Every tablet, cream, syrup or capsule legally made in India is made under a manufacturing licence issued by a State Drug Authority under the Drugs and Cosmetics Rules, 1945. This is the working guide: which form applies to you, what the file must contain, how the inspection actually runs, why applications stall, and what revised Schedule M has changed about all of it.
01 · Definition
A drug manufacturing licence (commonly "ML") is a site-and-scope permission. It authorises a named premises, with named technical staff, to manufacture a named list of products or dosage forms. It is not a company-level credential. Change the address, change the competent technical person, or add a dosage form you were not licensed for, and you are outside the scope of the licence until an endorsement is granted.
That framing matters more than the paperwork. Most enforcement action against mid-sized manufacturers is not "you had no licence" — it is "you manufactured outside the scope of the one you had", or "the person named on the licence was not the person supervising the batch".
The scope is written into the licence itself as a schedule of categories: tablets, capsules, oral liquids, external preparations, dry powders, and so on. Sterile products, large volume parenterals, sera and vaccines sit in a separate, tighter category with mandatory central involvement.
Ayurvedic, Siddha and Unani manufacture runs on a parallel track under Rule 153 with Form 24D/25D, and cosmetics under Form 31/32. The mechanics below are broadly the same; the technical staff qualifications and GMP annexure differ.
02 · Authority
India runs a dual-authority system. The Drugs and Cosmetics Act is central law, but licensing is executed by the states. The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India, sets standards, approves new drugs, controls imports, and runs risk-based inspections. Your actual licence, however, is signed by the State Licensing Authority — typically the State FDA or Drugs Control Administration where the plant stands.
In practice the two overlap constantly. Specified categories under Schedule C/C(1) require a joint inspection by state and central inspectors. WHO-GMP certificates and CoPPs are issued by the state on the strength of the same ML, but against CDSCO-published guidance. And since the risk-based inspection programme, a CDSCO team can arrive at a state-licensed plant without the state being the trigger.
The practical consequence for a multi-plant manufacturer: you are managing a portfolio of licences with different issuing offices, different renewal clocks, different inspectors and different local interpretation — and a lapse at any one site is an enforcement event for the group.
| Function | State Licensing Authority | CDSCO |
|---|---|---|
| Grant of ML | Yes — signs Form 25 / 28 | Joint inspection for Schedule C/C(1) |
| Product permission | Yes, for approved formulations | New drugs, FDCs, biologicals |
| Routine inspection | Primary inspector | Risk-based and joint inspections |
| WHO-GMP / CoPP | Issues the certificate | Sets the guidance and format |
| Import / export NOC | Limited role | Primary authority |
| Suspension / cancellation | Yes, under Rule 85 | Recommends and directs |
03 · The file
State portals list documents as a flat set. Inspectors do not review them that way. They review the constitution, then the site, then the people, then the systems, then the products. A file assembled in that order clears queries faster.
Establishes who is applying and that they are legally fit to hold a licence.
Proves the site physically supports the sections you are applying for.
Rule 71 / 76 competence is the single most queried group in a first-time file.
Capacity claimed on paper must match what the inspector can point at.
Where revised Schedule M inspections now spend most of their time.
Filed per formulation — scope decided late here means a fresh application later.
04 · Process
Fix the dosage-form categories, whether any product falls under Schedule C/C(1), and whether you need a loan licence or a repacking endorsement alongside the primary ML. Scope decided late means a fresh application later, not an amendment.
Classified areas, HVAC, water system, warehouse segregation, QC lab and change rooms should be complete and qualified. Applications filed against a half-built plant generate an adverse first inspection report that then follows the file.
Qualification and experience must satisfy Rule 71/76 on the day of inspection, with appointment letters, joining reports and independent QC reporting shown on the organogram.
Submit Form 24 / 27 (or 24A / 24D as applicable) with the fee challan and the full annexure set. Most states now run online single-window portals; scanned annexures must be legible, signed and page-numbered against an index.
The licensing office reviews the file and raises written queries. Response quality here determines whether inspection is scheduled in weeks or months. Answer each query with the document reference, not a narrative.
Drugs Inspectors visit the site — joint with CDSCO for Schedule C/C(1). Expect walkthrough of flows, interrogation of QC capability, review of SOPs and validation, and direct questioning of technical staff on their own responsibilities.
Observations are answered with a corrective and preventive action plan, evidence of completion, and target dates for anything ongoing. Photographic evidence and revised SOP copies close observations faster than commitments.
Form 25 / 28 is granted with the approved category schedule. Individual product permissions are endorsed against it — and every future product, dosage form, staff change or layout change needs its own endorsement.
05 · Failure modes
The person is capable but the degree, or the documented experience at a licensed unit, does not meet Rule 71/76. Experience letters that omit the licence number of the previous employer are treated as unverified.
FixVerify qualifications against the rule text before appointment, and collect experience letters that quote the previous employer's licence number and the dosage forms handled.Applying for external preparations and oral solids on a layout with a shared corridor and no separate change rooms. The blueprint contradicts the application before anyone visits.
FixHave the layout reviewed against the Schedule M area requirements for each category claimed, and mark man/material flow on the drawing itself.Purchased or copied SOP sets that reference equipment the site does not own, or formats the site does not use. Inspectors detect this in one question: "show me the record generated by this SOP."
