What is e-Aushadhi?
e-Aushadhi is the digital licensing platform operated by the Ministry of Ayush, Government of India for regulatory activities relating to AYUSH medicines. The Ministry's Drug Control Cell coordinates the regulatory and quality-control provisions applicable to Ayurveda, Siddha, Unani and Homoeopathy drugs in association with State Licensing Authorities.
The current system contains modules covering areas such as manufacturing licences, Public Testing Laboratories, existing or legacy licences, additional products, revised products, amendments and verification. Fresh user registration reopened in April 2026, and the portal states that previous registrations are not carried forward — an easy detail to miss for manufacturers who registered years ago.
Manufacturers → State Licensing Authorities → Approved Testing Laboratories → AYUSH regulatory systems.
The objective is not merely digitisation. The Ministry has described e-Aushadhi as a mechanism intended to improve transparency, reduce processing delays and enable real-time monitoring of licensing applications and certifications.
The mandatory-use notice for AYUSH licensing activities beyond 30 May 2026 was announced in April 2026, fresh licence and legacy modules opened from late April 2026, and compliance guidelines requiring licence-related activities to be processed exclusively through the portal followed on 1 June 2026.
Why e-Aushadhi matters to AYUSH manufacturers
For many manufacturers, e-Aushadhi is initially seen as a documentation exercise. In reality, it increases the importance of having defensible product specifications and reliable analytical evidence.
A product may involve questions around its raw materials, dosage form, pharmacopoeial standards, microbial safety, contaminants, marker compounds, declared shelf life and the basis on which that shelf life has been assigned.
"Which document should I upload on e-Aushadhi?"
Manufacturers should first ask instead:
"Is my product technically ready for regulatory scrutiny?"
That distinction is important. A correctly uploaded application cannot compensate for incomplete product specifications, unsupported shelf life or inadequate quality-control data.
The quality journey of an AYUSH product
A good AYUSH quality-control programme starts before the finished medicine reaches the laboratory. The journey typically begins with identification and qualification of the ingredients. For plant-based raw materials, this can include botanical identity, microscopy or macroscopy where applicable, physicochemical quality and chromatographic identification.
After manufacturing, the finished formulation must then be evaluated against the applicable specification. Depending on the formulation and regulatory requirement, testing may include identity, appearance, pH, loss on drying or moisture, ash values, extractive values, assay or marker compounds, microbial limits, specified pathogens, heavy metals, pesticide residues, aflatoxins and other product-specific parameters.
The exact test panel should not be copied blindly from another product. It should be based on the dosage form, ingredients, applicable pharmacopoeial monograph, licence specification and risk profile of the product — particularly for patent and proprietary formulations, where a manufacturer may have to establish a product-specific quality specification rather than relying entirely on a single classical monograph.
e-Aushadhi and AYUSH Public Testing Laboratories
The e-Aushadhi portal specifically recognises Public Testing Laboratory (PTL) workflows and provides separate modules for fresh and legacy PTL licensing. The portal's public document-verification system also has a separate Public Testing Laboratory category. This is important because laboratory approval under the Drugs Rules and laboratory accreditation are related but different concepts.
A technical point manufacturers should understand
Approval of institutions to carry out testing of Ayurvedic, Siddha and Unani drugs sits under Rules 160A–160J of the Drugs Rules, 1945. Within that framework:
Forms under the ASU drug testing laboratory approval framework
| Form | What it is |
|---|---|
| Form 47 | Application for approval to carry out tests on Ayurvedic, Siddha and Unani drugs and their raw materials on behalf of licensees for manufacture. |
| Form 48 | The approval granted for carrying out those tests or analyses. |
| Form 49 | The certificate of renewal of that approval. |
Avoid describing a laboratory only as a "Form 49 Approved Lab". A technically stronger and more credible description is: AYUSH-approved drug testing laboratory holding Form 49 certification, with NABL-accredited testing capabilities — provided that wording matches the laboratory's actual current approvals and scope. Regulatory readers notice when Form 49 is presented as the original approval document.
The biggest 2026 change: AYUSH stability studies
In July 2026, the Ministry of Ayush notified the Drugs (Eleventh Amendment) Rules, 2026. Among several changes, the amendment introduced a clearer regulatory framework for shelf-life determination using accelerated and real-time stability studies under Rule 161B, applicable from 24 July 2026. This matters to virtually every manufacturer developing new AYUSH formulations, changing dosage forms or trying to establish a defensible expiry period.
