Category Archives: Drug Regulation

Drug Regulation

Special Report: The Judicial and Policy Quackery Behind the Regulatory Restrictions on Oxytocin


Long read There has been panic and alarm amongst doctors, especially gynecologists, since the announcement by the Ministry of Health & Family Welfare (MOHFW) on June 27, 2018 that only one public sector undertaking, Karnataka Antibiotics & Pharmaceutical Ltd. (KAPL) would be authorized to manufacture and supply oxytocin for the Indian market from July 1, 2018. The drug oxytocin is considered a critical hormone for maternal healthcare since it is used for inducing labour and more importantly, to control bleeding…


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Drug Regulation Patent

Pharma Update: Russia Grants First Compulsory License for Anti-Myeloma Drug Revlemid, As German Supreme Court Upholds CL for HIV Drug Isentress


In moves that should have significant global impact on public health, an Arbitration Court in Moscow, Russia, granted Russia’s first Compulsory License for Lenalidomide (trade name Revlemid). In a similar development this month, the German Federal Supreme Court upheld a preliminary Compulsory License granted by a lower court for the HIV drug Isentress. The Russian License Unlike in India, the Russian judiciary has the exclusive authority to issue compulsory licenses. The CL is an outcome of the suit filed in…


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Drug Regulation

The Problematic Advocacy that Portrays Bedaquiline as a Wonder Drug


On June 22, 2018 the Wire re-published my last piece, along with a rejoinder by Anand Grover, in our ongoing debate on the manner in which Bedaquiline was approved by the DCGI after waiving Phase III clinical trials. Grover ends his piece with the following dramatic question: “The question is, if the use of bedaqualine is going to cure two out three persons, and in its absence, they would face certain death, would any reasonable medical person withhold that drug…


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Drug Regulation

A Reply to Anand Grover on the Bedaquiline Issue


In a piece published on June 13, 2018 on the Wire, Anand Grover takes issue with several pieces that I have written regarding the approval of bedaquiline, a new drug meant to treat a certain type of multi drug resistant tuberculosis (MDR). Surprisingly, he doesn’t refer to my 6th piece on the issue, published on Newslaundry, where I discuss the law on clinical trials. While I’m glad that we are debating this issue, I disagree with Grover on multiple issues….


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Drug Regulation

Finally, The Hindu Acknowledges the Clinical Trials Issues Regarding New TB Drugs but through Rose-tinted Glasses


The Hindu published yet another story in today’s edition on the issue of access to the new TB drugs like bedaquiline and delaminid. We’ve been tracking The Hindu’s coverage of this issue on the blog over here, here and here. Unlike the earlier reportage, The Hindu has finally acknowledged some of the issues that we have flagged relating to safety and efficacy of both drugs, given pending clinical trials. Today’s report notes that both drugs “are yet to pass large-scale…


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Drug Regulation

RTI Replies Reveal the Deal between Janssen and the Ministry of Health on Bedaquiline


Co-authored with Balaji Subramanian, 5th Year student NALSAR University of Law Subsequent to our previous post, we got a copy of some of the correspondence between Janssen and the Ministry of Health under the RTI Act. We were under the impression that our request for the information was transferred to the CDSCO which then disposed the application without giving us the requisite information. However, it appears that the application was transferred back to the Central TB Division, which processed the…


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Drug Regulation

Special Report: The Smoke & Mirrors Surrounding the Approval of Bedaquiline


Co-authored with Balaji Subramanian, 5th year student, NALSAR University of Law Prologue Last Sunday, The Hindu ran a piece on its front page alleging that  the government was not even considering the option of issuing compulsory licenses for a newly patented drug called bedaquiline, despite access to the drug being restricted to less than 1,000 patients. Bedaquiline, which is currently the most promising drug candidate to treat multi-drug resistant tuberculosis (MDR-TB) was developed and patented by Janssen and The Hindu…


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Drug Regulation Others

Part II: Seizure of Medicines In Transit #EU Law, TRIPS, Doha Declaration & GATT


In Part I, we discussed a WHO Discussion Document, along with broad issues at play, regarding seizures of in-transit medicines. Over the course of this post, we will be covering the following: I. The European Union (EU) Law on Seizure of Drugs In-Transit. II. TRIPS, Doha Declaration and the GATT. A thorough introduction to the issue can be found here. The EU Law on Seizure of Drugs In-Transit Understand the EU law is relevant as the majority of reported in-transit seizures…


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Drug Regulation Others

Part I: Seizure of Medicines In Transit #Broad Issues At Play


I write to bring to your notice a World Health Organization (WHO) “Discussion Document” (non-binding) that proposed “possible justifications for an intervention on the ground of public health” with respect to seizures of medicines in-transit. The same is a relevant concern because  transit countries have, in the past, seized drugs meant for other countries solely on account of the drugs violating the transit country’s patent regime.  After a series of seizures of in-transit drugs of Indian origin during the period…


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Drug Regulation Patent

Sovaldi Saga Rages On – Malaysia Issues Government Use License Despite Gilead’s Voluntary License Deal


The World Health Organization records that as of October, 2017, 71 million people were affected by the Hepatitis C Virus (HCV), a debilitating virus which attacks the liver. Around 12 million people are affected by HCV in India – about one in every hundred. Just a few years ago, in 2014, the global incidence of HCV reported by the WHO was between 130-140 million. The remarkable decline in the HCV-affected population can probably be attributed to the blockbuster drug, Sofosbuvir….


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