In a bizarre move, the provincial health department has approved a private pharmaceutical company to refill, repackage, and label Sputnik-V for re-export and local sale.
It is being said that the Russian vaccine will be produced and distributed in collaboration with the Dow University of Health Sciences (DUHS); after fulfilling all legal rules, regulations and codal formalities.
The Karachi-based Kapai Pharma Pvt Ltd had formally sought the Sindh health department’s approval for the matter on July 15 2021. Interestingly enough, the company was issued an expedited response on the same day, in the form of a no-objection certificate (NOC); green-lighting the private limited company to move ahead with its plans.
Health experts have raised various technical objections on the government’s approval of the company’s request. They claim that the decision was hurriedly made without their consultation and thus poses a potential risk to public healthcare.
Meanwhile, speaking to The Express Tribune, Drug Regulatory Authority of Pakistan (DRAP) CEO Asim Rauf maintained that it is his organisation that holds exclusive discretion to authorise any vaccine in the country. The provincial government, however, had greenlit the drug without DRAP’s prior approval, which the authority claims is in defiance of its jurisdiction.
In this regard, a copy of the NOC issued by Sindh health department to Kapai Pharma for refilling, repacking and labeling of the imported vaccine, has been forwarded to the relevant division of DRAP. Its acceptance or rejection will be notified on Monday. “However, Sputnik-V has been approved for use in the country and could be sold on a large scale in the future,” the CEO told The Express Tribune.
Commenting on the development of the vaccine, Dow University spokesperson Muhammad Naeem Tahir revealed that Kapai Pharma is yet to reach any written agreement on the matter with DUHS, but talks could be held in the coming days.
What appears to be another hornet’s nest waiting to be stirred, is the cloud of duplicity surrounding the Karachi-based pharmaceutical company that has been greenlit for vaccine refilling. Per Kapai Pharma’s own letter-head, it’s office is supposed to be located in the neighbourhood of Khayaban-e-Iqbal, in Clifton Block-09.
However, a visit by a representative of The Express Tribune revealed the said premises belongs to a different company and does not seem to bear any marking that suggests Kapai Pharma Pvt Ltd’s presence in the area.
In addition to that, Pakistan Pharmaceutical Manufacturing Association (PPMA) CEC Member Dr Kaiser Waheed also confirmed that the said company is not a member of his association. This realisation, along with the company’s debatable presence, has raised several concerns about the provincial government’s questionable involvement in the matter.
It is also to be noted that the development of Sputnik-V is intended to be carried out at Dow University’s Institute of Life Sciences. The same institute had earlier announced the development of a dog-bite vaccine, which despite millions in grants and eight years in the making, still remains a no-show.
According to health experts, there seems to be no plausible justification for the health department’s expedited approval of the pharmaceutical company’s intriguing request. “Why is there the need to locally refill an imported vaccine when the drug is free for affected countries?” asked an expert on conditions of anonymity.
The Express Tribune also tried to contact the office of Sindh Health Minister Dr Azra Pechuho and Health Secretary Dr Kazim Jatoi, for some clarity on the matter. However, both officials remained unavailable to comment, while the health minister recently returned from a visit to the United States of America.
Published in The Express Tribune, August 10th, 2021.
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