• Verdict surprises pharmaceutical industry; drug lawyer says punitive actions could lead to ‘toning down’ of drug laws
ISLAMABAD: Considered to be one of the first cases in the history of Pakistan, the Rawalpindi Drug Court has awarded imprisonment and heavy fines to the CEO and other employees of a pharmaceutical company in a case involving a medicine that was found to be ‘substandard’.
The company, GlaxoSmithKline (GSK), which is considered one of the most credible and well-reputed companies in Pakistan and across the globe, has denied any wrongdoing in the matter and announced its intention to challenge the judgement before the appellate forum.
According to the judgement seen by Dawn, the complaint was filed by the Provincial Inspector of Drugs Tehsil Hasan Abdal. He stated that in 2018, another drug inspector, Uzma Khalid, took a sample of tablet Septran, batch number HSBDS, manufactured by GSK and sent to Drug Testing Laboratory Rawalpindi, which had declared the drug substandard.
The representatives of the company were charge-sheeted by the court in February 2023. However, all the accused pleaded not guilty to the charges and faced a trial.
The judgement said that GSK, with an estimated net worth of $82.38 billion, has production and quality control units. However, it did not bother to recall or stop marketing the drug, nor did it conduct any inquiry regarding the manufacturing of the substandard drug.
The court found the company’s CEO, production manager, quality control manager and warrantor guilty.
The CEO was awarded imprisonment until the rising of the court and an overall fine of Rs4.7 million. She may face three months in prison if she fails to pay the fine.
The three others have each been awarded two years in prison and a fine of Rs600,000. They will face an additional six months’ imprisonment each in case of failure to pay the fines.
However, GSK Secretary Agha Salman Taimur has announced the company’s intention to challenge the judgement before the appellate forum.
In a letter to the Pakistan Stock Exchange, seen by Dawn, he wrote: “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.”
Verdict triggers debate
The judgement was announced by a three-member bench headed by Chairman Drug Court Rawalpindi, Nadeem Babar Khan, and has triggered a debate in the pharmaceutical sector and health fraternity.
While explaining the case, Pakistan Drug Lawyers Forum President Noor Muhammad Mahar said that there was nothing wrong with the quality of the medicine.
“In simple words, it had an accurate percentage of molecules, but during testing, the dissolution time of the tablet was not accurate. The tablet was taking more time to disintegrate,” he said.
When asked about the dissolution, he explained that film-coated tablets disintegrated within 30 minutes in the stomach and other coated tablets disintegrated within 60 minutes. If a tablet took more time to disintegrate, it would take more time to cure the ailment.
“All medicines should disintegrate as per the standards of the US Pharmacopoeia, and action can be taken in case of any difference. However, even I could not digest the imprisonment.”
He feared that this verdict may prompt a campaign to amend the Drug Act and tone down the punishments contained in it. “If this happens, in the future, we will see only the imposition of fines instead of imprisonment,” he said.
Mr Mahar warned that the decision could have a negative impact, and patients would ultimately suffer as laws might be relaxed in the future and the Drug Regulatory Authority of Pakistan (Drap) could become dysfunctional. He suggested establishing a commission to look into the case.
The head of a pharmaceutical company, who asked not to be named, said that he had never heard of such a decision before.
“It seems that the decision was taken because of some issue, as the court was issuing notices again and again but the company was not taking it seriously. The company representatives should have been more submissive in court rather than arguing too much. This decision serves as a lesson for other companies as well,” he said.
A senior officer of the health ministry, requesting anonymity, said that the courts make decisions according to the law.
“All courts have the power to take strict action and award imprisonment, so pharmaceutical companies should not take the drug courts lightly,” he said.
Published in Dawn, April 25th, 2024
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