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Clinical trials are essential for the pharmaceutical companies for the development of new interventions such as medicine, vaccine, to check whether they could be used for the general population.
Karimnagar: Clinical trials are essential for the pharmaceutical companies for the development of new interventions such as medicine, vaccine, to check whether they could be used for the general population.
The pharmaceutical companies in Hyderabad and Bengaluru will follow the same procedure like preparing the medicine, conducting experiments phase-wise and finally checking the medicine on humans, i.e., clinical trials. The medicines will be released in the market only after these clinical trials are proved successful.
It is mandatory for the drug manufacturing companies to prove to the regulatory authorities that these clinical trials will have no dangerous side-effects on the humans. But these companies are reportedly not following the rules and regulations.
Instead, the managements of pharma companies are appointing special agents to lure rural people to become volunteers by luring them with money and have been conducting clinical trials on them, violating rules and regulations. The volunteers are being paid about Rs 20,000 for undergoing clinical trial.
A senior medical practitioner, Raghu, alleged that a few private hospitals were playing key role by helping the representatives of certain pharmaceutical companies present in Hyderabad and Bengaluru in conducting clinical trials on the patients, who admit in the hospitals, without their consent. They conduct the trials as a routine treatment.
The label on the medicine often does not specify that it is meant for trial and many innocent people end up being used as lab rats, he added. This business is rampant in Karimnagar district. Many rural people are lured by the agents of pharma companies and clinical trials are being conducted on them in three phases to test the effect of drug prepared by the companies.
The drug companies are not in the least bothered about the health condition of the volunteers on whom they are conducting clinical trials. They are allegedly not taking any precautionary steps before conducting clinical trials.
Eight months ago, Vangara Nagaraju of Nagampet village in Jammikunta mandal, joined as a volunteer in ‘Lotus’, a Bengaluru-based pharmaceutical company. The company conducted clinical trials on Nagaraju, who fell ill after that. The company did not provide any treatment for him and Nagaraju died after three months.
Based on the complaint by Nagarju’s parents, postmortem was conducted to his body in the presence of Circle Inspector Prashant Reddy and under the supervision of Forensic Department Dean of Kakaitya Medical College Rajmalik Khan and Prof Krupal Singh. But the report is not submitted till date.
As per the contract signed by Nagaraju, it is the responsibility of the pharma company to provide treatment to him if any side effects are noticed after testing the drug through clinical trials. And in case of death the company must pay insurance amount of Rs 25 to Rs 30 lakhs. But the pharma company has not fulfilled its promise.
Another case also came to light that Chiluveru Ashok Kumar of Kothapalli village was suffering from dementia (loss of memory) and other health issues after undergoing clinical trials. His family members had to shed more than Rs 50,000 for his treatment.
“He barely recognises us. His health is deteriorating,” lamented his mother. She lodged a complaint with the police and demanded the government for taking stringent action against the Lotus Pharmaceutical company, which is conducting clinical trials on innocent people by violating rules.
In another incident, Bogam Suresh of Kothapalli village was admitted in hospital for blood vomiting. Suresh joined as a volunteer through an agent in Appotex pharmaceutical company, Hyderabad and was going through clinical trials since a few months. He was suffering with severe body pains and had blood vomiting on Saturday, who later was admitted in hospital for treatment.
By Puli Sharath Kumar
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