Pakistan-based ATCO Laboratories Group has obtained PIC/S certification for its sterile manufacturing facility, becoming the first company in the country to receive this accreditation for injectable medicines and eye drops. This milestone enables ATCO to export to over 50 regulated markets, including Malaysia, Africa, Central Asia, and ASEAN countries, signaling new sourcing opportunities for overseas distributors and clinic buyers seeking compliant sterile products.
Certification details
ATCO's sterile manufacturing facility, used for injections and eye drops, was certified under the internationally harmonized PIC/S Good Manufacturing Practice (GMP) standards. The certification was granted by Malaysia's PIC/S authority, according to Dr. Munir Anwar, Head of Pharma Development at ATCO Group. He confirmed that two consignments of certified products have already been exported to Malaysia since the certification.
Regulatory context
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international framework uniting over 50 regulatory authorities to harmonize pharmaceutical inspection and manufacturing standards. Drug Regulatory Authority of Pakistan (DRAP) CEO Dr. Obaidullah Malik noted that this development could help increase Pakistan's pharmaceutical and medical device exports beyond the current $1 billion annually. DRAP has amended regulations and launched a structured program to facilitate global accreditation.
Market signal
Pakistan's pharmaceutical exports grew by 34% in FY2024-25, the highest growth rate in two decades, reaching $457 million. Industry sources estimate that around 10 additional pharmaceutical companies are pursuing certifications from PIC/S, WHO, MHRA, EU, and US FDA. Six Pakistani companies previously obtained PIC/S certifications for non-sterile products like capsules and tablets, but ATCO is the first for sterile injectables.
What buyers should watch
Overseas importers and clinic buyers seeking sterile injectables and eye drops from compliant manufacturers should monitor ATCO's expansion into EU and UK markets. Dr. Anwar stated, "Our next target is European Union and MHRA of England. We are working on that." This certification positions ATCO as a potential supplier for regulated markets requiring PIC/S GMP compliance.
Source: Read the original report | Published: June 01, 2026