CDSCO Mandates Strict Timelines for RTI Applications and Appeals
The Central Drugs Standard Control Organization (CDSCO) has issued new internal guidelines to ensure the timely disposal of RTI applications and appeals, in strict compliance with the RTI Act, 2005. The move comes after the First Appellate Authority (FAA) noted several instances of delayed responses, including appeals that were pending beyond the prescribed 45-day timeline. This notice was issued on September 22, 2025.
CDSCO Launches New Dedicated Portal for NSQ Drug Alerts
The Central Drugs Standard Control Organization (CDSCO) has launched a new dedicated link on its official website to improve access to its monthly alerts on drugs that are “Not of Standard Quality” (NSQ). This notice was issued on August 28, 2025.
ICMR and CDSCO Seek Public Comments on TB Diagnostic Protocols
The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have jointly released a set of standard evaluation protocols for In-Vitro Diagnostics (IVDs) for tuberculosis (TB). These protocols are designed to facilitate the licensure process for TB diagnostics under the Medical Devices Rules, 2017, by ensuring the quality and performance of these kits.
CDSCO Issues Alert on Theft of Novo Nordisk Drugs
The Central Drugs Standard Control Organization (CDSCO) has issued an alert regarding the theft of multiple drug products from M/s Novo Nordisk during transit. The theft occurred on a route from the Bhiwandi Hub to Nagpur, Raipur, Cuttack, and Kolkata. The products are r-DNA origin injectables that require specific storage at 2°C to 8°C to maintain their quality and ensure patient safety.
Government Takes Strict Measures to Prevent Sale of Adulterated Drugs
The Central Drugs Standard Control Organization (CDSCO), in collaboration with state regulators, has implemented a series of stringent regulatory and enforcement measures to prevent the entry of substandard, adulterated, or spurious drugs into the market. Union Minister of State for Health and Family Welfare provided this information in a written reply in the Rajya Sabha on August 12, 2025.
ICMR and CDSCO Release Draft Protocols for In-Vitro Diagnostics
The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have jointly drafted and released standard evaluation protocols for a range of In-Vitro Diagnostics (IVDs). This initiative aims to streamline the licensure process for IVDs under the Medical Devices Rules, 2017, by providing clear guidelines for manufacturers and testing labs in India.
CDSCO Mandates Online Submission for WHO-GMP (COPP) Applications
The Central Drugs Standard Control Organization (CDSCO) has re-emphasized that all applications for the grant of World Health Organization – Good Manufacturing Practices (WHO-GMP) and Certificate of Pharmaceutical Product (COPP) must be submitted exclusively through the ONDLS portal after August 15, 2025. This follows a series of extensions granted to accommodate industry concerns and facilitate a smooth transition to the online system.
CDSCO Launches New Online Dual Use System on SUGAM Portal to Streamline Approvals
The Central Drugs Standard Control Organization (CDSCO) has launched a new online Dual Use System on its SUGAM Portal. This initiative is a significant step towards enhancing the “ease of doing business” by streamlining the process of issuing No Objection Certificates (NOCs) for drugs imported in bulk for non-medicinal use.
Govt. Directs States to Step Up Monitoring of Ranitidine Over NDMA Contamination Concerns
In a move to address ongoing safety concerns surrounding the widely used antacid Ranitidine, the Central Government has issued a directive to all State and Union Territory Drug Controllers, calling for enhanced oversight of the drug’s quality due to the presence of N-Nitrosodimethylamine (NDMA) impurity. This notice was issued on July 24, 2025.
CDSCO Streamlines Export NOC Process for Unapproved and New Drugs
The Central Drugs Standard Control Organisation (CDSCO) has introduced guidelines for the online issuance of No Objection Certificates (NOCs) for the manufacture of unapproved or approved new drugs specifically for export purposes. Manufacturers holding valid licenses in Form-25, Form-28, Form 28D, and their respective loan licenses can now obtain these NOCs from CDSCO’s Zonal offices. The new procedure is applicable to unapproved drugs and approved new drugs, with the exception of Narcotic Drugs and Psychotropic Substances (NDPS) and banned drugs.
CDSCO Releases New SEC Guidelines to Streamline Drug & Device Approvals
Central Drugs Standard Control Organization (CDSCO) has released the Subject Expert Committee (SEC) Guidance Document – Version 1.0 (2025). This new guideline provides a framework for the operation, composition, responsibilities, and decision-making processes of SECs, which are crucial to India’s regulatory approval ecosystem for drugs and investigational medical devices.
CDSCO Reinforces Visitor Protocols & Introduces Digital Appointment Booking
The Central Drugs Standard Control Organization (CDSCO) has issued a fresh reminder to all stakeholders and staff regarding the conduct and movement of visitors within its CDSCO building. CDSCO has also introduced a digital appointment booking process for visitors to FDA Bhawan, Delhi.