Business Recorder
KARACHI: In a historical development, a Pakistan-based pharmaceutical company has secured the prestigious PIC/S recognition for having matched global quality standards for producing medicines in injection form and eye drops in line with the international benchmarks, claiming to become the first company in the country to receive the international accreditation for its sterile manufacturing facility. The global certification has opened doors for the company to expand its circle of exports to regulated high-end markets including Malaysia, Africa, Central Asia and ASEAN countries from Pakistan. ATCO Group says it is the first and only pharmaceutical company in Pakistan to have its sterile manufacturing facility compliant with internationally harmonized PIC/S GMP standards. PIC/S is the world’s gold standard in pharmaceutical inspections, uniting over 50 regulators from all developed countries globally to ensure one language of quality, the company said. FDA, WHO, European Union and MHRA of England are a few other globally renowned accreditation bodies in pharmaceutical industry at world across. There is marginal difference in guidelines for quality production among them. Talking to Business Recorder , Drug Regulatory Authority of Pakistan (DRAP) Chief Executive Officer Dr Obaidullah Malik confirmed the company has received the international recognition recently, projecting this will help the country boosting its export of pharmaceutical products and medical devices beyond the current $1 billion a year. DRAP’s laws have been amended and the authority has started a structured programme for the purpose of global accreditation and implementation by regulatory authority. The structured programme facilities both companies and regulatory authority for international accreditations, he added. Atco Laboratories Group Head Pharma Development Dr Munir Anwar said “Malaysia PIC/S has certified our sterile manufacturing facility [that is used to manufacture injections and eye drops]. We have already exported two consignments of the certified products to Malaysia since the recent certification.” The Malaysian accreditation has certified the firm to expand its circle of export to more than 50 countries that are part of the PIC/S framework, in addition to Malaysia. “The certification confirms that we meet the technical criteria required by all PIC/S member countries. However, to eventually export to each of the more than 50 countries, we will still need to register our products, submit dossiers separately in every market, and fulfil their specific regulatory requirements as well,” the company representative said. Initially, the company targets to export the certified products to Malaysia, Africa and Central Asia. “Our next target is European Union and MHRA of England. We are working on that,” Dr Anwar said. The production of sterile and injection remains highly technical field in pharmaceutical manufacturing. Their making demands a highly specialized environment. While, the PIC/S guidelines are so strict and number of requirements are also high, he added. Previously, according to industry officials, six pharmaceutical companies operating in Pakistan obtained PIC/S recognition. These firms were exporting their certified products including medicines in capsule, tablet and syrup forms to highly regulated markets. Besides, the country also has one WHO-prequalified pharmaceutical company and another accredited by MHRA of England, both of which were exporting their products to high-end markets across the globe. Estimates suggest some 10 other pharmaceutical firms are preparing for global accreditation including from PIC/S, WHO, MHRA of England, European Union and FDA. This will help boosting Pakistan’s pharmaceutical exports significantly. Pakistan’s pharmaceutical exports growth hit a two-decade high of 34% in the fiscal year ended June 30, 2025, securing the fifth position among the fastest-growing export categories in the country with sales of the locally produced medicines rising to USD457 million in overseas markets in FY25. Copyright Business Recorder, 2026
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