Category: pharma

Health Policies in India and its Implementation

8th August, 2023 - 5:39 am Categories: pharma

Introduction Following the pandemic India, a developing nation with limited resources, has created a number of policies to expand its healthcare system. The government has not only changed existing policies to better suit the times, but it has also boldly introduced new ones. The article’s goal is to discuss some policies with their goals and … Continue reading Health Policies in India and its Implementation

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Medical Device Registration Process In India: A Primer

18th July, 2022 - 12:43 pm Categories: pharma

In the preceding five years, the medical device industry in India has undergone significant changes, particularly on the regulatory front. Still at a transitory phase, the medical device industry To begin with, the Medical Devices Rules, 2017 (“MDR”), were enacted to regulate and standardise medical devices in India, among other things. The rules came into … Continue reading Medical Device Registration Process In India: A Primer

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Note on CCI’s Report on the Pharmaceutical Sector

24th December, 2021 - 4:21 am Categories: pharma

Key findings and observations from a market analysis conducted by the Competition Commission of India (CCI) were revealed on November 18, 2021. There are many components of the study, including trade margins, disputes between online and offline distributors, trade associations, and modes of distribution, that are examined. To date, there have been 43 complaints about … Continue reading Note on CCI’s Report on the Pharmaceutical Sector

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Enantiomer Patents: Non Obviousness In Secondary Pharmaceutical Patents

26th October, 2021 - 11:46 am Categories: pharma

Enantiomers, Racemate & Chirality ‘Stereochemistry’ is the study of spatial arrangements of atoms in a molecule. A molecule may be similar in chemical makeup to another molecule, however, the spatial arrangements of atoms in these may differ. Molecules so related are called stereoisomers. Enantiomers exist as subsets of these stereoisomers, where, the spatial arrangement of … Continue reading Enantiomer Patents: Non Obviousness In Secondary Pharmaceutical Patents

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Highlights of National Commission for Indian System of Medicines Bill, (need for preserving, regulating, organizing the Age Old Medicine Systems)

20th March, 2019 - 4:33 am Categories: pharma

Introduction As a child growing up in India, or even as an adult, each one of us has had a fair experience of how grandmothers in Indian households peculiarly happen to have herbal prescriptions for all the ailments that could come our way, famously known as ‘Daadi ke nuskhe’ and we have to agree, most … Continue reading Highlights of National Commission for Indian System of Medicines Bill, (need for preserving, regulating, organizing the Age Old Medicine Systems)

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E- Pharmacy In India (Ban Or No Ban)

27th December, 2018 - 9:24 am Categories: pharma

‘E-pharmacies’ are in quandary after the decisions taken by country’s two High Court’s over the issue of online sale of medicines. The Hon’ble Delhi High Court deferred the hearing on the matter and extended its interim stay on the online sale of medicines through e-pharmacies. However, the Hon’ble Madras High Court temporarily suspended the ban … Continue reading E- Pharmacy In India (Ban Or No Ban)

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Injunction against Cipla COPD Drug ‘INDAFLO’ Upheld: Delhi High Court

14th April, 2017 - 6:30 am Categories: Legal Issues pharma

Reportedly, on an appeal filed by Cipla pertaining to COPD drug INDAFLO, the Delhi High court division bench maintained the interim injunction imposed by single judge against Cipla. As per the order, Cipla has now been restrained from, inter alia, using, manufacturing, importing, selling any pharmaceutical products etc. containing ‘INDACATEROL‘ or ‘INDACATEROL Maleate‘, alone or … Continue reading Injunction against Cipla COPD Drug ‘INDAFLO’ Upheld: Delhi High Court

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Analysis of the rejection of Lumacaftor (Polymorph) patent application in India

11th January, 2017 - 6:20 am Categories: India News & Updates Patents pharma

We have been receiving requests from our Pharma clients/readers of the blog for the analysis of the decision/ facts that led to rejection of Lumacaftor (Polymorph) patent application in India since last year. Here is our take: Details of the Patent Application and important dates: Patent application number in India 2056/KOLNP/2010 Title of the invention … Continue reading Analysis of the rejection of Lumacaftor (Polymorph) patent application in India

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Merk’s patent valid but Teva’s Nasonex generic non-infringing

27th December, 2016 - 7:37 am Categories: News & Updates Patents pharma

In Merck Sharp & Dohme Corp. (hereinafter referred to be as “Merck”) v. Teva Pharms. United States, Inc. (hereinafter referred to be as “Teva”) decided on November 16, 2016, Teva’s application of Abbreviated New Drug Application (hereinafter referred to as “ANDA”) no. 205149 had triggered Merck to file infringement suit against Teva in respect of … Continue reading Merk’s patent valid but Teva’s Nasonex generic non-infringing

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Combating Opioid Misuse – COMBAT (Curb Opioid Misuse By Advancing Technology Act of 2016)

3rd May, 2016 - 7:14 am Categories: India News & Updates pharma

The Congress recently introduced a bill on the COMBAT Act (Curb Opioid Misuse By Advancing Technology Act of 2016) to incentivize the development of abuse-deterrent opioids by amending the Federal Food, Drug, and Cosmetic Act to extend the exclusivity period for certain drug products developed or labeled so as to reduce drug abuse, and for … Continue reading Combating Opioid Misuse – COMBAT (Curb Opioid Misuse By Advancing Technology Act of 2016)

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