Category Archives: Drug Regulation

Drug Regulation

The Ethics of Early Access to Experimental Drugs Like Bedaquiline That Have Not Yet Completed Phase III Trials

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Following my criticism of an opinion piece in the Hindu by R. Prasad for his recommendation to ramp up access to bedaquiline without tackling the ethical issues regarding the flawed informed consent form for bedaquiline, he published a news report in yesterday’s Hindu on the ethics of denying early access to bedaquiline. Titled ‘Unethical to withhold bedaquiline while waiting for Phase III results’, he cites Dr. Karin Weyer at the World Health Organisation (WHO) who claims that it would be…


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Drug Regulation

The Ministry of Health Is Yet to Communicate with J&J on the ASR Hip Implant Issue

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For the last few months, the Indian media has been doggedly tracking the J&J hip implant scandal. To briefly recap the main facts, the company sold its new ASR hip implants to around 4,700 patients between 2006 and 2010. Around 2010, J&J decided to withdraw the implants from the market because of quality issues with the product that threatened patient safety. One of the issues debated in the press is the need to compensate the patients. After unprecedented patient activism…


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Drug Regulation

Yet Another Journalist Pitches for Ramping Up Access to Bedaquiline before Phase III Trials, Without a Mention of the Flawed Consent Forms

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In a column published on September 4, 2018 the Hindu’s science editor R. Prasad has explained why India should ramp up access to bedaquiline to treat MDR-TB. Unlike most of the other cheerleaders for bedaquiline, Prasad thankfully points out that the drug demonstrated higher cardiotoxicity and that Phase IIb trials experienced more deaths and that the Phase III trials are yet to be completed. He however concludes that the recent revision of the WHO treatment guidelines on bedaquiline, that was…


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Drug Regulation Patent

IPO Grants Patent to Brodalumab

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Last week, our IPO granted a patent to Amgen covering the drug Broadlumab.  Brodalumab is a human monoclonal antibody designed for the treatment of inflammatory diseases including psoriasis  In the United States, Broadlumab is known as Siliq and in Europe it is Kyntheum. The application for Broadalumab was filed as a PCT application – PCT/US2007/021174 (click here to see the page on WIPO – Patentscope) and was accorded application number: 2350/CHENP/2007. One can see the entire file on this link – https://www.quickcompany.in/patents/il-17-receiptor-a-antigen-binding-proteins Sandeep Rathod –…


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Drug Regulation

The Bedaquiline Patient Consent Form in India & the Perils of Single Issue ‘Access to Medicine’ Activism

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‘Access to medicine’ activists at MSF are kicking off yet another campaign to increase access to Janssen’s new drug bedaquiline. Based on a new study and a new set of guidance from the WHO, the activists want the government to give all multi-drug resistant TB patients in India access to bedaquiline. A recent piece published on India Spend, with “support from MSF”, interviews the lead author of an earlier study of bedaquiline in light of a more recent study in the…


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Drug Regulation Patent

Standing Against XTANDI: An E-mail Campaign to Ensure Accessibility to Cancer Wonder-Drug

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In their latest efforts to stop the University of California, Los Angeles (UCLA) from pursuing a patent for Xtandi, the Universities Allied for Essential Medicines (UAEM) is sending an e-mail petition to Janet Napolitano, the President of University of California. This attempt comes after UAEM made a representation before the Regents of the University of California for a third time, demanding that Xtandi be made more accessible in India. Xtandi has an eventful if not long history of controversies in…


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Drug Regulation

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

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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

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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

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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

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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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