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Glenmark says clinical trial suspended at Jaipur hospital


Glenmark says clinical trial suspended at Jaipur hospital

New Delhi: Drug firm Glenmark Pharmaceuticals said it has suspended the clinical trial at the Malpani Hospital in Jaipur as soon as it became aware of the alleged irregularities at the hospital.

The company has “received the show-cause notice pertaining to the monitoring of the clinical trial at Malpani Hospital…,” Glenmark Pharmaceuticals said in a BSE filing.

Coming out with a clarification on the news reports regarding clinical trial, the company said,” As soon as the company became aware of the alleged irregularities at Malpani Hospital, the trials at the site were immediately suspended in the interest of patient safety.”

The company also said that it will respond to the notice in the stipulated time-frame.

The hospital in Jaipur is one of the many sites that had recently initiated phase II clinical trial for the company’s molecule GRC 27864 in patients with moderate osteoarthritis pain, Glenmark said.

Malpani Hospital is a CDSCO-approved site for clinical trials and has been conducting trials for many companies including multi-nationals over the past several years, it added.

Read also: Jaipur Hospital, Top Pharma Co face allegations of Conducting Unethical Human drug Trials



Source: PTI
1 comment(s) on Glenmark says clinical trial suspended at Jaipur hospital

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  1. user
    Dr Gramle Amol May 6, 2018, 8:57 pm

    This news is disturbing. Does this speak of the fact that the clinical trial was suspended because irregularities were identified and then it forced the authorities to suspend the clinical trial?

    The last statement of the article mentions that Malpani Hospital is an approved site by CDSCO and has conducted many clinical trials in the past, for multinationals too. What about the Credibility of human data that came from this centre?
    Responsible authorities must take appropriate action and permanently suspend this centre.