KARACHI: Drug Regulatory Authority of Pakistan (DRAP) has exempted the Alternate Medicines and health products till December 2015 from provisions of section 7 read with sub clause VII of clause ‘a’ of sub section (1) of section 23 of Act of 1976, an official gazette notification issued on Monday, October 12 said.

The notification acknowledges the complication due to the policy of DRAP as it says that “Authority” has received thousands of applications for the enlistment of manufacturers, contract manufacturers, importers and producers but unable to entertain the same due to “ human resources and capacity issues to process “ and decide the same. This in turn resulted in the non availability of the said medicines and products for the general public.

The exemption was however conditional making the importer responsible for quality, efficacy and safety of the alternative medicine and health products, to immediately recall defective medicines from the market under report to DRAP.

DRAP earlier through a public notice informed that Alternative medicines including homeopathic, Unani, Ayurvedic, Biochemic ,Chinese or any other system of treatment have been brought under the regulatory control of the DRAP and that manufacture and market authorization has become mandatory. The said notice made the clearance certificate necessary for release of imported consignment. The chemicals required for the manufacture of  bulk drugs being allopathic raw materials were exempted.

As a result of confusion created by the different public notices and letters, consignments worth billions of rupees were stuck up and piled up at which Collector Custom, MCC East Abdul Majid Yousafani wrote a letter addressed to the Assistant Drug Controller (I & E) of DRAP in which stating legal position DRAP was informed that  a prior permission (clearance certificate and drug import license) is required only on import of the active allopathic ingredients having therapeutic and prophylactic effect imported for the manufacture of pharmaceutical products and not for Alternative medicines.

The legal position taken by the Pakistan Customs Karachi forced the DRAP to lift the ban and announce exemption for clearing of piled up consignment. The problem is likely to recur in first quarter of 2016. The industry sources and importers believe that the exemption is likely to be extended beyond December 2015 as this benefits a few in DRAP.