CDSCO
Drug manufacturing licences on Form 25 and Form 28
From layout and Schedule M gap closure through to the joint inspection and grant.
- Authority
- State Licensing Authority, with CDSCO participating in joint inspection for Schedule C and C(1) products
- Governing rules
- Drugs and Cosmetics Act, 1940 with the Drugs Rules, 1945 and revised Schedule M
- Typical timeline
- 4 to 9 months including facility readiness
Drug Manufacturing Licence (Form 25 & Form 28): what it involves
Manufacturing licences for drugs are granted by the State Licensing Authority. A licence on Form 25 covers the manufacture of drugs other than those specified in Schedules C, C(1) and X, and is applied for in Form 24. A licence on Form 28 covers drugs specified in Schedule C and C(1), such as sterile products and biologicals, and is applied for in Form 27. Schedule X substances follow their own stricter route.
Whichever form applies, the licence turns on the facility rather than the paperwork. Revised Schedule M raised the bar on premises, equipment qualification, quality management, documentation and self-inspection, and inspections now probe those areas properly. The sensible order of work is to fix the facility and the quality system first, then file, which is how we sequence every project.
Who needs this
- New pharmaceutical manufacturing units
- Existing plants adding a new section or dosage form
- Companies moving from loan licensing to their own manufacturing
- Units upgrading to meet revised Schedule M requirements
- Manufacturers preparing for WHO GMP or export certification later
Documentation
Documents required
Arrange these and the file moves. We tell you exactly which format each one has to be in, and we draft the technical annexures ourselves.
- Application in Form 24 for a Form 25 licence, or Form 27 for a Form 28 licence
- Site master file and plant layout with clean area classification
- List of products with composition and proposed dosage forms
- Equipment list with make, model and installed capacity
- HVAC design, validation protocols and qualification records
- Water system design and validation records
- Qualification, experience and appointment letters for technical staff
- Quality control laboratory details with instrument list
- Constitution documents, premises proof and site plan approvals
- Schedule M documentation set including SOPs, batch records and self-inspection formats
How we work
The process, stage by stage
Indicative durations for a file where documents arrive on time. We tell you at the outset which stage is most likely to slip in your case.
- 1
Feasibility and section planning
1 to 2 weeksWe define which sections the plant will hold, what each dosage form requires in terms of area, air handling and segregation, and whether the licence should be pursued on Form 25 or Form 28.
- 2
Layout and engineering review
2 to 4 weeksThe layout is designed or reviewed for personnel and material flow, clean room classification, pressure cascade and change room sequencing, so that the engineering does not have to be redone after inspection.
- 3
Schedule M documentation
4 to 8 weeksWe prepare the site master file, quality manual, SOPs, batch manufacturing records, validation protocols and self-inspection system aligned to revised Schedule M.
- 4
Application filing
3 to 5 daysThe application is filed with the State Licensing Authority with the full technical annexure set and prescribed fees.
- 5
Joint inspection and grant
1 to 3 monthsWe prepare the plant and the team for inspection, attend the inspection, draft the compliance response to observations and follow through to grant.
Questions
Frequently asked questions
What is the difference between Form 25 and Form 28?
Form 25 is the licence to manufacture drugs other than those specified in Schedules C, C(1) and X, applied for in Form 24. Form 28 is the licence for drugs specified in Schedule C and C(1), which covers sterile products, biologicals and similar categories, applied for in Form 27. Form 28 carries stricter facility requirements and a joint inspection.
How much space does a small plant need?
Revised Schedule M prescribes minimum area requirements per section, and they vary considerably by dosage form. We size the requirement against your intended product list at the feasibility stage rather than after you have signed a lease.
Can I apply before the plant is built?
The licence is granted after inspection of a ready facility, so the plant must be complete and qualified. What we do is run documentation and engineering in parallel with construction so the file is ready the week the plant is.
Do I need a separate licence for each section?
One licence can cover multiple sections at the same premises, but each section must be individually endorsed and must independently satisfy the Schedule M requirements for that dosage form.
Related services
Often taken together with this
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Typical timeline · Varies by route, from 45 days to 9 months
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Read moreTell us what you are manufacturing. We will tell you what you need.
Share your product category, premises and turnover. You will get a written scope covering the exact licences that apply, the documents to arrange, and a realistic timeline.