Cdsco india. It provides online systems, guidelines, approvals, standards, and enforcement for drugs and medical devices. Mar 29, 2025 · Introduction to CDSCOOverview of the Central Drugs Standard Control Organization (CDSCO)The Central Drugs Standard Control Organization (CDSCO) is India’s apex drug regulatory authority operating under the Ministry of Health and Family Welfare. he Central Drugs Standard Control Organisation (CDSCO)under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India. It also approves new drugs and clinical trials, licenses blood banks and vaccines, and bans harmful substances. 5 days ago · The Centre is finalising the Drugs, Medical Devices and Cosmetics Act, 2025, to strengthen India’s drug quality testing and surveillance system. Under the Ministry of Health and Family Welfare, CDSCO ensures the country’s safety, efficacy, and quality of medical devices. It regulates the import, manufacture, sale and distribution of drugs, medical devices and cosmetics in the country, and participates in IMDRF activities. The document provides an overview of the best principles and approaches, as well as additional clarifications and recommendations to be considered by the parties responsible for clinical trials 5 days ago · India’s weak oversight India’s Central Drugs Standard Control Organisation (CDSCO) is responsible for the oversight of new drugs, imports, clinical trials, and setting national standards. The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for drugs and medical devices. CDSCO Reports to Drug Controller General of India (DCGI) Major Role of CDSCO: Oct 15, 2024 · The Central Drugs Standard Control Organization (CDSCO), an Indian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to Good Clinical Practices. Jun 6, 2025 · The Central Drugs Standard Control Organization (CDSCO) ensures that drugs sold in India are safe, effective, and meet required quality standards. Access various downloadable resources and documents related to CDSCO, including forms, guidelines, and manuals. It confirms that a pharmaceutical product, medical device, or cosmetic complies with regulatory standards and is safe for use. The DCGI is responsible for the approval of the manufacturing of certain drugs (vaccines, large volume parenteral, blood products, r-DNA derived), and new drugs. The CDSCO is also responsible for supervising the Drugs Consultative Committee (DCC), the Drugs Technical Advisory Board (DTAB), and the Central Licensing Approving Authority (CLAA), which is tasked with ensuring Jan 31, 2019 · The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for Discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. In India, the manufacturing, import, sale To get marketing authorization of a drug in India, it is important to conduct the clinical trials in India. 4 days ago · New Delhi, 16-10-2025 — India’s drug regulator (CDSCO) has invited stakeholder comments on whether and how to “ensure a level playing field” when several applicants file for approval of the same new drug and only the first applicant bears the cost of local clinical trials while later applicants obtain approval on bioequivalence (BE) alone. The new law will replace the 1940 Act, empower the CDSCO with statutory authority, and address global concerns over substandard medicines May 19, 2025 · The Indian Central Drugs Standard Control Organisation (CDSCO) has recently issued a draft guideline for biosimilars, which is a significant change in its perspective. It falls under the Union Health Ministry, and licenses large manufacturers and handles export approvals. CDSCO is the Central Drugs Standard Control Organisation under Ministry of Health & Family Welfare, Government of India. Apr 16, 2024 · The Indian pharmaceutical industry is poised for a significant boost with the Central Drugs Standard Control Organisation’s (CDSCO) release of a revised guidelines for Industry document (Version 1. CDSCO has a good track record with the World Health Organization (WHO) . The Central Drugs Standard Control Organization (CDSCO) is the primary regulatory body for medical devices in India. As the apex regulatory authority under the Central Drugs Standard Control Organization (CDSCO), the DCGI oversees drug approval, clinical trials, import/export of pharmaceuticals, and Good The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals. As the national regulatory body for pharmaceuticals and medical devices in India, CDSCO is responsible for approving new drugs, regulating clinical A need was, however, felt to develop our own Indian Guidelines to ensure uniform quality of clinical research throughout the country and to generate data for registration for new drugs before use in the Indian population. Aug 2, 2025 · The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority responsible for approving drugs, overseeing clinical trials, and ensuring the quality and safety of medicines. CDSCO is India's national regulatory body for cosmetics, pharmaceuticals and medical devices. This guide outlines the CDSCO registration process, the necessary forms, the required documents, and the procedure for bringing clinical Sep 17, 2024 · News Detail CDSCO releases draft guidelines on good clinical practices for consultation (17-09-2024) New Delhi, 17 Sept 2024: The Central Drugs Standard Control Organization (CDSCO) has begun a 30-day consultation into proposed changes to the good clinical practice (GCP) guidelines in India. It provides information on import and export, test licences, banned drugs, spurious drugs, blood banks and more. 5 days ago · Owlet™ Secures CDSCO Approval for Dream Sock® and Plans 2026 Expansion into India Owlet expands its global footprint, entering one of the world’s most promising digital health markets, with . 2) for Clinical Trial in India. Overview The Central Drugs Standard Control Organization (CDSCO) functions as India’s primary regulatory authority overseeing pharmaceuticals, medical devices, and cosmetics. The CDSCO certificate is an official document issued by the Central Drugs Standard Control Organization (CDSCO) in India. 2 days ago · CDSCO is the national regulatory authority for drugs and cosmetics in India. If your company is involved in manufacturing, importing, or marketing pharmaceuticals in India, obtaining CDSCO licensing is essential for legal compliance and market success. The notice flags that this creates a cost gap May 15, 2025 · Decoding the Role of DCGI in India’s Pharmaceutical Regulatory Oversight The Drug Controller General of India (DCGI) plays a pivotal role in the regulatory framework of India’s pharmaceutical industry. The Drug Controller General of India (DCGI) is the key official within the CDSCO. Objectives of CDSCO Import Clearance System 1) To put in place a system for online issuance of NOC for Import of Drugs. The 2025 CDSCO Draft Guidelines on Similar Biologics 1 represent a progressive shift toward harmonizing Indian regulatory requirements with global standards set by the European Medicines Agency (EMA) 2, FDA, and the UK’s Nov 20, 2023 · 1. Nov 5, 2024 · Cdsco is the Central Drugs Standard Control Organization that regulates drugs, medical devices, cosmetics and other health products in India. It is under the Ministry of Health and Family Welfare and has 8 divisions, including Drug Controller General of India. It is responsible for overseeing the import, manufacture, sale, and distribution of medical devices in the country. An Expert Committee set up by Central Drugs Standard Control Organisation (CDSCO) in consultation with clinical expert has formulated this GCP guideline for generation of 6 days ago · According to the note circulated by India's regulatory agency - Central Drugs Standard Control Organization (CDSCO) - there is "lack of level playing field" between the first company that obtains a new drug for the first time in the country based on clinical trial and bioequivalence study data and the subsequent applicants that obtain approval Need CDSCO registration for your medical devices or IVDs in India? Discover the requirements, application process, and how to gain market access with CDSCO certification. Central Drugs Standard Control Organisation Directorate General Of Health Services Ministry of Health &Family Welfare, Government of India SUGAM - An e-Governance solution for CDSCO The Organization functions under the Ministry of Health and Family Welfare and regulates drugs, cosmetics and biological products in India. Below are some key guidelines and requirements for clinical trials in India: Clinical Trial Approval: Before the conduct of any clinical trials in India, an approval is required from CDSCO via the office of DCGI. qto klqm2 kj62yc twx fsiee6 mtd5admp bu auzb ycu xnd1r