Sectors · Healthcare and pharma
Biotechnology and life sciences
Biotechnology and life sciences enterprises operate under CDSCO licensing, patent law and clinical trial regulation, and those regimes overlap with company law and insolvency in a way that matters when the principal asset of the company is its intellectual property.
Reviewed
What this covers
- CDSCO regulatory compliance and licensing
- Restructuring and insolvency where patents are the principal asset
- NCLT proceedings and company law matters
- Clinical trial regulation and related disputes
- Technology transfer and IP licensing agreements
- Promoter and shareholder disputes in life sciences companies
- Drug pricing and NPPA compliance
- Cross-border investment structuring
The notes behind these capabilities
When a pharmaceutical or biotechnology company enters the corporate insolvency resolution process (CIRP) under the Insolvency and Bankruptcy Code, 2016 (the Code), its drug manufacturing licence and clinical trial permission are not suspended or terminated on the ground of insolvency while current dues are paid, under the Explanation to section 14(1) inserted in 2020. Neither the Drugs Rules, 1945 nor the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules) transfers either grant, and their record retention periods keep running through the process. Section 31(5), in force since 26 May 2026, protects a licence tied to an approved resolution plan. Patents are intangible assets that belong in the information memorandum and the valuation under the Insolvency and Bankruptcy Board of India (Insolvency Resolution Process for Corporate Persons) Regulations, 2016 (CIRP Regulations), while trial data has no named place in either.
Reference
Regulators in this sector
Forums
Practice areas that apply
Advocates in this sector
Other notes in this sector
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