The recent recall of eye drops in the US due to serious infections and deaths has shed light on the safety norms of pharmaceutical manufacturing in India. Global Pharma, an Indian manufacturer, has been implicated in the outbreak, prompting the Food and Drug Administration (FDA) to conduct an inspection of its plant in Chennai city. The FDA’s report revealed several violations related to sterilization and hygiene, raising concerns about the quality of drugs manufactured in India. This article will explore the details of the FDA’s findings, the implications for Global Pharma, and the broader issues of drug manufacturing practices in India.
The Eye Drops and the Outbreak
The eye drops in question, marketed under the brand names EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, were linked to a deadly outbreak of drug-resistant infections in the US. In March, the US Centers for Disease Control and Prevention (CDC) identified 68 patients across 16 states with a rare strain of Pseudomonas aeruginosa, a bacteria that can cause serious infections, especially in immunocompromised people. The drug-resistant strain had never been found in the country before this outbreak. In addition to three deaths, eight patients suffered vision loss, and four had their eye surgically removed, highlighting the severity of the situation.
FDA’s Inspection and Findings: The FDA conducted an 11-day inspection of Global Pharma’s plant in India’s Chennai city in February, following which it published a report outlining several violations related to sterilization and hygiene. The report revealed that the plant had a “black, brown colored greasy deposit” on a bowl, and several parts of the sterile manufacturing area such as doors and handles were not cleaned properly. Furthermore, surfaces that came into contact with the drug packaging were not cleaned, sanitized, decontaminated, or sterilized, indicating lapses in the manufacturing process. These findings raise concerns about the adherence to safety norms at Global Pharma’s plant, and highlight the need for stricter regulations and monitoring of pharmaceutical manufacturing in India.
Recall and Consequences of Eye Drops
Following the FDA’s recommendation, Global Pharma recalled the eye drops in February and the FDA also stopped imports of the products. The recall initially included the eye drops called EzriCare Artificial Tears Lubricant and Delsam Pharma Artificial Tears Lubricant, but was later expanded to include an eye ointment marketed by Delsam Pharma as well. The recall and the FDA’s findings have serious consequences for Global Pharma, as it tarnishes the company’s reputation and raises questions about its adherence to safety standards. The company’s claim that it had no role in the “actual manufacturing” of the product, despite marketing it, further highlights the need for greater accountability and transparency in the pharmaceutical industry.
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Broader Issues of Drug Manufacturing Practices in India
The recent incident involving Global Pharma is not an isolated case, as several Indian pharmaceutical companies have come under scrutiny for the quality of their drugs in recent months. Marion Biotech, another Indian firm, had its manufacturing license cancelled by India’s drug regulator due to its cough syrups being linked to 18 child deaths in Uzbekistan. The World Health Organization also issued an alert last October linking four Indian-made cough syrups to child deaths in The Gambia. While Indian authorities have claimed that the medicines comply with specifications when tested domestically, the international concerns raise questions about the manufacturing practices followed by Indian pharmaceutical companies.
The FDA’s findings of safety violations at Global Pharma’s plant in India have highlighted the need for stricter regulations and monitoring of pharmaceutical manufacturing practices in the country. The recall of the eye drops due to serious infections and deaths underscores the importance of adhering to safety norms and ensuring the quality of drugs.
