Islamabad-Drug Regulatory Authority of Pakistan (DRAP) rejecting the Transparency International’s observations regarding misappropriations in the department said on Monday that the international watchdog has been ‘misguided’ by the people having vested interests.

An official said that a high level meeting was held here at Ministry of National Health Services Regulations & Coordination (NHSR&C) to look into the charges and observations made by Transparency International on the irregularities in DRAP.  The statement issued said that the facts have been misrepresented and exaggerated in the letter as initially, 3500 manufacturers and importers and contract-givers applied for the grant of enlistment under the Alternative Medicine & Health Products (Enlistment) Rules, 2014.

“Almost 2500 applications of various firms were rejected due to non-compliance to the stipulated rules,” the statement said.

NHS responded that allegations of corruption and pendency of 40 thousand applications are baseless and rejected.  Similarly, DRAP entertains applications of NOC and Free Sale Certificates on priority basis provided the codal formalities are complete in all respect.

More than 6000 products of various pharmaceuticals have been approved for grant of enlistment by the Enlistment Evaluation Committee (EEC) under the rules, said the NHS ministry.  The statement said that contrary to the complaint, Transparency International earlier acknowledged the working of Health and OTC Division and wrote to the provincial chief ministers for implementation of rules at provincial level. Hundreds of FIRs have been registered against the manufacturer and sellers of unregistered and spurious drugs. It is also important to state that Health & OTC division has enlisted more than 735 manufacturers and importers in short span of three years. 

Ministry said that product applications are also processed on priority basis and those fulfilling the prescribed criteria are placed before the Enlistment Evaluation Committee (EEC) and if approved are granted product enlistments accordingly.

The campaign against the unregistered and spurious drugs has also offended those having vested interests. A number of FIRSs 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 those having vested interests. Consultants are under panic and levelling false allegations to defame DRAP,” the statement said.

A former judge of Supreme Court Justice Zia Pervez from the Transparency International had written a letter on the performance of Directorate of Health and asked to take immediate action on alleged irregularities in DRAP.

The letter mentioned drastic drop in the export of medicines due to unnecessary delay in issuance of No Objection Certificate (NOC) and free sales certificate by the Drug Regulatory Authority of Pakistan.

International watchdog stated that about 30 to 40 thousand applications for medicines enlistment are pending with the department and NOC for grant of export permission takes two to three months which lead to refusal to the export orders by buyers, causing not only commercial loss but also loss for the country in shape of foreign exchange.

The international watchdog expressing serious concerns on the performance of the Directorate of Health alleged that the department could not provide clear directions for issuance of Form 7 related to the registration of the products.

In the letter it has been also observed that selected manufacturers have been given Form 7 for herbal, Unani and Nutraceuticals but now they are asking to submit an undertaking from manufactures that they will apply for only one section (Herbal, Unani or Nutraceuticals).