From rxpgnews.com
National Drug Authority envisaged by mid-2007
Jan 19, 2006 - 11:17:00 PM
New Delhi, Jan 19 (IANS) A central drug legislation is likely to be in place by next year, paving the way for creating a National Drug Authority to check the manufacture and trade of spurious medicines, Health Minister Anbumani Ramadoss said Thursday.
"So far we have only taken up the issue of legal and penal punishment recommended by the Mashelkar Committee on spurious drugs. The draft recommendations are with the standing committee," Ramadoss told an Editors' Conference on Social Sector Issues.
"The remaining part of the report on regulation of drug industry is being studied now. Once the National Drugs Authority, for which the building is ready in the capital, is constituted, all licenses for new drug molecules would be centralised."
Currently, if a manufacturer is denied permission or forced to close operations, he is able to get a licence in another state due to the lack of a central law.
"By the winter session (of parliament in 2006), we hope to get cabinet clearance for the centralised drug legislation and within a year and a half, to get the National Drugs Authority established," he said.
Ramadoss hoped that the proposed National Drugs Authority, which is expected to be an autonomous body, would oversee the quality of both drugs and food products.
Though the food processing ministry has drafted an integrated food law, the prime minister is expected to take a decision on an expert committee's recommendation on the implementing agency for this proposed law.
"If the food law is brought under the health ministry, than we will be looking after it. Our proposal is to have 10 divisions in the National Drugs Authority to look after various issues like safety, licensing, industrial systems, and medical devices among others," Ramadoss said.
To be manned by about 150 professional experts, the authority is expected to have wide representation from stakeholders like consumers, professors, civic society and other professional links.
"It is envisaged that within the next five years all licensing of drugs and drug manufacturers will be done by the National Drugs Authority as per the Mashelkar Committee report," he said.
Ramadoss said his ministry has allocated Rs.3.7 billion for upgrading the food and drug testing laboratories in India as part of steps suggested by R.A. Mashelkar, a senior scientist and director general of the Council of Scientific and Industrial Research (CSIR), for better monitoring of medicine quality.
Indo-Asian News Service
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