ISLAMABAD: Pakistan is facing serious shortage of pneumonia and influenza vaccines as the government failed to timely import the medicine putting lives of thousands of children at stake. The Special Assistant to the Prime Minister (SAPM) on National Health Services, Dr Faisal Sultan, in response to a question asked by Business Recorder here on Wednesday, while acknowledging the fact, said that the government did not take timely action as it was combating spread of the Covid-19.
He said that within the coming few weeks the situation would improve as the government had placed orders for the procurement of the vaccine. Responding to another question regarding further increase in drug prices, the SPAM said that the government had already increased the prices, and there was no such plan under consideration.
Earlier, speaking at the launch of Pakistan Integrated Regulatory Information Management System (PIRIMS) jointly organised by the Drug Regulatory Authority of Pakistan (DRAP), in partnership with the United States Agency for International Development (USAID), Sultan said that the health regulator of Pakistan was moving in the right direction. He said that the DRAP had adopted transparent policies for giving a better environment to all the stakeholders, adding that the government was introducing massive reforms in the DRAP.
He said that to facilitate pharmaceutical industry of the country the DARP had already introduced online application to ensure availability of quality medicines to the masses. He said that the introduction of online system in DRAP would help improve not only the capacity of the regulator but would also enable it to serve better to the stakeholders.
He added that entire record of pharmaceutical industry would be maintained by this system. Secretary National Health Services Aamir Ashraf Khawaja, who is also chairman Policy Board of DRAP, said that this new system was the ultimate platform for enhancing DRAP's efficiency through strict timelines and ease of doing business.
Asim Rauf, chief executive officer of DRAP, said that Pakistan Integrated Regulatory Information Management System (PIRIMS) was an online application management system which had been deployed for its testing in DRAP. He said that PIRIMS online system would ensure online linkage of pharmaceutical companies and applicants with the authority.
This system is of paramount importance for improving the functions of the DRAP and will promote transparency. Besides enhancing the efficiency of the DRAP's operation, this system has been designed to monitor performance of the DRAP's officers and staff.
He informed the participants that the PIRIMS was developed during the last two years and multiple tests runs had been performed on it. Trainings were conducted of DRAP's assessors and inspectors on PIRIMS as well as pharmaceutical companies in the first phase, he added. Applicants will now be able to see the progress made on their requests in real time throughout the application's life cycle.
Accordingly, regulatory correspondence related to shortcomings will also be performed electronically. The online application management system links the functions of licensing, registration, inspection, post-market surveillance, and pharmacovigilance on one platform.
Applicants can keep track of their applications for registration and licensing functions of therapeutic goods and manufacturers with realistic timelines. Speaking on the occasion he said, US government, launched an innovative online platform that will enable the Government of Pakistan to more quickly and effectively evaluate the safety and effectiveness of medicine, leading to greater health security in the country.
The Government of Pakistan and the United States, through the United States Agency for International Development (USAID), worked together to create the platform to comply with international pharmaceutical standards. The platform, called the Pakistan Integrated Regulatory Information Management System (PIRIMS), will integrate the registration, inspection, licensing, and monitoring of approved medicines.
With PIRIMS, regulators can more quickly and effectively monitor medicines in the development and approval processes, and pharmaceutical companies will be able to more quickly and easily apply for permission to produce a medicine. The USAID Deputy Mission Director Michael Nehrbass, speaking on the occasion, said that in the past, it could take several years and cost millions of rupees for a pharmaceutical company to register a drug; that time and cost will now be greatly reduced, allowing Pakistani companies to bring safe, effective medicines to market more quickly and less expensively.
He said that this partnership would allow Pakistan to increase its participation in the international pharmaceutical market and apply for Level Three Compliance with the World Health Organization's Global Benchmarking Tool, a globally-accepted model to evaluate the maturity of a country's regulatory framework.
He said, "We are pleased to partner with the Government of Pakistan to ensure this system complies with international standards, strengthening health services across the country."
He said that Pakistan already had one of the best laboratory networks in the region as a result of our work together, and the new capability would further lead to development and international investment in the pharmaceutical industry.
Copyright Business Recorder, 2020