ISLAMABAD: Drugs Regulatory Authority of Pakistan (DRAP) Wednesday approved 106 product enlistment applications of nutraceuticals and 21 herbal and Unani from local manufacturers and importers.
According to DRAP spokesman, the decision was taken in DRAP’s 35th meeting of Enlistment Evaluation Committee (EEC) to make a decision on 166 product enlistment applications of local manufacturers and importers which were presented for consideration of the committee.
The authority has also deferred 24 applications for the fulfilment of prescribed criteria while 10 applications were deferred for product specific inspection (PSI), and five applications were rejected by the committee.
Two cases for the enlistment of the local manufacturer and six cases of importers were also considered and approved.
He said that meetings of EEC were being held on a weekly basis and product applications were also being processed on priority, those fulfilling prescribed criteria were placed before the Enlistment and Evaluation Committee (EEC) and if approved granted product enlistment accordingly.
He made it clear that incomplete applications could not be granted approval under the rules and hence such applications were rejected if the applicants fail to complete it despite reminders.
He said that the traditional medicines were a complex subject and is regulated in low and middle-income countries gradually.
He added the division of health and OTC was struggling to regulate 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.
He added that it was the main priority of the division to provide safe, effective and quality herbal and Unani medicines with rational use at the patient’s doorstep. In a three year short period, the division of Health and OTC had issued 727 enlistment numbers to local and foreign manufacturing firms.
He said that the division was committed to facilitate 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.
He said that the DRAP was regulating alternative medicines including unani, herbal and nutraceuticals for the first time in the country.