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Articles for Regulatory

UN General Assembly Endorses Political Declaration On UHC

The declaration is hailed as a vital catalyst for the international community to take big and bold actions and mobilize the necessary political commitments and financial investments to attain the UHC target of the Sustainable Development Goals (SDGs) by 2030.

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G20 Health: Digital Health & The Missing $200 Million Fund

However, it encountered challenges in advancing a USD 200 million fund for a digital health program and establishing a permanent platform for sharing knowledge, intellectual property rights, and resources related to vaccines, diagnostics, and therapeutics under the Delhi Declaration

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Delhi HC Dismisses Plea Seeking Ban On Anti-Tobacco Ad Campaign At Cinemas

The Petitioner, being a non-smoker and not a consumer of any tobacco products, is wrongfully subjected to the compulsory watching of these graphic images in the anti-tobacco health spots during a film in the cinema hall and during TV programmes at home

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Akums Gets Fixed Drug Combination Approval From DCGI For Erectile Dysfunction

Tamsulosin is primarily used when an enlarged prostate impedes normal urine flow and bladder emptying. Conversely, Tadalafil's mechanism of action supports the development of a naturally induced erection, contingent upon sexual stimulation

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Strides Pharma Gets Tentative Approval For Treatment For HIV

Dolutegravir, Lamivudine and Tenofovir Disproxil Fumurate tablets are a complete regimen for the treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs

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Zydus Gets Final Approval For A Hormonal Transdermal Patch From USFDA

Ahmedabad-based Zydus Lifesciences has received final approval from the United States Food and Drug Administration for Norelgestromin and Ethinyl Estradiol Transdermal system, 150mcg /35mcg per day

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DCGI Issues Alert On Abbott's Digene Gel For Quality; Abbott Voluntarily Recalls Product In India

The Drug Controller General Of India (DCGI) Dr Rajeev Raghuvanshi has red-flagged a Digene Gel product manufactured by the pharmaceutical company Abbott India. In a letter dated 31 August 2023, the DCGI issued an alert calling the impugned product 'unsafe' and the use of which may result in adverse reactions

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WHO Warns Of A Spurious Rare Disease Drug Defitelio Floating In India

Defitelio (defibrotide) is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy

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