A three-member team each from the Central Drugs Standard Control Organisation (CDSCO) and the State Drug Controller visited the plant in Tamil Nadu's Kancheepuram, 40 km from Chennai, on Friday after the company recalled the eye drop.
The Bombay high court on Thursday said the Union government's allocation of Amphotericin-B, a key drug used in the treatment of mucormycosis or black fungus, appeared to be irrational, and the supply to Maharashtra was not adequate considering the number of cases in the state.
Company had earlier received an import alert in February this year from the US Food and Drug Administration.
The Bombay high court on Wednesday ordered for fresh testing of Johnson & Johnson baby powder samples and permitted the company to manufacture the product but to not sell it, as per the Maharashtra government order. The company had filed a petition challenging two orders of the state government- one dated September 15 cancelling the license and the second dated September 20 ordering to immediately stop manufacturing and sale of the company's baby powder product. The orders were passed by the joint commissioner and licensing authority of the state Food and Drug Administration (FDA).
The US Food and Drug Administration (FDA) says it does not follow an India agenda.
The protestors called the state's administrative measures "only partial victory" of their movement.
Hindus for America First, a newly created grassroots organisation, has announced it will endorse Republican presidential candidate Donald Trump and launch a campaign against Democratic nominee Vice President Kamala Harris in the key battleground states of Pennsylvania, Georgia and North Carolina.
A day after getting a show-cause notice from the Indian regulator, senior executives from Ranbaxy Laboratories approached the drug controller's office on Tuesday afternoon, it was learnt.
Generic drugmakers cannot be sued under state law for adverse reactions to their products.
The Indian Council of Medical Research's national task force for COVID-19 has decided against including antiviral drug Molnupiravir in the clinical management protocol for COVID-19 as of now, official sources said on Tuesday.
'There is no reason why we should break this business up.'
Bolstered by an impressive performance in the global specialty business and outstanding results in the Indian market, Sun Pharmaceutical Industries, the largest pharmaceutical (pharma) company in the country, showcased a strong performance in the July-September quarter (second quarter, or Q2) of 2023-24 (FY24).
Delhi Cabinet Minister Saurabh Bharadwaj Sunday alleged that Tihar authorities have now requested a diabetologist from All India Institute of Medical Sciences (AIIMS) in contradiction of their earlier stance of adequate medical facilities for diabetics being present in the prison.
Sputnik V is already approved in India and Sinovac is unlikely to come in as it does not meet the criteria.
The Delhi minister also claimed that Kejriwal used to take 50 units of insulin daily before he was sent to jail.
He had taken charge as the 25th director general of the Indian Coast Guard on July 19 last year.
Even as most of its large-cap pharmaceutical peers have struggled to stay above water on the returns front, Zydus Lifesciences has been one of the big outperformers within the sector over the past year with a return of over 30 per cent. The gains have come on the back of multiple triggers such as the scaling up of new product launches in the US market, clearance for its Moraiya (Gujarat) facility and steady performance in the domestic market. Though it has been the top pharma gainer in the 2022-23 financial year (FY23), brokerages continue to maintain their 'buy' stance, given the strong visibility in the US market.
There is no evidence that the drug can fight the virus, and regulators warn it may cause heart problems.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
The company did not comply to the 'good manufacturing practice' norms.
India on Monday raised serious concerns over the USFDA's audit inspections of Indian pharma companies and 'disproportionate penalties' in some instances and said it would submit a discussion document on the issues to the US.
"It has been decided that for approval of COVID-19 vaccines in India for restricted use in emergency situation which are already approved for restricted use by US Food Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, Pharmaceuticals and Medical Devices Agency Japan or which are listed in WHO Emergency Use Listing and which are well established vaccines from the stand point that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and of testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of country of origin," it said.
The recent terror acts are a sign of our enemy's desperation, he said, in an apparent reference to Pakistan.
As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
'Investors looking at the next 6-12 months can be certain that the Fed will maintain its easing cycle, and we expect the overall environment to be conducive for fixed income investments for portfolio diversification.'
Currency played an important role in Q2, with US dollar, Japanese yen and euro appreciating vis-a-vis the Indian rupee, while the Brazilian real, South African rand and Russian ruble depreciating against rupee.
'In a complex situation a PM coming was not necessary'
The respondents were from over 22 states with 85 percent of them being under 35 years while 61 percent were interns or postgraduate trainees.
Harris will appoint hundreds of extreme far-left judges to 'forcibly impose crazy San Francisco liberal values' on Americans nationwide, he alleged, invoking the spectre of San Francisco -- a liberal city long used as shorthand by conservatives eager to denigrate Democrats.
The company said the drug will be made available across India through the group's strong distribution chain reaching out to government and private hospitals treating COVID-19 patients.
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.
Maharashtra Chief Minister Uddhav Thackeray has handed over portfolios of nine rebel ministers, who are currently camping in Guwahati, to other ministers.
Even smaller companies like Torrent Pharma and Alembic file five to 10 ANDAs every year.
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.
Embattled US President Joe Biden on Sunday announced that he will end his candidacy for re-election in 2024 and endorsed Vice President Kamala Harris as the Democratic Party's new nominee, saying "it is in the best interest of my party and the country".
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
According to a gazette notification of the draft rules published on June 5, a hospital or medical institution may import new drug for 'compassionate use for treatment of patients suffering from life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need', which has not been permitted in the country, but under Phase-III clinical trial (human trial) in the country or abroad, by making an application to the Central Drug Regulator.
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.
Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
