KARACHI: While the Drug Regulatory Authority of Pakistan (Drap) is solely responsible for regulating the pharmaceutical industry, senior government officials have raised alarm over violation of the Drug Act of 1976 and neglect of critical issues, including mechanism of medicine pricing, by the authority.

Over the years, many senior officials have tried to streamline the working of Drap to benefit the general public, but they were either transferred, forced to quit or sacked, both by the previous PML-N government and the incumbent Pakistan Tehreek-i-Insaf-led set-up.

Last month, the authority came in the spotlight again when the Islamabad High Court dismissed a petition seeking reinstatement of former Drap chief executive officer Sheikh Akhtar Hussain, who was removed from the post since his PhD degree is from a non-chartered university. The court also ruled against the appointment of incumbent CEO Asim Rauf.

While many senior bureaucrats privately acknowledge the Drap’s shortcoming, one senior officer decided to highlight the issues being faced by the drug regulator.

Covid-19 has exposed institutional shortcomings of the authority, says letter sent to NHS secretary

Incumbent Special Secretary of Communication Dr Tanveer Ahmad Qureshi, who has earlier served as federal health secretary, recently sent a letter to National Health Services (NHS) Secretary Amir Ashraf Khawaja, stating that during his tenure he had found many gaps in the institutional framework of Drap, including capacity issues.

“Critical issues regarding the pharmaceutical safety, quality control, manufacturing, licencing and pricing of essential and non-essential medicines are neglected and ignored in serious breach of the Drug Act-1976,” said the two-page letter, a copy of which is available with Dawn.

Dr Qureshi stated that Drap had a critical role in regulating the pharmacological drug chain at the national level and with the global supply chain at the international level. “From drug importation through licencing, manufacturing, quality assurance, to the point of sale of all prescription and over-the-counter drugs, the role of Drap is crucial for the health security of the country.”

Dr Qureshi stated that Covid-19 had exposed the fragile healthcare infrastructure, including the institutional shortcomings that Drap faced. He urged the authorities to bring reforms “to ensure better management of any contagion in future”.

He said that Drap might face difficulties to meet its legal obligations as no attention was given on framing of rules and the authority was being run on an ad hoc basis.

“In the medium to long term, the legal and administrative void must be rectified to halt the process of ad hoc and makeshift arrangements that has compromised Drap’s performance,” he stated.

He observed that the issues needed to be resolved quickly and all those officers who were either forced to quit or sent home without following the due process should be brought back.

Dr Qureshi was apparently referring to former Drap deputy director Dr Roohi Bano Obaid who had to resign when the NHS ministry did not act on frequent exposure by her of alleged corrupt practices prevalent in the authority.

Recognising the expertise of another former Drap officer, Dr Obaid Ali, who happens to be the spouse of Dr Roohi, the senior bureaucrat stated: “I have no hesitation to acknowledge that I found Dr Obaid knowledgeable and well-informed person during my informal consultations on Drap-related issues. He would have been an asset to the Authority.”

Dr Ali, who had highlighted several incidences of malpractice and corruption in the pharmaceutical industry, is currently fighting a legal battle before the Federal Services Tribunal as he was sacked earlier this year.

Dr Qureshi stressed the need for deciding “administrative and disciplinary cases” faced by Drap officials without any delay.

“These [cases] have been pending in the ministry and other forums for long. And it seems as if they remain undecided due to extraneous reasons. Already, the institutional infighting has hampered the growth of Drap leading to its functional erosion, besides facing capacity issues in carrying out its core business.

“The early disposal under the law will not only motivate Drap employees, but also encourage those proved innocent to work with devotion in this overworked and undermanned authority — at least in the short term,” he stated.

NHS Secretary Khawaja did not respond to queries when Dawn tried to reach him. Drap CEO Asim Rauf, for whom the IHC ruled that he was assigned the post on a ‘look after basis’, was also not available for comment.

Published in Dawn, October 22nd, 2020