Provision and Process for Registration, Manufacturing & Importation of any Drug in Nepal

Outline of the provision and process each for registration, manufacturing and importation of any drug in Nepal.

For any drug to be sold and distributed in Nepal, the drug needs to be registered in the regulatory authority, Department of Drug Administration as per the Drug Act 2035. Manufacture,sale, distribution and export-import of drug is specified on the chapter 4 of section 7, 8, 9, 10 and 11 of Drug Act. Before the product of an industry is registered, the industry producing the drug should be registered.

For the registration, sale, distribution and manufacture of any drug following steps are required:

First Step: Obtaining the letter of recommendation for establishment of drug industry

Under the basis of section 7 of Drug Act 2035 application should be submitted to the department for obtaining the letter of recommendation for establishment of drug industry as refer as in schedule 1.
After necessary inquiry department will issue a recommendation letter as specified in schedule 2 after paying specified fee as illustrate on schedule 14.

Second Step: Obtaining product license for production of drugs

Under the basis of section 8 of Drug Act 2035 application should be submitted to the department for obtaining product license for production of drugs as refer as in schedule 3.
Then product is register in registration book as refer as in schedule 4.
Finally after necessary inquiry department will issue a product license as specified in schedule 5 after paying specified fee as illustrate on schedule 14.

Third Step: Obtaining drug sale & distribution registration certificate for sale & distribution of drug

Under the basis of section 8A of Drug Act 2035 application should be submitted to the department for Registration of drug for sale and distribution as refer as in schedule 4A.
After necessary inquiry department will issue drug sale and distribution registration certificate as specified in schedule 4B after paying specified fee as illustrate on schedule 14.

For export-import of drug: Obtaining the letter or recommendation for export-import of drugs is specified in section 9 of Drug Act. Any firm wishing to work as importer should apply application to department according to schedule 6 and authority will provide the letter of recommendation according to schedule 7.

The shop or firm desiring to sale and distribute drugs in Nepal should register their name by submitting their application to department and should be certified according to schedule 9. At present to open a new firm or shop the department has made the legislation that the person must have completed his Diploma in Pharmacy.

For importation of any drug in Nepalese market, the most important thing is the registration of the industry as well as the product of industry. For the registration of foreign industry it requires $1500 as for the inspection fee [For SAARC Countries] for inspection.

After the inspection the company should be registered. The registration fee for the industry registration is Rs 50,000. Then for product registration the registration fee varies according to the form of drug. It is different for life saving, generic and brand drug. The registration procedure is similar and for import the firm should be licensed.

Note:

This is the frequently asked question of Loksewa Aayog Pharmacy Officer and B Pharmacy Exam Pharmaceutical Jurisprudence.