ISLAMABAD: Transparency International-Pakistan has pointed out irregularities in the Drug Regulatory Authority of Pakistan (Drap), creating panic in the Ministry of National Health Services (NHS).

A letter written to Secretary NHS Naveed Kamran Baloch and copies sent to the prime minister, chairman NAB, registrar Supreme Court and the chairman Senate (also available with Dawn), stated that Transparency had received a complaint about the performance of the directorate of health and OTC (over-the-counter). OTC medicines do not require the prescription of a doctor for purchase.

The letter said Drap Act was passed in November 2012 and the Alternative Medicines and Health Products (Enlistment) Rules on May 27, 2014, in consultation with all stakeholders and notified by the federal government.

Says since 2014 four directors were changed and due to unstable leadership no uniform policies could be formulated

Alternative system of treatment has been regulated for the first time in Pakistan and required periodic assessment and progress by the competent authority for immediate decisions.

The letter said the period of a former CEO was very problematic for Drap.

According to the Transparency letter written by a former judge of the Supreme Court, Zia Perwez, since 2014 four directors had been changed in Drap and due to the unstable leadership no uniform policies could be formulated.

“Approximately 30-40 thousand applications are pending for enlistment. There has been a drastic drop in export business due to the unnecessary delay in issuance of no-objection and free sales certificates.”

It alleged that because of the delaying tactics the door for massive corruption had been opened and those who applied for Form-7 (provisional certificate for enlistment of products) had to wait for long while certain “blue eyed manufacturers and importers” were issued the certificate allowing them to create a monopoly in the market.

The letter stated that selected manufacturers had been given Form-7 for all herbal, Unani and nutraceuticals. However, other manufacturers were being told to apply for only one section (herbal or Unani or nutraceuticals).

Assistant directors of health and OTC even refuse to accept the product dossiers (enlistment applications) without any reason which was against rules. Moreover, getting an NOC for grant of export permission takes two to three months as a result buyers refuse export orders due to which the country faced losses in the shape of foreign exchange.

The secretary NHS was requested to examine the complaints and take action. The letter claimed that Transparency International-Pakistan was striving for across the board application of rule of law which was the only way to stop corruption.

When contacted, spokesperson for the ministry of NHS Sajid Shah told Dawn that all allegations in the letter were baseless and it seemed some companies wanted to use Transparency International-Pakistan for their vested interests.

He said there were issues in 2013 but things had improved during the last four years.

There were around 14,000 pending applications but today there is no pending application. Drap takes just a few months to approve or reject an application, he added.

“We cannot allow any company to manufacture medicines without any check because it can compromise on the life and health of citizens. Things have improved and even the chief justice of Pakistan has observed that Drap is moving in a right direction,” he said.

In the past Drap used to hold meetings once in two months but now it meets every week to take decisions on applications for new products, he said.

Published in Dawn, June 9th, 2018