Manufacturing Drug Licence (Form 25 & Form 28)
Any unit that manufactures allopathic medicines for sale needs a manufacturing licence under the Drugs Rules, 1945, granted by the State Licensing Authority. In Haryana that is the State Drugs Controller under the Food and Drugs Administration. We prepare the Form 24 or Form 27 application, the site and staff file, and follow it through inspection to grant.
What it is
A manufacturing drug licence is the State’s permission to make medicines for sale at a named site, under named technical staff, for a listed set of products. Without it, a fully built plant cannot make one saleable batch. The licence is product-wise: each item you make must be on the licence or added to it later.
Think of a promoter who has leased a shed in an industrial sector of Faridabad to make tablets and capsules. The machines may arrive quickly. The licence takes longer, because the layout, the staff and the product list all have to line up before the inspector visits. Start the paperwork while the civil work is still going on.
The law is the Drugs and Cosmetics Act, 1940 and Part VII of the Drugs Rules, 1945. For most drugs you apply under Rule 69 in Form 24 and receive the licence in Form 25. Schedule X drugs use Form 24-F, and Schedule C and C(1) drugs, such as many biologicals, use Form 27 for a licence in Form 28. Since the 2017 amendment the licence is valid perpetually, so long as you pay a retention fee every five years.
Who it applies to
You are building a new plant
A company setting up a tablet, capsule, liquid, ointment or injectable unit. Most promoters first form a company through private limited company registration so the licence, land and loans sit in one entity.
You are adding products or sections
A licensed unit that wants to add new products or a new dosage-form section. Say a Ballabgarh ointment unit now wants to make oral liquids. That is a new section, so it goes to the same authority as an addition, with its own fee and usually a fresh inspection of the new area.
You make APIs or bulk drugs
Units making active pharmaceutical ingredients for sale to formulators also need a manufacturing licence for those drugs.
Why it matters
Lets you sell legally
Wholesalers, hospitals and government tenders ask for the licence number before they buy. No licence, no market.
Opens export routes
CDSCO export NOCs are issued only to holders of a valid Form 25, 28 or 28-D licence.
Stays valid without renewal
You no longer renew every five years. Pay the retention fee on time and the licence simply continues.
Documents required
About the company
- Certificate of incorporation or partnership deed
- Board resolution or authorisation for the signatory
- Proof of possession of the premises (sale deed or lease)
- Constitution details of directors or partners
About the plant
- Site plan and layout plan of manufacturing and testing areas
- List of plant, machinery and laboratory equipment
- Water system and HVAC details
- Pollution board consent and other local approvals held
About people and products
- Qualification and experience papers of the technical staff
- Appointment letters and affidavits of the staff
- Product list with composition, by category
- Challan for the licence and inspection fee
How it works
Sort the product list by category
We group your products into Schedule M categories, since the fee is per category, and flag any new drug that needs CDSCO permission under the New Drugs and Clinical Trials Rules, 2019 first.
Build the Form 24 or Form 27 file
We prepare Form 24 or Form 27 with the staff, premises and equipment annexures, and match them to your layout.
File and pay online
We file on the State’s online drug licensing system and pay the fee. DCGI asked all States on 17 December 2021 to issue manufacturing licences through the ONDLS portal built by CDSCO and C-DAC.
Face the inspection
Drugs inspectors visit the site to check it against Schedule M. Here is the catch: most queries at this stage are about paperwork, not machines, such as a staff affidavit that doesn’t match the appointment letter. We prepare the paper side; your QA team and consultants handle the technical side.
Collect the licence and diarise the retention fee
After grant we diarise the five-yearly retention fee and help you add products as the range grows.
Revised Schedule M at a glance
| Point | What the rule says |
|---|---|
| Notified | 28 December 2023 |
| Large manufacturers (turnover above ₹250 crore) | Compliance due by 28 June 2024 |
| Small and medium manufacturers (₹250 crore or less) | Extended, on conditions, to 31 December 2025 |
| New units applying in 2026 | Must meet the revised Schedule M from day one |
Timelines
Before production
The licence must be in hand before the first saleable batch. Trial or validation batches follow the conditions the inspector sets.