The new sub-rule also creates a follow-up obligation: where a shelf life has been granted on the strength of accelerated data, the real-time stability report is to be submitted to the Licensing Authority within the prescribed timeline. In other words, accelerated data buys a manufacturer a defensible starting position — it does not close the file. A second new provision addresses dosage-form changes: where the dosage form of an Ayurvedic, Siddha or Unani drug is changed, the expiry date for that category must be supported by accelerated or real-time stability data, as applicable.
Manufacturers who begin stability programmes now will hold real-time data by the time longer shelf-life claims are questioned. Manufacturers who wait will be asked for evidence they cannot generate retrospectively — because real-time data, by definition, takes real time.
What is a stability study?
Will this medicine continue to meet its required quality specifications throughout its proposed shelf life?
A product can look perfectly satisfactory when it is manufactured and still change during storage. Over time there may be changes in appearance, colour, odour, moisture, pH, viscosity, tablet characteristics, marker compound content, microbial quality or packaging behaviour.
The objective of a stability programme is therefore not merely to "keep samples in a chamber." It is to repeatedly evaluate stability-indicating quality parameters and determine whether the product remains within specification. Government Ayurveda research programmes themselves use pharmaceutical standardisation, quality-control testing, marker analysis and accelerated stability studies together when evaluating Ayurvedic formulations — the approach described here is not a private laboratory convention.
What is an accelerated stability study?
An accelerated stability study places a product under controlled conditions designed to increase the rate at which stability-related changes may become visible — allowing scientists to obtain useful stability information earlier than would be possible by simply waiting out the complete intended shelf life.
India sits in ICH Climatic Zone IVb — hot and very humid. The conditions commonly applied in Indian stability programmes reflect that reality, and a study designed for a temperate market is not automatically appropriate here.
Storage conditions commonly applied for Zone IVb programmes (illustrative — the protocol should be set product by product)
| Study type | Typical condition | Typical minimum duration |
|---|---|---|
| Long-term / real-time | 30°C ± 2°C / 75% RH ± 5% | Through the claimed shelf life |
| Accelerated | 40°C ± 2°C / 75% RH ± 5% | 3 or 6 months (see Rule 161B) |
| Intermediate | 30°C ± 2°C / 65% RH ± 5% | Used where a significant change occurs on accelerated |
"Three months in a chamber automatically proves that any Ayurvedic medicine will remain stable for several years."
That assumption is wrong. The study must still have an appropriate protocol, product specification, baseline results, defined testing intervals and scientifically relevant parameters — and the current AYUSH rules place clear limits on what accelerated data alone can support.
3-month vs 6-month accelerated stability study
The 2026 Drugs Rules amendment now provides a particularly important relationship between accelerated data and initial shelf life. Where an AYUSH product's approval is based on accelerated stability studies:
- 3 months accelerated stability data → 1-year shelf life
- 6 months accelerated stability data → 2-year shelf life
The accelerated study report is to be submitted to the Licensing Authority. This is one of the most valuable things a manufacturer can understand early, because many still assume accelerated stability can automatically justify a much longer expiry period. It cannot.
Can accelerated stability give a shelf life beyond two years?
No. Under the July 2026 amendment, shelf-life determination beyond two years must be based on real-time stability study data. The Rules are specific on this point. For a manufacturer, the correct approach is therefore not accelerated OR real-time stability — it is:
Accelerated stability + continuing real-time stability, with the programme designed according to the regulatory objective of the product.
What is a real-time stability study?
A real-time stability study evaluates the product over time under the intended or justified storage conditions. Unlike accelerated testing, real-time testing directly observes how the product performs as its actual storage period progresses.
Real-time stability therefore becomes particularly important when a manufacturer wants to support a longer shelf life. The 2026 rules require the real-time stability report following accelerated-data-based shelf-life approval to be submitted within the prescribed regulatory timeline, and specifically state that shelf life beyond two years must be based on real-time stability data.
Accelerated stability vs real-time stability
| Accelerated stability | Real-time stability |
|---|---|
| Produces earlier stability information | Observes the product over actual time |
| Useful during product development and initial shelf-life justification | Used to confirm longer-term product stability |
| 3-month data may support 1 year under the 2026 AYUSH framework | Essential when establishing shelf life beyond 2 years |
| 6-month data may support 2 years | Continues to build evidence during the product lifecycle |
| Does not replace real-time data for longer shelf-life claims | Provides direct evidence for long-term stability |
The regulatory relationship between 3/6-month accelerated data and 1/2-year shelf life comes from the July 2026 amendment to Rule 161B.
