The three products have been classified as new drugs and thus qualify for non-application of the DPCO 2013
Drug price regulator National Pharmaceutical Pricing Authority (NPPA) has exempted Wockhardt’s three insulin products from price controls for a period of five years with effect from January 8 this year. The drug firm had applied to the NPPA for non-application of price control provisions of the DPCO 2013 on the three drugs.
“…NPPA allows Wockhardt, Mumbai exemption from the provisions of DPCO, 2013 under para 32,” the regulator said in a statement.
The three products that have exempted for a period of five years are Insulin Human Injection, 200IU/ml, Isophane Insulin Human Suspension, 200IU/ml and 70 per cent Isophane Insulin Human Suspension and 30 per cent Insulin Human Injection, 200IU/ml, the statement said.
The three products have been classified as new drugs and thus qualify for non-application of the DPCO 2013.
The exemption on the three products would be with effect from January 8, 2015, which is the date of grant of marketing approval by the Drugs Controller General (India), it added.
The company has been further directed by the NPPA to inform it about the maximum retail price fixed in respect of above said formulations. NPPA said it considered the decision of an expert committee that was constituted to study the issue.
The products, insulin human injection, isophane insulin human suspension and another one, a 70 per cent isophane insulin human suspension and 30 per cent insulin human injection are classified as a new drug and thus qualify for non-application of the DPCO 2013.
At present, the government caps prices of essential drugs based on the simple average of all medicines in a particular therapeutic segment with sales of more than one per cent.
Besides, the government regulates prices of all other medicines and companies are allowed to hike prices of such drugs by only up to 10 per cent in a year.
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