Drug Regulatory Authority of Pakistan (DRAP) rejects reports of Transparency International (TI) which has levelled incorrect and baseless accusations, the regulator said in a statement issued on Monday.
Drap said that although TI has already appreciated the working of the authority, some of the people with vested interests have misguided it after countrywide campaign for eradication of unregistered and spurious drugs, the statement said.
Hundreds of FIRs have been registered against the manufacturer and sellers of unregistered and spurious drugs, it said.
It is also important to state that Health and OTC Division of Drap has enlisted more than 735 manufacturers and importers in a short span of three years.
The facts have been misrepresented and exaggerated. Initially, 3,500 manufacturers and importers and contract givers applied for the grant of enlistment under the Alternative Medicine and Health Products (Enlistment) Rules, 2014.
Almost 2,500 applications of various firms were rejected due to non-compliance to the stipulated rules. After the rejection of applications of firms, their product applications also stand rejected.
Product applications are also being processed on priority basis. Those fulfilling the prescribed criteria are placed before the Enlistment Evaluation Committee (EEC) and if approved are granted product enlistments accordingly.
It is also important to mention that majority of the applicants file incomplete applications though they are properly guided by the technical staff of the division to complete the prescribed criteria. Contrary to the complaint, TI has acknowledged the working of Health and OTC Division and they have written to the provincial chief ministers for implementation of rules at provincial level. Uniform policy has been adopted by the Drap.
Allegations of corruption and pendency of 40,000 applications were frivolous, baseless and Drap rejects them.
Likewise, Drap entertains applications of NOC and Free Sale Certificates on priority basis provided the codal formalities are complete in all respect. It is also false that clear guidelines have not been provided for the guidance of industry people. All the relevant rules, forms, SOPs, checklists and minutes of the meetings have been uploaded on Drap’s website.
To discourage exploitation by unscrupulous elements, an assistant director has been deputed to guide the applicants on the spot on regular basis.
Published in The Express Tribune, June 12th, 2018.