Drap approves 106 product enlistment applications

The Drug 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 the DRAP spokesman, the decision was taken at the DRAP's 35th meeting of Enlistment Evaluation Committee (EEC) to make decision on 166 product enlistment applications of local manufacturers and importers which were presented for consideration by the committee.
The authority has also deferred 24 applications for 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 enlistment of local manufacturer and six cases of importers were also considered and approved.
He said that meetings of EEC were being held on 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 the 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 are a complex subject and are being regulated in low and middle income countries gradually. He added that the Division of Health and OTC were struggling to regulate these medicines as per SRO 412(I).
He said that it is the main priority of the division to provide safe, effective and quality herbal and Unani medicines with rational use at patient doorsteps. In a short period of three year, the Division of Health and OTC issued 727 enlistment numbers to local and foreign manufacturing firms.
He said that the division is committed to facilitating all those firms which intend to export to provide no objection certificate (NOC) within one to three days. Those culprits found to manufacture substandard herbal medicines will be dealt with an iron hand. He said that the DRAP is regulating alternative medicines including Unani, herbal and nutraceuticals for the first time in the country.