The United States Food and Drug Administration on Tuesday banned the import of more than 30 generic drugs manufactured by Ranbaxy Laboratories Limited alleging that poor quality control at the firm's factories could be harmful to users of these medications used to treat everything from high cholesterol to Type 2 diabetes to everyday allergies.
In a shocker, the US Food and Drug Administration has discovered the presence of mice, ants and cockroaches in food served on airlines in the country.
The Narcotics Control Bureau (NCB) on Saturday said it has arrested Jaffer Sadiq, a Tamil Nadu-based alleged dealer of narcotics, in connection with an international drugs trafficking investigation case.
Indian drug maker Alembic Ltd plans to expand its bulk drugs business in the United States by joining hands with US formulations makers, the Bombay Stock Exchange said on Thursday.
Orchid Chemicals & Pharmaceuticals on Monday said it has received US health regulator's approval to sell anti-epileptic levetiracetam tablets in the American market.
In comparison, Indian companies received only 23 out of 139 final approvals (16.54 per cent) in the corresponding period in 2006.
The anti-depressant drug market in the US is primarily ruled by Effexor XR (Venlafaxine) of Wyeth (now owned by Pfizer).
Sun Pharma Ltd has received tentative approval for cancer drug Ondansetron from US Food and Drug Administration.
Around 7.4 per cent of Indians aged 60 and above are affected by dementia. This number is expected to rise from the current 8.8 million to 17 million by 2036, marking a 97 per cent increase.
"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.
Scientists have developed a new and more effective drug to help smokers quit the habit, which is known to reduce the life span of those addicted by about 10 years and is the single most important factor for heart attacks the world over.
Ranbaxy Laboratories, Dr Reddy's Laboratories and Sun Pharma's US subsidiary Caraco Pharmaceuticals are among the 13 generic manufacturers to get first generic approvals from the US Food and Drug Administration to manufacture and market generic versi
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.
China has started producing five drugs that can be used in four different cocktails to treat AIDS patients, whose numbers are rising alarmingly.
Lupin Ltd received US Food & Drug Administration's approval for its abbreviated new drug application for Cefuroxime Axetil tablets.
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.
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.
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.
Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration to manufacture and market Fosinopril Sodium and Hydrochlorothiazide tablets in 10 mg/12.5 mg and 20 mg/12.5 mg strengths
The new US bio-terrorism law, which mandates prior registration of food suppliers with the USFDA, is likely to adversely affect the Indian food and marines exports, warns a leading non-government organisation EAN-India.
The government said it would amend the existing law, to provide for life imprisonment to offenders.
The US Trade Representative noted that India's average applied tariff rate stood at 17% per cent, the highest of any major world economy.
Sun Pharmaceutical Industries on Friday said that it has received the US Food and Drug Administration's nod to market a generic version of alprazolam, an anti-anxiety drug, in the US market.
Whistle-blower Dinesh Thakur tells briefing on US Capitol Hill: 'One in five medicines manufactured and distributed in India are spurious.' Aziz Haniffa reports from Washington, DC.
Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration to manufacture and market Lamivudine Tablets in 150 mg strength, the company announced on Saturday.
Earlier, Jaslok Hospital had issued an advisory to its doctors to avoid prescribing drugs manufactured by Ranbaxy.
'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.'
The Food Safety and Standards Authority of India (FSSAI) has commissioned a quality check on MDH and Everest products. This follows complaints that several popular spice mixes of the two leading brands contained traces of ethylene oxide more than the permissible levels, official sources said. This move by FSSAI comes after Hong Kong and Singapore recalled variants of the two masala majors' products in their countries.
Ranbaxy on Tuesday announced it had got final approval from the US Food and Drug Administration to market its Metformin HC1 tablets for diabetes.
Riluzole is indicated for the treatment of amyotrophic lateral sclerosis.
Ranbaxy Laboratories Ltd today said it has received tentative approval from the US Food and Drug Administration to manufacture and market Glimepiride tablets of 1 mg, 2 mg, 4 mg and 8 mg.
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