ISLAMABAD: In a landmark case for Pakistan, the Rawalpindi Drug Court has sentenced the CEO and several employees of a pharmaceutical company to imprisonment and substantial fines over a medication deemed ‘substandard’.
The company in question, GlaxoSmithKline (GSK), renowned both locally and globally, vehemently denies any wrongdoing and plans to appeal the verdict.
As per documents obtained, the case was initiated following a complaint by Provincial Inspector of Drugs Tehsil Hasan Abdal. In 2018, Drug Inspector Uzma Khalid sampled a batch of tablet Septran, bearing batch number HSBDS, manufactured by GSK. Subsequent testing at the Drug Testing Laboratory Rawalpindi revealed the medication to be substandard.
In February 2023, the court charged the company’s representatives. Despite the charges, all accused pleaded not guilty and underwent trial.
According to the verdict, GSK, boasting an estimated net worth of $82.38 billion, maintains production and quality control units. Nonetheless, it neglected to recall or halt the drug’s marketing and failed to investigate the manufacturing of the substandard drug.
The court found the company’s CEO, production manager, quality control manager, and warrantor culpable. The CEO received a sentence of imprisonment until the court’s adjournment and a total fine of Rs4.7 million. Failure to pay may result in a three-month imprisonment.
The other three individuals were each sentenced to two years in prison and fined Rs600,000. They face an additional six months’ imprisonment if fines are not paid.
However, GSK Secretary Agha Salman Taimur announced the company’s intention to contest the verdict in the appellate forum. In a letter to the Pakistan Stock Exchange, he asserted, “GSK and the officers involved deny any wrongdoing and are actively challenging the judgment.
Verdict triggers debate
The verdict, delivered by a three-member bench led by Chairman of the Drug Court Rawalpindi, Nadeem Babar Khan, has sparked discussions within the pharmaceutical sector and health community.
Explaining the case, President of the Pakistan Drug Lawyers Forum, Noor Muhammad Mahar, clarified that the medicine’s quality was not compromised. “In essence, it contained the correct percentage of molecules, but during testing, the tablet’s dissolution time was inaccurate. The tablet took longer to disintegrate,” he explained.
Regarding dissolution, Mahar elaborated that film-coated tablets typically disintegrate within 30 minutes in the stomach, while other coated tablets disintegrate within 60 minutes. Any delay in disintegration could prolong the treatment process.
He emphasized the importance of adherence to the standards outlined in the US Pharmacopoeia for all medications. However, he expressed disbelief at the severity of the imprisonment.
Mahar feared that this ruling might trigger efforts to amend the Drug Act, potentially reducing penalties. “If this occurs, we may witness fines being imposed instead of imprisonment in the future,” he cautioned.
He warned that such a decision could negatively impact patients, as relaxed laws might lead to dysfunctionality within the Drug Regulatory Authority of Pakistan. He suggested the establishment of a commission to investigate the case.
A pharmaceutical company’s head, preferring anonymity, expressed surprise at the unprecedented decision. “It appears that the decision stemmed from some underlying issue, as the court had repeatedly issued notices, but the company did not take them seriously. The company representatives should have been more cooperative in court rather than engaging in extensive arguments. This verdict serves as a lesson for other companies,” they remarked.
A senior official from the health ministry, speaking anonymously, emphasized that courts act in accordance with the law. “All courts possess the authority to impose strict measures and sentence imprisonment, so pharmaceutical companies should not underestimate drug courts,” they advised.
