ISLAMABAD: An official of the Drug Regulatory Authority of Pakistan (Drap) was demoted while several officials are under scrutiny over an issue pertaining to the delay in the export of medical devices to Belarus.

Sources said the action was taken after the Belarus president took up the matter with the prime minister, Shehbaz Sharif. The premier formed a committee, and subsequently the official was penalised.

According to the health ministry’s documents, dated July 3, in pursuance of the health ministry’s speaking order, Additional Director Dr Muhammad Fakhrududin Amir has been awarded major penalty of reduction to the lower post and pay-scale of deputy director for a period of one year with effect from July 2, 2025.

Dr Amir was issued a show-cause notice on May 29, informing that he failed to ensure the timely registration of medical devices as the director of the Medical Devices and Medicated Cosmetics Division (MDMC), Drap from July 2020 to February 2023. It was also alleged that he failed to hold regular meetings of the board.

Director claims innocence, says worked day and night to clear backlog

It was also alleged that large backlogs of undecided applications and consequent court cases left no option for the federal government but to approve the third extension in the exemption period. It is worth mentioning that the federal government gave extensions in the Medical Devices Rules after 2018 and the same was repeated after Covid-19, which affected all functions in 2020 and onwards.

According to another document, dated July 2, the prime minister, while taking notice of the frequent exemptions from registration/enlistment sought for medical devices, constituted a committee to examine the rationale for previously granted exemptions and to recommend a way forward.

Drap Chief Executive Officer Dr Obaidullah Malik was reluctant to comment on the issue, but an official told Dawn that the matter that led to the demotion was highlighted by the Belarusian president with PM Shehbaz.

He said that after the inquiry, one officer was demoted and some may face some penalties in the near future for the delay. He further said that it was unfortunate that action was taken against an additional director rather than the Drap head.

Another document showed that 100 per cent registration cases were disposed of in 2018 but in 2020 only 27pc cases for the medical devices registration were disposed of. Similarly, less than 42pc cases were disposed of till 2024 and then in 2025 once again, all cases were disposed of.

Muhammad Fakhruddin Amir, while talking to Dawn, said that it was unfortunate that he was demoted despite disposing of 100pc cases in a year.

“The fact is that it was the federal cabinet which had been giving extensions for medical devices rules since 2018. Later, cases were delayed and piled on during Covid-19... I did not have human resources but I kept on working and cleared all cases... In 2024-25, I cleared 100pc backlog by working late in the evenings and even on weekends. However, [still] I was asked why I did not dispose of cases in the previous years,” he added.

Replying to a question, he said that he was not aware that if some companies had to export medical devices to Belarus. He said, if there were a few dozen cases like that, he should have been informed by the authorities to dispose them of on priority.

Dr Amir said that he would contact all possible platforms to get relief.

Published in Dawn, July 8th, 2025

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