HYDERABAD: The state government is contemplating to come up with a legislation making it mandatory for the pharmaceutical companies and laboratories to register with the AP Drug Control Administration to run their units in Andhra Pradesh.
The proposal came up after realising the fact that the state government had no control over the pharma companies and laboratories which conduct clinical trials in the state.
So far, the pharmaceutical companies and laboratories are required to obtain permission from the Central Drug Control Administration and other Central agencies to set up their units. The issue came to light during the preliminary investigations into the incident where the Hyderabad based pharma companies conducted clinical trials on women from Piduguralla in Guntur district.
“We are working on a draft of the legislation comprising guidelines to be followed by the pharma companies and laboratories to conduct clinical trials. The guidelines will be in tandem with the Centre’s norms but will make it mandatory for the companies to register with the state government to ensure some monitoring over their operations,” said a senior official in the health department.
The state government has already urged the Centre to delegate some powers to it for monitoring the functioning of these companies.
Meanwhile, the 11 sick women from Piduguralla, who fell sick after undergoing clinical trials conducted by some pharma companies to test the efficacy of anti-breast cancer drug, have been shifted to Guntur General Hospital (GGH) on Saturday. Eight of them were suffering from eye infection and the other three had developed liver complications.
GGH superintendent B Phanibhushan said all tests have been conducted on the patients based on which the doctors will send a report to the government on the health condition of the women.
On the other hand, Rangareddy district medical and health officer Jaya Kumari submitted her inquiry report to the state government on Saturday.
In her report, Jaya Kumari explained that Axis Clinicals Limited at Miyapur here conducted clinical trials on women from Piduguralla. According to the report, the pharma laboratory obtained temporary permission from the Central government to run the clinical trials but violated norms without cautioning the victims about the likely complications that they could suffer. The pharma unit also did not bother to intimate the district health officials about its operations.
Senior officials said that the report will be forwarded to the Central Drug Control Administration for taking necessary action against the company.
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