Government monitoring of non scheduled drug formulations prices a public policy concern says Delhi High Court.

November 14, 2023by Primelegal Team0

Case name: Union of India v Bharat Serums and vaccines ltd

Case no.: CM no 7868/2023

Date:8.11.2023

Coram: Subramonium Prasad, J

Introduction

The Delhi HC went into a deep dissection of Para 20 of the 2013 DPCO, and shone light on the necessity of government monitoring of non scheduled drug formulation prices. 

Facts of the case

The appellants in the current appeal have approached court for clarification on interpretation of Paa 20 of the 2013 DPCO [ Drug Prices Control order] which talks of monitoring the prices of non scheduled formulations. DPCOs are orders issued by government of India under Essential Commodities Act, they are passed to regulate and monitor drug prices in invida. The 2013 DPCO, para 20 says that the government shall monitor MRP of all drugs including non scheduled formulations, in order to ensure that no manufacturer increases prices of any drug over the MRP. 

Court’s analysis:

The court said that the 2013 DPCO only applied to drug formulations and not to bulk drugs. It clarified that the government has control over scheduled formulations drug prices, but it can only monitor the price changes in non scheduled formulations, and thus 2013 DPCO does not form part of the price control regime. 

It is also clarified that the 2013 DPCO instructions are centrally concerned with public policy and consumer interests, and ensures equitable distribution of drug. Para 20 of the DPCO cannot said to be wholly a penal provision.

The court went into a deep analysis of the DPCO and provided detailed clarifications on the interpretation of Para 20 of the same. 

It dismissed the appeal along with any pending applications. 

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Written by: Radhika Shekhawat

Primelegal Team

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