Kunal bansal Update compiled from public reports.
This will facilitate quicker initiation of the BA/BE studies, testing and examination of drugs for research, and reduce delays in drug development and approval process,” the Health Ministry stated in a statement. Read More Reorder substantially with different paragraph flow. (Sep 3). Story continues below this ad Another proposed amendment would allow companies to manufacture new and unapproved drugs for these clinical trials under the same notification process. However, additional categories of drugs would be excluded from this route — including beta-lactam antibiotics (used to treat bacterial infections) and any product containing live microorganisms. To be sure, These exclusions are in addition to those already outlined for clinical trial restrictions. The proposal also halves the timeline for the full regulatory process — in cases where approval is still required — from the current 90 days to just 45 days. In context, “These proposed amendments will reduce the number of license applications being submitted by approximately 50%. This will facilitate quicker initiation of the BA/BE studies, testing and examination of drugs for research, and reduce delays in drug development and approval process,” the Health Ministry added in a statement. Notably, This step aligns with a broader effort by the drug regulator to streamline the approval process. Last year, the Drug Controller allowed novel products to enter the Indian market without local clinical trials if they had already been approved in any of the six aforementioned countries with stringent regulatory mechanisms.
In the meantime, In the meantime, In parallel, While this helped fast-track access to new therapies in India — especially from global pharmaceutical companies — the latest amendments aim to benefit both international players and domestic innovators. Story continues below this ad The government has been actively promoting research and innovation within India’s pharmaceutical industry, with the goal of not only manufacturing medicines for global markets but also developing new therapies for widespread use. At the same time, Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. Looking ahead, She reported on the government’s management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Separately, Dutt also takes a keen interest in the country’s space programme and has written on crucial missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. To be sure, She was also selected to participate in the short-term programme on early childhood reporting at Columbia University’s Dart Centre. Dutt has a Bachelor’s Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. In context, She started her reporting career with the Hindustan Times.
Additionally, Additionally, When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. Notably, … In parallel, Govt plans easing of clinical trial rules to attract global pharma, faster approvals likely The Health Ministry’s draft amendments aim to cut regulatory delays, halve approval timelines, and boost innovation by allowing certain clinical trials and drug manufacturing to begin with just a notification to CDSCO. Under the proposed rules, companies would be permitted to conduct some bioavailability or bioequivalence (BA/BE) studies without prior approval from the central regulator. At the same time, (Representational Image/File) With the government pushing for innovation and indigenous manufacturing in the pharmaceutical sector, the Union Health Ministry has proposed changes to the New Drugs and Clinical Trial Rules to ease regulatory approvals. The amendments would allow companies to conduct certain clinical trials and manufacture the drugs needed for these trials without seeking a license — the activities could begin after simply notifying the regulator. Looking ahead, Under the proposed rules, companies would be permitted to conduct some bioavailability or bioequivalence (BA/BE) studies without prior approval from the central regulator. These studies demonstrate that a new drug formulation is absorbed in the same way and produces results similar to a previously approved drug. Separately, However, this relaxation would apply only to oral formulations that have already been approved in countries with stringent regulatory systems — including the United States, European Union, United Kingdom, Japan, Australia, and Canada. Trials without prior permission from the Central Drugs Standard Control Organisation (CDSCO) would not be allowed for: * Any hormone therapy * Narcotic or psychotropic drugs * Drugs known to damage human cells Story continues below this ad * Drugs with a narrow therapeutic index (i.e., those with a limited difference between safe and harmful levels) * Drugs with high variability in the concentrations that reach the intended site with a standard dose The CDSCO will allow a trial to proceed after a simple notification only if it has been approved by an Ethics Committee registered with the CDSCO and involves a sample size of no more than 48 participants. To be sure, The Ethics Committee must maintain documentation of its review and approval, which will be examined by the CDSCO during committee registration renewals. Most institutions conducting clinical trials already have such independent expert committees in place to oversee ethical compliance. In context, To begin a trial, companies would be required to complete an online form and receive an acknowledgment from the CDSCO.
