Over 1000 FIRs lodged against culprits involved in counterfeit medicines: DRAP

Islamabad: During the last three years, 1,018 FIRs have been lodged and fines worth Rs203.63 million charged to culprits involved in the business of counterfeit, spurious and falsified drugs, the CEO of the Drug Regulatory Authority Pakistan (DRAP) Aslam Afghani informed the media here Thursday.

“Around 53,371 samples were collected and analysed and a cumulative fine of Rs203.63 million imposed, with 1,018 FIRs launched against culprits during 2015-2017,” Aslam Afghani stated at a press conference convened to highlight DRAP’s achievements over the last three years.

The CEO cited examples of how DRAP has strived to improve regulatory functions in line with its mandate under the DRAP Act 2012. Some of the strategic outcomes listed by him included efficient drug registration, better market surveillance to stop counterfeit, spurious and falsified drugs and therapeutic goods, and preparation and implementation of new regulations.

The CEO said new drugs for treatment of Hepatitis-C have been registered and a new policy for orphan and critically needed drugs has been developed. “In accordance with Drug Pricing Policy 2015, MRPs of 192 new drug formulations and 198 additional packs of registered drugs were determined in 2016. Similarly, in 2017, the government granted approval of 113 cases of fixation of prices of new drug formulations and 132 additional packs of registered drugs. New initiatives of costing and pricing haves been made by incorporating strict punishment to control black marketing and overcharging on drug prices by amendments in schedule II and III of DRAP Act, 2012,” the CEO stated.

The CEO informed the media that it’s Registration Board has conducted 32 meetings in the last three years and granted registration to about 12,000 products for various drugs. Furthermore, the pace of review and consideration for registration of drugs has been brought at par with international practices, leading to approval of 67 new manufacturing licenses and 142 new/additional sections for pharmaceutical drug manufacturing. Moreover, 44 new sites for establishment of drug manufacturing units and 214 building layout plans for expansion of pharmaceutical units were approved in 2017, he added.

The Central Drug Laboratory (CDL) has developed a Quality Management System and has completed the first round of proficiency testing in June 2017, with the second round under process. CDL, Karachi, he stated, will acquire the status of WHO Prequalified Lab by end-2018.

The CEO also stated that the enlistment and registration process of medical devices is being carried out through an online database system, which enables firms to submit their applications electronically. An online registry for cardiac stents has been established to ensure tracking of stents from importation till usage in the Catheter Lab, he concluded.