Centre has asked Drug Controllers of all states and UTs to take measures to ensure testing before the manufacture and release of each batch of pharmaceutical formulations to the market. In a letter, Directorate General of Health Services said that this must be done through monitoring during inspections, and sensitising the manufacturers through circulars.

 

 

The direction has come in the wake of recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups and concerns related to quality of these cough syrups. States and UTs have also been asked to ensure that the manufacturers have robust vendor qualification system in place and use raw materials including excipients from reliable approved vendors only.

 

 

DGHS emphasised that as per Drugs Rules, the licensee shall test each batch or lot of the raw material used for the manufacture of his product and also each batch of the final product. The licensee should also maintain records or registers showing the particulars in respect of such tests.