Our team of experts is proficient with the legal frameworks concerning the pharmaceuticals industry and offers advice on a wide range of matters in this sector.
Spice Route Legal
Pharmaceuticals
We take a proactive approach towards the pharmaceuticals industry working closely with our clients to understand their business goals, R&D pipelines, and commercial strategies. We assist with regulatory compliance, helping clients navigate complex domestic and international regulatory restrictions.
We are therefore well-versed in handling matters related to drug approvals, marketing, labelling, and post-market surveillance. We also assist our clients in protecting their intellectual property through patent and trademark prosecution, protection, and monetisation.
Work Highlights
Advised an affiliate of India’s second-largest pharmaceutical company on over 10 acquisitions, in 2021 and 2022.
Assisted one of India’s largest online pharmacies with identifying a restructuring mechanism that would ensure compliance with Indian law.
Assisted an affiliate of a prominent Indian pharmaceutical company with negotiating a development services agreement with one of India's largest pharmaceutical companies, to develop a compound required for the manufacturing of an active pharmaceutical ingredient (API) in the United States.
Assisted an American pharmaceutical company established in 1887, with structuring the ‘downsizing’ of its India operations, including evaluating labour law practices in India for laying off employees, settlement agreements, providing severance packages, gratuity, and leave encashment benefits.
Assisted an American drug development company with negotiating a co-development agreement with an Indian R&D institute to execute the development of a topical ophthalmologic formulation to treat inflammation in the eye.
Advised an American multinational company that manufactures products for the healthcare industry on drafting responses to FDA Ahmedabad and FDA Pune for allegedly selling low-quality medical adhesive tapes.
Advised India’s largest pharmaceutical companies on cross-border data transfers.
