Availability of more than 400 lifesaving drugs may be jeopardized due to some bureaucratic snags, leading to a major health crisis in the country, especially in Sindh and Khyber Pakhtunkhwa, market sources claimed.
It has been learnt that the supply of some lifesaving biological products, including insulin, vaccines, plasma-derived products, recombinant biologicals, etc, has been in the doldrums since March 13 last.
And the reason behind this is that the signing authority has not been appointed at the National Control Laboratory (NCL) by the federal government since then to approve the hundreds of release applications of the pending lot.
Resultantly, thousands of patients are suffering as the hospitals in Sindh and the KPK do not possess these important products, the sources claimed.
Also, the shortage of lifesaving biological products both at government and private institutes has been reported, the sources added.
The products include vaccines for rabies, tetanus, pneumococcal, typhoid; recombinant biologicals (erythropoietin, hepatitis B vaccine); plasma-derived products (tetanus immunoglobulin, rabies immunoglobulin, anti-D immunoglobulin, intravenous immunoglobulin, albumin); equine/rabbit serum products (rabies antiserum, anthithymocyte globulin, anti-snake venom serum); oncology (monoclonal antibodies); cardiology (heparin, streptokinase); insulin and many more.
"The vaccine for rabies is not available at the hospitals in the KPK while hundreds of angina patients there seriously need Heparin," said the source.
Besides, added the source, dialysis patients in KPK are also in a dilemma since they need drugs for their protein requirements after dialysis sessions.
Moreover, added the source, shortage of tetanus vaccine, which is produced locally, has also been reported since its release also requires approval by the NCL.
The source said that the companies will need three days to market the backlog of the products even if the government gives release orders immediately.
"As many as 25 applications are submitted to the NCL everyday, but bureaucratic hurdles delay arrival of the products in the upcountry," said the source.
The source said that the importing companies will have to make fresh orders for the biological products after the approval so that they can reach Pakistan in the next six months.
"These companies prefer imported products because they go through trials under the WHO guidelines," said the source.
In this regard, the Pakistan Chemists and Druggists Association also wrote a letter to the chief executive officer of the Drug Regulatory Authority of Pakistan.
"In the light of the extremely difficult situation the country is going through, we cannot afford to withhold supplying lifesaving biological products to the market due to lack of Lot releases from the NCL. We urge you to urgently look into this matter and streamline the issuance of all pending and new lot release applications being submitted to the NCL," said the letter.
The association stated that they understand that there is currently no signing authority to process these pending applications therefore expect DRAP's earliest possible action in this matter.