When does an AYUSH product need a stability study?
Stability becomes particularly relevant when developing or licensing patent and proprietary products, when establishing a product-specific expiry, when introducing a new dosage form, or when regulatory authorities require shelf-life evidence.
The 2026 amendment is especially important for dosage-form changes. Where the dosage form of an Ayurvedic, Siddha or Unani drug is changed, the expiry date of that category must be supported by accelerated or real-time stability data, as applicable. For example, converting a formulation from a traditional form into a tablet, capsule or other modified presentation can raise questions that cannot always be answered simply by copying the shelf life of the original dosage form.
The product has changed. Its moisture exposure, excipients, manufacturing process, surface area, packaging and degradation behaviour may also have changed — so the stability justification may need to change with it.
Stability testing for patent & proprietary AYUSH medicines
Patent and proprietary medicines deserve their own stability strategy. Unlike a straightforward classical formulation with a clearly applicable pharmacopoeial specification, a proprietary formulation may combine multiple ingredients, extracts, excipients and dosage-form technologies. The manufacturer therefore needs to answer several questions:
- What defines the identity of the finished formulation?
- What should be used as the marker or assay parameter?
- Which physical characteristics are critical?
- What microbial limits apply, and which contaminants are relevant?
- What changes would indicate that the medicine is no longer stable?
- And what shelf life is actually supported by the data?
The Drugs Rules contain separate regulatory provisions for patent and proprietary ASU medicines, including requirements around ingredients, safety and evidence, and licensing. A useful stability programme therefore begins with a well-designed finished-product specification, not merely with the purchase of chamber space.
What should be tested during an AYUSH stability study?
There is no intelligent one-size-fits-all stability panel — the test parameters should be chosen according to the formulation.
Tablet / Vati / Gutika
Physical characteristics (appearance, hardness, friability, disintegration), moisture-related parameters, assay or markers, microbial quality.
Syrup / Asava & Arishta / Liquids
Appearance, pH, specific gravity or relevant composition parameters, alcohol content where applicable, marker content and microbial stability.
Taila & oil-based formulations
Physical characteristics plus deterioration-related chemical parameters such as acid value, peroxide value, iodine value, saponification value and rancidity indicators.
Churna & herbal powders
Moisture, physicochemical constants (ash values, extractive values), particle characteristics, marker profile and microbial or contaminant risk.
Ointments, creams & lepa
Appearance, homogeneity, pH where applicable, viscosity or spreadability, phase separation, preservative efficacy and microbial limits.
Patent & proprietary formulations
A specifically designed panel combining pharmacopoeial parameters with product-specific quality markers agreed before the study begins.
Test the parameters most likely to tell you whether the medicine has changed.
Why T0 testing is important
Every stability study should begin with a reliable baseline. This initial result is generally referred to as T0 — Time Zero. If you do not know the condition of the product when the study begins, later results have very little context. A scientifically useful stability programme therefore compares future testing points with the original specification, the T0 results and the previous stability results.
This allows trends to become visible. For example, a result might remain technically within specification but consistently move toward the acceptance limit — that trend can be important even before a specification failure occurs.
A stability study that starts without a complete T0 dataset can be scientifically weak from day one — and the gap usually cannot be filled later, because the sample at T0 no longer exists.
Why marker analysis matters in Ayurvedic stability studies
Herbal formulations are chemically complex. Unlike a single synthetic molecule, an Ayurvedic medicine may contain dozens or hundreds of naturally occurring constituents. It is therefore often useful to identify appropriate marker compounds or chromatographic fingerprints that can help monitor consistency. Techniques such as HPLC, HPTLC, UV-Visible spectroscopy and GC/GC-MS can contribute different types of information depending on the product.
CCRAS pharmaceutical research projects have combined pharmacopoeial testing with marker-based quantification and advanced analytical techniques while studying Ayurvedic products and their stability — this is where modern analytical science complements traditional medicine rather than competing with it.
Why microbiological stability matters
A herbal medicine can remain chemically acceptable while its microbiological quality changes. Moisture, packaging integrity, preservative performance, manufacturing hygiene and storage conditions can all influence microbial behaviour.
