Chapter Section & Content

Chapter-2 Drug consultative council & Drug Advisory council

3-Drug consultative council
4- Drug Advisory committee
Chapter-3 Research & control of Drugs
5- Department of Drug Administration
6- Drug Research Laboratory & other laboratories
Chapter-4 Manufacture, Sale, Distribution Export & Import of Drugs
7- Recommendation letter to be obtained establish drug industry
8- Product license to be obtained
8A- Registration of drug
9- Recommendation letter to be obtained for exportation or Importation
10- Registration of name for sale & distribution of drug
10A- Sale & distribution of registered drug only
11- Validity period & renewal of product license recommendation letter & certificate
Chapter-5 Quality Standard of Drugs
12- Drugs to be safe for public consumption efficacious and of quality standard
13- Prohibition on manufacture Sale distribution export import storage or consumption
of drug not conforming to prescribed standard
14- Return of drug which is not safe for public consumption efficacious and of quality
standard
15- Provision of compensation
16- Submission of letter of guarantee to department
17- Categorization of drugs
18- Prohibition on misuse or abuse of drug
19- Prohibition on false or misleading advertisement of drug
Chapter-6 Inquiry and Inspection
20- Power of inspector to make inquiry & inspection
21- Filling complaint against order of administration
22- Procedure to be followed while making inspection or inquiry
23- Qualification of inspector & Analyst
24- Sending sample of drug for test
Chapter-7 Miscellaneous
25- Power of government of Nepal Prohibit manufacture sale distribution storage
transportation export import of consumption of drug s
26- Power to fix price of drug
27- Provision relating to prescription
28- Prohibition on manufacture sale distribution dispensing of storage without making
arrangement of required human resource or resources
29- Prohibition on adulteration in drug & sales of adultered drugs
30- Prohibition on sale or distribution of date expired drug
31- License to be obtained from department for clinical trial of new drug
32- Disclosure of system of drug & other particulars while manufacturing drug
33- Narcotic & poisonous drug to be kept safely
34- Penalties
 35- Celling of fine and imprisonment in lieu of fine
36- Right to register patent of drug
37- Delegation of authority
38- Government to be the plaintiff
39- Investigation & Filling of case
40- Power to frame Rules
Birhospital 1890(1947) RD RL NML 1964,1965 Narcotic Drug 1976
Chemi drug 1970(2026) I pharm 1972 Drug ACT 1978(2035)
NPA 1972 RDRL RDL NML 1972 DCC+DAC 1980
DDA 2041MOHP 1979(2036) Drug mamu fod 1984 Soft and dust 1986
D.Req.Regulation 1981 Appon 1990 National H po 1991
Inqu& inspection 1983 B.pharm ku 1994(2051) NatiDrug polic 1995
NPC ACT 2000(2057) TU B.pharm 2000 NPC establis 2001(2058)
B.pharm Pokhra 2001(2058) GMP imp 2004 DiplomaCTVT 2004
M.pharm ku 2004 D.pharm Purbanc 2062(2005) Dpharmfaseout 2008
Pharm D ku 2010 New nationa H.P 2014 Newsales D.C 2071
MFG code 2072 Hospital ph kantip 2072 Dateof1stReq 2071
RDL MOHP 1993AD H teach product 2074 Drug ACt 2035(1978)
st nd
1 2045-7-10 2 2057-8-
14
DCC DAC 1980AD/2037
Chairman: Minister of MOHP Chairman: Secretory MOHP
M.Secratory: chief DDA M.Secratory: Sr officer of DDA
Members: 11 Members: 13
Aoushadhi pramars parisad Aoushadhi sallah kar samiti
Functions: Advice on theoretical and ad Functions: Advice technical matter, std of
activity S/D/M/I/E fixe price of drug, potent of drug Nep pharmacopeia classification
drug, transportation Recognize foreign
research lab
DDA (1979/2036-07-01) forest & Soil DDA 2041 MOHP
Drug registration requisition 2038-4-19/1981

1st Amendment 2058(2001-5-18)

Total 12 section 3Recc letter to obtained indust 4product license
6 To obtain certificate of regof name shopS/D 8 Clinical trials 10 classification of drug k kh g
Drug standar requsation 1986/2043-4-27 14 Protection of Narcotic and poisonous drug
15 record of narcotic & pois drug
Drug manufacturing code person: Manufacturer /owner of industry 1984/2041

6.1 Liquid (Elixir syrup lotion ointment

6.2 Ointment pest semisolid
6.3 Tab/Cap
6.4 Parenterals
13 Packing labeling
Drug enquiry inspection reg.(1983-8-1,2040-4-16 1st am:2047(1991)

8 Sample of Drug
9 Method of Sealing
10 Stamp (4 thaunma)
12 Reports
14 Stamp box sent to analyst
National Health policy 1991 New 2014/2071
23 health worker /10000 14 policies
National drug policy 1995 from NHP (1991)
Amendment of NDP 2001AD procurement done under generic name

4.3.1 Education And training

4.3.2 Drug information
4.3.3 Antibiotic
2071 Codes and sales and distribution
8 Pharmacovigilance
2072 Manufacturing code
National drug act 2033/1976 Ammendment 3times (2043-2049-2050)
Penalties: Chapter 3 sec-14)
Consume:1mahina+2000. 25ota plant 3mahina+3000 more than 25 plants 3 years +5000-25000
Total member of registrar 10 term of office 4 year meeting mnth 3 (chapter 7 section 36)
9 Function duty of council 12 App for registration of name
13 Inquiry of App 14 Examination
15 Registration of Name 16 Certificate
18 Deletion of name for registration Cter 5 Function duty of chairman registrar
1 Preliminary (1-2) 2 Est /fuction duty (3-10
3 Req of name (11-20) 4 Req of ed degree/certificate(21-24)
5 Chairman registrar (25-26) 6 Fund (27-28)
7 Miss(29-36) NPC registration exam 2071-6-4BS
2014-09-20 AD

First Pharmacist= Purna parsad lamsal 2nd Mohan lal joshi DDA chairman1= Amir bahadur
sheresth 2nd Dr.P.N Suwal 1st NPC chairman Dr Shiba bahadur karki 2nd Shanta Raj Joshi.

Soon after birth BCG (6 weeks DPT,Hep-B,Polio,PEV) (10 hafta DPT,Hep-B,Polio,PEV

14 hafta DPT,Hep-B,Polio,IVP (9 mahina PVC,MMR) (12mahina Japanese enc
15 mahina MMR