US health regulator pulls up Sun Pharma for lapses in Gujarat plant

• The company’s supply reportedly decreased, falling to around 2.37% in the US market compared to 3% of the combined business in 2021-2022
• The letter highlighted Sun Pharma’s failure to implement quality control and other manufacturing practices at its plant
• The Sun Pharmaceutical Industries Ltd is one of the world’s largest generic pharmaceutical firms, with global sales of over $5.1 billion

The US health regulator Food and Drug Administration (USFDA) has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow written procedures designed to prevent microbiological contamination of drug products at its Gujarat-based plant. The health regulator issued a warning letter citing flaws at the Halol factory, which manufactures finished pharmaceutical goods.

The Sun Pharmaceutical Industries Ltd is one of the world’s largest generic pharmaceutical firms, with global sales of over $5.1 billion, per its website. The company is supported by more than 40 manufacturing facilities that produce high-quality, low-cost medications. It also claimed the USFDA was satisfied with the company’s remedies.

The health regulator inspected the manufacturing facility from 26th April to 9th May 2022 and placed the unit on ‘import alert’ last week. It means that future shipments of items developed at the plant will be denied entry into the US market. The company’s supply reportedly decreased, falling to around 2.37% in the US market compared to 3% of the combined business in 2021-2022.

The FDA’s warning letter highlighted Sun Pharma’s failure to implement quality control and other manufacturing practices at its plant. One of the major lacunas pointed out by the regulator includes a lack of a microbiological contamination system.

The USFDA in the warning stated: “This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals… Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated.”

The letter also pointed out drug the firm’s failure to establish and follow appropriate procedures. “Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas,” it said.

It further said: “Your ISO 5 cleanroom areas used for aseptic compounding and filling were poorly designed and lacked adequate protection.” The ISO 5 area is critical because sterile drug products are exposed and therefore vulnerable to contamination, it added.

“Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance,” USFDA said.

Company share declines

The Sun Pharma shares closed 3.57% lower at Rs 980.95 on Thursday on the Bombay Stock Exchange (BSE) post the USFDA import alert.

Soon Sun Pharma clarified saying it “continues to cooperate with the USFDA” and assured that necessary steps would be taken to resolve issues highlighted by the regulator.