The Supreme Court is today scheduled to hear a Public Interest Litigation or PIL that asks for a ban on medicines manufactured by Ranbaxy Laboratories, India's largest drug company by sales. The petition says that selling adulterated drugs, which Ranbaxy admitted to in the US recently, is "a heinous crime" and "amounts to committing murder."
Here is your 10-point cheat-sheet to this story:
- The petitioner, an advocate named M L Sharma, says that India must cancel the licence granted to Ranbaxy Laboratories for producing drugs in the country.
- Mr Sharma says that no action to stop Ranbaxy drugs from being sold in India has been taken though the company pleaded guilty in May to criminal charges of selling adulterated medicines and agreed to a $500 million settlement.
- "It is not a tale of cutting corners or lax manufacturing practices but one of outright fraud, in which the company knowingly sold substandard drugs around the world, including in India, Africa and USA while working to deceive regulators," Mr Sharma says in his petition.
- The fraud in the US, investigated over eight years by federal authorities, was brought to light by a whistle-blowing ex-employee, who said Ranbaxy created "a complicated trail of falsified records and dangerous manufacturing practices."
- Mr Sharma wants the government to seal Ranbaxy's manufacturing units in India, including those in Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh. The US Food & Drug Administration had found these two plants to be in violation of good manufacturing practices mandated in that country.
- Mr Sharma has also sought action against Indian drug regulator, Central Drug Standards Control Organisation (CDSCO), for permitting Ranbaxy to sell drugs in India.
- Last week, Ranbaxy was fined 81 crores or nearly 10 million by the European Commission for blocking the supply of a cheaper anti-depressant drug to the market . The company has said it will challenge that fine. Eight other companies were fined for pay-and-delay agreements which involve brand-name firms paying generic companies not to market rival versions of their medicine. The generics usually cost a fraction of the original drug, though the issue is complicated by patent ownership.
- Earlier this month, Apollo Pharmacy, a chain of 1500 stores that is part of the Chennai-based Apollo Hospitals withdrew a "cautionary advisory" against drugs made by Ranbaxy. The pharmacy chain said it had worked with Ranbaxy to ensure that quality standards were being followed.
- Japanese drug company Daiichi Sankyo which bought Ranbaxy in 2008, has alleged that the Indian firm's former owners hid vital information about US regulatory inquiries at the time of the $4.6-billion purchase in 2008.
- The charges have been strongly denied by the billionaire Singh family which used to control the company.
(With inputs from agencies)