Unethical human clinical trials for jobs, total violation of medical ethics says Civil Society

Jaipur: About 21 healthy men from Churu came to Jaipur in the hope of earning some money. However, they had been kept in dark about the nature of the work that the Jaipur-based multispecialty Hospital would be giving them to do. On arrival these men were admitted and asked to have a medicine, which the doctor claimed would help in digestion, 17 of those admitted while four denied.

For the uninitiated, Malpani Hospital in 2017, along with several other hospitals across India had been authorized to conduct the phase II clinical drug trial of a medicine formulated by Glenmark Pharmaceuticals. The 17 who were administered a medicine prior to their meals now allege that they had been unethically used by the hospital for the scheduled clinical human drug trial.

“The recent incident in which 20 healthy poor persons brought from villages of Churu and Bharatpur districts under the pretext of getting them employment and then were administered medicines which led to serious medical complications is a total violation of all medical ethics for clinical trial,” reacted the civil society of Rajasthan, as a united unit.

In a press communiqué, they collectively said, “We condemn the sinister manner in which the clinical trials are being carried out in Malpani Hospital, VKIA Area, Jaipur by flouting all protocols and standard procedures laid down by the Drug Controller General of India.”

Collectively criticizing the horrific act, were — Jan Swasthya Abhiyan (JSA) Rajasthan, PUCL, Actionaid, BGVS, BARC, Prayas and several other human rights, women and child rights organizations, networks and individuals.

They also expressed their concern over how India was becoming a hub of clinical trials for pharmaceutical companies, a majority of whom are transnational companies. “Poor and uneducated people of the country are being coerced to become guinea pigs for a paltry sums of money and in the process are subjecting themselves to adverse medical consequences without being compensated properly,” stated the press release.

According to NGOs that have been protesting against the recent flouting of rules, Malpani Hospital, Jaipur administered medicine (code name GRC27864-201 expiry April 30, 2019), manufactured by Glenmark Pharmaceuticals, headquartered in Mumbai and that caused adverse consequences among those who were administered the medicine. They claim that the medical well being of these individuals need to be further investigated to rule out adverse effects and also to determine if the reactions are just symptomatic or have caused more serious damage to the body organs.

They have also demanded for the setting up of regulatory bodies to monitor clinical trials in India and the immediate cancellation of the clinical trial registration of Malpani Hospital, Jaipur. “Enquiry should be conducted to find the violations of norms in clinical trials conducted by Malpani Hospital and prosecuted accordingly after filing criminal cases,” said Kavita Srivastava.

They have also demanded that the government needs to ascertain through proper investigation with regards to any violations made by Glenmark when it launched the clinical drug trial of its new medicine.

Among other demands that the civil society have put forward before the government are, compensation for the 17 people, evaluation of the extent of damages caused to the body because of the drug trial and rigorous monitoring of the centres where the trials are conducted.

They added that JSA Rajasthan and other organizations have planned a campaign against unethical clinical trials and would soon be organizing a protest against Malpani Hospital.

The seventeen labours have lodged an FIR against the hospital, and Rajasthan government has ordered probe on it too.