Sun Sep 15 12:16:54 UTC 2024: ## India Introduces New Code for Drug Inspectors to Standardize Inspections and Enhance Accountability

**New Delhi:** The Drugs Controller General of India (DCGI) has implemented a new code for drug inspectors across the country to ensure uniformity, predictability, and accountability in their inspections, sample collections, and permits. The code, issued on September 12th, replaces a decade-old set of guidelines to reflect advancements in the regulatory system.

The new code mandates a uniform drug sampling method and focuses on identifying risks during the selection of samples of drugs, cosmetics, and medical devices throughout the supply chain. Each drug inspector, in consultation with their authority, must create monthly and annual sampling plans that encompass rural areas, drugs used in disease-endemic regions, and medications for seasonal illnesses. This will ensure effective surveillance of the quality and efficacy of products available in the market.

Furthermore, inspectors will maintain a centralized monthly list of substandard or spurious drugs, publicly disclosing this information to prevent their use and ensure the availability of authentic products. They will also conduct on-site inspections to evaluate compliance with Good Manufacturing Practices (GMP) standards, ensuring manufacturers adhere to both national and international regulations.

Despite the new code, a significant shortage of drug inspectors exists within CDSCO and state governments. With 303 vacant posts out of 504 sanctioned, the situation is particularly challenging in the medical device sector. Rajiv Nath, forum coordinator of the Association of Indian Medical Devices Industry, emphasizes the need for qualified medical device officers with engineering and science backgrounds to effectively regulate the growing number of medical devices coming under regulations.

The health ministry spokesperson did not respond to queries regarding this critical shortage. The new code is expected to significantly impact the drug industry by standardizing processes and enhancing transparency.

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