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Watchdog approved failed drugs for bribes: CBI busts racket

The CDSCO, a national regulatory body for pharmaceuticals and medical devices, is now on the agency's radar for the assent it granted to samples that failed testing

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The Central Bureau of Investigation has unearthed a corruption racket which allowed pharmaceuticals companies to "buy" approval to sell life-saving drugs of substandard quality in the Indian market by bribing officials of the Central Drugs Standard Control Organisation. The CDSCO, a national regulatory body for pharmaceuticals and medical devices, is now on the agency's radar for the assent it granted to samples that failed testing. The agency has arrested six people, including a top CDSCO officer, in the past week.

CDSCO, which falls under the union health ministry's Directorate General of Health Services, is responsible for conducting clinical trials, laying down standards for drugs, controlling the quality of drugs imported in the country and coordinating activities of state drug control organisations. It is jointly responsible with state regulators to grant of licences for specialised categories of critical drugs such as blood and blood products, IV fluids, vaccine and sera.

The health ministry said on Sunday that Naresh Sharma, deputy drug controller (I) based in CDSCO headquarters in New Delhi, caught red-handed while accepting a bribe by undercover CBI sleuths. He was taken into custody on Friday and is being investigated under the Prevention of Corruption Act, 1988. "Sharma has been suspended with immediate effect," the ministry said.

On Wednesday, the CBI had arrested drug inspector Ankur Bansal, based in Solan in Himachal Pradesh, and some Kwality Pharmaceuticals employees, including its managing director Ramesh Arora, in a bribery case of Rs 1 lakh. Samples of dobutamine injection manufactured and processed by the firm had failed CDSCO trial, but the drug inspector agreed to approve the samples, in connivance with officers at the Delhi HQ, in exchange for the bribe.

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