Tag: Drug Controller General of India
January 30, 2023
Intellectual Property | Patent
Intellectual Property | Patent
Exports under the Bolar Exception: A Key Arrow in the I...
India is the largest producer of generic drugs in the world, and thus, it is no surprise that a great deal of patent litigation in India has centred on the manufacture of generics. While there are provisions in the law that permit the use of patented drugs for research and development (“R&D”) and for obtaining regulatory approvals, permissibility around the export of such drugs for similar purposes can be in the grey. ......
August 25, 2020
Intellectual Property | Patent
Intellectual Property | Patent
Medical Devices: Basis of Patenting and Entering in the...
The Indian medical device market is among the top 20 in the world and is expected to reach INR 794.29 billion by the end of 2023. Whilst highly lucrative, this market also presents a highly competitive environment. To stay ahead in the game, therefore, protecting one’s invention and ensuring its timely introduction in the market are key factors. ......
Bottled ‘Pride’: A Trademark Whisky War in India
How far can ‘pride’ go in succeeding in a trademark passing off suit? The Supreme Court of India had occasion to consider this, although not quite literally,...
The DPIIT Working Paper on AI and Copyright: Regulatory Signals and Practical Implications...
Artificial intelligence ("AI") is no longer at the margins of business strategy. For many organisations, it has become embedded in product design, customer engagement, internal workflows and long-term planning...
Vague Definitions, Harsh Penalties and Constitutional Incompatibility: Why the Karnataka H...
On December 10, 2025, the Government of Karnataka tabled the Karnataka Hate Speech and Hate Crimes (Prevention) Bill, 2025 (the "Bill") to prevent dissemination and punish perpetrators of hate speech and hate crimes...
Broadening the Small Company Net: Implications of the New Threshold
On December 1, 2025, the Ministry of Corporate Affairs ("MCA") via Notification G.S.R. 880(E) ("Notification"), introduced pivotal amendment to the definition of a "Small Company" under Sec-tion 2(85) of the Companies Act...
Privacy at the Price of Transparency: Legal Implications of the Amendments to Section 8 of...
The Ministry of Electronics and Information Technology ("MeitY") recently notified the Digital Personal Data Protection Rules, 2025, on November 14, 2025. This notification brings into force the Digital Personal...
Recalibrating Corporate Governance: An Analysis of the SEBI LODR 5th Amendment, 2025
On November 19, 2025, the Securities and Exchange Board of India ("SEBI") notified the fifth amendment to the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations...
Drafting deepfake defences: comments on India’s proposed amendments to the IT Rules
On October 22, 2025, the Ministry of Electronics and Information Technology ("MeitY") proposed significant amendments ("Proposed Amendments") to the Information...
Formulation fight: Amgen case tests patentability of biopharmaceuticals in India
In a high-stakes case, the Madras High Court examines whether Amgen's specific formulation is non-obvious and patentable, and whether the prior art guides...
Implementation of India’s Four Labour Codes: Key Changes and the Road Ahead
On November 21, 2025, the Ministry of Labour and Employment issued notifications operationalizing substantial portions of India's four labour codes...
The Digital Personal Data Protection Rules, 2025: A New Digital Frontier
The Ministry of Information and Technology (“MeitY”) on Thursday, November 13, 2025 notified the Digital Personal Data Protection Rules, 2025 (the “DPDP Rules”), framed under the Digital Personal Data Protection Act, 2023 (the “DPDP Act”).
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