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ANTIMICROBIAL DRUGS REGULATION
FDA approval puts Wockhardt’s Zaynich in $9 billion antibiotics marketWockhardt's new antibiotic, Zaynich, has received US FDA approval. This drug uses a novel mechanism to fight drug-resistant bacteria. It ta...- Wockhardt secures US FDA approval for antibiotic ZaynichWockhardt's novel antibiotic, Zaynich (cefepime and zidebactam), has received US FDA approval for complicated urinary tract infections. Thi...
- Drugmakers flag concerns over blue-strip antibiotic labelsThe government mandated a blue line on antibiotic packaging to curb misuse. However, pharmaceutical companies argue this will disrupt opera...
- Pharma firms asked for side-effects of common medicinesIndia's drug regulator has issued new safety warnings for common medicines. Doxycycline, an antibiotic, will now list side effects like anx...
- Govt to bring in barcodes to fight fake drug menaceTo tackle fake drugs, the Union health ministry will soon mandate barcodes or QR codes on certain medicines. This applies to antimicrobials...
- Regulator set to monitor antimicrobial resistanceTo combat antimicrobial resistance (AMR), India's drug regulatory authority is collaborating with the Department of Animal Husbandry and Da...
- Govt may mandate QR codes on vaccines, key drugs to curb counterfeitsThe government is considering mandating bar codes or QR codes on labels for vaccines, antimicrobials, narcotics, psychotropic substances, a...
- FSSAI sets stricter rule for antibiotics in food items"If enforced strictly, the regulations will ensure safer food products for consumers by setting stricter residue and contaminant limits acr...
- Cipla expects to commence supplies to US from China plant later this yearCipla plans to start supplying from its China facility to the US market by the second half of the current fiscal year, following USFDA appr...
- Alembic gets USFDA approval to market Clarithromycin tablets in AmericaAlembic's product is therapeutically equivalent to AbbVie Inc's Biaxin Filmtab Tablets, which is antimicrobial indicated to treat mild to m...
- Lupin arm gets supplemental new drug application approval from US regulator for SolosecThe drug was approved in the US in 2017 for the treatment of bacterial vaginosis in adult women, the company said.
- Superbug-related death spurs drug regulator warningThe Centre has also asked state drug regulators to take "strong policy measures including stringent regulatory action on the over-the-count...
- Government to come up with list of over-the-counter drugs soonThe move is aimed at promoting self-care & reducing cost of treatment without compromising patient safety.
- Commonly used antibiotic in India under USFDA lensUSFDA has ordered safety labelling changes for the antibiotics to strengthen the warnings about the risks and make them more consistent acr...
- 64% of antibiotics sold in India unapproved, finds UK studyThe report said millions of antibiotic pills in the Indian market have not been regulated in India, the UK or US, worsening the problem of ...
- Health ministry moves to limit antibiotics in meatThe ministry has specified the maximum permissible limits of various antibiotics in meat products.
- Government proposes new e-portal to check AMR, substandard drugsIndia currently does not have a track-and-trace mechanism for drugs sold within the country even while it has a bar-coding system in place ...
- Antimicrobial resistance poses serious consequences: J P NaddaAMR is resistance of a microbe to an antimicrobial medication that used to be effective in treating or preventing an infection caused by it.
- HIV breakthrough: FDA approves new drug with fewer side effectsA new treatment for HIV infection has been approved by US federal regulators which does not have the side effects associated with other dru...
- Superbug threat: Govt mulls introducing new 'schedule' in ActThe threat of a multi-drug resistant superbug looming large has forced the government to consider introduction of a separate schedule in th...
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