Drug License registration for manufacturers - Process, Fees, Docs

The following documents are required to be submitted while applying for a drug manufacturing license:

• Covering Letter
• Authorization Letter and duly filled Form 27
• Identity and Address Proof of the Applicant
• Approved Manufacturing Premises Layout
• Key Plan and Site Plan Blueprint
• Proof of Possession of Premises (Owned/Rented/Leased)
• Affidavit of Non-Conviction as per prescribed format
• Details of Competent and Qualified Technical Staff for Manufacturing
• Details of Technical Staff for Testing and Quality Control
• Site Master File
• Device Master File (applicable only for medical device manufacturers)
• Details of Standards followed for Product Evaluation and Quality Control
• ISO Certificate, if applicable
• Quality Assurance Certificate/Documents
• Acceptance Letter from Approved Testing Laboratory for specialized or advanced testing
• Details of Specific Environmental and Storage Requirements, wherever applicable
• Particulars of Medical Devices, if applicable
• NOC from Pollution Control Board

The total fee for obtaining a Drug Manufacturing License is INR 1,31,400, inclusive of GST and applicable government fees.

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Drug License Registration for Manufacturers is an obligatory legal approval under the Drugs & Cosmetics Act, India. This kind of license allows a firm to produce pharmaceutical items with an absolute adherence to the highest quality standards right from the beginning of the production process. Applicants need to submit their applications in Form 24, Form 24A, and Form 24B to obtain a drug manufacturing license.

Drug Licenses in India are classified based on the type of pharmaceutical activities including manufacture, sale, distribution, import, and retail or wholesale operations. The applicable license type depends on the category of drugs, type of business, and regulatory requirements prescribed under the Drugs and Cosmetics Act, 1940.

• Manufacturing Drug License: Manufacturing Drug License is an essential licensing requirement for the entities engaged in the manufacture of pharmaceuticals, and other relevant products as listed in the Drugs and Cosmetics Act of India.
• Loan License: CDSCO loan license is provided to drug manufacturers who utilize the manufacturing facility of a registered licensed manufacturer, without owning their own factory.
• Multi-Drug License: Multi-Drug license is issued to organizations involved in drug trade across multiple states of India under the same organizational name. Under the Drugs & Cosmetics Act, 1940 it is mandatory to have separate licenses for each location.
• Import License: Companies importing pharmaceuticals and their raw substances in India must register for an import license with the CDSCO.
• Retail Drug License: Medical or pharmacy stores involved in selling drugs directly to consumers are required to obtain a retail drug license.
• Wholesale Drug License: Wholesale drug licenses are required for businesses that distribute bulk quantities to retailers or hospitals. It is mandatory to meet the required premise size and storage standards. Obtaining a Wholesale Drug License in India ensures legal distribution, storage, and adherence to pharmaceutical regulations.

Drug manufacturing licenses in India are primarily classified as Form 25 and Form 28 depending upon the type of pharmaceuticals products being manufactured. These licenses ensure that all manufacturers of conventional and biological drugs follow the necessary guidelines as prescribed in the Drugs and Cosmetics Act, 1940.

• Form 25 License : Form –25 license is issued to manufacturers aiming to produce non-biological medicines including tablets, capsules, ointments, and other non-biological formulations. The license ensures that production facilities adhere to the standards set by the regulatory authorities, guaranteeing the safety, efficacy, and quality of the medicines produced. Manufacturers intending to sale or distribute non-biological medicines must obtain this license.
• Form 28 License : Form 28 is mandatory for entities intending to sell, produce, or distribute biological products, including vaccines, blood products, and other biologically derived medicines in India. The license ensures that manufactured biological products are produced under stringent conditions, ensuring their safety, efficacy, and adherence to the quality standards set by the regulatory bodies.

Listed below are the key requirements for a drug manufacturing business:

• Appointment of qualified and competent technical staff with qualifications in pharmacy, pharmaceutical chemistry, microbiology, or similar fields.
• Proof of premises which must comply with Good Manufacturing Practices (GMP) as per Schedule M of the Drugs and Cosmetics Rules. The premises must be clean, well-ventilated, and equipped with proper machinery.
• Must have proper equipment for manufacturing, testing, and storage.
• A separate lab with qualified staff for testing raw materials and finished products.
• If manufacturing certain drugs like Schedule X drugs (narcotics and psychotropic substances), additional approvals are needed from the Drug Controller General of India (DCGI).

Drug manufacturers are required to maintain continuous compliance with regulatory, quality, and operational standards even after obtaining the manufacturing license

• GMP Surveillance: Revised schedule M has mandated Good Manufacturing Practices (GMP) for license holders. GMP refers to keeping quality systems active, training staff regularly, validating equipment, and maintaining clean, well-segregated facilities. CDSCO and state inspectors carry out joint audits, and any repeated lapse can lead to license suspension.
• ADR Reporting: Every manufacturer must report adverse drug reactions (ADRs) to the Pharmacovigilance Programme of India (PvPI). Serious reactions must be reported within 15 days, and non-serious ones within 90 days.
• Annual Returns: Licensed units must file yearly production returns with the State Licensing Authority. This includes details of how much was manufactured, sold, and stocked.

Manufacturing pharmaceutical products without obtaining the required Drug Manufacturing License is a violation of the Drugs and Cosmetics Act, 1940. Non-compliance can lead to regulatory action such as fines, temporary closure of business operations, seizure of products, revocation of licenses, and legal proceedings by the concerned authorities.

Under Section 27(b)(ii) of the Drugs and Cosmetics Act, 1940, any person involved in the manufacture, sale, or distribution of drugs without a valid license may face imprisonment for a term not less than one year, extendable up to three years, along with fine often exceeding ₹1 lakh, or three times the value of seized products.

Drug Manufacturing License applications may be rejected due to non-compliance with regulatory requirements, inadequate infrastructure, incomplete documentation, lack of qualified technical staff, or failure to meet the prescribed standards under the Drugs and Cosmetics Act, 1940.

• Incomplete Site Plan: Plans submitted without proper scale, dimensions, or clear zoning are rejected immediately.
• Unqualified Staff: Production head and quality control head must each meet the qualifications under Rules 71 and 76. The same person cannot hold both roles. Missing degrees, unattested documents, or part-time staffing are quick grounds for rejection.
• Missing GMP Documents: Applications often fail due to missing or generic paperwork — no Validation Master Plan, unsigned SOPs, no vendor qualification list, or expired calibration certificates.
• Premises Issues: Common problems include insufficient floor area, rough or unwashable surfaces, poor water and air systems, missing HEPA filters, and a quality control lab that shares space with production instead of being separate.

As per the 2017 amendment (GSR 1337), a drug manufacturing license is valid for a lifetime, subject to payment of a license retention fee every 5 years from the date of issuance. It can be renewed before expiry by logging into the respective drug control portal, submitting the license number, filling up the renewal application, and submitting the required documents along with the renewal fees.

There are several benefits of obtaining manufacturer drug license certification in India:

• Statutory Authorization: A valid manufacturing drug license enables your company to manufacture pharmaceuticals under the Drugs and Cosmetics Act, 1940, safeguarding you against any actions by authorities.
• Improved Brand Reliability: Drug license certification assures healthcare providers, distributors, and consumers about the authenticity of your brand.
• Expanded Business Opportunities: Obtaining the drug license helps the companies quote for government and other large sources of supplies.
• Regulatory Guidance & Industry Recognition: The licensed manufacturers have the benefit of being governed by the law, getting the requisite information regarding the aspect of compliance, and even being right in line with the best practices