NPPA Approves Manufacturer Change for Brands Under Guidelines

The approval to shift manufacturing to their own facilities at the existing retail price has been granted by the National Pharmaceutical Pricing Authority (NPPA) to Torrent Pharma and Sun Pharma Laboratories. The decision has been made by the Authority following its previous meetings where guidelines were set for evaluating cases of manufacturer change in formulations that already have fixed retail prices. During a recent meeting, the Authority took note of the proposed changes by the marketers to independently manufacture the brands.

Torrent Pharmaceuticals has submitted applications for the manufacturing of diabetes formulations such as Azulix 3MF and 4MF, as well as cardiology drugs like Unistar Gold 20 and Rozuplatt capsules. In addition, the meeting extensively discussed the submitted applications from Sun Pharma Laboratories pertaining to their diabetes medications, namely Istamet D-XR 500 mg tablet, Oxramet-S XR 500 mg tablet, and Sitared-MD XR 500 mg tablet, as per pharmabiz.

The matter was thoroughly discussed by the Authority, who observed that the marketing companies, planning to transfer the manufacturing operation to their own facility, have already introduced the formulations and obtained approval for the notified retail price from NPPA, according to the statement. The Authority added that as a result, marketers are allowed to produce and sell formulations under their current brand name at the retail price approved by NPPA, as long as it does not surpass the current retail price for already released formulations. Please take note that the Authority established guidelines during its meetings on May 26, 2023, and July 31, 2023. These guidelines were formulated to address cases where marketers undergo a change in manufacturer for formulations that have already had their retail price notified by the NPPA. The market witnessed the introduction of the formulations under a designated brand, accompanied by the establishment of guidelines aimed at maintaining uniformity and reliability during the examination of such cases.