13 May 2024 Central Drugs Standard Control Organisation (CDSCO)
THIS ARTICLE COVERS ‘DAILY CURRENT AFFAIRS’ AND THE TOPIC DETAILS OF ” Central Drugs Standard Control Organisation (CDSCO)”. THIS TOPIC IS RELEVANT IN THE “Science and Technology” SECTION OF THE UPSC CSE EXAM.
Why in the News?
Recently, the Central Drugs Standard Control Organisation (CDSCO), India’s drug regulatory authority, has revoked the power previously granted to State licensing bodies to grant No Objection Certificates (NOCs) for producing unapproved, prohibited, or novel drugs for export purposes. This decision was made in response to international criticisms regarding the quality of pharmaceuticals exported from India. Consequently, the CDSCO is the sole authority issuing manufacturing licenses for drugs destined for export markets.
In an order issued by Drug Controller General India, Dr Rajeev Raghuvanshi, the CDSCO has asked the industry to submit fresh only applications for no objection certificates (NOCs) from 15 May onwards.
What is the Central Drugs Standard Control Organisation (CDSCO)?
The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority of India for the medical devices industry under the provisions of the Drugs and Cosmetics Act 1940. Operating under the Ministry of Health & Family Welfare, the Central Drugs Standard Control Organization (CDSCO) is overseen by India’s National Regulatory Authority (NRA). The Drugs Controller General of India (DCGI) holds the leadership role, and the organisation’s headquarters are in New Delhi. The key functions include:
- Regulatory Approval: CDSCO is responsible for approving new drugs, biological products, and medical devices for marketing in India. It evaluates applications submitted by pharmaceutical companies and assesses the products’ safety, efficacy, and quality before granting marketing authorisation.
- Clinical Trials Oversight: It regulates and monitors clinical trials conducted in India to ensure compliance with ethical and regulatory standards. It evaluates trial protocols, reviews applications for clinical trial permissions, and monitors the conduct of trials to safeguard the rights, safety, and well-being of trial participants.
- Quality Control: It establishes and enforces quality standards for pharmaceuticals, medical devices, diagnostics, and cosmetics manufactured or imported in India. It conducts inspections of manufacturing facilities and laboratories to ensure compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Import and Export Regulation: It regulates the import and export of drugs, medical devices, and other healthcare products to and from India. It scrutinises import and export licenses, verifies product quality and compliance with regulatory requirements, and takes action against unauthorised or substandard imports or exports.
- Post-Marketing Surveillance: CDSCO monitors the safety profile of marketed drugs and medical devices through post-marketing surveillance activities. It collects and evaluates adverse event reports, conducts inspections of adverse event reporting systems, and takes appropriate regulatory actions to mitigate risks to public health.
About the Drugs and Cosmetics Act, 1940:
The Drugs and Cosmetics Act of 1940 is an important legislation in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics in the country. The Act was enacted to ensure the safety, efficacy, and quality of pharmaceuticals and cosmetics and to protect consumers’ health. The Act distinguishes drugs and cosmetics based on their use, mandates licensing for manufacture, distribution, and sale, and requires registration for certain items before they are made, imported, or sold in India.
The Act benchmarks drug and cosmetics’ quality, safety, and effectiveness. It grants authority to the Central Drugs Standard Control Organization (CDSCO) and the State Drug Regulatory Authorities to uphold these benchmarks via inspections, tests, and product sampling. Additionally, the legislation oversees the management of clinical trials for experimental drugs and cosmetics. It details the process for securing approvals from regulatory bodies, mandates adherence to ethical standards during trials, and necessitates documenting and reporting any adverse incidents and results.
The Act prescribes penalties for offences such as the manufacture, sale, or distribution of spurious, adulterated, or misbranded drugs and cosmetics. Offenders may face fines, imprisonment, or cancellation of licenses, depending on the severity of the violation.
CONCLUSION:
The Central Drugs Standard Control Organization (CDSCO) protects public health by ensuring that pharmaceuticals, medical devices, and other healthcare products in India adhere to strict regulatory standards, guaranteeing they are safe, effective, and high-quality. The 1940 Drugs and Cosmetics Act, together with its related Rules, forms an extensive regulatory framework for the pharmaceutical and cosmetics sectors in India, ensuring that the public has access to healthcare products that are safe, effective, and of high quality.
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Mains Practice Question:
Q. How does the CDSCO balance the need for rapid drug approval, especially in emergencies like the COVID-19 pandemic, with the imperative to ensure the safety and efficacy of these drugs?
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