The decision comes in the wake of the drug regulator finding certain discrepancies at the clinical trial site linked to a phase two clinical trial of Glenmark’s osteoarthritis pain drug.

Viswanath Pilla
  • Glenmark

The Drug Controller General of India (DCGI) is said to be scrutinizing clinical trials done at Jaipur’s Malpani Multispecialty Hospital to verify if the hospital had breached any protocols for testing drugs on patients.

“We will take a look at all the trials,” a source at DCGI said on the condition of anonymity, referring to Malpani hospital.

The decision comes in the wake of the drug regulator finding certain discrepancies at the clinical trial site including an alleged falsification of patient enrollment data linked to a phase two clinical trial of Glenmark’sosteoarthritis pain drug (GRC 27864).

Last week DCGI issued show cause notices to Glenmark, the sponsor and Dr Rajiv Gupta, the Principal Investigator of the trial at Malpani hospital.

Glenmark was also pulled up by DCGI for inadequate monitoring of trials at the site. DCGI asked them to respond within 10 days of receipt of the notice.

Glenmark said it is in the process of responding to the DCGI’s notice and added that it has suspended that trial at the site in the interest of patients’ safety, as soon as it heard about the alleged irregularities.

The DCGI decision could have a bearing on 47 ongoing clinical trials of around 24 drug-makers conducting trials at Malpani hospital.

The list of the drug makers include Novartis, Gilead Sciences, Daiichi Sankyo, Sun PharmaCiplaCadila Healthcare among others. The Indian Council of Medical Research (ICMR) – the government’s medical research body is also testing its drug at Malpani.

Out of 47, six clinical trials related to osteoarthritis and rheumatoid arthritis drugs belonging to Novartis, Cipla, Glenmark, Cadila and Amneal Pharmaceuticals are administered under the supervision of Dr Rajiv Gupta who is under DCGI scanner.

Emails sent to Novartis and Cadila Healthcare were not answered. US-based Amneal could not be reached.

Cipla said the principal investigator Rajiv Gupta named in the Glenmark trial isn’t the same person who is administering their trial.

The website of Malpani Hospital has the name of only one Rajiv Gupta who is listed as the orthopedic and sport medicine specialist.

Malpani Hospital approved by the Central Drugs Standard Control Organization (CDSCO) has been conducting clinical trials in Jaipur since 2010 under supervision of around 20 specialist doctors.

The 50-bed hospital founded by NK Malpani, a senior laproscopic surgeon and gastroenterologist includes a research center, trauma and emergency care facility.

https://www.moneycontrol.com/news/business/companies/dcgi-to-put-clinical-trials-of-malpani-hospital-under-scanner-2566391.html

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