ISLAMABAD: In what is regarded as one of the first cases in Pakistani history, the Rawalpindi Drug Court has sentenced the CEO and several executives of a pharmaceutical business to prison terms and hefty fines in connection with a medication that was determined to be “substandard.”
GlaxoSmithKline (GSK), one of the most reputable and respectable firms in Pakistan and the world at large, has declared its desire to appeal the decision before the appellate forum and denied any misconduct in the case.
The complaint was submitted by Tehsil Hasan Abdal, the Provincial Inspector of Drugs, according to the ruling that Dawn was able to view. He said that in 2018, Uzma Khalid, a different drug inspector, obtained a sample of a GSK tablet, batch number HSBDS, and sent it to the Drug Testing Laboratory Rawalpindi, which found the medicine to be substandard.
In February 2023, the court issued charge sheets to the company’s representatives. But each defendant entered a not guilty plea to the allegations, and they would all go on trial.
The verdict stated that GSK possesses production and quality control units and has an estimated net worth of $82.38 billion. It did not, however, take the trouble to recall the medication or cease selling it, nor did it look into how the inferior medication was made.
The CEO, production manager, quality control manager, and warrantor of the company were all found guilty by the court.
The CEO received a total fine of Rs4.7 million along with jail until the court’s ruling. If she doesn’t pay the fee, she could go to jail for three months.
The other three have each been sentenced to two years in prison and a Rs. 600,000 fine. If the fines are not paid, they will each be sentenced to an extra six months in prison.
Agha Salman Taimur, the secretary of GSK, has declared the company’s plan to appeal the decision to the appellate forum.
“GSK as well as the officers impleaded in the proceedings hereby deny any sort of wrongdoing in the matter and are taking immediate steps to challenge the aforementioned judgment before the appellate forum,” he said in a letter to the Pakistan Stock Exchange that Dawn was able to view.
Decision starts a discussion
The ruling, which was delivered by a three-judge panel led by Nadeem Babar Khan, Chairman of the Drug Court of Rawalpindi, has sparked discussion among the medical community and pharmaceutical industry.
Noor Muhammad Mahar, President of the Pakistan Drug Lawyers Forum, clarified the situation by stating that the medication’s quality was fine.
Put simply, the tablet’s dissolution time during testing was inaccurate while having an accurate percentage of molecules. It was taking longer for the tablet to break down,” he stated.
In response to a question concerning the dissolving, he stated that other coated pills decomposed in 60 minutes and film-coated tablets in 30 minutes. It would take longer to heal an illness if a medication took longer to dissolve.
“All medications should dissolve in accordance with US Pharmacopoeia regulations; discrepancies may be reported and corrected as needed. But even I was unable to process being imprisoned.
He was concerned that this decision might spark a movement to change the Drug Act and lessen the severity of the penalties it imposes. “In the future, we will only see the imposition of fines instead of imprisonment if this happens,” he declared.
Mr. Mahar issued a warning that the judgment would have unfavorable effects and that patients would ultimately suffer as a result of potential future law-easing and dysfunction within the Drug Regulatory Authority of Pakistan (Drap). He recommended setting up a commission to investigate the situation.
A pharmaceutical company’s head, who wished to remain anonymous, stated that he was unaware of any prior instances of such a choice.
The fact that the court kept sending letters and the corporation kept ignoring them suggests that there was a problem that led to the decision. The company’s representatives need to have argued less in court and instead shown more submission. Other businesses can learn from this move as well,” he stated.
Requesting anonymity, a senior health ministry official stated that the legislation governs the courts’ decision-making process.
“Pharmaceutical companies should not take the drug courts lightly, as all courts have the authority to take strict action and award imprisonment,” he stated.
