Novartis to probe Indian drug approval allegations

ZURICH Thu May 10, 2012 9:10am EDT

A man walks past the logo of Swiss drugmaker Novartis AG in front of a plant in Basel October 25, 2011. REUTERS/Arnd Wiegmann

A man walks past the logo of Swiss drugmaker Novartis AG in front of a plant in Basel October 25, 2011.

Credit: Reuters/Arnd Wiegmann

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ZURICH (Reuters) - Swiss drugmaker Novartis said on Thursday it would investigate alleged drug approval irregularities in India after a parliamentary report found the country's regulator colluded with pharmaceutical firms to speed up approval procedures.

"We will investigate the allegations presented in the government's report," Novartis said in a statement.

The parliamentary committee reviewed 39 randomly selected drugs approved by the Central Drugs Standard Control Organization (CDSCO).

In the case of 11, including Novartis' everolimus and aliskiren, it found that "mandatory" Phase III trials - the final stage of testing before a drug is approved - had not been conducted as required.

Specifically, in the case of everolimus, the CDSCO relied on the judgment of non-medical staff rather than seeking the opinion of independent experts, the report said.

Novartis said it followed one global ethical standard for conducting clinical trials worldwide and stood behind the safety and efficacy of its products.

(Reporting by Caroline Copley; editing by Ben Hirschler)

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