ISLAMABAD: Drug Regulatory Authority of Pakistan (Drap) on Thursday registered 127 medicines, deferred 34 cases and rejected five applications.

“The applications were rejected or deferred because they were incomplete or the drug composition was wrong. Besides, they did not give the name of manufacturers and the margin of safety was less,” spokesperson for Ministry of National Health Services Sajid Shah said while talking to Dawn.

According to a statement the 35th meeting of Enlistment Evaluation Committee (EEC) was held under the Chairmanship of Director Health and over the counter (OTC).

“Total 166 product enlistment applications of local manufacturers and importers were presented for consideration of the committee. Out of 166 applications, 106 applications of nutraceuticals and 21 applications of herbal/Unani were approved and 24 applications were deferred for fulfillment of prescribed criteria, 10 applications were deferred for product specific inspection (PSI), and five applications were rejected by the committee. Moreover, two cases for enlistment of local manufacturer and six cases of importers were also considered and approved,” it stated.

The Drap spokesperson said meetings of EEC were being held on weekly basis. Product applications are also being processed on priority.

Those fulfilling prescribed criteria are placed before the EEC and if approved granted product enlistment accordingly.

Incomplete applications could not be granted approval under the rules. Such applications are rejected, if the applicants fail to complete it despite reminders.

He further said that the traditional medicine was a complex subject and being regulated in low and middle income countries gradually.

Division of Health and OTC is regulating these medicines as per S.R.O. 412(I) Alternative Medicines and Health Product (Enlistment) Rules, which was an unregulated sector being a country having 210 million population.

Drap said that it is the main priority of the Division is to provide safe, effective and quality herbal/Unani medicines with rational use at patient door step.

Division is committed to facilitating all those firms which intend to export to provide No Objection Certificate within one to three days.

Those culprits found to manufacture substandard herbal medicines will be dealt with iron hands.

Published in Dawn, June 14th, 2018