ICMR Releases Ethical Guidelines for Integrative Medicine Research
The Indian Council of Medical Research (ICMR) has published an addendum to its National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017), establishing a structured ethical framework for Research in Integrative Medicine (RIM). The addendum provides clear ethical guidelines for research that combines traditional Ayush systems with modern medical practices, ensuring ethical rigor and regulatory compliance.
CDSCO Expands Online Application Process for Clinical Trial Modifications via SUGAM Portal
The Central Drugs Standard Control Organization (CDSCO) has announced the expansion of its online application process through the SUGAM portal to include applications for Clinical Trial Site Addition and change of Principal Investigator for clinical trials of biological products, specifically vaccines and rDNA products.
CDSCO Clarifies Gastro-Resistant & Delayed-Release Drugs as “New Drugs”
The Central Drugs Standard Control Organization (CDSCO) has issued a directive clarifying that gastro-resistant and delayed-release dosage forms of drugs are to be considered “New Drugs” under the New Drugs and Clinical Trials Rules, 2019. This includes enteric-coated tablets and capsules.
CDSCO Adds To Functionality Of Online Applications For Clinical Trials
The Central Drugs Standard Control Organisation (CDSCO) has announced a shift towards online applications for adding clinical trial sites and changing Principal Investigators. CDSCO is now accepting these submissions through the SUGAM portal. The CDSCO has also implemented a “deemed approval” system for applications submitted through SUGAM.
India’s Pharmaceutical Industry With Ambitious Growth Plans
India’s pharmaceutical industry is a significant force in the global market, boasting a strong domestic presence and a rapidly growing export sector. National Institutes of Pharmaceutical Education & Research (NIPERs) spearhead research efforts.
CDSCO Requires Registration Of Clinical Research Organizations
The Central Drugs Standard Control Organization (CDSCO) has announced amendments to the New Drugs and Clinical Trials Rules, 2019. These amendments aim to strengthen the regulatory framework for clinical research organizations (CROs) in India. CROs are now required to register with the Central Licensing Authority before conducting clinical trials.
Relaxing Norms for Toxicity Studies in Drug Approval
The CDSCO aims to streamline the drug approval process without compromising safety. The New Drugs and Clinical Trials Rules, 2019 allow for the acceptance of preclinical toxicity data generated in other countries, provided the data is of high quality and meets specified standards.
Applications for PAC in Vaccine Clinical Trials Now Online
The Central Drugs Standard Control Organisation (CDSCO) has issued a circular on the launch of the online system Post Approval Changes (PAC) with respect to the clinical trials of vaccines and associated approvals. With the introduction of the online system of SUGAM portal, the CDSCO seeks to streamline the regulatory submission procedure.
