Mumbai: Industry associations have urged the Department of Pharmaceuticals (DoP) to implement prospective batch pricing to avoid Drug Prices Control Order (DPCO) based litigations.
Currently, once ceiling prices are notified, they take immediate effect, posing logistical challenges for nearly nine lakh pharmacies to adjust promptly. The industry proposes that pricing changes be applied to future batches, easing compliance burdens and allowing timely adjustments through the Integrated Pharmaceutical Database Management System (IPDMS 2.0).
This system, introduced by the National Pharmaceutical Pricing Authority (NPPA), aims to streamline operations by centralizing submissions required under the DPCO-2013, ensuring accurate and timely price revisions across scheduled and non-scheduled formulations and active pharmaceutical ingredients (APIs).
Industry experts emphasize the need for clear guidelines from the DoP to preemptively manage stock recalls and pricing revisions, thus averting disputes over alleged overcharging by manufacturers due to discrepancies at retail level.
Currently, under existing regulations, once ceiling prices are notified, they come into immediate effect. This sudden implementation poses considerable challenges for the industry, particularly in ensuring that nearly nine lakh pharmacies across the country promptly adjust their pricing structures.
The proposal put forth by industry stakeholders suggests that pricing adjustments should apply to future batches of pharmaceutical products. This approach aims to facilitate smoother compliance with DPCO guidelines by allowing manufacturers to implement changes gradually through the Integrated Pharmaceutical Database Management System (IPDMS 2.0).
IPDMS 2.0 serves as a centralized platform for the submission of pricing information and other regulatory requirements mandated by the DPCO-2013. The system is designed to enhance operational efficiencies within the pharmaceutical sector by providing a unified interface for companies to update pricing data for scheduled, non-scheduled formulations, and active pharmaceutical ingredients (APIs).
Industry experts have underscored the importance of clarity and advance notification from regulatory bodies such as the NPPA and DoP regarding the procedures for stock recalls and price revisions. This proactive approach, they argue, will enable companies to adhere to guidelines effectively and preemptively avoid potential disputes related to overcharging allegations at retail levels.
As discussions continue between industry representatives and regulatory authorities, stakeholders remain optimistic that collaborative efforts will lead to a more streamlined and transparent drug pricing regime that supports both regulatory compliance and operational efficiency across the pharmaceutical sector.
