Softgel Capsule Manufacturing in India: What to Know
Softgels suit oils and oil-soluble actives, and almost nothing else. The shell is also animal-derived unless you specify otherwise. Fill compatibility, shell material, leakage and heat behaviour are the four things to settle before committing.
What Softgels Are For
This guide is for brand owners considering softgel capsules in India.
A softgel is a sealed shell enclosing a liquid or semi-liquid fill. The format suits oils, oil-soluble actives and liquid suspensions, and it is the standard choice for fish oil, vitamin E, vitamin D in oil and similar products.
It does not suit water-based fills, because water affects the shell. It does not suit large powder doses, because a powder has to be suspended in a carrier and that limits how much active fits. And it is a more constrained format than hard capsules in terms of what can go in it.
So the first question is whether your active is suited to the format. If your active is a powder that would need a large dose, a softgel is probably the wrong choice and a hard capsule or tablet will serve better.
The second question is the shell. Standard softgel shells are gelatin-based and therefore animal-derived. Plant-based alternatives exist and must be specified explicitly if your product is to be vegetarian.
What to Verify With the Manufacturer
Capability questions before formulation.
| Question | Why It Matters |
|---|---|
| Softgel encapsulation capability | Specialised equipment, not all manufacturers have it |
| Shell material options | Gelatin or plant-based, and which they run |
| Drying and curing capacity | Softgels require a controlled drying stage |
| Humidity-controlled areas | Shell moisture content is critical |
| Seal integrity testing | Per batch, for leakage |
| Fill weight control | Determines dose accuracy |
| Fill compatibility assessment | Whether they test shell and fill interaction |
| Minimum order quantity | Usually higher than for hard capsules |
| Licence scope | Covers your category and this form |
| Printing or marking capability | Where you want the capsule marked |
Minimum order quantities for softgels are typically higher than for hard capsules, because the encapsulation process has a substantial setup and the equipment is configured for volume. Establish the figure early, since it may rule the format out for a first launch.
The Four Technical Issues
Each one causes real failures.
Leakage
The commonest complaint. A seal failure leaks oil into the pack, which looks alarming and ruins the product. Require seal integrity testing per batch and assess across stability.
Shell and Fill Interaction
Over time some fills soften, harden or discolour the shell. Require stability assessment of the shell itself, not only the fill.
Heat Behaviour
Indian warehouse and transit temperatures soften shells, causing sticking, deformation and leakage. Require high-temperature stability and transit testing.
Moisture
Shell moisture content determines whether it is brittle or sticky. Both tight specification and barrier packaging are needed.
Softgels sticking together in a bottle is a frequent field problem in Indian conditions and it is almost always a heat and moisture issue rather than a manufacturing defect. Test for it before launch rather than discovering it seasonally.
Specification Points
What belongs in your brief.
- Shell material: gelatin source or plant-based system, specified explicitly.
- Shell composition including plasticiser, with any colour or opacifier.
- Shell moisture content range.
- Capsule size and shape.
- Fill composition, with carrier oil specified and its own quality parameters.
- Fill weight with tolerance.
- Active content per capsule, with assay method.
- Peroxide and free fatty acid maximums where the fill is an oil.
- Seal integrity requirement and test method.
- Disintegration or dissolution requirement as applicable.
- Appearance including shell clarity and absence of bubbles.
- Stability including shell condition, leakage and sticking.
- Packaging with moisture barrier; blister considered.
- Microbial and heavy metal limits per batch.
The Vegetarian Question
Needs settling before the label.
Standard softgel shells are gelatin-based, which is animal-derived, so the mandatory non-vegetarian declaration applies. Plant-based softgel shells are available and must be specified explicitly rather than assumed.
Plant-based shells behave differently: they can have different moisture sensitivity, different heat behaviour and different cost. A formulation developed in a gelatin shell is not automatically transferable, so treat a switch as development work with its own stability study.
The fill also carries declaration implications. A fish oil fill is non-vegetarian regardless of the shell, and some vitamin forms are animal-derived. Check every component, not just the shell.
Take professional advice on the correct declaration and its placement, and obtain written source confirmation for every component before printing any symbol.
Pre-Development Checklist
Confirm before committing.
- Confirm your active is oil-soluble or suspendable at the dose needed.
- If it is a large powder dose, consider hard capsules or tablets instead.
- Confirm the manufacturer has softgel encapsulation and drying capability.
- Confirm which shell materials they run.
- Establish the minimum order quantity early.
- Verify licence scope covers your category and this form.
- Decide gelatin or plant-based shell and specify it explicitly.
- Obtain written source confirmation for shell and every fill component.
- Take professional advice on the vegetarian or non-vegetarian declaration.
- Specify shell moisture range and composition.
- Specify carrier oil with its own quality parameters.
- Specify fill weight tolerance and active content with assay method.
- Require seal integrity testing per batch.
- Require shell condition and leakage assessment across stability.
- Require high-temperature stability and a transit test in summer.
- Choose moisture-barrier packaging and consider blisters.
- Treat any shell material change as new development with fresh stability work.
Considering Softgels for Your Range?
Share your active, dose and shell preference and our team will set out feasibility, minimums and documentation.
Frequently Asked Questions
What are softgels suited to?
Oils, oil-soluble actives and liquid suspensions. They do not suit water-based fills, because water affects the shell, and they do not suit large powder doses, since a powder must be suspended in a carrier which limits how much active fits.
Are softgel shells vegetarian?
Standard shells are gelatin-based and therefore animal-derived, so the non-vegetarian declaration applies. Plant-based shells exist but must be specified explicitly, and they behave differently in moisture sensitivity, heat and cost.
What is the commonest complaint?
Leakage from seal failure, which leaks oil into the pack. Require seal integrity testing per batch and assess leakage across stability, not only at release.
Why do softgels stick together?
Almost always heat and moisture rather than a manufacturing defect. Indian warehouse and transit temperatures soften shells, causing sticking, deformation and leakage. Require high-temperature stability and a summer transit test before launch.
Are minimum orders higher for softgels?
Typically yes, because encapsulation has a substantial setup and the equipment is configured for volume. Establish the figure early, since it may rule the format out for a first launch.