New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has exempted Sun Pharmaceutical Industries’ gemcitabine hydrochloride injection from price control in its last meeting on 30 October, according to minutes of the meeting.
The approval for the ready-to-use infusion bags of gemcitabine hydrochloride injection, which exhibits anti-tumor activity and is used to treat various kinds of cancer.
Under paragraph 32 of the Drug (Price Control) Order, 2013, the NPPA can exempt drugs from price control which are either new or have a new delivery system that is developed through indigenous research.
Sun Pharma got the approval for gemcitabine hydrochloride injection of 10mg/ml strength in ready to use infusion bags of 120ml, 140ml and 160 ml.
While the Standing National Committee on Medicines raised concerns that there was no clinical study to suggest that the product offered significant therapeutic advantage and increased efficacy as compared to other forms of the drugs, the NPPA pointed out that increased therapeutic advantage and efficacy were not pre-conditions for getting price control exemption for new drugs, as per the minutes.
The committee oversees revision of National List of Essential Medicines, which are drugs that come under price control.
As per information on the NPPA website, Sun Pharma sells gemcitabine 200mg powder for injection at ₹1,231.65 per pack.
The NPPA on 30 October also deferred its decision to exempt a cardiac stent developed by Meril Life Sciences Pvt Ltd from price control pending review of its efficacy as well as concerns raised over its safety.
Meril Life Sciences had filed a plea for exemption of bioresorbable vascular scaffold system MeRes100, which dissolves naturally in the body, from price control.
However, after the All India Drug Action Network raised health and safety concerns regarding usage of the stents, the matter was referred to the Drug Controller General (India), Director General of Indian Council for Medical Research and the health ministry.