Every five years
Pay the licence retention fee before each five-year period from the date of issue ends.
Six-month grace
Missed it? You can still pay with a late fee of 2% of the retention fee per month for the next six months.
What happens if you miss the retention fee
Late fee builds up
Each month of delay adds 2% of the retention fee, for up to six months.
Licence deemed cancelled
If the fee is still unpaid after six months, the licence is deemed to be cancelled. You would then apply afresh, with inspection.
Production without a licence
Making drugs for sale without a valid licence is an offence under the Drugs and Cosmetics Act, 1940, and stock made in that period cannot be sold.
Frequently asked questions
Who grants a drug manufacturing licence in Haryana?
The State Licensing Authority grants it, which in Haryana is the State Drugs Controller under the Food and Drugs Administration. CDSCO, the central regulator, steps in for new drugs and export NOCs, but the manufacturing licence itself is a State licence. We prepare the application, file it online, follow up with the office and coordinate the inspection dates.
What is the difference between Form 25 and Form 28?
Form 25 is the licence for most drugs, applied for in Form 24. Form 28 is the licence for drugs in Schedule C and C(1), applied for in Form 27. The forms differ because Schedule C and C(1) products, such as many biologicals, carry extra conditions. Schedule X drugs have their own route through Form 24-F. We check your product list and file under the right form from the start.
What is the government fee for a Form 25 licence?
Rule 69 prescribes a licence fee of ₹6,000 plus an inspection fee of ₹1,500, covering up to ten items in each category of drugs listed in Schedule M. Each additional item costs ₹300. Schedule X drugs under Form 24-F carry the same ₹6,000 and ₹1,500. We work out the exact amount from your product list before filing.
Who can be the technical staff for manufacturing?
Rule 71 requires full-time competent technical staff. A graduate in pharmacy or pharmaceutical chemistry needs 18 months of manufacturing experience; a science graduate with chemistry as a principal subject, or a graduate in chemical engineering, chemical technology or medicine, needs three years. The testing unit needs its own head. We check the staff papers against these rules before the file goes in, so the inspection isn’t held up.
Does the licence need to be renewed?
No. Since the 2017 amendment to the Drugs Rules, a manufacturing licence stays valid perpetually, provided the retention fee is deposited before every succeeding five-year period from the date of issue ends. Late payment is allowed for six months with a 2% monthly late fee. After that the licence is deemed cancelled. We diarise the date and remind you well in advance.
Does revised Schedule M apply to a new unit?
Yes. Revised Schedule M was notified on 28 December 2023. Large manufacturers had to comply by 28 June 2024, and small and medium manufacturers got a conditional extension to 31 December 2025. That window has now closed, so a unit applying in 2026 should be designed and documented to the revised standard. Your GMP consultant handles the technical design; we make sure the licence file reflects it.
Can I add products to my licence later?
Yes. You apply to the same Licensing Authority to add products, paying the additional item fee where you exceed ten items in a category. A new drug needs CDSCO permission under the New Drugs and Clinical Trials Rules, 2019 before the State can add it. We file product additions and keep an up-to-date list of what is on your licence.
Do you design the plant or carry out testing?
No. Plant design, validation and testing are done by your engineers, GMP consultants and approved laboratories, and inspection is done by the drugs inspectors. Our role is the application, the documents, the online filing, liaison with the Licensing Authority and ongoing compliance such as retention fees and product additions. We work alongside your technical team so their work reaches the authority in the right shape.
What other approvals does a pharma unit in Haryana need?
Usually a company or firm registration, GST registration, consent to establish and operate from the Haryana State Pollution Control Board, a factory licence under the Factories Act and a fire NOC, plus labour registrations once staff join. The drug licence inspector often asks for some of these. We can run them in sequence with the drug licence, so construction, consent and licensing don’t wait on each other.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
Government fee under Rule 69 for Form 24 / Form 24-F: ₹6,000 licence fee plus ₹1,500 inspection fee for up to ten items per category, and ₹300 for each additional item.
Ready to begin?
Share your product list and site plan, and we will map the right licence form, fee and filing plan for your unit.