Govt bans brands with annual sales worth Rs 3,728 crore.
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.
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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.
A strong performance in the July-September quarter of 2023-24 (Q2FY24), an upward revision in the margin guidance and sustained momentum in US sales has helped the stock of pharmaceutical major Cipla gain about 2 per cent over the last two trading sessions. The brokerages have upgraded the earnings estimates for this financial year (FY24) by 6-9 per cent to factor in the improved margin guidance and sales in the US market. Led by the US market, which rose by 31 per cent, the company posted a 16 per cent growth in revenues.
Alarmed by the growing number of advertisements on 'miracle' drugs being shown on television channels, Maharashtra Food and Drug Administration
India is one of the largest manufacturers of pharmaceutical products in the world with the annual production valued at over Rs 2 lakh crore.
It was also found at many places that spurious medicines, particularly Ayurvedic medicines, are being manufactured without licence from the competent authority.
Indian companies are unable to raise prices because 35 per cent of the drugs sold in the country come under the government's price control order.
India has capped the prices of 36 drugs, including those used to treat infections and diabetes, in its latest move to make essential medicines more affordable, a senior official of the country's drug pricing authority told Reuters on Friday.
The United States accused cyclist Lance Armstrong on Friday of defrauding the US Postal Service by taking its sponsorship money at the same time he was doping and using performance-enhancing drugs in violation of cycling rules.
In the final part of a three-part series on America's war on substandard Indian generic drugs, Aziz Haniffa speaks about American doctors' contempt for drugs exported from India and the ineptitude of the US Food and Drug Administration to stop the menace.
A public interest litigation was filed in the Delhi high court on Monday against permission to exchange Rs 2000 banknotes without obtaining any requisition slip and identity proof.
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.
Some US doctors are becoming concerned about the quality of generic drugs supplied by Indian manufacturers following a flurry of recalls and import bans by the Food and Drug Administration.
Amneal Pharmaceuticals is set to pip Sun Pharma as the fifth largest generics maker in the US, reports Sohini Das.
Drugs under exemption make up roughly 95 per cent of the antiretrovirals used by India's AIDS patients
Competition in the US pharmaceutical market swelled in recent years, with increasing generic penetration.
The PIL , filed by advocate M L Sharma, sought action against Ranbaxy for allegedly supplying substandard and adulterated drugs
Germany's drug regulator has banned the sale of 80 generic medicines with immediate effect on the grounds that their clinical trials conducted by India's pharmaceutical research company GVK Biosciences were "insufficient".
India's leading drug maker Ranbaxy has initiated a voluntary recall of 4,348 cartons of its skin infection drug Sotret (isotretinoin) in the United States. The entire lot pertains to a single batch of tablets which were found to be 'out of specification'.This is the second instance in four months when Ranbaxy has initiated a recall. In July, the company had pulled out a lot of Sotret from the US market after it was found to be degraded.
Novartis markets Nilotinib globally as Tasigna, which is used as the second-line therapy for Gleevec-resistant patients in the case of chronic myelogenous leukemia.
Indian pharma firms under European drug regulator's scanner.
The USTR has placed India on its "priority watch" list for two years in a row, saying the country's patent laws unfairly favour local drug makers.
Justice Rajiv Sahai Endlaw allowed 454 petitions moved by various pharma and healthcare majors, like Pfizer, Glenmark, Procter and Gamble and Cipla, challenging the government's March 10 notification banning the FDCs, saying the decision was taken by the Centre without following procedure prescribed in the Drugs and Cosmetics Act.
Roche expects to start selling Actemra by April 2009, company sources said. India will be the second country to launch the drug, Japan being the first. The Indian drug regulator Drug Controller General of India usually approves a new drug marketing application based on safety and efficacy data cleared by regulators in the US, EU and other developed countries.
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In 2012, drugs worth $35 billion went off-patent in the US, while the market size of drugs which will see patent expiry in 2013 will halve to $17 billion.
The US Food and Drug Administration (FDA) says it does not follow an India agenda.
The US Food and Drug Administration has seized drug products manufactured by Caraco Pharmaceutical, at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom, the US FDA said on Thursday. The FDA seeks to immediately stop Caraco from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements, it added.
An Indian pharmaceutical company is gearing up to sell a cheap version of the leading patented antiviral flu drug Tamiflu to emerging economies, in a move that will pitch intellectual property rights against affordable access to medicines.
The U.S. Federal Bureau of Investigation and others have been investigating whether Texas billionaire Allen Stanford was involved in laundering drug money for Mexico Gulf cartel, ABC News reported on Wednesday, citing federal authorities.
The voluntary move comes a little more than a year after the Central Drugs Standard Control Organisation, the central authority that approves new drugs for marketing, had asked the drug makers to withdraw the 'combination drugs' as they are 'unnecessary' and may pose health hazards. The Drugs Controller General of India had banned 294 combination drugs sold under nearly 1,053 brand names from the market in June 2007.
commercial airlines and air navigation service providers have to carry out random drug tests on at least 10 per cent of their flight crew and air traffic controllers every year.
Several companies, including Indian units of Abbott Laboratories and Pfizer Inc, and domestic firms like Cipla Ltd and Macleods Pharmaceuticals, went to the Delhi High Court to try to get the ban lifted.
In a landmark judgment that has the potential to change the direction of India's pharmaceutical business, the apex court said on Monday that the drug failed to qualify for a patent according to Indian law.
Povidone iodine ointment and solutions are available in the market under various popular brands such as Betadine and Wokadine.
The US Food and Drug Administration (USFDA) has issued a warning letter to RPG Life Sciences for violation of current good manufacturing practice (CGMP) norms at its two plants at Ankleshwar and Mumbai.
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