The FDA Commissioner Margaret Hamburg is slated to travel to India soon.
Indian pharma firms under European drug regulator's scanner.
The Bombay high court on Thursday directed the Maharashtra government to investigate how celebrities and politicians procured anti-COVID-19 drugs and injections to help those in need when the same were available only in scarce quantities across the country.
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The Drug (Prices Control) Order implemented in May last year brought into its purview 652 packs of 348 formulations.
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.
In an affidavit filed in the top court, the SLA has given details of the steps taken by it against Patanjali and Divya Pharmacy.
Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid. Similarly, Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia.
The Mumbai police seized more than 700 kg of mephedrone worth Rs 1,400 crore following a raid at a drug manufacturing unit at Nalasopara in Palghar district, and arrested five persons, officials said on Thursday.
During the meeting, scheduled to be held through video conference at 6 pm on Tuesday, the Department of Biotechnology will make a presentation and also coordinate with all the participants, sources added.
'Someone posts a job on LinkedIn and there are a thousand resumes in an hour? This is not the America IT professionals are used to.' 'Once they lose their job, it's impossible to get a job.'
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.
Avigan comes in a complete therapy pack of 122 tablets with a two-year shelf life.
'A long-term investor with a 4 to 5 year horizon could invest in this theme via SIPs.'
Congress leader Rahul Gandhi on Thursday said Prime Minister Narendra Modi thinks that the Constitution of India is 'blank' because he has never read it.
'We are also seeing the birth of new evil, the new face of drug distribution where human interface has reduced; consumers are using the Dark Web to source supplies and using cryptocurrencies as payment mode.'
To burnish production-linked incentive (PLI) schemes, the government is considering an overhaul of some of them relating to sectors such as textiles and pharma, and making incentive payments quarterly, officials in the know said. In a bid to cut the delay in processing incentive claims, the government is looking at switching to a quarterly disbursement of incentives. Currently, in most schemes, incentives are annual.
Favivir is the second drug developed by Hetero after Covifor (Remdesivir) used in the treatment of COVID-19.
Drug firm MSD has decided to enter into voluntary licensing agreements for investigational oral antiviral drug candidate 'Mmolnupiravir', which is being studied for the treatment of Covid-19, with Indian drug firms Sun Pharma, Cipla, Dr Reddy's, Emcure Pharma and Hetero Labs, its Indian arm said on Tuesday.
Research and development (R&D) spending by BSE 100 companies has grown steadily, rising from 0.89 per cent of revenue in FY20 to 1.32 per cent in FY24, averaging around 1 per cent over the period in-between, according to data compiled from Bloomberg and company annual reports. Also, these companies more than doubled their R&D spending in absolute terms over these five years: From Rs 25,041 crore to Rs 63,072 crore. While this reflects a prioritisation of innovation, corporate R&D investment remains relatively conservative.
The government is expediting visa-related issues to bring technicians to India from any country, not just China, as and when required, to ensure the smooth implementation of the flagship production-linked incentive (PLI) scheme aimed at boosting domestic manufacturing. "If those under the PLI scheme need to get their equipment installed, we try to expedite the ability to get technicians into India from any country, whichever it may be," Union Commerce and Industry Minister Piyush Goyal told Business Standard in an interview.
The department also said there is nothing to suggest that the state authorities failed to address any shortage of COVID-19 drugs.
Indian drug firms get a shot in the arm in the $12 bn Australian drug market as the Therapeutic Goods Administration (TGA), Australia agrees to accelerate the drug approval process in that country for Indian players who already have an approved plant and product from one of the stringent regulatory authorities like US, EU or Canada. From current sales of $340 mn, the Indian firms can see a significant upside in sales; felt Dinesh Dua, former chairman of the Pharmaceutical Exports Promotion Council of India (Pharmexcil), and the MD of Nectar Lifesciences. He highlighted that only 12 percent of the Australian drug market is generic, as against 80-90 per cent in the US or EU. Of this $1.5 bn generic drug market in India, Indian companies have a small share.
Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy's Laboratories alleging that the Indian drug-makers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance (palbociclib) before expiration of its patent.
The new regime aims to bring in ease of doing business, as the NITI Aayog has proposed to do away with the need to have manufacturing licences to register medical devices or to get a certificate of compliance.
In an order, the government's Drugs Control Department said that the step has been taken to address reports of "acute shortage of COVID-19 management drugs due to a sudden rise in COVID-19 cases in Delhi".
With intermittent disruptions in the supply chain of raw materials from China, the Indian pharma industry has braced itself with bigger inventory. Even smaller drug makers are now carrying a month of buffer stock of key raw materials, said industry insiders. The lockdown in various Chinese provinces, including Shanghai, is likely to delay shipments by two weeks to a month, said domestic players. Shipments are critical for the Indian drug industry, which imports 70 per cent of its raw material from China.
Delhi's drugs control department has told the Delhi high court that it has launched prosecution against Gautam Gambhir Foundation and Aam Aadmi Party MLAs, Imran Hussain and Praveen Kumar, before a court for allegedly illegally stocking and distributing Covid drugs during the infection's second wave.
Niclosamide, a drug on the World Health Organisation's list of essential medicines, has been used to treat tapeworm infestation for more than 50 years. The oral antiviral drug was also used to treat patients during the SARS outbreak of 2003-04.
The government hopes that the PLI schemes would provide 200,000-300,000 direct employment over five years, according to sources in the know.
The police have so far seized approximately 1,700 kg of mephedrone from Pune and a couple of locations in Delhi.
The Centre is looking to procure around 1 billion syringes between September and December to support the COVID-19 vaccination drive.
FabiFlu is the first oral favipiravir-approved medication in India for the treatment of COVID-19. Favipiravir can be used for coronavirus patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID-19 symptoms.
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India
'Three central agencies hounding a single woman, just because she was in love with a drug addict and a person suffering from mental health issues'
The CBI probe was ordered following a recommendation by Delhi Lt Governor V K Saxena on the matter in December last year.
Even as the Supreme Court had recently dismissed the industry's plea against prices fixed by the regulator and its timely implementation, the National Pharmaceutical Pricing Authority has asked companies to pay the overcharged dues with 15 per cent interest.
A case against Majithia under various sections of the NDPS Act was registered on the basis of a 2018 status report of probe into the drug racket in the state.
The NCB has widened its probe into a recent seizure of about 50 kg of heroin from a house in south Delhi's Shaheen Bagh area with the arrest of three more people on Friday, officials said.
Gland Pharma beat muted expectations for Q2FY25. There was increased Ebitda (Earnings before interest, taxes, depreciation and amortisation) loss at Cenexi, the CRAM subsidiary. However, overall Ebitda margin was better than expectations at 21.1 per cent. But given two years of earnings decline in FY23 and FY24, the business may have bottomed and upper-teens EPS (earnings per share) growth looks possible over next two financial years.
The Narcotics Control Bureau has seized about 50 kg of 'high-quality' heroin and arrested a man after it conducted raids in the Shaheen Bagh area of Delhi's Jamia Nagar, the federal anti-narcotics agency said on Thursday, claiming to have busted an Indo-Afghan drug-smuggling racket.
