Fake Drug Crisis Worsens as FDA Faces Severe Staff Shortage

The issue of fake drug supply remains unresolved. Adding to this, it has now come to light that 50% of sanctioned posts are vacant in the Food and Drug Administration (FDA). As a result, controlling the circulation of counterfeit drugs has become increasingly challenging. Now, there are concerns about how the FDA can manage its operations with such limited human resources. The most significant impact is being felt in the issuance of drug licenses and inspections.

The Under the Drugs and Cosmetics Act of 1940 and 1945, the FDA is responsible for safeguarding public health and ensuring drug quality. However, the department’s current state reveals a troubling picture: out of 417 approved posts, 216 are vacant, leaving the organization operating at only 50% of its capacity.

According to internal sources, 117 out of 200 sanctioned posts for drug inspectors are unfilled. Additionally, 13 out of 40 positions for analytical chemists and 29 out of 45 positions for senior technical assistants are vacant. This large number of vacancies across various roles is adversely affecting the FDA’s operations.

Drug testing and inspections were hindered

Drug inspectors, tasked with collecting samples to prevent fake drug from reaching consumers, are falling short due to a lack of manpower. Each inspector is assigned a monthly target for sample collection, but resource constraints are hindering both sample collection and testing.

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FDA Unable to Conduct Tests

Between 2016 and 2022, the FDA set a target to collect 25,802 drug samples across the state. Of these, 25,065 samples were collected. However, due to lack of manpower, only 22,800 samples could be tested. Among these, 1,888 samples were found to be of poor quality.

Over 1,000 Drug Companies Uninspected

Similarly, drug inspectors are required to inspect all establishments licensed to sell medicines at least once a year. However, during the current government’s tenure, annual inspections of over 65% of allopathic drug manufacturing companies were not conducted. The CAG report also revealed that out of 4,954 companies manufacturing Ayurvedic medicines, 1,182 were not inspected.

To combat the rising threat of fake drugs and maintain its quality standards, the FDA urgently needs to address its staffing crisis. Filling vacant posts, especially those of drug inspectors and technical staff, is imperative to ensure timely testing and comprehensive inspections. Without adequate human resources, the FDA’s ability to safeguard public health remains severely compromised.

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