ISLAMABAD: Drug Regulatory Authority of Pakistan (DRAP) recently launched an online application management system to ensure accountability, quality and transparency.
The system, named Pakistan Integrated Regulatory Information Management System (PIRIMS), has been developed with the support of United States Agency for International Development (USAID) and will ensure online linkage of pharmaceutical companies and applicants with DRAP.
"It is a paradigm shift and DRAP has presented itself for accountability. Now representatives of companies do not have to come to the office, they just have to apply online for the licences, registration and inspections of pharmaceutical units. The system will provide paperless environment and applicants will be able to monitor their applications by themselves," DRAP Chief Executive Officer, Dr Asim Rauf told a local newspaper.
Replying to a question, he said four months training programme was also launched in Lahore and Karachi to acquaint companies with the new system.
"We have also introduced a helpline for applicants who can contact DRAP in case of any confusion. This system is of paramount importance for improving the functions of the authority and will promote transparency."
Besides, enhancing the efficiency of DRAP's operation, this system has been designed to monitor the performance of officers and staff.
"PIRIMS was developed during the last two years and multiple tests runs have been performed on it. It has all the features in line with the best international regulatory practices," he said.
Speaking at the launching ceremony, Special Assistant to the Prime Minister (SAPM) on Health Dr Faisal Sultan said it was the responsibility of the regulator to ensure quality and safety of medicines.
"We cannot ensure quality and affordable medicines as long as we do not make things easy for the industry. Now companies will be able to trace the applications and ultimately the general public will be the beneficiary as they will get quality medicines," he added.
Former special assistant on health Dr Zafar Mirza, who initiated the process of PIRIMS, said the new system would protect and promote public health in a better way.
Pakistan Pharmaceutical Manufacturers Association, Chairman, Touqeer ul Haq said it was a great initiative as the industry used to run after files, and in a number of cases, the files went missing.
Later, talking to a local newspaper, Mr Haq said it was a state-of-the-art system and hoped that the process of registration would be expedited.
Chief of Party of Promoting Quality of Medicine Pulse (PQM+) Pakistan Activity, Dr Khalid Saeed Bukhari said due to the system it had become possible for the applicants and management to know when the application was filed.
"Application for the Actemra drug (which is being used against COVID-19) was filed with the department in 2009 and the medicine was registered in 2016. One can imagine how much time and resources of the company were wasted due to delay in registration," he said.
The representative of USAID, Micheal Nehrbass said that agency would continue to provide technical assistance to ensure quality medicine and discourage spurious medicines.
The system, named Pakistan Integrated Regulatory Information Management System (PIRIMS), has been developed with the support of United States Agency for International Development (USAID) and will ensure online linkage of pharmaceutical companies and applicants with DRAP.
"It is a paradigm shift and DRAP has presented itself for accountability. Now representatives of companies do not have to come to the office, they just have to apply online for the licences, registration and inspections of pharmaceutical units. The system will provide paperless environment and applicants will be able to monitor their applications by themselves," DRAP Chief Executive Officer, Dr Asim Rauf told a local newspaper.
Replying to a question, he said four months training programme was also launched in Lahore and Karachi to acquaint companies with the new system.
"We have also introduced a helpline for applicants who can contact DRAP in case of any confusion. This system is of paramount importance for improving the functions of the authority and will promote transparency."
Besides, enhancing the efficiency of DRAP's operation, this system has been designed to monitor the performance of officers and staff.
"PIRIMS was developed during the last two years and multiple tests runs have been performed on it. It has all the features in line with the best international regulatory practices," he said.
Speaking at the launching ceremony, Special Assistant to the Prime Minister (SAPM) on Health Dr Faisal Sultan said it was the responsibility of the regulator to ensure quality and safety of medicines.
"We cannot ensure quality and affordable medicines as long as we do not make things easy for the industry. Now companies will be able to trace the applications and ultimately the general public will be the beneficiary as they will get quality medicines," he added.
Former special assistant on health Dr Zafar Mirza, who initiated the process of PIRIMS, said the new system would protect and promote public health in a better way.
Pakistan Pharmaceutical Manufacturers Association, Chairman, Touqeer ul Haq said it was a great initiative as the industry used to run after files, and in a number of cases, the files went missing.
Later, talking to a local newspaper, Mr Haq said it was a state-of-the-art system and hoped that the process of registration would be expedited.
Chief of Party of Promoting Quality of Medicine Pulse (PQM+) Pakistan Activity, Dr Khalid Saeed Bukhari said due to the system it had become possible for the applicants and management to know when the application was filed.
"Application for the Actemra drug (which is being used against COVID-19) was filed with the department in 2009 and the medicine was registered in 2016. One can imagine how much time and resources of the company were wasted due to delay in registration," he said.
The representative of USAID, Micheal Nehrbass said that agency would continue to provide technical assistance to ensure quality medicine and discourage spurious medicines.
-MN Report