Pakistani Pharmaceutical Company Achieves International PIC/S Certification for Sterile Manufacturing

A Pakistani pharmaceutical company has achieved a significant international milestone by obtaining Pharmaceutical Inspection Co-operation Scheme (PIC/S) certification for its sterile manufacturing facility producing injections and eye drops.

According to ATCO Group, the certification recognizes its compliance with globally accepted Good Manufacturing Practices (GMP), making it the first Pakistani company to secure PIC/S approval specifically for sterile manufacturing operations involving injectable medicines and ophthalmic products.

PIC/S is regarded as one of the most respected international frameworks for pharmaceutical inspections and quality standards, bringing together regulatory authorities from more than 50 countries to ensure harmonized drug manufacturing practices worldwide.

Chief Executive Officer of the Drug Regulatory Authority of Pakistan (DRAP), Dr. Obaidullah Malik, confirmed the development and stated that the achievement is expected to strengthen Pakistan’s pharmaceutical and medical device exports in international markets.

ATCO Laboratories’ Group Head Pharma Development, Dr. Munir Anwar, revealed that the company’s sterile manufacturing facility was approved by Malaysia’s PIC/S regulatory authority. Following the certification, the company has already exported two consignments of approved products to Malaysia.

The company believes the certification will open opportunities to export pharmaceutical products to more than 50 countries operating within the PIC/S framework, subject to local registration and regulatory requirements.

Industry experts describe sterile manufacturing as one of the most technically demanding sectors of pharmaceutical production, requiring strict compliance with quality control, safety, and hygiene standards.

The achievement comes as Pakistan’s pharmaceutical exports continue to grow rapidly. Official figures show that pharmaceutical exports increased by 34 percent during fiscal year 2025, reaching 457 million dollars, marking the highest annual growth rate recorded in the last two decades.