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The Indian pharmaceutical industry has urged the Department of Pharmaceuticals (DoP) to amend the Drug Price Control Order (DPCO) 2013 to delete the term 'retailer' from the definition of 'dealer' under Para 2(e) of the DPCO-2013.
The proposed amendment seeks to clarify the distinction between 'dealer' and 'retailer' as defined in the regulatory framework, which the industry claims has implications for the pharmaceutical supply chain.
“According to Para 2(e) of the DPCO 2013, the term 'dealer' currently includes 'retailer'. However, in subsequent sections of the DPCO—specifically Para 24(4) and Para 25(3)—the terms 'retailer' and 'dealer' are referred to separately. This inconsistent usage has led to ambiguity over whether the two are distinct entities or interchangeable under the law,” industry experts voice their concern.
Experts pinpoint that this lack of clarity has raised concerns among pharmaceutical manufacturers, particularly regarding their legal responsibilities under Para 24(3) of the DPCO. Under this provision, manufacturers are required to provide a Form-V price list to 'dealers'. The inclusion of 'retailer' within the definition of 'dealer' has led to confusion over the extent of this obligation, potentially extending the manufacturer's liability beyond wholesalers to include retailers as well.
The industry has since long advocated for the deletion of the word 'retailer' from the definition of 'dealer' in Para 2(e). This recommendation is aimed at limiting the manufacturer's obligation to provide the Form-V price list exclusively to wholesalers, as originally intended by the law. The industry associations argue that the inclusion of 'retailer' in the definition unnecessarily expands the scope of the manufacturer's liability, causing logistical complications for the entire pharmaceutical supply chain.
"We believe the law should reflect clear distinctions between different entities in the supply chain. Dealers and retailers serve different roles, and their separate mention in other parts of the DPCO reinforces the need for this distinction. Manufacturers should not be held responsible for providing Form-V price lists to retailers, as this creates an undue burden on them," according to a manufacturer.
If the industry’s recommendation is accepted by the government, manufacturers will only be responsible for providing the price list to wholesalers. This would streamline regulatory compliance for pharmaceutical companies, ensuring that their obligations are limited to interactions with dealers in the traditional sense—i.e., wholesalers—rather than retailers.
Such a change could also lead to greater operational efficiency within the pharmaceutical distribution network. Retailers, who typically interact with consumers directly, would be excluded from the manufacturer’s direct regulatory responsibilities, thereby allowing the focus to remain on the wholesale distribution channel.
The industry's proposal is currently under review by the government. The association hopes that by clarifying the roles of dealers and retailers, the amendment will promote better understanding and compliance with DPCO provisions across the industry. Manufacturers are keenly awaiting the government's decision, as it could potentially alleviate some of the regulatory burdens they currently face.
For now, the pharmaceutical industry remains watchful as discussions continue around this key issue of regulatory clarity. The outcome of the government's decision on the industry recommendation will likely set an important precedent for future amendments to the DPCO-2013.
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