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| Govt may set up 300 cells to study adverse side-effects of drugs... |
| Joe C Mathew / New Delhi Jun 13, 2010, 00:14 IST |
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The central government plans to set up cells in 300 medical colleges to study the harmful side-effects of medicines available in the country. Seven drugs, including commonly used ones like nimesulide and rosiglitazone, will be monitored, it is learnt.
While 10 such cells, known as pharmacovigilance centres, will start functioning by September, the rest will be started in a phased manner, health ministry officials say.
All India Institute of Medical Sciences (AIIMS), New Delhi, will be the central point of the programme. The funds for creation and maintenance of the cells would be routed through the zonal offices of the country’s apex drug regulator, the Drugs Controller General of India, the officials said.
The seven medicines were selected after several countries either restricted their use or initiated more clinical trials to study their safety. Officials say other drugs will be added to the list as and when Indian centres begin to report adverse drug reactions.
According to the two-phased plan prepared by the health ministry, 30 medical colleges will have such centres by March next year. Depending on how well the programme works, it will be extended to 300 colleges in the next five years.
The cells will upload adverse reactions on to the pharmacovigilance centre of the World Health Organisation in Uppsala, Sweden.
The ministry will also tighten clinical trials regulations by making it mandatory for companies to register with the drug department before trials are sanctioned.
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