Pakistani pharma company secures PIC/S certification for sterile medicines facility

Pakistan-based ATCO Laboratories Group has obtained PIC/S certification for its sterile manufacturing facility, becoming the first company in the country to receive the accreditation for the production of injectable medicines and eye drops, Business Recorder reported.

The company said its sterile manufacturing facility has been certified under the internationally harmonised PIC/S Good Manufacturing Practice (GMP) standards, enabling the company to expand exports to regulated markets, including Malaysia, Africa, Central Asia and ASEAN countries.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international framework that brings together more than 50 regulatory authorities to harmonise pharmaceutical inspection and manufacturing standards.

Drug Regulatory Authority of Pakistan (DRAP) Chief Executive Officer Dr Obaidullah Malik confirmed that the company had recently secured the certification and said the development could help increase Pakistan's pharmaceutical and medical device exports beyond the current level of $1 billion annually.

He said DRAP had amended its regulations and launched a structured programme to facilitate global accreditation and compliance with international regulatory standards for both pharmaceutical companies and the regulator itself.

Head of Pharma Development at ATCO Group Dr Munir Anwar said the certification was granted by Malaysia's PIC/S authority for the company's sterile manufacturing facility used to produce injections and eye drops.

“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,” he said.

“Our next target is European Union and MHRA of England. We are working on that,” he added.

Industry officials said sterile pharmaceutical manufacturing remains one of the most technically demanding segments of the industry due to strict production and quality requirements.

According to industry estimates, six pharmaceutical companies in Pakistan have previously obtained PIC/S certifications for products such as capsules, tablets and syrups, enabling exports to regulated international markets.

Pakistan also has one World Health Organization (WHO)-prequalified pharmaceutical company and another accredited by the UK's MHRA, both of which export medicines to regulated markets.

Industry sources estimate that around 10 additional pharmaceutical companies are currently pursuing certifications from PIC/S, WHO, MHRA, the European Union and the US Food and Drug Administration (FDA).

Pakistan's pharmaceutical exports grew by 34% in FY2024-25, the highest growth rate recorded in two decades. Export earnings from locally manufactured medicines reached $457 million during the fiscal year, making pharmaceuticals the country's fifth-fastest-growing export category.