Editor's comment: Addressing the knowledge gap

India has become the world’s largest exporter of generic drugs, and the country with a record of GMP warnings issued by the FDA

In the August issue, Connect 2 Cleanrooms execs discuss customer service and global challenges

Summer has been surprisingly busy on the news front, and the August issue is a testament to that. Cleanroom build projects are cropping up in the US, across Europe, in China, Japan and, most notably, in India. In the days running to press, we learned about plans in the drawing board of Telangana government officials to forge a pharmaceutical powerhouse in Hyderabad.

The capital of the state in southern India is at the heart of a scheme to create a US$100 billion research and manufacturing cluster in the coming decade. Projects in the pipeline include the Pharma City, a 19,000-acre infrastructure catering to the value chain; a medical devices park; and a biological scale-up manufacturing facility.

The potential demand in India for cleanrooms, equipment, services and technology providers is colossal and triggers optimism for business opportunities, but these developments should also call for caution.

The potential demand in India for cleanrooms, equipment, services and technology providers is colossal

India has become the world’s largest exporter of generic drugs, and the country with a record of GMP warnings issued by the FDA in the US, with breaches ranging from open toilet drains to malfunctioning equipment and quality control oversight.

Last May, for example, Hospira Healthcare India, a Pfizer subsidiary, was caught with data integrity and microbial control issues. Ten out of 53 warning letters issued worldwide in 2018 went to drug-making factories in India, and 16 to China, according to a Bloomberg report.

Cumbersome as it may be, adherence to manufacturing standards in a highly-regulated industry such as the pharmaceutical is paramount, and the backbone of our Cleanroom Technology Conference, which we review in this issue. Turn to p22 for tips and tricks of the trade and to learn about the world-class event in 2020 set to tackle this and other pressing issues.

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