‘Draft of code of ethics to curb unethical medical practices finalised’

The Drug Regulatory Authority of Pakistan (DRAP) has finalised a draft of a code of ethics to curb unethical practices by the pharma industry and doctors and to safeguard the interest of patients.

“We have prepared a code of ethics to regulate the relationship between the pharmaceutical industry and doctors, and in this regard the Pakistan Medical and Dental Council (PMDC) is also being involved to take action against doctors who are found indulged in unethical practices, which include acquiring monetary benefits from the pharmaceutical industry,” said DRAP chief executive officer (CEO) Dr Muhammad Aslam while talking a group of journalists in Karachi on Wednesday.

Doctors are often accused of prescribing unnecessary medicines to patients in exchange of monetary benefits, foreign and local tours, and several other incentives. Some doctors also sell medicines of particular pharmaceutical companies at their clinics and obtain commissions in return.

Dr Aslam said that under the new code of ethics being prepared by his regulatory authority, doctors serving at public and private hospitals would not be contacted by pharmaceutical companies directly for foreign tours; instead, managements of the hospitals would decide to send doctors to 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 found to be indulged in unethical practices, he maintained.

This year so far, he noted, they had cancelled the licences 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 Rs75 million, lodged hundreds of FIRs and sealed 33 pharmaceutical units for producing substandard and spurious drugs. In 2016, we imposed a collective fine of Rs105 million and lodged over 600 FIRs against producers of spurious and substandard drugs.”

Similarly, for the first time in the history of Pakistan, doctors, pharmacists and nurses had been penalised and criminal cases lodged against them for giving fake and spurious drugs to patients at their private clinics and workplaces, he added.    

WHO’s pre-qualification

The Central Drug Testing Laboratory in Karachi is in the final stages of getting the World Health Organisation’s (WHO) pre-qualification status, and by the end of this year, the CDL of the Drug Regulatory Authority of Pakistan would become accredited, and that would help in improving the quality of local drugs and enhance their exports, said Dr Aslam.

“Not a single drug testing lab in Pakistan is pre-qualified by 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.”  

Surveillance of drugs 

The DRAP chief further claimed that they had also started post-marketing surveillance of drugs for the first time in the history of the country and this would help them in knowing the efficacy, safety and adverse effects of drugs after they reached patients and consumers.

“This system would also help us in rooting out the menace of spurious and substandard drugs from Pakistan and would also save precious lives.”

Dr Aslam further claimed that DRAP had made the process of registration of drugs transparent and now nobody was being asked by its staff to pay them money illegally for speeding up the drug registration process.

“We are trying our best to safeguard the interest of patients as well as of the pharmaceutical industry so that nobody has complaints against each other and the relationship remains beneficial to either of them.”  

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. A notification in this regard was issued in June 2017, making it mandatory to have bar codes on the packs the drugs. 

Dr Aslam said: “The system of bar codes would eliminate the chances of fake and spurious drugs as nobody would be able to scan the bar code to find out the legal and production information about the medicines being sold in the market.”