CEO DRAP shared performance of various DRAPs divisions viz. licensing, registration and pricing

August 09, 2016

 Islamabad, August 9, 2016: A meeting of National Assembly’s standing committee on Health was held in the Committee room of M/o National Health Regulation, Services and Coordination under the Chairman ship of Mr. Kahlid Hussain Magsi. Ms. Saira Afzal Tarar, Minister of State; Mr.Ayub Shaikh, Secretary and Dr.Muahmmad Aslam Chief Executive Officer (CEO), Drug Regulatory Authority of Pakistan (DRAP) also attended the meeting. The Committee offered fateha for victims of Quetta bomb blast.

CEO, DRAP gave a detailed presentation on working of DRAP. He briefed that after promulgation of DRAP’s Act, 2012, necessary legislation has been done for regulating Health & Over The Counter drugs, Medical Devices and Medicated Cosmetics and pharmaceutical products. He shared performance of various DRAP’s divisions viz. licensing, registration and pricing and shared that despite of human resource constraints, performance of these divisions have been increased. He also informed that World Health Organization has conducted initial assessment of DRAP and in 2017 Central Drugs Testing Laboratory, Karachi will be WHO pre-qualified and accredited laboratory. To further strengthen inspection system of pharmaceutical manufacturing units, DRAP has started working with Pharmaceutical Inspection Co-Operation Scheme (PIC/S), Australia and planning for further training of DRAP’s officers for effective implementation of Good manufacturing Practices in pharmaceutical manufacturing units. Moreover in order to further strengthen pharmaceutical registration system, DRAP will start receiving registration applications on Common Technical Document format in early 2017. It will further help in increasing national pharmaceutical exports, which are otherwise decreasing.

CEO, DRAP shared that first time in history, a comprehensive Drug Pricing Policy has been approved in 2015 by the government, which was declared by independent analysts as fair, transparent and balanced policy with least discretionary powers. In this policy, annual price increase is linked with Consumer Price Index. Moreover, hardship category and orphan drug policy was introduced to provide solution for unfeasible and critically needed drugs. This policy is not only about price increase but for first time price reduction mechanism is also introduced. Some pharmaceutical companies have increased the prices of their drugs at their own and then got stay orders from Sind High Court, Karachi. DRAP is vigorously following these cases in higher courts and has requested the courts for early fixation of dates for disposal of the cases. Moreover, the government has also drafted legislation for imposing punishment and fine for unauthorized increase in prices of drugs by pharmaceutical companies.

In order to curb the menace of spurious drugs, DRAP has decided to introduce bar coding system first time in the country as in developed world and legislation for this purpose will be finalized soon. CEO briefed that recruitment process in various cadres of DRAP has been finalized and soon we will have new human resource in the organization for more speedy work.

Meeting of National Assembly’s standing committee will further continue for coming 2 days and will also discuss other matters related to DRAP and National Health Regulation, Services and Coordination.