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October 22, 2020

WHO-approved PDTRC gets licence to act as bioanalytical lab

National

October 22, 2020

LAHORE: The Drug Regulatory Authority of Pakistan (DRAP) has issued licence to Pakistan Drug Testing & Research Center (PDTRC) Lahore to act as bioanalytical laboratory – a step towards ensuring medicines and vaccines meeting international standards.

The DRAP issued licence to PDTRC to act as Contract Research Organisation after World Health Organisation (WHO) approved it as its newly prequalified quality control laboratory in Pakistan. According to WHO, Pakistan Drug Testing & Research Center PDTRC, Lahore, Pakistan is the 50th QCL to achieve prequalification and the first government laboratory in Pakistan to be prequalified.

The PDTRC, Punjab, was established as the first state-of-the-art research centre in government sector under the umbrella of Punjab Industrial Estates Development and Management Company (PIEDMC) in Sunder Industrial Estate, Raiwind, Lahore. It was aiming to acquire DRAP licence after international prequalification by WHO.

The DRAP notification on 19.10.20, appointed former chief drug controller Punjab Dr Zaka-ur-Rehman – the approved expert – to head the laboratory.

According to a notification, the licence shall be valid for a period of three years from the date of issue unless earlier suspended or cancelled.

The licencee shall maintain the conditions of GCP and GLP; minimum safety standards shall be observed by the licencee; licence holder shall develop protocols or Standard Operation Procedures (SOPs) for the conduct of studies or trials and get formal approval from the DRAP; and the licence holder shall maintain adequate arrangement for storage of the study material as per protocol of the study.

The Drug Lawyers Forum (DLF) and Young Pharmacists Association (YPA) have welcomed the issuance of licence to the Pakistan Drug Testing & Research Center (PDTRC), Lahore, to act as bioanalytical laboratory in the public sector. “It will enable Pakistan to test biological drugs and vaccines, such as Interferon and polio vaccine, for the first time in public sector, which will not only ensure uniform standards but also quality medicines to the people in the country,” said Noor Muhammad Mehar, chairman DLF, in a statement Wednesday. Previously, he said there was only one WHO’s prequalified bioanalytical laboratory in the private sector. He said the lab will enable to conduct bio-equivalence study locally to ensure international standard of all medicines and vaccines in the country.