Overview of CDSCO Issued Regulatory Guidelines
On February 9th, 2024, the Directorate General of Health Services Central Drugs Standard Control Organization (CDSCO) released a circular outlining regulatory guidelines for drug, cosmetics, and medical device sampling by inspectors from Central and State Drug Authorities in India.
Underlining the importance of high-quality medicines and the risks associated with substandard or counterfeit products, the circular emphasizes their detrimental impact on patients and the healthcare system. India’s intricate drug regulation process involves numerous approvals, inspections, and post-marketing surveillance activities to ensure compliance with Good Manufacturing Practices (GMP) and the Drugs & Cosmetics Act. The guidelines are designed to streamline resources by prioritizing high-risk parameters during sampling and stressing the need for comprehensive monitoring and databases to track Not of Standard Quality (NSQ) and counterfeit products.
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Covering various aspects of sampling, the guidelines detail sampling plans, selection criteria, locations, sample quantities, timelines, and the role of testing laboratories. They emphasize the importance of structured sampling plans, risk-based selection, and inclusivity in sampling locations, including rural areas. Additionally, the guidelines specify sample quantities required for thorough analysis across different product categories, including drugs, cosmetics, vaccines, and medical devices. They also outline timelines for sample forwarding, method of analysis acquisition, and reporting of NSQ and counterfeit alerts to facilitate prompt regulatory actions.
Moreover, the guidelines address the role of testing laboratories and provide a list of notified laboratories at central and state levels for drugs, cosmetics, and medical devices. Annexures detailing sample quantities required for comprehensive analysis further enhance the circular’s comprehensiveness. Overall, the circular reflects a commitment to ensuring product quality and efficacy in the market through uniform drug sampling methodologies for inspectors under state and central drug regulatory authorities in India.
Refer to CDSCO’s latest official circular for more details.
Additionally, Operon Strategist, a renowned consultancy firm specializing in regulatory compliance for the medical device industry, applauds the issuance of these regulatory guidelines. With its expertise in navigating complex regulatory landscapes, Operon Strategist stands ready to assist medical device manufacturers in India in implementing these guidelines effectively. Operating at the forefront of regulatory affairs, Operon Strategist aims to ensure that medical devices meet the highest standards of quality and safety, ultimately benefiting patients and healthcare systems across the country.
