drugs to various other countries of the world”, he added. DRAP launches Post-Marketing Surveillance of drugs in Pakistan: DRAP Chief further claimed that they have also start the post marketing surveillance of drugs in Pakistan for the first time in the history of the country and this would help them in knowing the efficacy, safety and adverse effects of the drugs after they reach into the hands of patients and consumers. “This system would also help us root out the menace of spurious and substandard drugs from Pakistan and would also save precious lives in case of any spurious or dangerous drug being sold in the market”, he claimed. He further claimed that DRAP had made the process of registration of drugs transparent and now nobody was being asked by DRAP staff to pay them money illegally for speeding the drug registration process. “We are trying our best to safeguard the interest of the patients as well as pharmaceutical industry so that nobody have complaints against each other and the relationship remains beneficial either of them”, he added. Bar Codes on drug packs: All pharmaceutical companies have been given six months till December this year for having bar codes on the packs of their products after a notification in this regard was issued in June 2017, making it mandatory to have bar codes on the packs of the drugs, Dr. Aslam informed. “The system of bar codes would eliminate the chances of fake and spurious drugs as anybody would be able to scan the bar code to find out the legal and production information about the medicines being sold in the market”, he added.     Published in Daily Times, August 24th 2017.