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ISLAMABAD: Pakistan’s pharmaceutical industry exports have reached $325 million owing to enabling business environment and within the next few years exports will further grow as the authorities are taking additional steps in facilitating the sector.

This was stated by Asim Rauf, the chief executive officer (CEO) of the Drug Regulatory Authority Pakistan (DRAP), while talking to Business Recorder, here on Friday on the side-lines of an event. The DRAP chief further said that the authority with the active cooperation of the pharma industry has overcome the shortage of Panadol and other pain relief tablets which are now available across the country.

Earlier, Pakistan Single Window (PSW) and the DRAP signed a memorandum of understanding (MoU) to further expand their partnership for trade facilitation through the integration of cross-border business processes of the DRAP. The integration of the DRAP systems under the PSW will provide the electronic submission, processing, and issuance of licenses, imported products (drugs, medical devices, health, and over-the-counter products),no objection certificates (NOCs), and other certificates, as prescribed for specified products falling under the DRAP’s regulatory jurisdiction.

The DRAP CEO, Rauf, said, “DRAP is mandated for effective coordination and enforcement of the Drugs Act, 1976 to regulate the manufacture, import, export, storage, distribution, and sale of therapeutic goods in the country. Integration with the PSW system will provide DRAP to get better visibility of all import and export transactions and help improve its control measures while facilitating trade through the implementation of the integrated risk management system, digital payments, and electronic integration with labs and other relevant service providers. Going forward, the system will also provide an interface for the electronic receipt of commercial documents attested by Pakistani missions abroad to mitigate fraud risks and save time and cost of doing business”.

Pharmaceutical industry meets 95pc of country’s needs: PPMA

Rauf said that DRAP, in 2019, started digitally transferring manual data of the past 10 years containing 4.2 million files and now it was the first public-sector organisation having the capacity to perform duties from anywhere in the world. He said that the digitalisation will help save millions of dollars to the stakeholders as well as speeding up all the processes from registration to licensing.

Speaking on the occasion the CEO PSW, Syed Aftab Haider, said, “The pharmaceutical industry has long been identified as a priority sector by the government due to its size and contribution to the national economy and its potential for exports. Integration with the PSW system will help the pharmaceutical industry to reduce its time and cost of trading across borders by adopting the best practices in customs and regulatory clearances centered around technology and digitization of procedures and information requirements”.

The MoU signing ceremony marked the integration of DRAP under the PSW system that will help stakeholders in the clearance of pharmaceutical raw materials, products, and devices for imports and exports. Under the initiative, extensive business process reengineering of DRAP’s cross-border trade has been carried out, resulting in the redesign of 31 processes and the digitization of 56 paper-based documents. Going forward, the system will create the enabling environment for further digitization of DRAP’s back-end processes.

The PSW allows parties involved in trade and transport to lodge standardized information and documents with a single-entry point to fulfil all import, export, and transit-related regulatory requirements. The PSW system helps to reduce the time and cost of doing business by making trade-related business processes more efficient, transparent, and consistent. The PSWC is enabling Pakistan to better integrate into the global value chains and become part of evolving regional and global single windows.

This MoU is aimed at enhancing cooperation between two departments through digital integration of the IT System of the PSW with the regulatory process of the DRAP. This will enable the therapeutic goods industry to utilize an integrated electronic platform for the import and export of raw materials and finished products using a single entry point.

The PSW will support the international trade of therapeutic goods by recognising standardised information and documents on an online platform that will fulfil all import, export, and transit regulatory requirements.

Copyright Business Recorder, 2022

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Abid Hafeez Nov 12, 2022 12:13pm
There is no FDA approved factory in Pakistan as per my knowlege. We buy a lot of API's and other RM's from all over the world and cannot buy from Pakistan due to this issue. The USA market is the biggest and the most lucrative market in the world which Pakistan pharma industry is missing out on.
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Prashant Nov 12, 2022 04:21pm
Pakistan pharmaceutical industry totally comprises of formulations production which is glorified operation of mainly Chinese tablet & capsule machines. All important inputs like actives, excipients and often even packing materials are imported. Local value add is restricted to cheap labour and government subsidies.
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