International Desk

Counterfeiting and piracy are widespread in Pakistan, especially in pharmaceuticals, and dying from fake medicine is fatally frequent.

Perennial drug shortages in Pakistan have led to the inevitable flooding of the market with spurious and counterfeit products that follows when a product is needed but not available.

What's more the state seems unwilling to tackle the havoc caused by spurious drugs. The blame also lies with Drug Regulatory Authority of Pakistan (Drap) for slipshod monitoring and failure to curtail bogus medicine scams.

The use of raw material contaminated with diethylene glycol (DEG) and ethylene glycol (EG) impurities, which can pose serious health risks to consumers, is rampant among pharmaceutical manufacturers in Pakistan. There is unbridled retailing of dubious drugs in which Propylene glycol, sorbitol and glycerin are used as solvents in the manufacturing of oral liquid preparations. When used in oral liquid preparations of the pharmaceutical and alternative medicines industry, these solvents can lead to serious health risks due to DEG and EG toxicity. Many therapeutic goods manufacturers simply do not verify the quality and safety of their raw materials from authorised vendors.

Repeated accidents also indicate that drug regulation requires large-scale restructuring and enforcement of accountability and drug controls in the pharma industry, aided by a certified drug manual for practitioners, chemists and consumers. But in Pakistan, the absence of a steady availability of medicines at rational (ie, sustainable) prices forces patients to not only buy medicines in the black market at prices that are well above what local manufacturers are demanding, but they also carry a great risk of consuming medicines that may be spurious, even counterfeit.

In the absence of proper drug regulation Pakistan is losing access to world’s leading pharmaceutical companies. International pharmaceutical giants Eli Lilly and Fresenius have recently joined a string of multinationals exiting Pakistan after years of losses.

Unlike most countries, in Pakistan, the regulation of pharmaceutical pricing and medicine quality lies with the same regulator — the Drug Regulatory Authority of Pakistan (Drap). This is an outdated and unproductive approach, which relies on artificially controlling drug prices and ignoring its core responsibility of ensuring drug quality. As a result manufacturers do not make the investments required to achieve international certifications.

In September 2023, Several diabetic patients in Lahore, Kasur and Jhang lost their eyesight when they were administered adulterated eye drug- Avastin injections to address retinal damage. Among those affected was the brother of senior PPP leader Chaudhry Manzoor Ahmed. The official figures unveiled that the contaminated drug has severely affected the vision of 68 patients in the province since the scam surfaced.

The inquiry which followed, revealed that the owners were repackaging (compounding) the drug/injections in a highly unsterilized environment at a laboratory situated in the basement of a private hospital in Model Town, Lahore. More irregularities emerged when the probe was conducted - for one, a 400-ml injection, for instance, was found to cost Rs. 4000, but it was being sold for Rs. 40 each in syringes, which he described as an “illegal act”. The drug in question needs to be strictly kept at -2ºC to -8ºC while stocking and transporting it to the destinations with caution to be used within 24 hours, and was to be administered within six hours of its drawing from the vial. Unfortunately, the employees were transporting the drug on motorbikes in ice packs to maintain the cold chain in Lahore and the same was being sent to the distant cities, including Multan, Bahawalpur, Rahim Yar Khan, Sadiqabad and Mian Channu, probably by passenger buses.

Responding to the incident, on its website, Swiss pharmaceutical company ‘Roche’ said, “In Pakistan, the vision loss from Avastin has been identified by the authorities as a case of contamination by a third-party supplier.” It added, “Avastin is not approved for any use in the eye. Counterfeit medicines pose a health risk to patients because their content may be ineffective and contain harmful ingredients.”

In December 2023, the Dawn reported that illegal and unlicensed pharmacies have been cropping up in Karachi for quite some time. Their existence has serious implications on public health and safety. Recent years have seen a surge in the number of such pharmacies in the city. They are operating without necessary licences and regulatory oversight. These establishments often dispense medication without the supervision of qualified pharmacists, posing a grave risk to the wellbeing of the general population.

In March this year a factory in Ghouri Town where counterfeit medicines were being manufactured was discovered. Even veterinary drugs are being discovered as counterfeit. On May 16, 2024 a significant amount of unregistered and counterfeit veterinary medicines along with equipment used in manufacturing them was discovered at a shop located in Jawa Road, Islamabad.

Problems related to frequent adverse drug reactions, medication errors, medicines misuse and abuse, use of substandard and counterfeit medicines, and shortages of many life-saving and essential medicines have escalated in Pakistan. Notwithstanding this critically important matter, which is bound to severely affect the general public, the complete apathy of the federal government and the DRAP, in failing to take any remedial steps has resulted in a force majeure being triggered in respect of the pharmaceutical industry’s obligations to ensure uninterrupted availability of medicines in the local market and to the public at large