Alkem Labs was issued drug alerts twice last year -- in June and July -- for its drug Glimekem.
This will be Modi's first interaction with chief ministers following the recent approval of two coronavirus vaccines for restricted emergency use by India's drug regulator.
Last month, the US Food and Drugs Administration had placed Wockhardt's facilities in Waluj near Aurangabad on import alert, barring supply of various products from these facilities to the US.
Sun Pharmaceutical Industries and Lupin Ltd will soon add another generic drug each to their US product basket. The companies received approvals from the US drug regulator to market generic equivalent of Pfizer's Dilantin Kapseals and Abbot's Mavik r
The National Medical Commission in the Professional Conduct Regulations also bar doctors from endorsing any drug brand, medicine or equipment, or advertise them.
The category is expected to cross Rs 38,400 crore by 2020.
These drugs will be entering in their global Phase -3 clinical trials early next year.
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
The White House website had a new look with the bold banner headline 'America is back' seconds after Trump was sworn in as the 47th President of the United States on Monday.
Samples of the cough syrup have been taken from the manufacturing premises in Noida and sent to the Regional Drugs Testing Laboratory (RDTL) in Chandigarh for testing, Mandaviya said.
Maya Chemtech India Pvt Ltd supplied propylene glycol used in Marion Biotech's cough syrups that were found to be "not of standard quality", according to the regulator.
Data also show that several other leading domestic pharma companies have recalled their products from the US
Industry associations and companies in the United States, including the US Chamber of Commerce, Coalition of Services Industries and the iconic bike company Harley Davidson have called on the Donald Trump dispensation to push India to reduce tariffs, non-tariffs, and regulatory barriers to boost American exports.
Bharat Biotech applied to the Drugs Controller General of India (DCGI) seeking permission for conducting phase 1 and phase 2 clinical trials of the intranasal vaccine following which the subject expert committee of the CDSCO on Tuesday deliberated on the application and recommended granting permission for phase 1 trial.
As many as 34 new drugs were added to and 26 dropped from an updated list of essential medicines on Tuesday, with the government saying this will reduce "patients' out-of-pocket expenditure". The National List of Essential Medicines (NLEM 2022) has 384 drugs, up from 376 in 2015. "Drafting this list is a lengthy process, and around 350 experts from across India have held over 140 consultation meetings to draft the NLEM 2022," Union Health Minister Mansukh Mandaviya said.
Anti-infectives like Ivermectin, Mupirocin and Meropenem have also been added to the list, taking the total drugs under it to 384.
The fees for facility inspection of foreign companies have been reduced
The announcement comes a day after the Subject Expert Committee (SEC) on COVID-19 of the CDSCO recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.
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The Drugs Controller General of India is considering the recommendations of its advisory body to revoke the suspension of the sale of analgin-based medicines in the country.
The Drug Controller General of India has sent a letter to the Glenmark seeking clarifications on pricing as well as claims of therapeutic efficacy. While Glenmark has claimed this drug is effective in comorbid conditions like diabetes, hypertension, according to protocol summary (of clinical trials) the trial was not designed to access the Fabiflu in comorbid conditions.
Simona Halep questioned the "big difference" in how doping cases are treated after world number two Iga Swiatek was handed a one-month drugs ban
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The US Food and Drug Administration had in February approved Johnson & Johnson's COVID-19 vaccine that works with just one dose for emergency use.
Traction for its specialty portfolio, a strong showing in the domestic market, and better regulatory compliance are positives for the country's largest pharmaceutical (pharma) company, Sun Pharmaceutical Industries. Given the triggers, some brokerages have increased their earnings per share estimates and target price for 2024-25 (FY25). This should sustain the momentum for the stock, which has been one of the major pharma gainers in 2023-24 (FY24), rising 57 per cent. It is currently trading at Rs 1,547 per share.
Confirming the Drugs Controller General Of India (DCGI) approval, Serum Institute of India CEO Adar Poonawalla on Tuesday tweeted: '@SerumInstIndia's brand Covovax has completed bridging studies in India and has been granted Emergency Use Authorisation by DCGI for adults and for children above the age of 12. Younger age groups will follow shortly.'
As COVID-19 cases in China continue to rise, Beijing will soon start distributing Pfizer's Covid-19 drug Paxlovid to the community health centres in forthcoming days, CNN reported citing state media on Monday.
The move is in line with the NPPA's recent policy of putting a cap on prices.
India's drug regulator has initiated a probe and sought further details from the WHO after the global health body issued an alert that cough syrups manufactured by an Indian firm could potentially be linked to the death of children in Gambia.
After reports of contamination in cough syrups sent from the country, India is considering a system to test them before exporting. It is learnt that the Central Drugs Standard Control Organisation (CDSCO) has sent a proposal to the Union health ministry on this. The idea is to test the medicines at government labs before exporting.
The move comes even as India's drug regulator has extended Covishield's shelf life from six to nine months from its manufacturing date.
As of now, Gennova Biopharmaceuticals has launched a vaccine, Gemcovac-OM, which is based on the Omicron variant.
The US Trade Representative noted that India's average applied tariff rate stood at 17% per cent, the highest of any major world economy.
Australian health regulator Therapeutic Goods Administration is investigating Indian pharma major Ranbaxy, following US allegations of the company falsifying data and test results of new drug applications, a media report says.
Financial institutions are 300 times more vulnerable to cyberattacks than any other industry.
Roadblocks ahead as these medicines could face new clinical tests, more scrutiny
Global Pharma Healthcare is recalling entire lots of eye drop linked to vision loss in the US, according to the US Food and Drug Administration. The Chennai-based company is recalling all lots of artificial tears lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma to the consumer level due to possible contamination, the US health regulator said in a statement. "The Centres for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo--lactamase (VIM)- and Guiana-Extended Spectrum--Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare," USFDA said.
US President-elect Donald Trump has nominated Indian-American scientist Jay Bhattacharya to lead the National Institutes of Health (NIH), the country's top health research and funding institutions. Bhattacharya, a professor of Health Policy at Stanford University, is known for his research on the health and well-being of vulnerable populations. Trump also nominated Jim O'Neill as the deputy secretary of Health and Human Services to work alongside Robert F. Kennedy Jr.
Thousands of police personnel and CCTV cameras were deployed and traffic regulated across states on Tuesday to ensure public safety and prevent any untoward incident as the country geared up to welcome 2025.
