CDSCO Introduces Online Export NOC System on SUGAM Portal
New Delhi: Enhancing the ease of doing business, the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health & Family Welfare, Government of India, has streamlined the process of issuing export NOCs (No Objection Certificates) for unapproved or approved new drugs through the SUGAM Portal.
Further, with an aim to reduce the compliance burden, CDSCO has initiated the issue of a 1-year NOC, subject to prescribed conditions for such drugs.
Accordingly, the authority has introduced a revised Sugam checklist to streamline the application process for Export NOC.
"Application for Export NOC shall be submitted through the SUGAM Portal along with a prescribed checklist of documents," the notice added.
The notice further mentioned, " This modified system is now functional now on SUGAM Portal of (www.cocoonine.am.in)"
User Manual for SUGAM- An e-Governance solution Online Forms Submission NOC (Zone)- Export NOC by Central Drugs Standard Control Organization (CDSCO) has been published.
Explaining the registration process for the Online Form Submission NOC (Zone)-Export NOC, the notice mentioned that all the corporate users can submit online forms under NOC (Zone). Following are the steps involved in the same.
- When the applicant logins using his credentials, he needs to switch his role to corporate by selecting corporate from the list of Switch Role dropdown present on his dashboard. For better understanding, here is the image.
- After switching the role, the applicant needs to click on the Submit Application hyperlink present on the dashboard. The following popup will appear as mentioned below.
- Once the Applicant confirms to switch role by clicking OK in the above screen, the Online Form Submission page will open as shown below.
- There is a list of departments present in the Select Department dropdown. The Applicant needs to select NOC (Zone) form the list.
- After selecting NOC (Zone) department, two options would be available for select Form: Export NOC and Dual Use NOC.
1. Export NOC
- The Applicant selects Export NOC from the Select Form dropdown and clicking the checkbox, he can move further by clicking on Proceed button. The following screen will appear as shown below.
NOTE: All the license numbers present in the License No. dropdown are those licenses which have been added by the applicant. The Applicant can add more license numbers by following the below steps.
The Applicant needs to click on the Menu button present at the left corner of the screen. Then he can go to User Profile --> Add Wholesale/ Manufacturing License Details. Here is the screenshot for better understanding.
- On this page, there are the following options available under Applying for NOC for the first time; below is a screenshot of the same. There is a two-option option if the user is applying Yes or No.
1. After selecting the desired option from Applying NOC for first time dropdown, the Applicant can see two options on the Applied for option from the dropdown: Approved New Drug and Banned new drug, Material transfer, Narcotics and Psychotropic Substances Drug (NDPS), Unapproved Drug. We will see these in detail in the further sections.
- 1.1 After selecting the Approved New Drug
- The user has to select Purpose of Application Bulk Drug API, Finished Formulation, R&D for BD, and R&D for FF as mention in below screen.
- After selecting Bulk Drug API user have to select the License NO which was added in the drop-down by the User While clicking on the MENU button as screenshot added in the drop-down.
- Now user has to add a License No (How to manufacturing license number please referee page No. 6).
- After clicking Save and Continue Button by the user Page will be re-direct to the next page as per attached screenshots.
- Now the drug details page will be visible where users have to fill the drug details as per attached screenshots.
- Generic Name of drug (user have to entered correct drug name Pharmacopeia Monograph (can be select from the drop-down) Class of Drug (can be selected from the drop-down)
- Shelf life (in the filed user needs to entered the value in the number and they have to select shelf in Days, weeks, Month, year)
- Storage condition can be selected from the drop-down,
- Now user, have to select the country from the drop-down where he has to export the Products from * Multiple country can be selected from the drop-down.
- After clicking on save button drug details will be added successfully (user can add multiple drug) as per attached screenshots.
1.2 After selecting the Ban Drug
- User has to select Purpose of Application Bulk Drug API, Finished Formulation, as mention in below screen.
After selecting the Finished Formulation option and Licence No (How to manufacturing license number please referee page No. 6) from the drop-down user have to click on save and continue button for drug details entry as attached screenshots.
- Generic Name of drug (user have to entered correct drug name) Brand Name(this field is optional for user)
- Pharmacopeia Monograph (can be select from the drop-down) Class of Drug (can be selected from the drop-down)
- Shelf life (in the filed user needs to entered the value in the number and they have to select shelf in Days, weeks, Month, year)
- Storage condition can be selected from the drop-down.
- Quantity (can be entered in number value and volume can be selected from the drop- down)
- Now user, have to select the country from the drop-down where he has to export the Products from * Multiple country can be selected from the drop-down.
- Dosage form (can be selected from the drop-down).
- Strength can be entered in numeric value, and volume of strength can be selected
- Composition can be selected from the drop-down
Note to add drug details, the user needs to click on the save button to add a drug detail (User can multiple drug details on same page after clicking on save button).
1.3 - After selecting the" Material Transfer from the drop-down"
- Purpose of the applicant will be fixed to "Bulk Drug API"
- Now user has to add a License No (How to manufacturing license numberplease referee page No. 6)
- Now the user has to enter NOC no and have to select the zonal name from the drop-down as shown in attached screenshots below mention.
** Note Details should be entered in NOC number should be correct and zonal name also.
After entering the details user has to entered purchase order number, purchase order date, API name and Quantity as shown below.
1.4 After selecting the "NDPS"
- Purposed can be selected from the drop-down (Bulk drug API or Finished Formulation).
- Now user have to add an Licence No (How to manufacturing license number please referee page No. 6) from the drop-down.
- After clicking on save and continue button drug details page will be visible.
- Generic Name of drug (user have to entered correct drug name
- Pharmacopeia Monograph (can be select from the drop-down) Class of Drug (can be selected from the drop-down)
- Shelf life (in the filed user needs to entered the value in the number and they have to select shelf in Days, weeks, Month, year)
- Storage condition can be selected from the drop-down,
- Now user, have to select the country from the drop-down where he has to export the Products from * Multiple country can be selected from the drop-down.
1.5 After selecting the "Unapproved Drug from drop-down"
User can select multiple options from the drop as shown in below mention figure.
- Now user has to add an Licence No (How to manufacturing license number please referee page No. 6).
- While clicking on save and continue button drug details page will be visible.
- Where user has to fill the entire fill as mention below screenshots.
- After clicking save button draft page will be visible.
- After clicking Save and continue button checklist will be visible where user has to fill the entire checklist.
- After clicking on Submit button your file will be submitted successfully.
To view the official notice, click the below link:
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