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WAIVES LOCAL TRIALS
CDSCO waives local trials for drugs approved in major marketsThe Central Drugs Standard Control Organisation (CDSCO) has decided to waive local clinical trials for certain drugs approved in select ICH...18 Aug, 2024, 10.55 PM IST- India eases drug approval process, waives local trials for advanced therapiesIn a major policy shift, the Indian government has waived local clinical trial requirements for drugs and vaccines approved by major intern...09 Aug, 2024, 03.52 PM IST
- Takeda in talks to bring its dengue shot to IndiaIndia is not a part of the global Phase-3 trial of the Takeda dengue vaccine candidate, which means as per local regulation it will have to...17 Dec, 2021, 10.37 AM IST
- Proven vaccines no more need clinical trials in IndiaThe development comes against the backdrop of negotiations between the government and Pfizer over the import of its Covid-19 vaccine in Ind...02 Jun, 2021, 08.14 AM IST
- Sputnik V import: India in price talks, DRL to import initial doses after regulatory nodDr Reddy’s Laboratories has a tie-up with the Russian Direct Investment Fund, which backed the development of Sputnik V, and will import th...15 Apr, 2021, 01.40 PM IST
- J&J to apply for bridging study, to approach DGCI next week for trial of its single-shot Covid vaccineJ&J’s single-shot Covid vaccine has shown an overall efficacy of 66% in all age groups while it showed 85% efficacy in preventing death (se...10 Apr, 2021, 07.08 AM IST
- Waive bridging trials for fast vaccine rollout: ExpertsIn a “pandemic situation, credible evidence examined by reliable regulatory agencies in other countries may be accepted to fast-track appro...03 Mar, 2021, 06.44 AM IST
- India's Serum Institute seeks approval to conduct local trial for Novavax COVID-19 vaccineNovavax's UK trial, which enrolled 15,000 people aged 18 to 84, is expected to be used to apply for use in Britain, the European Union and ...29 Jan, 2021, 11.09 AM IST
- 5G lab trials: Telcos seek removal of gear & vendor restrictionsPeople familiar with the matter said that the latest letter is aimed mainly at pushing the government to clarify its official stance over t...03 Dec, 2020, 08.20 AM IST
- US pharma giant seeks marketing authorisation from India for remdesivir"Gilead Sciences has applied seeking marketing authorisation for its anti-viral drug remdesivir to India's Central Drugs Standard Control O...30 May, 2020, 10.28 AM IST
- Covid-19 treatment: Cipla, Hetero Lab get nod to manufacture and sell RemdesivirCipla, Hetero, and Jubilant Lifesciences have signed voluntary licensing agreements with Gilead.25 May, 2020, 08.22 AM IST
- Regulator waives off clinical trials, clears Sanofi TB drugIndia carries the highest burden of TB with about 2.69 mn cases in 2018. About 40% of the country’s population is estimated to have latent ...04 Nov, 2019, 10.36 AM IST
- Government notifies new rules for drugs and clinical trialsThe new rules will ensure patient safety, as they would be enlisted for trials with informed consent.25 Mar, 2019, 11.09 PM IST
- Department of Telecommunications (DoT) may levy Rs 5k fee per location for 5G field trialsDoT originally planned to charge for 5G trial spectrum allocations on ‘a per radiating node’ basis.21 Feb, 2019, 07.56 AM IST
- Health Ministry panel rejects Sanofi's clinical waiver plea for dengue vaccineThe decision of the apex committee is expected to delay the entry of the vaccine, which has been approved in Mexico, the Philippines and Br...05 May, 2016, 12.48 AM IST
- Government may exempt critical drugs from local clinical trialsThe decision, officials said, was taken at a recent meeting of the technical committee set up under the health ministry .02 Sep, 2014, 03.44 AM IST
- Crutch, break, in control: Hangin' on to dear lifeDrugmakers have demanded concessions for R&D, customs duty rationalisation and duty waivers for life-saving drugs in this Budget. They are ...03 Feb, 2003, 06.16 AM IST
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