Body to check drugs’ quality to be set up

Published October 21, 2002

ISLAMABAD, Oct 20: The government will set up Pharmaceutical Quality Control Authority (PQCA) to check quality of drugs and make recommendations to the federal and provincial control boards for further improvement in this regard, sources told Dawn.

The body will have a chairman for a two-year term and will not be eligible for re-nomination, the sources said.

They said the amendment in the Drugs Act 1976, for setting up of the authority, had been sent to the law division for vetting. They further said the cabinet, in its recently-held meeting, had agreed in principle to approve the proposed amendments and, after due vetting, would be submitted to President Gen Pervez Musharraf for signature.

They said the cabinet, considering the proposals submitted by the health ministry on amendments in the Drugs Act 1976, approved the draft Drugs (Amendments) Ordinance, 2002.

According to the amended act, a new section 10(A) has been added to the Drugs Act 1976, allowing the setting up of the PQCA.

The authority would comprise representatives of the federal and provincial governments with prescribed qualifications and expertise in evaluating the quality control of drugs and medical devices, it said.

The authority will also deal with matters arising out of the administration of this act, standardising the test and analytical methods for drugs to be used in quality control laboratory, besides conducting an annual validation of all instruments in the laboratories and upgrade them if required.

The authority, according to the amended drug act, will conduct training programmes to update government analysts and to improve their knowledge on the latest analytical methods and technology and perform other functions in such a manner as permissible under this act.

It further added that members of the central licensing board would be accountable to the federal government for all its proceedings and would publish a monthly report of their meetings and decisions taken.

The appellate board of the authority will meet atleast once every month, and will decide any appeal filed before it within 60 days of its filing.

The sources also added that the cabinet had also empowered the health ministry to hear appeals against pricing of registered and new drugs by the pharmaceutical companies.