Drug-maker filed response in US court yesterday. Under fire in the United States for giving distorted information on the generic drugs it sold, Ranbaxy Laboratories today said that it will file all relevant information within a month after which the legal case initiated against it by the US government will be withdrawn. This is a key disclosure in the response filed by Ranbaxy in a district court in Maryland yesterday against the "motion to compel" filed by the US government on July 3.

Drug Regulatory System In India Has Abysmal Standards And There's No Credible Mechanism To Monitor Adverse Drug Reactions K G Narendranath NEW DELHI

New US rules to free clinical trials of ethics it is alleged that Johnson and Johnson carried out clinical trials of its anti-psychotic drug, Risperdal, in Gujarat three years ago without the informed consent of patients. The study also used placebos despite drugs being available for treatment. Both these actions flout the Helsinki Declaration, adopted in 1964 by the World Medical

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The state government has ayed proposals for setting up three pharmaceutical units with an investment of Rs 275 crore in special economic zones at Indore and Gwalior. The Glenmark group would establish two units - Rs 175 cr - while Teva API India group would set up one over 29 hectares at Gwalior. The latter unit's products would be exported only and the group has three such pharma units in neighbouring Uttar Pradesh, sources said today.

Govt Looking At Several Ways To Ensure Availability Of Essential Drugs THERE may be good news for the pharma industry, which has been facing price caps and fighting high input costs. The government is learnt to be considering liberalising the 10% mandatory cap on price hike for drugs outside the price control.

Khomba Singh NEW DELHI THERE may be good news for the pharma industry, which has been facing price caps and fighting high input costs. The government is learnt to be considering liberalising the 10% mandatory cap on price hike for drugs outside price control. Non-scheduled drugs or drugs outside the government's direct price control account for about 75% of the Rs 33,000-crore drug retail market. According to drug pricing laws, companies cannot increase prices of drugs by over 10% within 12 months.

An Indian company buying a foreign company or a foreign company acquiring an Indian company should not inflate or deflate our pride -Jaskaran Singh Dhami

GlaxoSmithKline, the UK-based pharmaceutical company, is unlikely to receive US approval for its key cervical cancer vaccine until 2010 at the earliest, under a new timetable it released on Monday. After requests for fresh information on Cervarix from the Food & Drug Administration in December, GSK said it had decided to await completion of a pivotal clinical trial to be filed with the US regulator during the first half of next year.

Melody Petersen covered the pharmaceutical beat for The New York Times for four years. In 1997, her investigative reporting won a Gerald Loeb Award, one of the highest honors in business journalism. She is the author of Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs (2008).(An interview with Melody Petersen)

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