Pharmaceutical Jurisprudence Imporatnt Note Pharmacy License and Loksewa

Pharmaceutical Jurisprudence Imporatnt Note Pharmacy License and Loksewa

Pharmaceutical Jurisprudence in Nepal includes Drug Act, Drug Registration Regulation, National Drug Policy, Drug Manufacturing Code, Essential Drug List, Narcotic Act, Nepal Pharmacy Council Act, Drug Advisory Committe,Drug Consultative Council Rules and regulations, and the law relates to other pharmacy profession and the order of development of the pharmacy profession in Nepal.

Some Important Pharmaceutical Jurisprudence Note for Pharmacy License and Loksewa Exam below mention.

1. The beginning of pharmacy profession in Nepal is from the Banspati bibhag.
2. Department of Drug Administration (DDA) was established according to the Drug Act in 2036 BS under the Ministry of Forest and Soil Conservation, and in Poush, 2041 B.S, it came under the Ministry of Health
3. The pharmaceutical education was started in Nepal with the commencement of the Proficiency Certificate Level, a two and half year program (Intermediate in Pharmacy that is similar to Diploma of Pharmacy) at the Institute of Medicine, Tribhuban University in 1972.
4. Pharmaceutical industry history was started in Nepal, when Chemidrug Industries Pvt. Ltd established a production unit 2026 BS at Kathmandu.
5. APPON (Association of Pharmaceutical Producers of Nepal) was established in the year 1990 AD
6. NPA (Nepal Pharmaceutical Association) was established in 1972 AD
7. Santabhavan Hospital (present patan Hospital that was established in 1956) is pioneer to start hospital Pharmacy service in Nepal
8. Hospital pharmacy guideline published in 2072 BS (Hospital pharmacy service guideline ,2070 has been revoked.) Kanti children’s hospital pharmacy was first government hospital pharmacy of Nepal(2071)
9. The Bachelor of pharmacy (B. Pharm) program was started in  Kathmandu University in 1994 after twenty two years of PCL program. The B. Pharm programs later were started at Tribhuvan University in 2000, at Pokhara University in 2001 and at Purbanchal University affiliated Asian college in 2007.
10. 2037 BS the formtion of Drugs Advisory Council and Drugs Advisory Committee. The main function of the Council is to provide advice to the Government of Nepal on theoretical and administrative matters relating to drugs, taking into account of the main object to protect the national interest and make the country selfreliant by checking the import based production process and being more dependent on indigenous herbs etc.Where as the main function of committee is to give advice to the DDA on technical matters as to the research, development and control of drugs
11. National Drug Policy 1995 has been promulgated for implementation.
12. Drug Registration Regulation was published in 2038 BS and first time  ammendent in 2058 BS
13. Codes on Drug Manufacturing was published in 2041 BS
14. Modern allopathic medicines were introduced in 1816 AD
15. Chandra dispensary started in 1816 AD.
16. Bir Hospital established in 1889AD (1947 BS)
17. Royal Drug Research Laboratory established  in 1964 AD  and conversion of Royal Drug Research laboratory into National Medicine Laboratory in 1972 AD(2029 BS)
18. Allopathic medicine manufacturing  started in 1969 AD.
19. Narcotics Drug (Control) Act was promulgated in 1976 AD (2033 BS).
20. Drug act was implemented in 2035 BS ( 1978 AD) first time revised in 2045 BS, second time revised in 2057 BS & third time revised in 2079, consist of 40 section and 7 chapter
21. Drug inquiry and Inspection Regulation was published in 1983 AD (2040 BS).
22. Drug Manufacturing Codes was published in 1984 AD (2041 BS) . [Note: New GMP Code was published in 2072 BS (2015 AD)
23. Drug Sale and distribution Codes was published in 1984 AD (2041 BS)].  (Note: New Codes on drug sale and distribution published and implemented in  2071 BS (2014 AD).
24. Drug Standard Regulation was published in 1986 AD (2043 BS).
25. National Health Policy was published in 1991 AD.
26. Nepal pharmacy council was established in 2001AD (2058 BS) and its implementation in 2002 AD (2059 BS).
27. Good manufacturing practice (GMP) implemented in 2004 AD
28. Purna Prasad Lamsal is the first pharmacist of Nepal
29. Date of first name registration exam taken by Nepal Pharmacy Council 2071/6/4
30. The Government of Nepal has fixed the prices of 96 types of medicines
31. The Government of Nepal has provided 98 medicines free of cost
32. Essential Drug List of Nepal (EDL) first time published in 1986 AD and 6th time revised in 2021, consist of 398 medicines.
33. Nepalese National Formulary (NNF) was published in 1997, first edition published in 2010 and second edition published in 2018.
34. Nepal’s pharmacopiea has not been made yet, 10 International pharmacopiea are recognized in Nepal
35. List of Domestic Pharmaceutical industries listed in DAMS till 29/09/2022 is 128.
36. Pharmaceutical Products for marketing authorization upto Ashadh 2076 Domestic  9166
37. Pharmaceutical Products for marketing authorization upto Ashadh 2076 Foreign 9940
38. There are 16990 Registered Drugs in Nepal (Updated in 2080 Baishakh 1)
39. There are 27903 Registered Pharmacy in Nepal (Updated in 2080 Baishakh 1)
40. There are 169 Registered Importers in Nepal (Updated in 2080 Baishakh 1)
41. There are 128 Registered Domestic Pharmaceutical Industries in Nepal (Updated in 2080 Baishakh 1)
42. Minimum requirements for the recognition of Diploma in Pharmacy, Date of approval by the Nepal Pharmacy council: 18 September 2002 (2 Ashwin, 2059)
43. Minimum requirements for the recognition of Diploma in Pharmacy, First amendment: 14 November 2002 (28 Kartik, 2059) , Second amendment: 22 June 2007 (8 Ashard, 2064)
44. Drug Act 3rd time ammendent in 2079 Baishak 25.
45. Mr. Shiva Bahadur Karki is the first Chairman of Nepal Pharmacy Council.
46. Chemi Drug is first Pharmaceutical Industry of Nepal, which is established in 2026 B.S.
47. Deurali Janta Pharmaceutical Industry is Nepal’s First WHO – GMP certified Pharmaceutical Industry.
48. Drug Registration Regulation was first time ammendent in 2058 B.S.
49. First Pharmacist  of Nepal – Purna Prasad Lamsal
50. I Pharma phased out from IOM – 2008 AD (2065 BS)
51. Second Pharmacist of Nepal – Mohan Lal Joshi
52. First Director of DDA – Dr. Amir Bahadur Shrestha
53. In Nepal Pharmacy Course strated in 1972 ( I. Pharma TU)
54. RDRL, Named as NML in 2063/4/19 BS
55. Diploma in Pharmacy Course ( 3 Year course) strated under CTEVT in 2061BS (2004 AD)
56. Concept of PHC comes in Nepal 1978
57. Drug Registartion Regulation publised in 2038, first time amendent in 2058, second time amendent in 2070 & third time amendent in 2077 BS.
58. Medicine Registartion Guidance was published in 2073
59. Government of Nepal nominated Department of Drug Administration (DDA) in October 2004 as the focal point (National Pharmacovigilance centre)
60. Nepal became a WHO Pharmacovigilance programme member in July 2006.
61. At present, there are 15 regional pharmacovigilance centers in Nepal
62. National database contains about 972 ADR reports till date 2080 Baishak 1

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