- The National Pharmaceutical Pricing Authority (NPPA) has regulatory authority over the price of pharmaceuticals in India. The NPAA maintains a list of drugs—the National List of Essential Medications—that must be sold within a specific price range. The goal is to keep the prices of certain drugs affordable for as many people as possible .
- The NPPA has accused Novartis India of overcharging for the common analgesic Voveran (diclofenac), an essential medication, and has requested a response from the company within two weeks justifying its actions and explaining why it should not be fined for overcharging.
- Novartis is one of several pharma companies that have protested the NPPA's price caps in the New Delhi High Court.
In July, BioPharma Dive reported on the NPPA's efforts to cap not only "essential" drugs, but some "nonessential" drugs as well. The India Pharma Alliance has been protesting the provisions of the NPPA's price capping initiatives; however, the agency has stood firm, arguing that its pricing guidelines must be followed.
The NPPA reserves the right to fine companies that do not observe pricing guidelines. Novartis is currently facing a $49 million penalty, and is now in the position of having to justify its pricing to avoid the fee. With a total of 385 drugs now capped by the NPPA, Novartis is not the only company that is at odds with the organization's pricing. In July, Novartis was joined by Cipla and GSK in protesting the High Court's mandates.