Scheduled formulations are medicines — both generic and branded — whose ingredients are listed in the First Schedule of the Drugs (Prices Control) Order (DPCO), 2013. Considered essential medicines, the retail prices of 928 scheduled formulations are capped by the government to ensure affordability and public access.
The directive follows concerns raised by the drug pricing regulator over the irregular submission of mandatory data by several entities, leading to gaps in assessing the availability of essential formulations and the active pharmaceutical ingredients used in them.
Under Para 21(1) of DPCO, 2013, manufacturers of scheduled formulations are legally required to furnish quarterly production information through Form 3 online via the Integrated Pharmaceutical Database Management System (IPDMS) 2.0.
“Accordingly, all entities covered under the definition of manufacturers under DPCO, 2013, are directed to ensure timely and regular submission of Form 3 through IPDMS 2.0,” NPPA said in an office memorandum dated June 23.
The authority has also directed manufacturers to immediately file any pending Form 3 returns for missed quarters and ensure regular quarterly compliance going forward. “Non-submission or delayed submission may invite action under DPCO and other applicable regulations,” it added.
The authority did not provide a detailed description of the action that could be taken. However, industry executives told Business Standard that legal and operational consequences under the DPCO framework could invite penal provisions under the Essential Commodities Act, 1955, along with fines and suo motu price fixation for the defaulting company.
“Withholding or failing to report data prevents NPPA from adequately monitoring availability and pricing. If a manufacturer fails to file Form 3 and comply with necessary price revisions, the authority has the power to notify prices based on standard market data,” an official in the know said.
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