BY:

A MI T S H R E S T H A
B H A S K A R S H R E S T HA
R A J A N G H I MI R E
S A J A N MA H A R J A N
S U MA N K U N WA R
Medicines registration & licensing
of pharmaceutical establishments
Legal framework & Institutional set-up
Drugs Registration Rules, 2038

To establish drug industry:

Recommendation letter to e otained from DD! "#$apter % &ection '(

Product Registration

)roduct license to e otained to manufacture drug (Manufacturing License)

"#$apter % &ection 8(

Registration of drug prior to sale and distriution (Marketing License) "#$apter %

&ection 8!(

Exportation or importation of drug

Recommendation letter to e otained from DD! "#$apter % &ection *(

+alidit, period and renewal of product license, recommendation letter and

certificate "#$apter % and &ection --(.

/ee for all ao0e is gi0en , &c$edule -%.

Impro0ements 1 2utcomes
3$ere s$ould e clear information aout w$ere and w$om
s$ould we consider during t$e process
4$ere and w$om s$ould we consider during registration is not
clearl, mentioned.
#larit, of Rules and Less confusion to people
5o time limit for recommendation letter, license or an, work
process
3ime limit for certain work process or licensing s$ould e
specified
6n$ance working efficienc, and &a0e time
Different section for eac$ group of medicine and separate
registration ook for eac$ t,pe s$ould e a0ailale
"5ew drugs, 7iological products, !ur0edic products, +eterinar,
and so on(

6ase in 8andling registration works

Less time consuming as works will e distriuted

&ame product registration is done twice
&ame product registration is done twice
9fg licence can e gi0en to a group of drugs to e
manufactured in same area and marketing licence can e
gi0en to indi0idual drug
9fg licence can e gi0en to a group of drugs to e
manufactured in same area and marketing licence can e
gi0en to indi0idual drug
Reduce registration cost $ence more product registration possile
Reduce registration cost $ence more product registration possile
/or eac$ product registration, manufacturer
s$ould go to DD!
&implif, t$e product registration process 0ia online registration
facilities
&a0ing of time, cost and laour
THANK
YOU