Used by 450+ corporate clients across India since 2015

Drug Manufacturing License in India for Pharma Firms

A drug manufacturing license is the State permission, granted under the Drugs and Cosmetics Act, 1940, that a plant needs before any drug is made for sale: Form 25 for most formulations, Form 28 for most Schedule C and C(1) drugs, and a loan licence when another firm's plant does the manufacturing. LexComply prepares the application, checks your plant against the revised Schedule M before the joint inspection and keeps each licence on a platform used by 450+ corporate clients.

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Blister-packed tablets on a stainless-steel line in a pharmaceutical plant in India, representing LexComply's drug manufacturing license services

Our Drug Manufacturing License Services

Each route below matches a way drugs are made for sale in India, plus the duties that start once the licence is granted.

Licence in Form 25 for Formulations

For drugs outside Schedules C, C(1) and X. We prepare the Form 24 application, map every product to its category and file with the State Licensing Authority where your plant sits, with a verified document set before submission.

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Licence in Form 28 for Schedule C Drugs

For most Schedule C and C(1) products, applied for in Form 27. Large volume parenterals, sera, vaccines and r-DNA drugs use Form 27D and 28D, and the Central Licence Approving Authority grants those licences on the State's report.

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Loan Licence in Form 25A or 28A

For a brand owner whose drugs are made at another licensee's plant, applied for in Form 24A, 27A or 27DA. We check the application against the host plant's licence, technical staff and testing set-up so both records match.

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Revised Schedule M Readiness

Schedule M, revised by G.S.R. 922(E) of 28 December 2023, sets the good manufacturing practice your plant is inspected against. We review premises, equipment, quality systems and records before the inspection, not after it.

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Retention Fee and Compliance Tracking

A licence stays valid if the retention fee is paid before each 5-year period from its issue ends. LexComply tracks that date, files each endorsement and monitors rule changes across 200+ government portals in one compliance platform.

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Medical Device and Cosmetic Licences

Devices are licensed under the Medical Devices Rules, 2017 and cosmetics under the Cosmetics Rules, 2020, not as drugs. Where one plant makes drugs alongside devices or cosmetics, we map each product line to the licence it needs.

See Device Licensing

A quality analyst in an Indian pharmaceutical laboratory examining a sample vial, the testing staff and facilities step in LexComply's drug manufacturing license process

How a Drug License Consultant Works With You

Route and Schedule Assessment

We sort each product by Schedule, decide between an own-plant and a loan licence, identify the State authority for your plant in India, and check whether any product is a new drug that needs central permission first. You receive a written note naming the forms and the authority.

Premises, Staff and Schedule M Check

Your premises, equipment and quality systems are reviewed against the revised Schedule M, and your manufacturing and testing staff against the qualifications the Rules require, before anything is filed. A Schedule M gap costs less to close on paper than in front of a joint Central and State inspection team.

Application and Document Set

We prepare the application with the documents the State asks for, including proof of constitution, site and key plans, equipment lists for manufacturing and testing, technical staff records and the product list, and check the full set against that State's portal format before it is submitted.

Inspection and Grant

Before grant, Central and State Drugs Inspectors jointly inspect the plant, and for the Rule 68A and Part XB categories the Central Licence Approving Authority grants the licence on the State's report. We answer every query, prepare your team for the inspection and record each submission.

Retention and Assurance

After grant, the licence moves into LexComply's compliance platform beside every other obligation your Indian plant carries. The retention fee is tracked against each five-year period from issue, new products are added by endorsement, and rule changes are picked up from 200+ government portals as they are notified.

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Is outside support worth it

When a Drug Manufacturing License Needs a Specialist

A manufacturer with one plant, a handful of Form 25 products and a seasoned technical team can usually manage the filing in-house. Outside help pays off when you hold licences in more than one State, rely on a loan licence at a contract plant, are moving into Schedule C or Form 28D products, or are upgrading an older facility to the revised Schedule M. Gaps tend to surface at the joint inspection, where they delay the grant. LexComply delivers a written licence route for each product, a pre-filing check of plant and staff, and retention dates tracked after grant.

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A clean pharmaceutical production corridor with mixing vessels behind glass, prepared for the inspection that precedes a drug manufacturing licence grant in India

From LexComply users

What Clients Say About the LexComply Platform

it keeps us updated with all regulatory and statutory changes, updates as soon as they're implemented/rolled out. It's been our saviour and alarm clock !!!

RachnaLawyer★★★★★

Contains every bit of information and the best part is it keeps updated with latest changes in acts rules etc.

Gaurav KapoorLegal Services★★★★★

Useful software for the organisation. Provide good control mechanisms for top management

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Licence plus tracking

Why Choose LexComply as Your Drug License Consultant?

