Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Permission to import or manufacture a new drug with a new molecule (Form CT-18 / CT-21)

India · Central Drugs Standard Control Organisation · New drugs

Full application, new active substanceHigh confidenceLast verified October 3, 2026

Review target

90 working days

regulation

Legal time limit

Not published

Steps

8 requirements

What is the Permission to import or manufacture a new drug with a new molecule in India?

The Drugs Controller, India, as the Central Licencing Authority, grants permission to import or manufacture a new drug that contains a molecule not yet approved in India. The rules give a 90 working day target for the decision. A separate import or manufacturing licence is needed after the permission. A drug, including a biological product, with an active ingredient not yet approved as safe and effective in India.

How long does the Permission to import or manufacture a new drug with a new molecule take?

The official review target is 90 working days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.

How much does the Permission to import or manufacture a new drug with a new molecule cost?

The permission to import a new drug, finished formulation is ₹500,000 for Sixth Schedule rates in force since 2019. A reduced fee of ₹250,000 applies in some cases (Micro, small and medium enterprises pay half).

What are the steps of the Permission to import or manufacture a new drug with a new molecule?

1. Optional pre-submission meeting; 2. Application in Form CT-18 (import) or CT-21 (manufacture); 3. Scrutiny by the Central Licencing Authority (90 days); 4. Optional expert committee advice (60 days); 5. Deficiency letter and applicant response (clock stopped); 6. Review of the response (90 days); 7. Permission or rejection; 8. Import licence or manufacturing licence; 9. Periodic safety update reports.

Outcome: Permission in Form CT-19 or CT-20 (import) or Form CT-22 or CT-23 (manufacture). The holder then applies for an import or manufacturing licence.

Legal basis: Drugs and Cosmetics Act, 1940; New Drugs and Clinical Trials Rules, 2019, Chapter X (rules 75 to 83) and Second and Sixth Schedules

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

About 180 days end to end with the official step targets. Targets, not actual times.

Approvals per year, full application, new active substance in India

From the official approvals data of this market, all products of this pathway type and segment

Steps

In order, with the official target for each step

1. Optional pre-submission meetingonly in some casesThe applicant can ask for a meeting with the Central Licencing Authority before applying, to get guidance on the rules and procedure.
2. Application in Form CT-18 (import) or CT-21 (manufacture)The application includes the data in Table 1 of the Second Schedule, including results of a local clinical trial, and the fee in the Sixth Schedule.
3. Scrutiny by the Central Licencing Authority90 working daysThe authority checks the data and documents and may make further enquiries.
4. Optional expert committee advice60 days, only in some casesThe authority may refer scientific questions to an expert committee, which gives its recommendations within 60 days of the reference.
5. Deficiency letter and applicant response (clock stopped)clock stopped, only in some casesIf the authority finds deficiencies that can be fixed, it tells the applicant, who fixes them within the period the authority sets.
6. Review of the response90 working days, only in some casesAfter the response, the authority decides within 90 days (import) or 90 working days (manufacture).
7. Permission or rejectionThe authority grants permission in Form CT-19 or CT-20 (import) or CT-22 or CT-23 (manufacture), or rejects with reasons. A rejected applicant can ask for reconsideration or appeal.
8. Import licence or manufacturing licenceAfter the permission, the applicant applies for an import licence or a manufacturing licence under the Drugs Rules, 1945.
9. Periodic safety update reportsReports every six months for the first two years, then once a year for the next two years.

Requirements

What the applicant must provide or meet

Clinical data

Local clinical trial resultsThe application includes results of a local clinical trial. For a drug new to India, a Phase III trial in India may be required before marketing unless exempted.

Eligibility

Local trial waiver for drugs approved in specified countries(in some cases)The local trial may not be required if the drug is approved and marketed in countries specified under rule 101, no major unexpected serious adverse events are reported, no ethnic difference is expected and the applicant commits to a Phase IV trial.

Nonclinical data

Animal pharmacology and toxicologyAnimal pharmacology and toxicology data as listed in the Second Schedule. Animal toxicity studies need not be repeated in India when an approving country already reviewed them, unless there are specific concerns.

Quality and manufacturing

Chemical and pharmaceutical informationData on the active ingredient and formulation, specifications, validation, stability and process validation, with samples and testing protocols.

Other

Official time targets

Targets, not actual review times

Review targetregulation. This is the time limit written in the rules. It is an official target, not a measured review time. Time the applicant takes to fix deficiencies is outside this period.

90 working days

Fees

Official amounts in the local currency

Fee	Amount
Permission to import a new drug, finished formulationApplication · Sixth Schedule rates in force since 2019 · Micro, small and medium enterprises pay half.	₹500,000reduced ₹250,000
Permission to import a new drug, active pharmaceutical ingredientApplication · Sixth Schedule rates in force since 2019 · Micro, small and medium enterprises pay half.	₹500,000reduced ₹250,000
Permission to manufacture a new drug, finished formulationApplication · Sixth Schedule rates in force since 2019 · Micro, small and medium enterprises pay half.	₹500,000reduced ₹250,000
Pre-submission meetingScientific advice · Sixth Schedule rates in force since 2019 · Micro, small and medium enterprises pay half.	₹500,000reduced ₹250,000
Reconsideration of a rejected import applicationOther · Sixth Schedule rates in force since 2019	₹50,000
Post-submission meetingScientific advice · Sixth Schedule rates in force since 2019 · Micro, small and medium enterprises pay half.	₹50,000reduced ₹25,000

Permission to import or manufacture a new drug with a new molecule (Form CT-18 / CT-21)

What is the Permission to import or manufacture a new drug with a new molecule in India?

How long does the Permission to import or manufacture a new drug with a new molecule take?

How much does the Permission to import or manufacture a new drug with a new molecule cost?

What are the steps of the Permission to import or manufacture a new drug with a new molecule?

How the pathway works

Timeline with clock stops

Approvals per year, full application, new active substance in India

Steps

Requirements

Clinical data

Eligibility

Nonclinical data

Quality and manufacturing

Other

Official time targets

Fees

Rule changes

Reference approval

Labeling

After approval