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In the wake of child deaths linked to allegedly contaminated cough syrups, the Central Drugs Standard Control Organisation (CDSCO) has launched a pan-India drive to audit, inspect, and ensure compliance by cough syrup manufacturers, urging states to submit their company lists
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The drug regulatory authorities have decided to issue strict instructions to drug manufacturers to implement or provide QR codes on anti-cancer drugs.
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The pharma firm had approached the Drugs Controller General of India (DCGI)seeking a waiver for the phase-III clinical trial of the drug and its market authorisation.
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DCGI issued the advisory following a compliant on August 9 alleging that one bottle of Digene Gel mint flavour is of regular taste (sweet) and light pink colour whereas another bottle of the same batch was of white colour with bitter taste and pungent odour
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Hyderabad-based vaccine manufacturer Biological E. Limited (BE) on Friday announced that it has received approval from DCGI
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Hyderabad: Hyderabad-based vaccine company Biological E Limited (BE) on Saturday announced that its Corbevax Covid-19 vaccine has been approved by the Drug Controller General of India (DCGI) as a heterologous booster dose to individuals aged 18 years and above. This can be used after six months of administration of primary vaccination (two doses) of Covaxin […]
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Hyderabad: Bharat Biotech International announced that its Covaxin has received emergency use approval in children aged between 6 and 12 years. It had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity Covaxin in healthy children and adolescents in the 2-18 age group. The clinical trials conducted in the paediatric […]
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New Delhi: Pune-based Gennova Biopharmaceuticals has submitted the phase-II and phase-III trials data of India’s first mRNA COVID vaccine to the regulator Drugs Controller General of India (DCGI) on Friday, said sources. The company has also developed an Omicron-specific vaccine which will be tested on humans for efficacy and immunogenicity. Earlier the DG, Indian Council […]
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Viralex® has been found to be effective and well tolerated in mild to moderate COVID-19, in two Randomized Controlled Clinical Trials conducted on 499 Indian patients.
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Sputnik Light is a one-dose vaccine and the same as the first component— recombinant human adenovirus serotype number 26 (rAd26) — of the two-dose Sputnik V vaccine, Dr Reddy's said in a statement.
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The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) had also recommended the internasal vaccine clinical trials during the last meeting.
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New Delhi: The Subject Expert Committee (SEC) of the Drug Controller General of India (DCGI) is expected to meet on Tuesday afternoon to discuss Bharat Biotech’s application for clinical trials of its intranasal Covid vaccine as a booster or a third dose. The Hyderabad-based manufacturer has proposed the booster dose for those who have been […]
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Hyderabad: Bharat Biotech on Saturday said it received DCGI approval for emergency use of Covaxin for children aged 12-18 years. The vaccine has established a proven record for safety and efficacy in adults for the original variant and subsequent variants. “We have documented excellent safety and immunogenicity data readouts in children. We look forward for […]
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Hyderabad: Hyderabad-based MSN Labs has launched anti-epileptic drug, India’s first generic vigabatrin powder for oral solution under the brand name Viganext. An infantile spasm is a seizure with sudden stiffening of the body and brief bending forward or backward of the arms, legs and head. Vigabatrin is recommended as the first-line therapy for infantile spasm, […]
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Hyderabad: The much-awaited first oral medication for Covid-19 based on Molnupiravir is expected to hit the shelves of drug stores in the coming months. While the oral pill has received lot of attention for its therapeutic promise in reducing hospital stay and death risk among Covid patients, the fact remains that Hyderabad, due to its […]
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Hyderabad: Hyderabad-based pharmaceutical company Dr Reddy’s on Friday said it hopes to submit phase 3 trial data of Sputnik V Light, the single dose vaccine, to the Drugs Controller General of India (DCGI) next month. The company is also starting trials on children in two cohorts involving children of the age groups of 2-12 years […]
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Hyderabad: Bharat Biotech completed the Phase 2/3 trials of Covid-19 vaccine, Covaxin for use in children under 18 years of age and is expected to submit the data by next week to the DCGI, Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella said on Tuesday here. Speaking to reporters, he said Covaxin […]
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Hyderabad: Hyderabad-based Hetero Group said that the Drug Controller General of India (DCGI) has issued Emergency Use Authorization (EUA) for the generic version of Tocilizumab in India for the treatment of Covid-19 in hospitalised adults. It is aimed to treat individuals who are receiving systemic corticosteroids and require supplemental oxygen, non- invasive or invasive mechanical […]
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The interim results on 353 patients showed that the drug has been successful in reducing viral load effectively with RT-PCR negativity.
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Developed by the DRDO, 2-DG has been granted permission by Drug Controller General of India for emergency use as adjunct therapy in moderate to severe Covid-19 patients.
