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Inquiry demanded at Maharashtra Assembly on export nod for over 200 pharma companies without stability testing
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Shardul Nautiyal, Mumbai
June 26 , 2024
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An inquiry has been demanded and a question was raised in the Maharashtra Legislative Assembly related to export permissions granted without proper stability testing for over 200 pharma companies in the state of Maharashtra.
This issue, which has been pending for the past year, was recently brought to the forefront and the situation has sparked significant concern among industry stakeholders and health advocates alike.
The matter was raised by Abhay Pandey, president of the All Food and Drug Licence Holders Foundation (AFDLHF), who has been a vocal advocate for rigorous drug testing standards. Following the legislative discussion, Pandey called for the constitution of an inquiry committee to thoroughly investigate the circumstances under which these export permissions were granted without adherence to standard stability testing protocols.
AFDLHF has engaged with both the Maharashtra Government and the Maharashtra Food and Drug Administration (FDA) to address these concerns. Stability testing is a fundamental component in the development of medicinal products, ensuring that they maintain their quality, safety, and efficacy throughout their shelf life. The absence of such testing poses potential risks to patient safety and undermines the credibility of exported pharmaceutical products.
Stability testing is a critical process in the pharmaceutical industry, involving extensive analysis to ensure that a drug maintains its intended quality over time under specified conditions. These tests are complex and resource-intensive, requiring significant investment in terms of cost, time, and scientific expertise.
The primary goals of stability testing include determining shelf life, evaluating the drug’s physical, chemical, microbiological, therapeutic, and toxicological properties under various conditions, providing data that confirm the drug's performance or efficacy throughout its shelf life and adhering to international guidelines set by organizations like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the World Health Organization (WHO).
The overarching aim of these tests is to ensure patient safety by accurately predicting the shelf life of drugs and determining appropriate storage conditions and labeling instructions. Stability testing evaluates how environmental factors, such as temperature, humidity, and light, impact the drug substance or formulated product.
The call for an inquiry committee by AFDLHF underscores the urgency of addressing the lapse in regulatory oversight. The committee's formation is anticipated to shed light on the procedural deficiencies and ensure that such oversights are not repeated.
The Maharashtra Government and FDA are expected to respond promptly to these concerns, reinforcing the importance of adhering to stringent testing standards to uphold the safety and efficacy of pharmaceutical exports. This proactive approach is crucial not only for safeguarding public health but also for maintaining the integrity of the pharmaceutical industry in Maharashtra and beyond.
“As this issue progresses, stakeholders within the pharmaceutical sector and health advocacy groups will be closely monitoring the developments. The resolution of this matter is imperative to restore confidence in the regulatory processes governing drug exports and to ensure that the highest standards of drug safety and efficacy are maintained,” Pandey stated.
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