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Mumbai, July 23 (PTI) The government will begin an audit of clinical trials by pharma companies in India from September 1, a move aimed at protecting the poor and gullible patients from being exploited for such trials. "We have decided to conduct quality related audit of clinical trial. We would be soon identifying the sites and by September 1 we would start the audit work," Drugs Controller General of India (DCGI) Surinder Singh told reporters here today. He noted that guidelines for the registration of ethical clinical trials would also be framed. According to him, a data bank having all the details of various clinical trials is expected to be operational by August 1. "The data bank would have all the details of the clinical banks functioning across the country. At the click of a button, we would get to see the list of the existing clinical trial sites as well as the new entrants," he added. As part of efforts to strengthen the overall system for clinical trials, plans are on the anvil to carry out overseas inspection of drugs which are imported into India. Singh said the DCGI has already received an in-principle approval for the plan from the Union Health Ministry. "We import a huge amount of drugs and vaccines from the foreign countries. To ensure that best quality drugs come to India through imports, we would be carrying out such (overseas) inspection," he said. The body would also seek help of the US Food and Drug Administration (FDA) in training inspectors for carrying out such inspections. Meanwhile, Union Health ministry has joined hands with the pharmaceutical industry and airport developers GVK and GMR for setting up dedicated cargo zones to handle the import and export of pharma products. Singh said that as a pilot project, the first such facility would be set up at Delhi and about Rs 25 crore would be spent on establishing each of the zones. "Once this project is successful, we would set up similar cargos at Hyderabad, Mumbai, Bangalore and even at Nhava-Sheva Port," he said.
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