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India Drug Product Registration

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India Drug Product Registration

Release Notes for the eSubmission Roadmap

MOH 

Ministry of Health and Family Welfare 

MOH Website 

https://main.mohfw.gov.in/

Regulatory Authority

Central Drug Standard Control Organization (CDSCO) 

Regulatory Website 

https://cdsco.gov.in/

Local Authorized Representative Required

Yes

Drug Approval Process

All manufacturers must get a license from the Zonal FDA and CDSCO to produce new API or new drug formulations for retail or distribution. This procedure must be followed to get CDSCO’s approval.

1. To obtain permission to create ND for testing and analysis in form CT-11, complete form CT-10.

2. To obtain a license to manufacture ND, submit a second Form 30 application (Form 29) to the state FDA.

3. Send in your CT-21 application using the SUGAM portal together with the required supporting files and the relevant government fee.

4. After reviewing the application, CDSCO can have questions if it isn’t pleased. Additionally, an IPC test letter will be supplied by CDSCO.

5. After reviewing the application, CDSCO can have questions if it isn’t pleased. Additionally, an IPC test letter will be supplied by CDSCO.

6. Send samples to the IPC labs, and after receiving the IPC report, submit the application (form CT-21) to be approved for use in CT-22 (API) and CT-23 (Formulation).

7. To request additional product approval, submit Form 25 to the state FDA once CT-22/CT-23 has been obtained. Manufacturers usually receive the license after the license processing is finished, which usually takes 90 days .

Documents Required for India Drug Product Registration

  • CMC data (include site master file, COAs, batch stability data, drug product details, batch manufacturing records of three batches, manufacturer’s details, and drug master file).
  • PK/PD and toxicity study reports and summaries of authorized preclinical research.
  • Reports and summaries of clinical studies for phase I, II, and III trials.
  • Announcements and pledges from manufacturers and sponsors.
  • Form 44 2.
  • Treasury Challan of INR 50,000.
  • Source of bulk drugs /raw materials.
  • To be clear, the applicant has two options: they can import or produce the API on their own, or they can get it from another domestic source.
  • Import the API: The applicant must submit an application, the necessary supporting documentation, and meet additional conditions to import the API.
  • Produce the API: The applicant must submit an application, attach all necessary documentation, and adhere to further guidelines for API manufacturing.
  • Purchase the API from a different manufacturer that has not yet received DCGI approval. In this scenario, the API manufacturer must submit a fresh application in Form 44 with the required amount of Treasury Challan and other pertinent documentation. This application and the application for the completed formulation will be handled together.

Process to Register Pharmaceutical Products in India

Sign in to your SUGAM portal account.

Submit “new application”

Select CT-21 from the new drug division's drop-down menu

Enter the drug's pharmaceutical information, information about the research sites, and any other pertinent information.

Submit all documents requested in CT-21

Pay the eligible fees

Submit completed application

Follow up on any CDSCO questions and obtain the form CT-22/CT-23 approval later

Different Types of Forms for Drug Product Registration in India

1

Form 8

Application for license to import drugs apart from those specified in Schedule X of the Drugs and Cosmetics Rules, 1945 (‘Rules’)

2

Form 8A

Application for license to import drugs specified in Schedule X of the Rules

3

Form 9

Undertaking accompanying an application for an import license

4

Form 12

Application for license to import drugs for purpose of examination, test or analysis

5

Form 12A

Application for the issue of a permit to import small quantities of drugs for personal use

6

Form 12AA

Application for license to import small quantities of new drugs by a government hospital or
autonomous medical institution for the treatment of patients

7

Form 14A

Application from a purchaser for test or analysis of a drug

8

Form 19

Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs apart from those specified in Schedule X

9

Form 19A

Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs by retail via dealers who don’t engage the services of a registered pharmacist.

10

Form 19AA

Application for grant or renewal of a license to sell, stock or exhibit or offer for sale by wholesale or distribute drugs from a motor vehicle

11

Form 19B

Application for license to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines

12

Form 19C

Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs specified in Schedule X of the Rules

13

Form 24

Application for the grant of or renewal of a licence to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C (1) and X of the Rules

14

Form 24A

Application for grant of a loan license or renewal of a loan license to manufacture for sale or distribution of drugs other than those specified in Schedule C, C (1) and X of the Rules

15

Form 24B

Application for grant or renewal of a license to repack for sale or distribution of drugs, being drugs other than those specified in Schedule C and C (1) excluding those specified in Schedule X of the Rules

16

Form 24C

Application for the grant or renewal of a license to manufacture for sale or for distribution of Homoeopathic medicines or a license to manufacture potentized preparations from back potencies by licensees holding a license in Form 20 C

17

Form 24D

Application for the grant or renewal of a license to manufacture for sale of Ayurvedic, Siddha or Unani drugs

18

Form 24E

Application for grant or renewal of a loan license to manufacture for sale of Ayurvedic (including Siddha) or Unani Drugs

19

Form 24F

Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedule C and C (1) of the Rules

20

Form 27

Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule C and C (1) excluding those specified in part XB and Schedule X of the Rules

21

Form 27A

Application for grant or renewal of a loan license to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in part XB and Schedule X of the Rules

22

Form 27B

Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedules C, C(I) and X of the Rules

23

Form 27C

Application for grant or renewal of licence for the operation of a Blood Bank for processing of whole blood and/or preparation of blood components

24

Form 27D

Application for grant or renewal of a license to manufacture for sale or for distribution of Large Volume Parenteral/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding those specified in Schedule X of the Rules

25

Form 27DA

Application for grant or renewal of a loan license to manufacture for sale or for distribution of Large Volume Parenteral/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding those specified in Schedule X of the Rules

26

Form 27E

Application for grant or renewal of license to manufacture blood products for sale or distribution

27

Form 27F

Application for grant or renewal of license for collection, processing, testing, storage, banking and release of umbilical cord blood stem cells

28

Form 30

Application for licence to manufacture drugs for purposes of examination, test or analysis

29

Form 40

Application for issue of registration certificate for import of drugs into India

30

Form 44

Application for grant of permission to import or manufacture a new drug or to undertake clinical trial

Generic Approval Process

 

Applicant

Submission of application on Form-44 along with Fees

Application verified for completeness

Review of CMC Data IPC NOC to Applicant

Conductance of BE study NOC to Applicant (If required)

Review of BE Report

Satisfactory CMC data IPC test report with compliance to Specification

Conductance of Inspection (If required)

Final approval

Registration Timeline

180 Days

License Validity

5 years

Registration Fee 

Rs.415546.25

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