Clinical trial goes wrong

Clinical trial goes wrong
Highlights

Clinical trial goes wrong, Axis Clinical Laboratory, Central Drug Standard Control Organisation. Drug Control authorities, who visited the lab on Saturday, said that the lab had permission from the Central Drug Standard Control Organisation (CDSCO).

  • Patients develop reactions and fall ill
  • The same clinic was found guilty in 2011
Twenty people fell sick after undergoing clinical trial at Axis Clinical Laboratory at Miyapur. This is not the first time that the firm is in trouble. In 2011, a similar incident occurred when the health of tribal women deteriorated after undergoing clinical trials. At that time the firm’s licence was suspended and was barred from conducting all bio-availability and bio-equivalence studies at the centre in Miyapur. However, in just two years after its licence was renewed, the firm is in the dock againOur Bureau
Twenty people complained of ill-health after they underwent clinical trials at Axis Clinical Laboratory, Miyapur. The victims complained of vomiting blood and acute diarrhoea. To show their angst against the company, the victims staged a dharna at its campus on Friday .There were a total of 72 such people who were tested. They belonged to various districts of the state. The trails were conducted for a period of three days. After they were administered the drug, they were put under observation and all those who showed signs of illness were asked to leave. Each of the persons was offered a sum of Rs 10,000 to undergo the trials. Giridhar, manager, Axis Clinical Laboratory Limited, said that all the tests were conducted under medical supervision. However, the patients allege that there were no doctors available on site to take care of them.
Drug Control authorities, who visited the lab on Saturday, said that the lab had permission from the Central Drug Standard Control Organisation (CDSCO).
P Nagabhushanam, director, Drug Control Authority (DCA), says, “Our officials visited the lab and the extent of damage would be studied depending on which a suitable case would be filed and maximum compensation extracted from the company.”
On the issue of money being given to the participants, the director said, “There has been no such rule that money can’t be offered to them. So it is not against the law. There is an elaborate law about the ethical conduct of clinical trials.”
Officials refused to divulge the generic name of the drug that was administered on the people. P Nagabhushanam says, “ Until we get a confirmed report from the CDSCO we would not know neither the generic name of the drug nor the chemicals that were used in the making of the drug. Even the doses that were administered to the people would be revealed then.”
The report is said to take two days to be made public.
But if any action has to be initiated against the laboratory it has to come directly from the CDSCO. Officials from the DCA say they have to wait for a report from the CDSCO to file a case.
Not the first case
This is not the first time that Axis Clinical Laboratory ran into trouble. Earlier in 2011, illiterate poor women from Piduguralla town in Guntur district were hospitalised after a drug trial by the institution. The trial was for testing the effectiveness of the breast cancer drug ‘Exemestane’ in Indian conditions. The drug being manufactured by Pfizer and sold under the name of ‘Aromasin’ in America.
The region has no dearth of volunteers and patients for clinical tests. Apart from hospitals, there are 10 Contact Research Organisations (CROs) in the state—nine of them in Hyderabad—which conducts trials.
Post the Piduguralla incident, the National Human Rights Commission (NHRC) asked the state health secretary to properly assess the health condition of the villagers and ensure suitable compensation for the victims. It had also asked the Central Drug Standard Control Organisation (CDSCO) to conduct a proper study in different parts of the country to ensure that the guidelines on clinical drug trials were not violated.
After the incident, the Drug Controller General of India (DCGI) suspended the clinical research organisation's licence. The firm was barred from conducting all bio-availability and bio-equivalence studies at their centre in Miyapur. The investigations revealed various irregularities committed by the lab in conducting the clinical studies. The authorities carried out a two-day inspection of the laboratory and the documents pertaining to the trials. Sources said that irregularities were found in various processes including recruitments of subjects and in taking their informed consent.
The DCGI also found that the ethics committee was not functioning independently, as was required for clinical trials. The lab conducted bio-equivalence studies for Exemestane tablets in its Miyapur centre during January 27 and February 15 this year. The study was conducted by administering the anti-cancer drug to women from Piduguralla without their consent.
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