Food, Drug & Medical Device Law
Our dedicated team delivers comprehensive legal, regulatory, and strategic advisory services throughout Nepal to safeguard corporate interests and ensure uninterrupted business operations. We regularly advise domestic manufacturers, regional distributors and multinational healthcare companies on navigating the complex and highly regulated requirements imposed by regulatory authorities of Nepal. Combining industry-focused expertise with a proactive risk-management approach, our team supports clients in developing effective compliance frameworks, obtaining essential licenses and approvals and responding to regulatory interventions and enforcement actions. Whether your business is launching an innovative pharmaceutical product, establishing a food processing facility or importing advanced medical equipment, we provide practical and tailored legal solutions aimed at reducing compliance risks, protecting commercial interests, and preserving market reputation.
Under Nepali law, the principal laws and regulations applicable to matters related to food, drugs, and medical devices are the following:
– Food Act 2023 (1966)
– Drug Act 2035 (1978)
– Consumer Protection Act 2075 (2018)
– Public Health Service Act 2075 (2018)
We assist our client with the following services:
- Regulatory Compliance & Licensing
- Client advice concerning food safety and pharmaceutical compliance
- Helping clients obtain permits, licenses, and other approvals from DFTQC and DDA
- Food Safety Compliance
- Assistance in food producer, processor and distributor compliance with hygiene and safety requirements
- Assistance to clients in complying with requirements concerning labeling, packaging and quality control
- Drug Registration & Pharmaceutical Law
- Helping pharmaceutical companies with their drug registration and approval
- Advising clients on import, export, production and distribution of pharmaceutical products
- Medical Device Law
- Advising clients concerning classification, registration and approval of medical devices
- Helping manufacturers and importers to comply with medical product regulations
- Product Liability & Consumer Safety
- Helping clients with liability claims regarding dangerous and defective products
- Legal representation of clients in disputes involving consumers
- Inspection, Investigation and Enforcement
- Assisting clients during food and drug safety inspection and compliance audit
- Representation of clients in cases of food and drug investigation and enforcement
- Import & Export Compliance
- Advising clients about food safety requirements in cross-border trade
- Helping clients import/export food products and medical products
- Advisory & Compliance for Advertising & Marketing
- Guidance on legal issues involved in promoting food, medicines, and medical devices
- Assistance to comply with regulatory limitations on the marketing of medicines
- Dispute Resolution & Litigation Services
- Representation in disputes pertaining to regulatory issues and product-based claims
- Arbitration, mediation, and litigation assistance in matters of food and medicines
- Policy Advisory Services & Regulatory Strategy
- Providing advice to businesses regarding regulatory strategy and policy compliance in the health and safety industry