Category Archives: Drug Regulation

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…


Read More »
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…


Read More »
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….


Read More »
Competition Law Drug Regulation

The CCI’s Identity Crisis and Dealing with Misplaced Criticism


The Competition Commission of India (CCI) will complete 14 years of its existence this year, having been established in 2003 (although it became fully functional only much later). Like all teenagers, the people around it can’t seem to identify its exact role in the universe. In the case of the CCI, the question is whether the institution is a part of the executive or the judiciary. This issue was raised before the Supreme Court in the case of Brahm Dutt…


Read More »
Competition Law Drug Regulation

Is Patent Enforcement Anti-competitive? Delhi HC Expresses Some Caution!


The Roche: Biocon saga over Herceptin took a dramatic new turn recently. Before getting into the details, here is a short timeline for those interested (I have not included a list of all the suits filed, for the sake of brevity). The Timeline Roche sued Biocon and Mylan before the Delhi High Court, seeking to restrain their sales of a biosimilar of Roche’s breast cancer medication, Trastuzumab. Rahul carried an analysis of that order over here and here. In this…


Read More »
Drug Regulation Patent

XTANDI Updates: Cancer Union and 56 others request UCLA to back down from Delhi HC review of IPO’s patent rejection order; Delhi HC refuses to hear the matter on priority


In a positive development, the Union for Affordable Cancer Treatment (UACT), along with 56 other organizations, has requested the University of California (UCLA) to withdraw from its proceedings before the Delhi High Court against the IPO’s rejection of its patent[1] in XTANDI. In its letter dated 24th May 2017, UACT reminds UCLA that its research for the blockbuster drug for prostate cancer was supported by US taxpayer dollars through the National Cancer Institute at the National Institutes of Health and…


Read More »
Drug Regulation

Delhi High Court Grants Biocon-Mylan Permission to Market New Biosimilar For Additional Indiciations


As reported in the Economic Times on March 4, 2017 a Division Bench of the Delhi High Court has passed an interim order allowing Biocon and Mylan to market their biosimilar of Roche’s drug, Herceptin, for two additional indications: early breast cancer and metastatic gastric cancer. (Although this order was passed on March 3, 2017 it took the High Court’s registry almost 13 days days to make available the order on its website. It is not clear why it took…


Read More »
Drug Regulation Others

Plain Apathy or Sheer Incompetence? Govt. Sets New Lows by Running Out of Child Anti-HIV Drugs


Roughly two years back, Kartik had brought up the role of non-IP factors, specifically government apathy, in impeding “access to medicines”. The discussion came up in the context of National AIDS Control Programme (NACO) facing reverses due to the dwindling of stocks of anti-retroviral medication. Two years hence, the government and its bureaucracy, in a shocking display of indifference towards the children living with HIV, have turned a blind eye towards the running out of stocks of syrup containing the…


Read More »
Competition Law Drug Regulation

Poorly Drafted Regulatory Laws are Becoming the New Barrier for Indians to Access More Affordable Biotech Products


In highly regulated industries like pharmaceuticals and biotechnology, where all market players are required to prove the safety and efficacy of their products to government regulators, the lack of an efficient regulatory mechanism can act as a substantial hurdle to competition and greater accessibility. In such cases, poor regulation provides IP owners a window to further delay competition even after their patent rights expire. To facilitate better competition in these sectors, it is necessary for governments to create new regulatory…


Read More »
Drug Regulation

In a Deeply Flawed Judgment, Delhi High Court Quashes Government’s Decision to Ban 344 FDCs


In a judgment that could have far-reaching implications for the safety of large numbers of Indian patients, a single judge of the Delhi High Court quashed the Government’s decision to ban 344 fixed dose combination (FDC) drugs earlier this month. On 10th March, 2016, the Central Government had prohibited the manufacture, sale and distribution of 344 FDCs, most notably the famous cough syrup Corex, in exercise of the powers conferred upon it by Section 26A of the Drugs and Cosmetics…


Read More »