Jan Swasthya Abhiyan Rajasthan, PUCL, Actionaid, BGVS, BARC, Prayas and several other human rights, women and child rights organizations, networks and individuals gathered outside Malpani Hospital today at 4 PM and protested against the unethical clinical drug trial that was carried out by Malpani Hospital, VKIA Area.
The Hospital infringed all protocols and standard procedures that were laid down by the Drug Controller General of India by conducting this drug trial. From the villages of Churu and Bikaner, 19 men were ensnared by an agent, promising them employment in Jaipur where their work would be taking care of elderly patients at a medical camp in Jaipur and in return they would be paid Rs. 500 per day. Many people from the village were ready to take up this job opportunity but he agent handpicked 19 men under the age group of 35 years. The men were brought to Malpani Hospital and were given medicines which led to serious medical complications. This is a gross violation of all ethics for clinical trial. This violates human rights of the people!
It is unfortunate that India is becoming a hub of clinical trials for pharmaceutical companies a majority of them are transnational corporations. Poor and uneducated people from the countryside are coerced to become guinea pigs for paltry sums of money and in the process they are subjected to adverse consequences without being compensated for them. The Malpani Hospital, Jaipur administered the medicine by the code name GRC27864-201 expiry April 30, 2019 of Glenmark Company headquartered in Mumbai to 15 persons of Bidasar area of Churu district and this caused acute health problems in majority of them. The pharma company and the hospital need to explain why healthy persons were given the drug when according to them it is phase 2 trial. According clinical trial protocol drug is administered to patients suffering from the disease it is being tested.
Not only investigation is required to be done ascertain why these acute symptoms were caused, a further in depth investigation is required to find out whether the adverse effects are just symptomatic or have caused more serious damage of body organs which will only be known after some gap. The withdrawal of drug trial by Glenmark company from the Malpani Hospital is just not sufficient as the same drug is being tested in other centres and similar kind of enrolment of healthy human being might have happened with similar kind of acute complications. The complicity of Glenmark company in promoting unethical trials cannot be ruled out unless investigations are done at all the centres and therefore Glenmark is equally responsible for this offence committed.
The civil society organizations demand the following:
- The Government and other regulatory bodies relating to the clinical trials in India immediately conduct detailed investigations about the violations committed by Malpani Hospital and Glenmark pharma and initiate action against them.
- Carry out investigation at all other sites where the trial of this drug is being done to find lapses.
- Cancel the clinical trial registration of Malpani Hospital, Jaipur.
- Enquiry is conducted against Glenmark to ascertain the violations it committed in launch of the clinical trial in question and initiate action.
- The victims of the unethical drug trial conducted by Malpani Hospital are examined properly and tested by the hospital and must be given a good quality medical care for free until the effects of the medicine administered under the drug trial wears off and the individuals return to their good health.
- The victims must be compensated due to the mental and physical agony that they received because of the medical complication after they were administered with the drugs.
- The government must revise the Drugs and Cosmetics Act, 1940and make regulation of clinical trials and monitoring stringent.