For products at risk of microbial growth, stability evaluation may therefore include appropriate microbiological parameters such as Total Aerobic Microbial Count, Total Yeast and Mould Count and specified pathogens, depending on the product and applicable specification — especially important for formulations containing water, natural sugars, plant material or other components that may support microbial survival or growth.
Heavy metals, pesticides and aflatoxins
These tests answer a slightly different question from stability testing. They are primarily safety and contaminant-control parameters, rather than conventional indicators of shelf-life degradation — but they are highly relevant to the overall quality assessment of herbal raw materials and Ayurvedic products.
Contaminant limits commonly applied to ASU drugs — verify the limit applicable to your specific product, category and market
| Parameter | Commonly applied limit | Typical technique |
|---|---|---|
| Lead (Pb) | Not more than 10 ppm | AAS / ICP-MS |
| Arsenic (As) | Not more than 3 ppm | AAS / ICP-MS |
| Mercury (Hg) | Not more than 1 ppm | AAS / ICP-MS |
| Cadmium (Cd) | Not more than 0.3 ppm | AAS / ICP-MS |
| Aflatoxin B1 / G1 | Not more than 0.5 ppm each | HPLC / HPTLC |
| Aflatoxin B2 / G2 | Not more than 0.1 ppm each | HPLC / HPTLC |
| Total aerobic microbial count | NMT 10⁵ CFU/g | Plate count |
| Total yeast & mould count | NMT 10³ CFU/g | Plate count |
| E. coli, Salmonella, S. aureus, P. aeruginosa | Absent | Selective enrichment |
| Pesticide residues | As per applicable WHO / pharmacopoeial limits | GC-MS / LC-MS/MS |
Change over time
Tells you how the product behaves as its shelf life progresses.
Hazard already present
Tells you whether unacceptable contamination exists in the material as made.
Both matter — but they answer different quality questions.
How packaging affects stability
Packaging is part of the product's stability system. A moisture-sensitive herbal tablet stored in a poorly protective container may behave very differently from the same formulation packed in a high-barrier system. Similarly, liquid preparations may interact differently with different container and closure combinations.
A useful stability programme therefore evaluates the product in its intended commercial packaging wherever appropriate. Changing the packaging after generating stability data creates a new scientific question:
Does the earlier stability evidence still represent the marketed product?
That is why formulation, packaging and stability planning should ideally begin together.
What is "cross stability"?
You may hear manufacturers use terms such as cross stability, comparative stability, different-pack stability or multi-pack stability. "Cross stability" itself is not the key term used in the current Rule 161B wording.
What manufacturers usually mean is whether one stability study can be used to justify another: another batch, another pack size, another packaging material, another strength, or another dosage form. That assumption should be made carefully. If a formulation, dosage form or packaging configuration can materially affect stability, the manufacturer should have a scientific justification before treating one study as representative of another.
The 2026 amendment is particularly clear that a change in dosage form requires appropriate stability support for the expiry date. A tablet's data does not automatically carry across to a capsule, a sachet or a liquid presentation of the same formulation.
Classical medicines vs patent & proprietary medicines
The quality strategy for a classical formulation and a patent/proprietary medicine may be different. A classical medicine is generally anchored more directly to authoritative texts and applicable pharmacopoeial standards. A patent or proprietary medicine may require a more product-specific approach to standardisation.
For a proprietary product, the manufacturer should think beyond only "Did my sample pass?" The better questions are:
- What is the product fingerprint, and what defines batch-to-batch consistency?
- What markers represent the formulation?
- Which safety parameters are critical?
- What is the proposed shelf life, and what stability evidence supports it?
This is how analytical testing becomes part of product development instead of a final compliance formality.
The role of NABL accreditation
NABL accreditation and AYUSH laboratory approval should not be treated as identical terms. NABL accreditation is based on the technical competence of a laboratory for defined testing activities within its accredited scope. AYUSH laboratory approval under the Drugs Rules relates to the laboratory's regulatory authority to conduct specified testing of ASU drugs and raw materials.
Manufacturers should therefore look not only at the logos on a laboratory's brochure but also at: the laboratory's approval status; its accredited scope, where NABL reporting is required; available instrumentation; method capability; relevant product experience; and whether the laboratory can actually test the complete parameter panel required for the product. That is a much more useful way to select a laboratory.
A simple stability roadmap
Most stability problems are sequencing problems. This is the order that avoids them.
Product finalised
Formula, process and manufacturing conditions locked. Changes after this point create new stability questions.
Specification established
Finished-product specification with acceptance criteria, methods and the parameters that are actually stability-indicating for this dosage form.
