India's Regulators Step Up Inspection Resources

02/07/2013

Effective regulation of pharmaceuticals and medical devices is set to increase after India's national regulatory body for pharmaceuticals and medical devices Central Drugs Standard Control Organization (CDSCO) announced it plans to increase its drug inspection staff 10 fold.  The expansion is part of the organizations’ efforts to more effectively regulate the industry, especially the growing clinical trials sector.

CDSCO, which is the Indian counterpart of Food and Drug Administration (FDA) currently employs over 200 staff who manage its drug and clinical trials inspection activities.  S. Eswara Reddy, Deputy Drugs Controller of India announced that the CDSCO would “hire 1,195 employees on the regular roles and another 1,100 on contract basis to strengthen the regulatory mechanism." He said the majority of the new staff would consist of drug inspectors and other supporting staff.

It is the growth of clinical trials amongst private sector companies in India that has prompted this move, along with drug safety concerns following recent well publicized cases.
 
As well as boosting staffing, the CDSCO also plans to set up 8 additional central laboratories and 6 more National Institutes of Pharmaceutical Education and Research. 
 

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