Medicines registration & licensing of pharmaceutical establishments of Nepal

1. Medicines registration &
licensing of pharmaceutical
BY:
establishments
AMI T SHRESTHA
BHASKAR SHRESTHA
RAJAN GHIMIRE
SAJAN MAHARJAN
SUMAN KUNWAR

2. Legal framework & Institutional set-up
“Drugs Registration Rules, 2038“
 To establish drug industry:
 Recommendation letter to be obtained from DDA (Chapter 4 Section 7)
 Product Registration
 Product license to be obtained to manufacture drug (Manufacturing
License) (Chapter 4 Section 8)
 Registration of drug prior to sale and distribution (Marketing License)
(Chapter 4 Section 8A)
 Exportation or importation of drug
 Recommendation letter to be obtained from DDA (Chapter 4 Section 9)
 Validity period and renewal of product license, recommendation letter
and certificate (Chapter 4 and Section 11).
 Fee for all above is given by Schedule 14.

3. Improvements + Outcomes
Where and whom should we consider during registration is not
clearly mentioned.
There should be clear information about where and whom
should we consider during the process
Clarity of Rules and Less confusion to people
No time limit for recommendation letter, license or any work
process
Time limit for certain work process or licensing should be
specified
Enhance working efficiency and Save time

4. Different section for each group of medicine and separate
registration book for each type should be available
(New drugs, Biological products, Aurvedic products, Veterinary
and so on)
 Ease in Handling registration works
 Less time consuming as works will be distributed
Same product registration is done twice
Mfg licence can be given to a group of drugs to be
manufactured in same area and marketing licence can be
given to individual drug
Reduce registration cost hence more product registration possible

5. For each product registration, manufacturer
should go to DDA
Simplify the product registration process via online registration
facilities
Saving of time, cost and labour