How to get a drugs manufacturing license for Schedule X Drugs ?

Pharmaceutical manufacturing in India is governed by strict regulatory controls to ensure product safety, efficacy, and compliance. Among various drug categories, those listed under Schedule X of the Drugs and Cosmetics Rules, 1945 require special attention due to their potential for abuse and stringent storage and distribution regulations.
Manufacturing such drugs—excluding those listed in Schedules C and C(1) (biological and special products)—necessitates obtaining a specific manufacturing licence using Form 24F. This blog explains the procedure, applicable rules, and exhaustive documentation needed to apply for this license.

What are Schedule X Drugs?

Schedule X under the Drugs and Cosmetics Rules includes drugs that:

• Have habit-forming or narcotic properties,
• Require stringent record-keeping and special storage conditions,
• Are regulated more strictly than common pharmaceutical products.

Examples include certain psychotropic drugs, barbiturates, and narcotics, which are used under prescription for treating neurological and psychiatric disorders.

Legal Framework for License

The Drugs and Cosmetics Act, 1940 and Rules, 1945, mandate that any person intending to manufacture drugs falling under Schedule X (excluding those in Schedules C and C(1)) must apply for a manufacturing licence using Form 24F.

• Form Used: Form 24F
• Licence Type: Manufacturing for Sale or Distribution
• Authority: State Licensing Authority (SLA) or Central Drugs Standard Control Organization (CDSCO), based on jurisdiction.

Key Requirements before Application

Before submitting Form 24F, the applicant must ensure:

• Availability of a qualified technical staff,
• Adequate infrastructure and machinery compliant with Good Manufacturing Practices (GMP),
• Appropriate storage conditions, especially for narcotic drugs

What is Form 24F?

Form 24F is the application format prescribed under the Drugs and Cosmetics Rules for the grant of a licence to manufacture drugs listed in Schedule X, except for biological products listed under Schedules C and C(1). 

Mandatory Document Checklist and Explanation (As Per Form 24F Checklist)

• Covering Letter
• Specific Power of Attorney in favour authorized signatory for submitting application on behalf of the company
• Site Plan and layout of the building with the name, address, scale, measurements of the area as per Schedule –M Requirement
• Self-attested copies of documents pertaining to the possession of premises
• Consent to establish from State Pollution Control Board
• List of Directors, Partners, Trustees, along with ROC Copy/Registered Partnership deed/Trust deed
• List of Competent Technical Staff, with their qualification, registration, experience, previous FDA approvals, etc.
• Appointment/Acceptance Letter of Competent Technical staff of Manufacturing Section
• Appointment/Acceptance Letter of Competent Technical staff of Testing Section
• Section-wise List of Plant and Machineries
• NOC of Department of Industrial Safety & Health
• HVAC Installation and Validation Certificate(s)
• Water System Installation and Validation Certificate(s)
• Site Master File
• Constitution Details of Firm
• List of SOPs/STPs
• Self-Declaration of Technical Person
• Self-Declaration of Directors
• Copy of Valid Test License in Form 29
• Source of Bulk Drugs along with current regulatory status
• Certificate of Analysis of the Bulk Drugs/Drug Substance
• Master Manufacturing Formula
• Manufacturing Procedure
• Product Development Report with Excipient Compatibility and Forced Degradation Study
• Process Validation Report
• Finished Product Specification including Impurity Profile
• Finished Product Method of Analysis
• Finished Product Analytical Method Validation Report
• Finished Product Certificate of Analysis for Three Consecutive Batches
• Stability Study Data Report
• Comparative Dissolution Release Profile with Approved Formulation
• Comparative Evaluation of Pharmaceutical Equivalence
• Draft Specimen of the Label and Carton
• Bioequivalence Protocol and Report
• Justification on Bioequivalence Study Waiver
• Details of Approval of New Drug in the Country
• Form 10 Issued by CDSCO
• Form 51 Undertaking
• Challan of Fees Paid
• Any Other Document
• Application in prescribed legal Form (Form 24F)

We will explain some important checklist items—what they are, why they are needed, and how applicants can prepare them properly.

1.    List of SOPs/STPs

• Standard Operating Procedures (SOPs): Outline standard practices across production, cleaning, handling, etc.
• Standard Testing Procedures (STPs): For quality analysis and laboratory operations.

2.    Valid Test License (Form 29)

Authorizes the applicant to manufacture drugs for the purpose of testing/analysis. This is often a prerequisite before commercial production.

3.    Certificate of Analysis (CoA) for Bulk Drugs

Lab-tested certificates ensuring the identity, purity, and quality of APIs or drug substances used in manufacturing.

4.    Master Manufacturing Formula (MMF) & Manufacturing Procedure

• MMF: Specifies quantities of raw materials per batch.
• Procedure: Details each production step from material charging to packaging.

5.    Product Development Report

Includes:

• Excipient compatibility studies,
• Forced degradation tests to establish drug stability.

6.    Finished Product Specifications, Method of Analysis, and Validation Report
Set quality standards,

• Analytical testing methods,
• Evidence that methods are accurate, repeatable, and sensitive.

7.    Stability Study Report

• Stability data, provided in tabular form, including:
• Batch number,
• Size,
• Manufacturing and testing dates,
• Packaging details.

8.    Comparative Dissolution and Equivalence Studies

• Required for oral dosage forms,
• Must compare drug release and composition with approved Indian/international products.

9.    Label and Carton Specimen

Designs must comply with labeling guidelines (including drug name, strength, batch number, expiry date, warning signs).

10.    Bioequivalence (BE) Protocol and Report

Scientific proof that the product is therapeutically equivalent to a reference drug.

11.    Justification for BE Study Waiver

Applicable for certain BCS Class I or highly soluble drugs. Requires scientific explanation.

Conslusion

Applying for a manufacturing license under Form 24F is not just a procedural requirement but a critical compliance checkpoint for companies dealing with Schedule X drugs. The exhaustive documentation ensures that only those applicants who are technically competent, ethically sound, and regulatory-ready are permitted to handle these sensitive substances.
With public health and national drug safety at stake, the process rightly demands:

• Transparent operations,
• Qualified professionals,
• Secure manufacturing systems,
• Ongoing adherence to Good Manufacturing Practices (GMP).

For any pharmaceutical entity aiming to venture into this space, careful preparation, legal consultation, and a proactive regulatory approach are essential for successful license approval.

For more details, Please visit www.metacorp.in