DPCO 2013

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Analysing Bharat Serums and Vaccines Limited v. Union of India & Ors. judgement

Price regulation of non-scheduled formulations has always been a contentious issue. While the Government can set prices of drug formulations that are listed on the National List of Essential Medicines (“NLEM”) – Scheduled Formulations, the Government can at best monitor prices of drug formulations that are not listed on the NLEM – Non-scheduled Formulations.

The Delhi High Court in its recent judgment in the matter of Bharat Serums and Vaccines Limited v. Union of India & Ors. provided much needed clarity on paragraph 20 Drugs (Price Control) Order, 2013 (“DPCO 2013”), which regulated the pricing of non-scheduled formulations and drugs, focusing on the legal implications ensuing from the breach thereof.Continue Reading Analysing Bharat Serums and Vaccines Limited v. Union of India & Ors. judgement

SEBI report on RPTs – Deeper Reflections

SEBI had implemented the Kotak Committee recommendations on Related Party Transactions (RPTs) by making amendments to the Listing Obligations and Disclosure Requirements Regulations, 2015 (“LODR”) on May 9, 2018. In less than two years, in November 2019, SEBI constituted a Working Group (WG) to re-examine the RPT provisions of the LODR, against the backdrop of new corporate scandals, which surfaced, where certain abusive RPTs were undertaken by the listed entity at a subsidiary level, which were not captured by the LODR provisions. The WG Report addressed this loophole and made several recommendations, which were examined by the author in his blog article titled “SEBI Working Group on Related Party Transactions: Will the net be cast too wide?” published on February 5, 2020.

In this Blog, the author wants to share his deeper reflections on some of the recommendation made in the WG report. The author argues that this WG report requires a more detailed scrutiny by the SEBI, before it is enacted into a law, by amendments to the LODR. Both these blogs should be read together to get a complete picture of the changes proposed in the WG report.
Continue Reading SEBI report on RPTs – Deeper Reflections

To Regulate or Not To Regulate DPCO 2013 and The Modi-Mundi Pharma Case

Drug price control has been a source of considerable agony to the pharmaceutical industry. Price caps on drugs, though flowing from a larger public interest perspective, has the power to throttle growth of the industry and limit availability of new life saving-drugs to the public at large. It is much to the chagrin of the major players and their business models. The Government has of course adopted the public comes first policy, which has also seen considerable support by the courts. Right or wrong depends on which side of the street one is on.

Price control as a measure has met with its fair share of challenges and is, as a policy issue, here to stay. Interpretation of price control regulations (DPCO) on the other hand is still a topic for many a contentious litigation before courts. The most recent one is a case where the Hon’ble Delhi High Court on July 17, 2018, passed a judgment in the case of Modi-MundiPharma Pvt. Ltd. v Union of India & Ors[1]. Here, the court opined that drugs developed through incremental innovation or a novel drug delivery system could only be included under the National List of Essential Medicines 2015 (NLEM) for the purpose of fixing the ceiling price, procurement etc. if they were explicitly listed. In other words, the court clarified on what kind of drugs are included.Continue Reading To Regulate or Not To Regulate: DPCO 2013 and The Modi-Mundi Pharma Case