ISLAMABAD - The Pakistan Pharmaceutical Manufacturing Association (PPMA) on Tuesday urged the Drugs Regulatory Authority of Pakistan (DRAP) to urgently approve the import of raw material from India to avoid the shortage of essential medicines.
Earlier, the PPMA had urged the Prime Minister (PM) for fast track registration of COVID-19 treatment drugs.
Now, a letter written to Chief Executive Officer (CEO) DRAP AsimRauf by PPMA asked to approve the API’s (raw material) from India.
The letter issued said that “it refers to PPMA letter No. PPMA/CEO (DRAP)/ 2020/258, May 21,2020 & subsequent reminder on June 5th 2020 regarding subject cited matter.”
The letter said that it has been revealed that APIs imported from India till June 12th have been allotted NOC only. However, API reached on ports after June 12th 2020 are yet to be cleared.
“You are well aware that API’s lying on ports may lose their shelf life in this hot temperature. Besides, the same will lead to severe shortages of essential medicine consequently.
PPMA said that in the absence of raw material, pharmaceutical industry is bound to shut down operation and shall not be responsible for shortages of essential medicines in the country and all the liability shall be on DRAP shoulders thereby.
Earlier, the PPMA also urged the Prime Minister (PM) Imran Khan for fast track approval of drugs needed in the current novel coronavirus (COVID-19) pandemic situation.
The pharmaceutical association in a letter written to the PM has asked for the fast registration of drugs Remdesivir and Faviipiravir.
The letter written said that PPMA would like to acknowledge the efforts of DRAP in expediting the process for approval of drugs that are required immediately to cope-up with the situation of Covid-19 pandemic in our country.
It further said that currently, Pakistan in particular and South-East Asia in general are facing the most critical time of this pandemic as the number of cases and mortality is rising on a daily basis with alarming trends.
The letter said “moreover, the most disturbing and concerning matter is that according to WHO and international health bodies, we have not yet reached our peak.”
“We are sure that like in the past, DRAP and other government health agencies will grant fast track registration of different anti-virals and other drugs to ensure their timely availability and access to all tiers of population in the country,” said PPMA in its letter written to PM.
It said that on behalf of PPMA, we again assure you to manufacture these urgently needed molecules with full compliance of quality parameters and guidelines, immediately after receiving their registration certification.
Meanwhile, Spokesperson Ministry of National Health Services (NHS) Sajid Shah in a statement issued had said DRAP has informed that registration letters for Remdesivir’s import and local manufacturing were issued, after fixation of price from the federal cabinet, for emergency use of this drug. Remdesivir was recently approved by the US FDA for emergency/compassionate use.
In a similar approval, DRAP authorised two importers and 14 local manufacturers for meeting the demands of the institutions and hospitals treating critically ill patients.
A statement said that registration letters are issued to importers and local manufacturers for making this drug available in sufficient quantities by a couple of weeks. This permission is granted with conditions that Remdesivir injection will not be placed in the open market and would be given to institutions and hospitals only. Local manufacturers having registration of Remdesivir will strictly monitor the clinical usage of this emergency use drug and report any unwanted effect to DRAP immediately.