Packaging finalised
The intended commercial container and closure. Stability data should represent the pack the market will receive.
T0 testing
Complete baseline analysis against the specification, before samples enter the chamber.
Accelerated study begins
Samples charged under the agreed accelerated condition, with pull points defined in the protocol.
Interim testing
Analysis at each pull point, compared against specification, T0 and the previous interval so trends become visible.
Initial shelf-life evidence
3-month or 6-month accelerated report supporting a 1-year or 2-year position under Rule 161B.
Real-time programme continues
Long-term samples continue on test through the claimed shelf life, with the report submitted as required.
Long-term shelf life confirmed
Real-time data supporting any claim beyond two years, and evidence for future licence or export requirements.
What manufacturers should prepare before sending a stability sample
Studies stall for boring reasons — missing specifications, insufficient sample quantity, an undecided pack. This is the checklist worth completing before anything is dispatched.
- Product name and dosage form
- Classical or patent/proprietary status
- Complete composition
- Manufacturing licence / product details where applicable
- Finished-product specification
- Proposed shelf life
- Storage instructions and final commercial packaging
- Batch number and manufacturing date
- Proposed marker / assay where applicable
- Applicable pharmacopoeial or in-house methods
- Required microbiological and safety parameters
- Sufficient sample quantity for all planned pull points
As early as possible in the commercial development of the formulation. Do not wait until the day an e-Aushadhi or licensing query asks for stability data. Starting early helps identify unstable markers, microbial deterioration, packaging incompatibility, moisture changes, physical separation or inadequate specification design before these problems delay a commercial launch. For patent and proprietary products especially, early stability planning can save months of regulatory delay.
Frequently asked questions
The Ministry of Ayush announced mandatory use of the e-Aushadhi portal for licensing-related activities beyond 30 May 2026, and issued compliance guidelines on 1 June 2026 requiring licence-related activities to be processed through the portal.
No. e-Aushadhi is a Ministry of Ayush regulatory and licensing platform. Laboratory testing remains a separate technical activity performed by appropriately approved or accredited laboratories, depending on the requirement.
Under Rules 160A–160J, Form 48 is the approval to conduct testing of ASU drugs and raw materials on behalf of manufacturers, while Form 49 is the certificate of renewal of that approval. Form 47 is the application for approval.
Stability data has become an important part of AYUSH licensing and shelf-life determination. Ministry of Ayush scheme documents have specifically recognised stability-study requirements under Rule 161B, and the July 2026 amendment now gives a clearer framework for accelerated and real-time stability data.
Under Rule 161B as amended in July 2026, three months of accelerated stability data may support a one-year shelf life where approval is based on accelerated data, subject to submission of the report to the Licensing Authority.
No. The 2026 Rules specifically state that determination of shelf life beyond two years must be based on real-time stability study data.
Yes. Where approval is based on accelerated stability data, the Rules provide for subsequent submission of the real-time stability report in accordance with the prescribed timeline. Accelerated data establishes an initial position; real-time data confirms it.
It can. The 2026 amendment specifically requires expiry dating for changed dosage forms to be supported by accelerated or real-time stability data, as applicable — a new stability question rather than an administrative variation.
NABL accreditation attests to a laboratory's technical competence for the specific tests within its accredited scope. AYUSH approval relates to a laboratory's regulatory authority to test ASU drugs on behalf of licensees. They are complementary, not interchangeable.
Enough for every planned pull point, plus a contingency for repeat analysis — which is why the protocol should be agreed before dispatch rather than after.
References & further reading
- Ministry of Ayush — e-Aushadhi Latest Updates
- Ministry of Ayush — e-Aushadhi User Manuals & SOPs
- Drugs (Eleventh Amendment) Rules, 2026 — Gazette notification dated 24 July 2026, amending Rule 161B of the Drugs Rules, 1945
- Press Information Bureau — Regulatory provisions regarding Ayurveda, Siddha, Unani and Homoeopathic medicines
- Central Council for Research in Ayurvedic Sciences — Pharmaceutical Research
- ICH — Q1A(R2) Stability Testing of New Drug Substances and Products
Disclaimer. This page is provided for general educational purposes and reflects the position as reviewed on 8 September 2026. It is not legal or regulatory advice. Regulatory requirements change and vary by product category, State Licensing Authority and destination market. Manufacturers remain responsible for their own licensing applications and submissions to the competent authority.