LAHORE: Pakistan has been under the global radar over sale of fake drugs owing to several recent instances, including the fake stents scam and the contaminated heart medicines that claimed over 100 lives in 2012.

The World Health Organisation (WHO) intervened and played a crucial role in the investigation of the issue, culminating in the issuance of a Drug Safety Update to inform governments and pharmaceutical regulators around the globe of the contamination.

Federal Investigation Agency (FIA) officials have investigated the issue and during raids seized many fake drugs along with printing material and manufacturing equipment.

“We have recovered many counterfeit drugs, for example, Exzelza, which contains bromazetam, jelatin and ampicillin sodium injections. Government-owned, but stolen drugs have also been recovered in the process,” FIA officials stated.

The law enforcement agency also recovered unregistered medicines during raids and found all violators breaching the Drug Regulatory Authority of Pakistan (Drap) Act 2012 and Drugs Act 1976.

Under the Drap Act 2012, the Drug Regulatory Authority of Pakistan (Drap) was established with a vision to create better coordination and implementation of the Drugs Act 1976 and harmonise inter-provincial trade and commerce of therapeutic goods.

Unregistered and fake drugs were seized and recovered by law enforcement agencies amidst media outcry over serious irregularities regarding medicines. This indicated there was a loophole in the system and Drap was not fully capable of regulating the acquisition or production and sale of drugs.

The challenge of dealing with sale of unauthorised drugs has been around for decades. The number of cases of fake drugs being investigated by the US Food and Drug Administration (FDA) has quadrupled from an average of five per year in the 1990s to about 20 in 2001 and 2002. The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) has estimated that seven per cent of all drugs sold around the world are fake. They also suggested that the value of this trade was over $30 billion. Similarly, the WHO estimates that the annual earnings from these drugs was over $32 billion.

An FIA source revealed that some pharmaceutical companies and health departments were violating the Drug Pricing Policy 2015. “Extremely high prices are charged for medicines to treat some of the deadliest diseases such as cancer. It is on record that a drug such as Nexavar 200mg (anti-cancer tabs), imported to Pakistan for Rs76,687, was sold for Rs232,800. The excess amount was Rs156,113. In India, the same drug was sold for Rs1,710,” the official revealed.

Mr Ishaq Meo, president of the All Pakistan Chemist Retailers Association, said: “Most of the drugs manufactured in Pakistan are at a much lower price when compared to those manufactured in India and other parts of the region.”

Under the Drug Act 1976, the Drap is responsible for registration and regulation of drugs. The former Drap chief, Aslam Afghani, opined that in the last 70 years the trade of medical devices was not regulated except for a very few instances under Drugs Act 1976. He further stated that with the enactment of the Medical Devices Rules 2017, at least non-medical devices would be registered and regulated and violators penalised.

Recently, on the orders of the Supreme Court, the Drap took action against unregistered and fake medicines. Dr Ghazanfar Ali, a Drap spokesperson, confirmed: “Since the order of Supreme Court, the Drap has taken action against violators. We have sealed the premises and seized the stock in some instances and lodged first information reports against the law breakers.”

Mr Afghani had claimed last year that a bar code system would be fully functional by the end of 2017 and the trade of fake drugs completely contained. However, according to Drap’s new management, the bar code system will be operational within the next two years.

By using modern technologies, consumers can get better and safe medicines and devices.

Dr Usman Anwar, a doctor and FIA director, suggested: “We should have a system such as a top-up mobile card. Under this method, a unique digital number will be displayed by scratching the card that can be texted to the authority for verification of a drug. For additional security and safety, that bar code will not be re-useable.”

In an age of increasing numbers of drug-resistant organisms, the occasional occurrence of previously unseen and deadly viral infections as well as the exponential pace in the progress of medical developments dealing with the basic issue of drugs and device genuineness and safety must be of paramount importance to the citizens of any state.

Published in Dawn, June 7th, 2018