Maha FDA asks DCGI to include balloon catheters and guiding catheters under NLEM
The Maharashtra Food and Drug Administration (FDA) has urged the Drug Controller General of India (DCGI) and the National Pharmaceutical Pricing Authority (NPPA) to include balloon catheters and guiding catheters under National List of Essential Medicines (NLEM) as was done for coronary stents. The Maharashtra FDA has submitted a study report to the DCGI in this regard. While a coronary stent is a small metal mesh tube that is surgically embedded in blocked coronary arteries, various accessories like balloon catheter and guiding catheters are used during the procedure to ease the pathway for flow of blood. Following complaints received by the drug pricing watchdog NPPA that hospitals had increased the prices of balloons and catheters after the capping of stent prices in February 2017, a government constituted panel had recommended that the accessories also be classified as essential drugs, bringing them under price control. Says a senior FDA official, “ Recommendation...