17/02/2021
Drug Act 2035 BS Nepal
1. Short title,extent and
commencement
2. Definations
3. Drug consultative council
4. Drug Advisory committee
5. Department of drug administration
6. National medicine laboratory
7. recommendation letter to be obtained from department to establish drug industry
8. Product license to be obtained for manufacture of drugs
8A. registration prior to or importation of drugs
9. Recommendation letter to be obtained for exportation or importation of drugs
10. Registration of name for sale and distribution of drugs
10A. Sale and distribution of registered drug only
11. Validity period and renewal
12. Drugs to be safe for public consumption,efficacious and of quality standard
13. prohibition on manufacture,sale,distribution,export,import consumption which are not safe for public consumption,efficacious and of quality standard
14. Return of drugs
15. Provision of compensation
16. submission of letter of guarantee to the department
17. Categorization of drugs
18. prohibition on misuse or abuse of drugs
19. prohibition on false or misleading advertisement about drugs
20. powers of inspector to inquiry and inspection
21. filing complaint against order of administrator
22. procedure to be followed when inquiry and inspection
23. qualification of inspector and analyst
24. sending sample of drugs
25. powers of government of Nepal to manufacture,sale,distribution,export,import,storage of any drugs
26. powers to fix price of drugs
27. provision relating to prescription
28. prohibition on manufacture,sale distribution,export import dispensing of drugs without making required arrangement of human resources or resources .
29. prohibition on adulteration of drugs and sale and distribution of adulterated drugs
30. prohibition on sale and distribution of date expired drugs
31. License to be obtained for clinical trial of new drugs
32. disclosure of system
33. Narcotics and poisonous drugs to be kept safely
34. penalties
35. Ceiling of fine and imprisonment in lieu of fine
36. right to register patent of drugs
37. Delegation of authority
38. Government of Nepal to be plaintiff
39. investigation and filing of case
40. Powers to frame rules