NEW DELHI: In a recent inspection, the United States (US) Food and Drug Administration (FDA) has uncovered significant deficiencies within the manufacturing plant of Aurobindo Pharma, India’s second largest pharmaceutical company. These findings have once again highlighted the ongoing challenges faced by India’s pharmaceutical industry in maintaining quality control standards.
During the FDA’s visit to the Aurobindo Pharma plant, several deficiencies were exposed, specifically related to equipment cleaning and storage controls. The density control equipment was found to be inadequately maintained, raising concerns about the overall cleanliness of the facility. Additionally, the laboratory controls did not adhere to scientifically correct and appropriate specifications, compromising the accuracy and reliability of testing procedures. Furthermore, raw materials were discovered to be stored in excessively hot and humid conditions, potentially impacting the quality of the final products.
This is not the first time Aurobindo Pharma has come under scrutiny from the FDA. The company had received a warning from the regulatory agency last year regarding deficiencies at its Daulatabad plant. The repeated instances of deficiencies suggest a lack of effective administrative oversight and control over the company’s drug manufacturing processes.
Indian Drugmakers Faces Multiple Negative Audits
Unfortunately, Aurobindo Pharma is not an isolated case. Indian drugmakers have faced multiple negative audits throughout the year, and the FDA has uncovered widespread lapses in various pharmaceutical companies across India in recent years. These revelations have sparked intense scrutiny of India’s $50 billion pharmaceutical industry, particularly in the wake of several scandals that have tainted its reputation.
Tragically, the consequences of these lapses in quality control have extended beyond India’s borders. Reports have emerged of dozens of children losing their lives in Gambia and Uzbekistan due to the consumption of adulterated Indian medicines. Countries such as the United States, United Arab Emirates, Gambia, and Uzbekistan have expressed outrage over the proliferation of fake medicines manufactured by Indian pharmaceutical companies.
The severity of the situation prompted the World Health Organization (WHO) to issue a global alert in December of last year, specifically warning about substandard Indian medicines. The FDA, empowered with regulatory authority, has the capacity to take measures such as import bans and delays in approvals for Indian companies found to be non-compliant with quality control standards.
The repeated instances of deficiencies at Aurobindo Pharma and other Indian pharmaceutical companies have placed India’s pharmaceutical industry in a critical position globally. It is imperative for the authorities to address these issues promptly and comprehensively to restore confidence in the quality and safety of Indian-made medications.