FixEvery SOP must name real equipment IDs and be backed by at least one executed record before inspection.Products claiming a pharmacopoeial specification requiring dissolution or assay by HPLC, at a site with no HPLC and no approved outsourced testing arrangement.
FixMap each finished-product specification to an instrument on site or a written contract with an approved NABL laboratory.Pollution Board consent applied for but not granted, fire NOC pending, or a purified water system installed without validation data. These are treated as blocking, not pending.
FixSequence NOCs and water system validation to complete before filing, not in parallel with it.Spreadsheets used for QC calculations, shared logins on instrument software, audit trails disabled. Under revised Schedule M this moves quickly from observation to critical.
FixUnique user accounts, enforced audit trails, and validated systems for anything generating a GMP record.Adding a dosage form, a new section, or changing the technical person without endorsement. Common, and one of the fastest routes to suspension under Rule 85.
FixTreat every change as a change control with a regulatory step attached, and track endorsement status per product.Perpetual licences created a false sense of permanence. The five-yearly retention fee is missed because nobody owned the calendar entry after the original team moved on.
FixHold the licence register in a system with owner, due date and escalating alerts — not in an individual's diary.06 · Retention & renewal
Before 2019, manufacturing licences were renewed every five years. The amendment replaced renewal with perpetual validity subject to a licence retention fee payable before the expiry of every five-year block from the date of issue. The licence does not lapse on a date printed on it; it lapses because a payment and declaration were not made.
Miss the due date and a late fee applies for a limited grace window. Beyond that window the licence is liable to cancellation, and the site is manufacturing without a valid licence from the day it lapsed — which contaminates every batch made since, including stock already dispatched.
Separately, GMP and WHO-GMP certificates carry their own shorter cycles, product permissions are endorsed individually, and technical staff approvals must be updated whenever the named person changes. A site can be perfectly current on its ML and still non-compliant because a WHO-GMP certificate expired mid-tender.
| Item | Cycle | Consequence of lapse |
|---|---|---|
| Manufacturing licence Form 25 / 28 | Perpetual; retention fee every 5 years | Late fee, then liable to cancellation |
| Loan licence Form 25A / 28A | Tied to the host site licence | Falls with the host licence |
| GMP certificate | Typically 3 years | Blocks tenders and institutional supply |
| WHO-GMP / CoPP | Typically 3 years / per consignment | Export consignments held |
| Product permission | Per product, endorsed | Product manufactured out of scope |
| Technical staff approval | On every change | Batches supervised by unapproved staff |
| Pollution / fire NOC | State-specific, 1–5 years | Site-level shutdown risk |
07 · How Mithavo helps
Mithavo holds licences as live master data connected to the operation — so scope, expiry and technical staff are enforced at the point where a batch is created, not discovered during an inspection.
Every ML, loan licence, GMP, WHO-GMP, CoPP and NOC held per site with authority, number, issue date, retention due date and the scanned document.
Escalating notifications at 180 / 90 / 30 / 7 days to a named owner, with an escalation to QA Head and MD when an action stays open.
Products are mapped to the licensed dosage-form category. Creating a batch for a product outside the site's licensed scope is blocked, not warned.
Approved technical persons are linked to sections and sign-off steps. If the named person changes, the pending endorsement is raised automatically.
A retention or renewal task opens with its document checklist, owner, approvals and audit trail — the same workflow engine used for deviations and CAPA.
Pick any batch and pull the licence in force, the approved staff, the deviation, the change control, the training record and the calibration status in one view.
Mithavo ERP's Certification Vault manages every licence and certificate your facility holds — Manufacturing Licence, WHO-GMP and GMP, Factory Licence, PCB consent and Fire NOC — with 60 / 30 / 7 day email alerts to the QA Head, a renewal workflow with a document checklist, and inspection-ready document retrieval in under 15 minutes.
08 · Questions
Form 24 (licence granted on Form 25) for non-specified allopathic drugs. Form 27 (licence on Form 28) for specified drugs under Schedule C and C(1) — large volume parenterals, sera, vaccines and similar. Loan licences use 24A/25A and 27A/28A. Ayurveda, Siddha and Unani use 24D/25D. Cosmetics use Form 31, granted as Form 32.
It is perpetual in validity but conditional on the licence retention fee being paid before the end of each five-year block, along with the prescribed declaration. Missing it attracts a late fee and then exposes the licence to cancellation.
Yes — through a loan licence on Form 25A/28A at a site already licensed for that dosage form, or through a straightforward third-party manufacturing agreement where the CMO manufactures under its own licence. In the loan-licence route the brand owner carries substantial regulatory responsibility, including for batch records and complaint handling.
It layers a Pharmaceutical Quality System over the existing GMP requirements: product quality reviews, quality risk management, supplier qualification, computerised system validation with enforced audit trails, and stronger data-integrity expectations. Existing holders are expected to upgrade, and inspections increasingly test the system rather than the building.
Statutory fees are modest and state-notified per category and per inspection. The real cost sits in the site itself — HVAC and classified areas, purified water, QC instrumentation, and the qualified staff needed to satisfy Rule 71/76. Budget the plant, not the fee.
Batches manufactured after the lapse date were made without a valid licence. Expect a show-cause notice, potential recall of affected batches, and scrutiny of every dispatch since the lapse. This is precisely why retention dates should be system-owned rather than person-owned.
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