ISLAMABAD: Most of the functions assigned to the Drug Regulatory Authority of Pakistan (Drap) have never been performed,according to the agenda for the authority’s next meeting.

The regulatory authority was established under the Drap Act 2012 in order to provide effective coordination for the enforcement of the Drugs Act 1976 and to bring harmony in inter-provincial trade and commerce of therapeutic goods.

According to a letter sent by the director health to the Drap CEO and other officials, and available with Dawn, the management of the authority has been informed that since the promulgation of the Drap Act, the functions of the authority have not been invoked in the form of guidelines, specifications, rules and regulations.

The letter goes on to say that there is a need to look into the licensing and manufacturing of therapeutic goods, drug specifications and laboratory practices, determining standards for biological manufacturing and testing.

Drap CEO Dr Mohammad Aslam says he has sought proposals from all directors regarding the deficiencies

The implementation of internationally recognised standards such as good laboratory practices, good manufacturing and cold chain management, stability studies about medicines and anti-spurious codes and other steps as per WHO recommendations also need to be examined, the letter says and suggests the regulation of advertisements and a ban on false adverts.

The letter says that the use of central research funds should be ensured and marketing practices should be regulated, the rational use of drugs and ethical criteria for the promotion of therapeutic goods in line with international practices be ensured.

The letter says that a code of conduct for the authority, under section 6(1), has not been finalised and needs to be considered.

An official of the National Health Services ministry said that under section 6(1), Drap’s boards and committees had to be completed, which they could not be due to the lack of staff.

“The major work which Drap has done is to prepare regulations for service rules, but some of the employees went to the Islamabad High Court about it, due to which the process had to be stopped,” he said.

“The authority’s functions are non-existent. The Punjab government started a crackdown against manufacturers of substandard drugs and other issues, but all the suspects will get out on bail due to the non-existent functions of the authority,” he said.

“Our medicine exports have dropped from $220 million per year to $200 million a year and there are some speculations that they amount to $180 million. We do not have a single US Federal Drug Authority (FDA) approved factory in Pakistan and we have been earning a bad name for ourselves,” he added.

Drap CEO Dr Mohammad Aslam said he had sought proposals from all directors regarding the deficiencies which he had assured them he will remove.

“We have made a lot of improvement and have been registering medicines. We want to regularise advertisements but the matter is pending with the federal government. The process for registering medicines has improved and as soon as we have all directors, we will remove all deficiencies. We have held 40 meetings of the authority and are revising the conflict of interest,” he said.

Secretary Ministry of National Health Services (NHS) Ayub Sheikh said departments take time making and need years to evolve and that the process of appointing 150 people was about to be completed.

“We have spent Rs254 million in the current year for research and soon, we will have WHO approved laboratories and FDA approved factories in Pakistan,” he said.

Published in Dawn, December 1st, 2016