USFDA pulls up Sun Pharma for lapses in Gujarat plant
The US Food and Drug Administration (USFDA) questioned India's top drugmaker Sun Pharma for alleged failures in preventing drug product contamination at its Gujarat-based factory, PTI reported. The health regulator issued a warning letter citing flaws at the Halol factory, which manufactures finished pharmaceutical goods. Notably, the warning was issued following an inspection conducted last year between April 26 and May 9.
Why does this story matter?
- The USFDA placed Sun Pharma's Halol 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 unless they meet Current Good Manufacturing Practice (CGMP) requirements.
- 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.
USFDA declared Sun Pharma drug products adulterated
According to reports, the USFDA's warning letter highlighted Sun Pharma's failure to implement quality control and other manufacturing practices at its plant in Halol, Gujarat. The prominent lacuna pointed out by the regulator includes a lack of a microbiological contamination system. "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," it said.
Drug regulator accuses Sun Pharma of violating rules
The following are some of the gaps identified by the USFDA in the letter: Inadequately delineated zones of sufficient size. Control mechanisms required to avoid contamination or mix-ups in aseptic processing facilities are not implemented. ISO 5 cleanroom spaces utilized for aseptic compounding and filling were poorly designed. Failure to employ appropriate equipment in the production, processing, packaging, or storage of pharmaceutical items.
Pharma company also accused of operating ineffective quality system
In addition, the US's health regulator also cited the Mumbai-based company's inability to adequately analyze any inexplicable disparity or failure of a batch. USFDA also criticized the pharma company for a lack of efforts to fulfill any of its criteria. "Significant findings in this letter demonstrate that your firm does not operate an effective quality system by CGMP," it noted.
Sun Pharma's shares decline after USFDA warning
As per reports, the company 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. It also claimed the USFDA was satisfied with the company's remedies.
What is Sun Pharma?
Sun Pharma (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. It said that the pharmaceutical company was supported by more than 40 manufacturing facilities that produce high-quality, low-cost medications. In addition, it is claimed to be a well-known brand among healthcare professionals and people in over 100 countries.