Islamabad, June 11, 2018 (PPI-OT): Drug Regulatory Authority of Pakistan (DRAP) rejects reports of Transparency International has levelled incorrect and baseless accusations. It is pertinent to mention that the said watchdog has already appreciated the working of the DRAP including Health and OTC division. It transpires that some of the people with vested interests have misguided the Transparency international after country vide campaign of DRAP for eradication of unregistered and spurious drugs. Hundreds of FIRs have been registered against the manufacturer and sellers of unregistered and spurious drugs. It is also important to state that Health and OTC division has enlisted more than 735 manufacturers and importers in short span of three years.
The facts have been misrepresented and exaggerated. Initially, 3500 manufacturers/ importers and contract givers applied for the grant of enlistment under the Alternative Medicine and Health Products (Enlistment) Rules, 2014. Almost 2500 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 been 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. Who are properly guided by the technical staff of the division to complete the prescribed criteria? Contrary to the complaint, Transparency International 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 thousand applications are frivolous, baseless and rejected.
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 the notorious people, Assistant Director has been deputed to guide the applicants on the spot on regular basis.
More than 6000 products of various pharmaceuticals have been approved for grant of enlistment by the Enlistment Evaluation Committee (EEC) under the rules. Meeting of EEC are held on weekly basis. All the minutes, applications and Form-7 issued for product enlistment are being uploaded on the DRAP’s website to make the system more transparent. It is obvious that incomplete applications could not be granted approval under the rules and hence such applications are rejected if the applicant fails to complete it despite reminders.
The campaign against the unregistered and spurious drugs has also offended some of the people having vested interests. A number of FIRs have been registered and their premises sealed for violations of the DRAP Act, 2012. Even some of the firms have been found involved in manufacturing of allopathic drugs under the garb of alternative medicines. DRAP has discouraged the involvement of consultants and third parties who exploit the firms for their vested interests. It seems that Transparency International has been misguided by these people having vested interests. Consultants are under panic and making fabricated allegations to defame the DRAP in animosity.
For more information, contact:
Principal Information Officer,
Press Information Department (PID)
Tel: +92-51-9252323, +92-51-9252324
Fax: +92-51-9252325, +92-51-9252326