New Delhi: India’s drug regulator conducted an investigation into a Glenmark clinical trial in Jaipur, and has sent a show-cause notice to the company and hospital staff, over alleged falsification of data on patients in the trial, reported Economic Times and LiveMint.
The Wire had reported on a controversy which broke out in Jaipur’s Malpani Multispecialty Hospital last month, where a group of men from Churu district alleged that they had been duped into participating in a clinical trial at this hospital.
Glenmark, as well as the designated investigators in-charge of this trial, at Malpani Multispecialty Hospital, have been sent notices and are to respond by May 12. Glenmark’s drug under trial at this site was a phase 2 trial for osteoarthritis pain. The trial is on in 37 other sites in India. Malpani hospital is registered as a site for 45 trials.
Investigators from India’s Central Drugs Standards Control Organization (CDSCO) found that the trial did not comply with the requirements of good clinical practice.
They found that the trial had falsified data on the three patients who the hospital said were successfully enrolled in the trial. LiveMint reported that two out of three patients were married to each other and had not visited the hospital in six months. The third person could not even be traced by the government’s investigators. According to Schedule Y of the Drugs and Cosmetics Rules, 1945, ethics committees have to review and approve the methods used to find and enroll new patients. This was not done at the Jaipur hospital.
CDSCO officials also noted that the site of Malpani Hospital does not have appropriate infrastructure for the trial such as proper ventilation, air conditioning, washrooms and proper bed spacing. Glenmark was found to have inadequately monitored this trial and the protocols being followed.
What about the villagers from Churu?
However, the CDSCO investigation appears to have not made remarks yet on what exactly happened with the villagers of Churu district. While the hospital was found to have engaged in unethical practice in this trial, and Glenmark was found to have been lax, no remarks appear to have been made about what exactly went wrong for the patients who were duped into this trial.
These villagers told The Wire that they became drowsy after consuming a tablet given by Rahul Saini at Malpani Hospital, who has also been sent a show-cause notice. They said they fell unconscious and woke up many hours later and have been feeling pain in their body since.
The Wire’s report found that the villagers may not have been given a Glenmark drug but were definitely given some other drug which caused adverse reactions. However, the incident opened the door to other malpractices at the hospital, including the situation with Glenmark’s drugs. The unethical practices followed by Malpani Hospital could extend to many other drugs which are also being tried or have been tried at this site in the past.
On its part, Glenmark had suspended this trial at Malpani Multispecialty Hospital soon after the news about the alleged irregularities began being reported. The hospital itself has been approved by India’s drug regulator, for clinical trials. According to the Clinical Trials Registry of India, there are 44 trials listed for this hospital, for a range of drugs and for several companies.