127 alternative medicines get approval from DRAP

ISLAMABAD: The drug regulator has approved the enlistment of 127 nutraceuticals and herbal medicines.

Nutraceuticals are products that serve as nutrition supplements and have medicinal benefits, including the prevention and treatment of diseases.

Spokesperson of Drug Regulatory Authority of Pakistan (DRAP) said that the 35th meeting of Enlistment Evaluation Committee (EEC) was held with the director of the Division of Health and Over The Counter Markets (OTC) in the chair.



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 medicines were approved and 24 were deferred for fulfillment of prescribed criteria.

Besides, 10 applications were deferred for product specific inspection (PSI), and five applications were rejected by the committee. Two cases for enlistment of local manufacturer and six cases of importers were also considered and approved.

Moreover, Drap said that meetings of EEC are being held on a weekly basis. Product applications are also being processed on a priority basis, those fulfilling the required criteria are placed before the EEC and if approved granted product enlistment accordingly. It is clear that incomplete applications could not be granted approval under the rules and hence such applications are rejected, if the applicants fail to complete them despite reminders.



Drap further said that traditional medicine is a complex subject and is being regulated in low and middle income countries gradually. Division of Health and OTC is regulating these medicines as per SRO 412 (I) Alternative Medicines and Health Product (Enlistment) Rules, which was an unregulated sector being a country having a population of 210 million.

Published in The Express Tribune, June 14^th, 2018.