New Delhi and Mumbai, Pan-India Filing

From New Delhi, where RSJ Lexsys was incorporated in 2015, and an associate office in Mumbai, LexComply handles drug manufacturing applications for plants across India, including Delhi's Drugs Control Department and Maharashtra's FDA.

Licence and Tracking in One Place

A drug licence carries duties long after grant: the retention fee every five years, endorsements for new products and Schedule M upkeep. LexComply's compliance platform, used by 450+ corporate clients, tracks each one.

Expert-Guided from Assessment to Inspection

Every application starts with a written view of the Schedule, forms and authority for each product, and closes only when the joint inspection is cleared and the licence is in your hands.

About LexComply

A RegTech company built by legal and finance practitioners

LexComply is the anchor brand of RSJ Lexsys Private Limited, a RegTech company incorporated in New Delhi in 2015. Its registration services cover Central and State licences across India, from legal metrology and EPR to factory licences and CDSCO approvals, and its leadership brings more than 80 years of combined experience across law, chartered accountancy, company secretarial practice and enterprise technology. LexComply's compliance platform and services are used by manufacturing, automotive, consumer goods, healthcare, real estate and logistics enterprises, including two of the Big 4 global accounting and tax firms. Today 450+ corporate clients and 20,000+ active users run their obligations on the platform. Once a licence is granted, its retention fee and amendments move into the same compliance register that tracks 10,000+ laws.

450+Corporate Clients
20,000+Active Users
80 yearsCombined Leadership Experience

Drug Manufacturing License FAQs

What is a drug manufacturing license?

It is the licence a company needs under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945 to manufacture drugs for sale or distribution in India. It is granted in Form 25 for most drugs, Form 28 for most Schedule C and C(1) drugs, Form 28D for large volume parenterals, sera, vaccines and r-DNA drugs, and Form 25A, 28A or 28DA as a loan licence.

Who issues a drug manufacturing license in India?

The State Licensing Authority of the State where the plant sits: the Drugs Control Department in Delhi, the Food and Drug Administration in Maharashtra. For the Rule 68A and Part XB categories, CDSCO's Central Licence Approving Authority grants the licence on the State's recommendation, and a new drug needs central approval before any licence is granted.

Which forms apply to a drug manufacturing license?

For drugs outside Schedules C, C(1) and X you apply in Form 24 and are licensed in Form 25. Most Schedule C and C(1) drugs use Form 27 and Form 28; large volume parenterals, sera, vaccines and r-DNA drugs use Form 27D and 28D. Loan licences are applied for in Form 24A, 27A or 27DA.

What is the validity of a drug manufacturing license?

The licence stays in force unless suspended or cancelled, as long as the retention fee is deposited before every five-year period, counted from the date of issue, runs out. Late payment attracts 2% of the licence fee per month for up to six months, after which the licence is deemed cancelled. Products added later need an endorsement on the licence.

What is a loan licence for drug manufacturing?

A loan licence lets a company that has no plant of its own, typically a brand owner, have its drugs made at another licensee's plant using that plant's facilities. It is applied for in Form 24A, 27A or 27DA and granted in Form 25A, 28A or 28DA.

What do I need before applying?

Premises, plant and equipment that meet the revised Schedule M, at least one whole-time qualified person to direct manufacture, a separate testing unit with a qualified head independent of production, and the documents the State lists. In Delhi, the Drugs Control Department currently grants manufacturing licences in industrial areas only.

Is a drug manufacturing license the same as a pharmacy drug licence?

No. A pharmacy needs a retail sale licence, such as Form 20 or Form 21. A drug manufacturing license lets you make drugs and sell your own products by wholesale; retail sale, or wholesale of drugs made by others, needs a separate sale licence such as Form 20-B or 21-B.

How much does a drug manufacturing license cost?

Two amounts apply: the licence and inspection fees fixed by the Rules, paid online to the State, and a separate fee for filing support. That second fee depends on how many plants, Schedules and products are involved and whether a loan licence is needed. Both are quoted in writing before any work starts.

Not sure which form or authority applies to you

Send your product list and plant location, and a specialist will name the forms and authority for each product.

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Independent recognition

Awards and Recognition

Compliance Management System of the Year 2023

Awarded at the UBS Forum, Mumbai.

Prithvi Awards, Startup Focused on ESG

Presented by Union Minister Shri Arjun Ram Meghwal.

Entrepreneur Awards 2023

MSME Online Business Entrepreneur of the Year, CS Gaurrav Jaiin.

Talk to a Drug Licensing Specialist Today

Tell us what you manufacture, which State your plant is in, whether a contract plant is involved and which Schedules your products fall under. A LexComply specialist will reply with the forms, authority and inspection steps that apply to your plant.

info@lexcomply.com

Request a Licence Assessment

Connect with one of our platform specialists to discuss how can we help your business stay out in front.

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