Author name: Prashant Reddy

T. Prashant Reddy graduated from the National Law School of India University, Bangalore, with a B.A.LLB (Hons.) degree in 2008. He later graduated with a LLM degree (Law, Science & Technology) from the Stanford Law School in 2013. Prashant has worked with law firms in Delhi and in academia in India and Singapore. He is also co-author of the book Create, Copy, Disrupt: India's Intellectual Property Dilemmas (OUP).

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

/ By / Drug Regulation

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

/ By / Drug Regulation

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

/ By / Drug Regulation

‘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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The State of Indian Copyright Societies (And Assorted Bodies) After the Copyright (Amendment) Act, 2012

/ By / Copyright

It has now been over 6 years since the revolutionary Copyright (Amendment) Act, 2012 was passed by Parliament. As most of our readers may remember, the background to that amendment was corruption in Indian copyright societies and allegations of patently unfair contracts being thrust onto Indian composers and lyricists. The amendments were aimed at changing the regulatory framework for Indian copyright societies and inserting statutory safeguards to protect songwriters and composers. We’ve covered the background of those amendments extensively on

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Did the Hindu’s Reporter Publish Fake News about Dr. Soumya Swaminathan Recommending a Compulsory License for Bedaquiline?

/ By / Patent

In July I had written about how I had filed applications under the Right to Information Act, 2005 seeking information from the government regarding assertions made in a news report by Vidya Krishnan of the Hindu in March of this year. A copy of the Hindu’s report was appended to my RTI application. In her report, Krishnan had mentioned that the government had requested Janssen and Otsuka for voluntary licenses for their new TB drugs, bedaquiline and delaminid and that

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

/ By / Drug Regulation

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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In A Blow to Creative Industry, Delhi High Court Upholds Constitutionality of Rule 56 etc. of Copyright Rules, 2013

/ By / Copyright

In a judgment delivered on May 28, 2018 (and which slipped under the radar until Shamnad was alerted to it), a Division Bench of the Delhi High Court has upheld the constitutionality of some provisions of the Copyright Rules, 2013 that were challenged by Anand Bhushan of Pitambar Publishing Co. Ltd. Originally the petitions filed by Mr. Bhushan in 2013 challenged several provisions of the Copyright Act and Copyright Rules. As the matter lay pending, the scope of the constitutional

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Notes from the WIPO-WTO colloquium for Teachers of Intellectual Property from Developing Countries and Countries in Transition

/ By / Others

Last month, I had the opportunity to attend the colloquium for IP teachers from developing countries that is organized jointly by the World Trade Organisation (WTO) and World Intellectual Property Organisation (WIPO). The event brings IP teachers from almost 30 different developing countries to Geneva, Switzerland, at the expense of WIPO-WTO for a rigorous and fun, 10 days event. The colloquium is a rare opportunity to meet IP academics from developing countries and hear about their national experiences in the

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New Law to Hardcode Public Interest into Injunction Jurisprudence

/ By / Patent

The upcoming session of Parliament may see the passage of a legislation that will have the effect of hardcoding ‘public interest’ into Indian injunction jurisprudence. The Specific Relief (Amendment) Bill, 2017 which has already been passed in the Lok Sabha is the offspring of a report submitted by a committee of experts which is yet to be released to the public. The Law Ministry never conducted a public consultation on the bill and the Lok Sabha passed the bill with

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RTI application regarding CL/VL status for bedaquiline gets transferred 3 times with no information provided

/ By / Patent

On March 4, 2018 the Hindu published a frontpage news report on bedaquiline, the new drug that has shown promise in treating multi-drug resistant tuberculosis (MDR-TB). While we have written extensively on other aspects of bedaquiline, the one issue that we have not commented on so far is the reporting in the Hindu on the compulsory licensing/voluntary licensing for the patents covering bedaquiline. The Hindu’s report made two assertions. The first assertion was that a panel headed by Dr. Soumya

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