The Telegraph
Tuesday , June 11 , 2013

SC ‘very serious’ tag on Ranbaxy charges

- Apex court seeks prima facie evidence before directing govt action against company

New Delhi, June 10: The Supreme Court today observed that even if there was a grain of truth in the charges that Ranbaxy was supplying adulterated drugs, it was a “very, very serious matter” but refrained from issuing any orders till it received “prima facie material”.

The court said that drug-testing standards in the US were different from those in India, and what was happening in America might not necessarily be happening in this country.

But it added that if sufficient material were brought before it, the court would be willing to direct the government to act against the pharma giant.

The bench of Justices Gyan Sudha Misra and Madan B. Lokur made the oral observation while asking petitioner Manohar Lal Sharma, a lawyer, to further research the matter. It posted the public interest litigation for hearing on Wednesday.

“What is the material placed by you before us to say the medicines are adulterated? We must be fully satisfied that the drugs marketed are adulterated,” the court said.

“What is the material placed by you to say that the drugs are… part of the same transactions coming to India? Those supplied in the US may not be the same (as those) in India.”

It added: “Even if there is a grain of truth (in the allegations), it is a very, very serious matter which cannot be overlooked. By all means, we would be anxious to interfere…. But where is the prima facie material in the writ petition?”

The court said the petitioner had not placed the order, if any, passed by America’s Food and Drug Administration fining Ranbaxy the equivalent of Rs 2,900 crore on charges of supplying adulterated and substandard drugs in various parts of the world.

A New York Times report said on May 13 that Ranbaxy had “pleaded guilty… to federal drug safety violations and will pay $500 million in fines to resolve claims that it sold sub-par drugs and made false statements to the Food and Drug Administration about its manufacturing practices at two factories in India.”

The newspaper added: “Ranbaxy has been operating under a consent decree with the Food and Drug Administration since last year after federal officials identified a host of manufacturing lapses at plants in India and one in the United States, and concluded that the company… submitted false data to the FDA. Ranbaxy has not exported drugs from the two Indian factories, known as Paonta Sahib and Dewas, to the United States since 2008.”

Sharma’s petition says Jaslok Hospital of Mumbai has banned “all medicines supply by Ranbaxy”.

“Of course, we have come across reports that some (Indian) hospitals have banned it but… we cannot pass any order on the basis of newspaper reports,” the court said.

“There is not a single hospital in this country which has said that ‘We have found something wrong with the drug’.”

The petitioner’s counsel agreed to place the material sought before the court. The bench asked Sharma to make the Union commerce ministry a party to the case along with the Directorate of Drug Control Administration and other authorities regulating the manufacture, sale and supply of medicines in India.

Sharma’s petition has sought registration of criminal cases under the penal code and the Drugs and Cosmetics Act, 1947, against the pharma company’s officials for allegedly cheating patients by supplying substandard and adulterated drugs. The charges carry a maximum punishment of life imprisonment.