Category Archives: Drug Regulation

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…


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Data Exclusivity Drug Regulation

Killing Me Softly: Of Data Exclusivity and Deadly Drugs!


In a recent post, Prashant took issue with the IPA’s contention that the Indian governments’ latest move to extend the moratorium for state drug regulatory approvals from 4 years to 10 years results in a long and damaging data exclusivity. Who is right? And who is wrong? Once one begins to trudge down this rabbit hole in search of answers, one realises that the alleged data exclusivity norm is the least of our worries. We have a far more deadly…


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Drug Regulation

Major Changes on the Cards for Drug Pricing Policy?


In a week when the cash in your hand was turned to pulp and the possibility of the planet itself being turned into pulp in the next four years became alive, it is hard to see any other news grabbing the headlines. Nevertheless, we have news which could potentially capture reader attention once the dust settles on the current events and life (hopefully) goes back to normal. As per reports (see, here and here) an “overhaul of drug policy” is…


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Data Exclusivity Drug Regulation Patent

IPA Alleges that New Rule Change will Bring in a Data Exclusivity Regime – Here’s Why I Think it Does no Such Thing


In a report published yesterday in the Bombay edition of the Times of India it has been alleged that the government is proposing a rule change to the Drugs & Cosmetics Rules, 1945 to introduce:  “a form of ‘data exclusivity’, a provision which will potentially give protection to Big Pharma, thereby delaying generic competition and hence impacting access and affordability of drugs.” The source of this information as per the news report is D.G. Shah, the spokesperson of the Indian Pharmaceutical…


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Drug Regulation Patent

Dozing DoP Wakes Up: Consults Ministries on Price Regulation of Patented Drugs


Vasundhara had recently alerted us about the Parliamentary Committee on Government Assurances pulling up the Department of Pharmaceuticals (‘DoP’) for their inaction on the control of patented drug prices. As reported by Live Mint, the chastising seems to have worked for the time being as DoP has now sought the views of different ministries on price regulation of patented drugs. Apparently, the Department of Industrial Promotion and Policy (‘DIPP’) is simultaneously examining if there needs to be a change in…


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Drug Regulation Patent

MCI Gives Generic Prescription A Shot in the Arm


Commentators have lamented the lack of a mandatory generic prescription regime in India, with some even pointing to a perceived nexus between pharmaceutical manufacturers (“innovator” companies, to be precise) and doctors, with the former offering incentives to the latter for prescribing branded drugs. Through a notification [MCI-211(2)/2016(Ethics)/131118] dated 21 September 2016, published in the Gazette of India on 8 October, the Medical Council of India has amended the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002. The amendment…


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Drug Regulation Patent

UN High Level Panel Releases a Hard Hitting Report on Access to Medicines and Health Technologies


The UN Secretary-General’s High-Level Panel on Access to Medicines (“Panel”) released its final report (“Report”) last month on the issue of promoting innovation and access to health technologies. It comes close on the heels of the UN Human Rights Council Resolution on Access to Medicines (see our post on it here) and echoes most of the sentiments expressed in the Resolution. The Report itself states that it builds on the “previous and existing work in the field of health technology…


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Drug Regulation Patent

Domino Effect: Teva withdraws patent application in India after USPTO invalidates its patent in blockbuster drug COPAXONE


In a groundbreaking development, Israeli behemoth Teva Pharmaceutical Industries Ltd. (Teva) has suffered a third consecutive blow after the US Patent Office (USPTO) invalidated its third patent [U.S. Patent No. 8,969,302] for COPAXONE (Glatiramer Acetate) on September 1, 2016. According to The Financial Express, the USPTO upheld a Mylan’s challenge in an Inter-partes Review (IPR) and found that all claims in the said COPAXONE patent were un-patentable. The 40mg version of COPAXONE is a $4 billion blockbuster injectable drug used…


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Drug Regulation

The Naked Truth: An Expose on Big Pharma


Medecins Sans Frontiers (‘MSF’) new must-watch short film, The Naked Truth is hilarious, strongly worded, and to the point.  In the video, MSF challenges Big Pharma’s age old claim of their medicines being necessarily priced as high as they are. Using metaphors that are nothing but apt, MSF strips away at Big Pharma’s supposedly continued expenses on drug research, demanding a revelation of their actual costs. MSF uses the medicines for Hepatitis C as an example, noting their $1000 per…


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Drug Regulation

The Sub-Standard Drug Problem: A Report Explaining the Failures of India’s Drug Regulatory System


Although this blog concentrates mainly on IP issues, we occasionally do cover drug regulatory issues. The state of drug regulation in India, as most of you will know, is quite alarming. Plant after plant is being banned by foreign regulators, while CRO outfits like the GVK Bio stand accused of serious fraud. Clearly, the present Drug Controller General of India (DCGI) G. N. Singh is presiding over a system which is failing at every level. He admitted as much when…


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