United States Senator Jim Banks has urged the Food and Drug Administration (FDA) to step up inspections of overseas pharmaceutical manufacturing facilities, expressing concern over poor-quality drugs being imported from countries like India and China.
The US Food and Drug Administration's (USFDA)'s new draft guidelines aimed at speeding up and reducing the cost of developing biosimilars - lower-priced, near-replicas of complex biologic medicines - could significantly benefit Indian biotech companies.
Amid controversy over USPresident Donald Trump's comments linking the use of Tylenol and other related paracetamol products by pregnant women to autism in children, experts and industry executives say that since India's export of the drug to the US is less, it will hardly affect the country's pharma exports to America.
State governments have requested the Centre for export incentives, lifting of import duty in the case of cotton for the textile sector and GST exemptions.
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.
The USTR report, released just ahead of the US' April 2 deadline for implementing reciprocal tariffs, has also cited high tariffs and price caps, which have not increased in line with inflation, as key obstacles for US businesses.
Drug maker Sun Pharmaceutical Industries on Thursday said it has received the US health regulator's nod for marketing a generic version of the Keppra injection, used for treating epilepsy, in the American market.
Wockhardt said it is launching the product immediately in the US market.
The letter mentions certain cGMP violation based on site inspections conducted between July and August 2009.
To be called Central Drug Administration or National Drug Authority, it will have 10 sub-authorities to deal with areas like cosmetics, blood safety, medical equipment, etc.
Orchid Chemicals & Pharmaceuticals on Monday said it has received US health regulator's approval to sell anti-epileptic levetiracetam tablets in the American market.
Glenmark said it along with its US-based partner has got the US health regulator's nod to manufacture and market two oxycodone products, used for treating moderate to severe pain, in the American market. The company's US arm, Glenmark Generics Inc and Lehigh Valley Technologies (LVT) have received US Food and Drug Administration nod for Oxycodone immediate release capsules, the company said in a filing to the Bombay Stock Exchange.
The heightened global uncertainty due to the US "reciprocal tariffs" on India may cause near-term corrections and market turbulence, but the long-term outlook remains constructive, market experts said on Thursday. The US has announced 27 per cent reciprocal tariffs on India, citing high import duties imposed by New Delhi on American goods.
Riluzole is indicated for the treatment of amyotrophic lateral sclerosis.
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The company has launched the Decitabine for injection in the strength of 50 mg in the US market following approval by the United States Food & Drug Administration of Dr Reddy's abbreviated new drug applications, it said in a statement.
The US Trade Representative noted that India's average applied tariff rate stood at 17% per cent, the highest of any major world economy.
'Leech therapy is a recognised minimal invasive Para surgical procedure and is a part of Ayurvedic surgery in India.'
Goods from sectors, including agriculture, precious stones, chemicals, pharma, medical devices, electricals, and machinery may get impacted if the US will go ahead with imposing reciprocal tariffs on Indian products, according to experts. They said that these sectors could face additional customs duties from the Trump administration because of the high tariff differential or gap, which is the difference between the import duties imposed by the US and India on a product.
With an increasing number of people from the Indian-American community playing a significant role in US elections, Congressman Raja Krishnamoorthi said there is a realisation among them that "if you don't have a seat at the table, you're on the menu -- that is why they are voting and running for office in large numbers".
The company's US-based subsidiary Lupin Pharmaceuticals Inc has launched its generic Rabeprazole Sodium delayed-release tablets, 20 mg in the American market after having received approval to market it from the US Food and Drug Administration, according to a statement by Lupin.
'No retaliatory tariffs now. You can retaliate after a few months.' 'Today, there is no need to retaliate because it is a question of long term benefits.'
A drug developed by the Defence Research and Development Organisation (DRDO) may reverse the heart damage caused by a protein in the SARS-CoV-2 virus, a study conducted in fruit flies and mice has found.
President-elect Donald Trump announced a slate of key Cabinet nominations, including tapping former Democratic presidential candidate Robert F. Kennedy Jr. as his Secretary of Health and Human Services and former Congressman Doug Collins of Georgia as Secretary for Veterans Affairs. Trump also named Jay Clayton as US Attorney for the Southern District of New York, Todd Blanche as Deputy Attorney General, and Dean John Sauer as Solicitor General of the United States.
Ranbaxy Laboratories is recalling 29,790 blister packs of anti-allergy drug in the US, manufactured by its arm Ohms Laboratories, due to defective packaging.
The US president said the drug has gotten a bad reputation only because 'he was promoting it'.
The country's drug companies have attracted the highest number of enforcements from the American drug regulator in 2013, a year that has seen the US Food and Drug Administration turning stricter to ensure compliance levels and quality of medicines.
The company has received final approval for its supplemental New Drug Application (sNDA) for Antara (Fenofibrate) capsules in 30 mg and 90 mg strengths from the United States Food and Drug Administration (USFDA), Lupin Ltd said in a statement.
Soon after Trump revealed to the world that he has been taking the medicine, the White House doctor said the president is in good health.
The company has received final approval from the US Food and Drug Administration for its Abacavir Sulfate Lamivudine, and Zidovudine Tablets, Lupin Ltd said in a statement.
The US president said that he has sought help from Prime Minister Narendra Modi to allow the sale of Hydroxychloroquine tablets ordered by the US to treat the growing number of coronavirus patients in his country, hours after India banned the export of the anti-malarial drug.
Dr Murthy, 43, a former United States Surgeon General, along with two other co-chairs -- Dr David Kessler and Dr Marcella Nunez-Smith -- would lead a team of leading public health experts who will advise Biden and Vice President-elect Kamala Harris on the deadly virus.
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.
As marketing rights for off-patent drugs in the US become less exclusive, companies are scrambling for fresh strategies to make up for the revenue loss.
Biden, 'plotting an ambitious presidency that would begin amid twin health and economic crises, is leaning on veteran advisers with high-level governmental experience rather than outsiders and ideological rivals to help guide him on subjects including the coronavirus pandemic and the country's diminished standing in the world', a report in The New York Times said.
Ranbaxy has acceded to the request of Health Canada to quarantine drugs produced from its Paonta Sahib facility at Himachal Pradesh, North American country's newspapers reported, highlighting the trouble in store for the Japanese-controlled drug maker. Health Canada is a department of the government of Canada with responsibility for national public health.
Meticulous hand washing is your best bet to get rid of the grime that clings to the hand, that might harbour nasty pathogens, including the coronavirus.
Cancer has no race, so why do new innovative cancer drugs discriminate based on race and ethnic groups, asks Digonto Chatterjee.
Sun Pharmaceutical Industries said it has received approval from US health regulator to market generic Clarinex tablets and Tiazac capsules, used in treating nasal allergies and hypertension, respectively, in the American market.
United States Food and Drug Administration (USFDA) has given final approval to Glenmark Generics Inc for their abbreviated new drug application (ANDA) for Norgestimate and Ethinyl Estradiol tablets USP in the strengths of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25/0.035 mg, the company said in a statement.
There is no evidence that the drug can fight the virus, and regulators warn it may cause heart problems.
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