Sindh provincial health department has approved a private pharmaceutical company to refill, repackage, and label Sputnik-V for re-export and local sale.
Drug Regulatory Authority of Pakistan (DRAP) is an institution that has been authorized by the government of Pakistan to look into the affairs of pharmaceutical matters in the country. For the manufacturing of medicines or for repacking or labeling etc., of any imported medicine, the approval of the DRAP is mandatory.
The government of Sindh has recently given the approval of refilling, repacking, and labeling of Sputnik-V to a Karachi-based pharmaceutical company, Kapai Pharma Pvt. Ltd for re-export and local sale. It was supposed that this vaccine would be produced and distributed in collaboration with the Dow University of Health Sciences after going through all legal requirements.
On the 15th of July, the pharmaceutical company applied to Sindh Health Department for refilling, repacking and labeling of the Russian vaccine, and surprisingly, the Health Department, being very kind, gave the approval on the same day.
The health experts of the country are amazed over this decision and are raising a number of technical queries. These scientists are of the opinion that the decision was made hurriedly without consulting at the appropriate level.
The Chief Executive Officer of DRAP, Asim Rauf says that Drap has the exclusive rights to authorize any vaccine in Pakistan. The approval of the Sindh government in this regard is totally unjustified.
However, a copy of the letter, bearing the approval of the Sindh government for refilling, repacking and labeling of Sputnik-V has been sent to the concerned department of the Drug Regulatory Authority of Pakistan.
The CEO of Drap said that “However, Sputnik-V has been approved for use in the country and could be sold on a large scale in the future.”
According to health experts of the country, it does not seem justified to give approval to a local company for repacking et., of the imported vaccine. The experts are of the view, “Why is there the need to locally refill an imported vaccine when the drug is free for affected countries?”
Moreover, the spokesman of the Pakistan Pharmaceutical Manufacturing Association said that Kapai Pharma Pvt. Ltd is not a member of their Association.