Tag: CDSCO
July 3, 2023
Intellectual Property | Patent
Intellectual Property | Patent
When medicines are out of reach: Managed Access Program...
Before a new drug, biologic or medical device is approved and authorized for market launch, it has to undergo a long and complex process involving extensive testing and clinical trials to ensure its safety and efficacy. However, for patients who have exhausted all other options, sometimes an unapproved or pre-approved or investigational drug could be the only hope. ......
April 21, 2020
Intellectual Property | Other | Pharmaceuticals
Intellectual Property | Other | Pharmaceuticals
Changes to the Regulatory Framework for Clinical Trials...
The total cost for bringing a new prescription drug to market is about USD 2 to 3 billion (DiMasi et al.). A significant portion of this cost is incurred in conducting clinical trials. The global clinical trials market size is expected to reach USD 69.8 billion by 2027, exhibiting a 5.1% compound annual growth rate (‘CAGR’) during the forecast period. ...
From Compliance Burden to Regulatory Agility: Key Highlights of the Corporate Laws Amendme...
The Corporate Laws (Amendment) Bill, 2026 ("Bill"), introduced in the Lok Sabha on March 23, 2026, marks another incremental and deliberate step in India's corporate law reform journey.
Legitimate Uses: India’s Most Flexible and Most Misunderstood Ground for Processing
The Digital Personal Data Protection Act, 2023 ("DPDP Act") introduces 'legitimate uses' as a lawful basis for processing personal data without consent.
Toward Inclusive Streaming: Understanding India’s New OTT Accessibility Guidelines, ...
On February 6, 2026, the Ministry of Information and Broadcasting ("MIB") issued the Guidelines for Accessibility of Content on platforms of Publishers of Online Curated Content (OTT Platforms) for Persons ...
The Semaglutide Dispute in India: Clarifying the Anticipation vs. Obviousness Divide
A typical patent infringement matter plays out thus: the patent holder / plaintiff sues for patent infringement, along with an application for an interim injunction to stop the infringer ...
Refining Press Note 3: Easing the path for Foreign Investment into India
On March 10, 2026, the Union Cabinet approved significant amendments to Press Note 3 ("Amendment Notification") which governs India's foreign direct investment policy towards investments ...
Why Delhi Companies Pay More: The Stamp Duty Discrepancy
The stamp duty applicable on the execution of agreements and various documents in India is governed by both, the Union Government and the appropriate State Governments ...
Is Your Indian Supply Chain Patent-Proof? Lessons from the Philips Case
Identifying actors in patent infringement requires pinning down the party directly manufacturing a patented product or performing the patented process in question ...
Compliances and Consents: The Legality of Recording Digital Interactions
In an era defined by digital connectivity and interactions driven by the continuous exchange of data, modern communication has become increasingly susceptible to external surveillance. ...
Revised ECB Framework: Borrowing From Tomorrow
The Reserve Bank of India (the “RBI”) has amended the Foreign Exchange Management (Borrowing and Lending) Regulations, 2018 through the Foreign Exchange Management ...
Startup India 2.0: A Deep Tech Reset
The Indian government has updated the definition, eligibility criteria, recognition process, and compliance framework for startups, and introduced a new category ...
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