The Supreme Court on Monday posed some tough questions to a lawyer, asking him to substantiate his "unfounded allegations" in a PIL that Indian pharma major Ranbaxy Laboratories Ltd was allegedly manufacturing and selling adulterated medicines.
Last year, Ranbaxy had paid around $4,20,000 to the US state of Idaho as part of a $500-million settlement that the drug firm had signed with US authorities.
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Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
The Gurgaon-headquartered drug maker, set to be acquired by another leading domestic company, Sun Pharmaceutical Industries, reported a consolidated net loss of Rs 186 crore for the quarter ended June.
4 Ranbaxy facilities in India have been barred from exporting to US.
In May this year, Ranbaxy had pleaded guilty to 'felony charges' for violating manufacturing norms and agreed to pay $500 million penalty to US authorities.
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.
A source said the competition watchdog would by next month suggest 'structural remedies' that included selling key drug segments as conditions for clearing the country's largest pharmaceutical industry merger.
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Sun Pharma would have to do a lot of work to get USFDA to revoke the ban on Ranbaxy facilities but it has not put any time-frame for this, company ChairmanIsrael Makov said.
Sporadic incidents of arson were on Monday reported as life in violence-torn Haryana limped back to normal with curfew being lifted gradually and Jat protesters starting to lift blockades after the Bharatiya Janata Party announced setting up of a committee to examine the quota demand of the community.
Last month, the US Food and Drugs Administration had placed Wockhardt's facilities in Waluj near Aurangabad on import alert, barring supply of various products from these facilities to the US.
Consultants are working with various teams on manufacturing, R&D, etc, to assess per-month productivity of each department.
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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And when an inspector asked about the contents of unlabelled vials in the laboratory glassware washing area, a plant worker dumped them down a sink and said the contents could not be determined, according to a July 18 letter from the US Food and Drug Administration to Wockhardt, which makes sterile injectable drugs and various forms of insulin.
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