Wockhardt had applied to the National Pharmaceutical Pricing Authority (NPPA) for non-application of price control provisions of the DPCO 2013 on the three drugs.
Drug regulator National Pharmaceutical Pricing Authority has exempted Wockhardt’s three insulin products from price controls for a period of five years with effect from January 8 this year.
The Mumbai-based drug firm had applied to the National Pharmaceutical Pricing Authority (NPPA) for non-application of price control provisions of the DPCO 2013 on the three drugs.
“…NPPA allows Wockhardt Ltd, 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% isophane insulin human suspension and 30% 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 1 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.
The government had notified DPCO, 2013, which covers 680 formulations, with effect from May 15, 2014, replacing the 1995 order that regulated prices of only 74 bulk drugs.