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Ranbaxy’s conduct will harm generics

Ranbaxy’s conduct will harm generics
It is a serious matter that Indian generic pharmaceutical giant Ranbaxy Laboratories Ltd’s United States subsidiary has pleaded guilty to felony charges this week relating to adulterated drugs made at two of Ranbaxy’s manufacturing facilities in India. This is just another example of how a drug company takes the people for a ride but was not expected of India’s largest pharmaceutical company. It will now pay $500 million in civil and criminal fines under the settlement agreement with the US Department of Justice. The huge size of the settlement, the largest-ever with a generic drugmaker over drug safety, and including $150 million in payments for a criminal fine and forfeiture and $350 million in payments for civil claims, is indicative of the extent of the culpability of the company over this serious issue. Ranbaxy USA has admitted to selling the acne medication Sotret, epilepsy and nerve pain drug gabapentin, and broad-spectrum antibiotic ciprofloxacin despite inadequate testing for stability, which defines a drug’s effective shelf-life over time and under various environmental conditions. There has been admission of other deficiencies as well, including the improper storage of drug samples that were waiting to be tested, continuing to sell a medication in the US even after it had failed purity tests and delaying a voluntary recall of medication that it knew would not maintain its expected shelf life. The charges also include making false statements to regulators and knowingly delaying making reports of inadequate testing to authorities.
 
All of these are grave charges and the company has fallen far short of the expected standards of responsible corporate behaviour. It has instead been actuated by criminal casualness and greed. In its efforts to cut corners and for financial gain it has neglected to adhere to the best manufacturing practices, aided undoubtedly by lax implementation of regulations and, possibly, corruption.  The issue of adulterated and substandard drugs is a grave one, not just in the United States or India but across the world, and at stake are the health and lives of millions of consumers who trustingly consume the products in the belief that these will help eliminate their illness and suffering. With Ranbaxy having been caught red-handed in the US, there are questions about its operations and drugs in the Indian market. These, too, must be brought under scrutiny and tested, so that the Indian consumers are suitably protected from substandard drugs and the corporate is made liable for its actions in this country as well.  
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