Mumbai : The US Food and Drug Administration (FDA) has flagged manufacturing-related quality and procedural lapses as well as deficient equipment and inspection flaws at Sun Pharma’s plant in Halol, Gujarat. Though analysts expect this may not impact the country’s largest drug company significantly and could be resolved within six months, the plant has had a troubled past with the US health regulator since 2015. A report (FDA form 483) was issued with 10 observations after a recent inspection at the Halol plant, a company filing said on May 10, without disclosing the details. The observations are largely related to “media-fill studies”, improvement in aseptic operations, cleaning & maintenance of equipment, personnel training, and inadequate root cause analysis, analysts said.
Exports to the US from Halol contributed 3-4% of the company’s consolidated revenues as of March 2020. The plant had 19 ANDAs (abbreviated new drug applications) pending for approval in the same year. The contribution reduced from around 10% of sales in December 2015 due to diversification of the product pipeline at alternate facilities.
The company’s scrip closed at Rs 886 on Monday, a 3% gain from Rs 862 on May 10 — the day the form 483 was issued. Queries sent to the company were unanswered till the time of going to the press.
The company in the BSE filing had said, however, it is preparing the response to the observations, which will be submitted to the US FDA within 15 business days. “It is committed to addressing these observations promptly and remains committed to working closely with the US FDA and continues to enhance its GMPs (good manufacturing practices) compliance on an ongoing basis,” it added.
The US FDA had conducted a GMP inspection of the plant from April 26 to May 9.
Equipment not cleaned, maintained and sanitised at appropriate intervals to prevent contamination that would alter the safety, purity, quality of the drug product, the form 483 said, a copy of which was accessed by TOI.
“One of the US FDA observations was related to rework on media-fill studies and improving the aseptic operations, while another pointed to the deficiency in the system for monitoring environmental conditions. Another observation was about separate/defined areas being deficient related to aseptic processing of drugs. There was also an observation with respect to stability testing program being not followed appropriately”, a note from Motilal Oswal said.
The delay in closure of root-cause investigation outcome and subsequent assessment of batches released in the US market was also highlighted.Significantly, regulatory troubles at Halol started in December 2015, when a warning letter was issued. The company resolved the issues after nearly three years in June 2018 after several audits. However, after an inspection in the following year, the US FDA highlighted eight observations. This inspection led to an ‘official action indicated’ (OAI) being issued in March 2020. An OAI means that the US FDA expects more corrective actions to be undertaken by the company for that particular facility.
