BIS Certification for Sanitary Napkins IS 5405:2019 – Mandatory ISI Mark Compliance in India

BIS Certification for sanitary napkins has become legally mandatory in India under IS 5405:2019 – Sanitary Napkins – Specification (Second Revision). Enforced through the Medical Textiles (Quality Control) Order, 2024, this regulation mandates that all disposable sanitary napkins sold, manufactured, or imported in India must carry a valid ISI mark issued by the Bureau of Indian Standards (BIS).

Given the direct contact of sanitary napkins with sensitive skin and their widespread use, the Government of India has strengthened quality controls to ensure hygiene, safety, and consistent performance. Non-compliance now attracts strict penalties under the BIS Act, 2016.

Yes. BIS certification is mandatory for sanitary napkins under IS 5405:2019.

Enforcement Deadlines (Already Applicable)

• Large & Medium Enterprises: 1 January 2025

• Small & Micro Enterprises: 1 April 2025

Post these dates, sanitary napkins cannot be manufactured, imported, distributed, or sold in India without an ISI mark.

IS 5405:2019 lays down comprehensive specifications to regulate the quality and safety of disposable sanitary napkins.

The standard applies to:

• Disposable (non-reusable) sanitary napkins

• External menstrual hygiene products

• Products made from nonwoven textiles with absorbent cores and barrier layers

Reusable sanitary pads are not covered under this standard.

IS 5405:2019 evaluates sanitary napkins across performance, material safety, and hygiene parameters, including:

1. Performance & Absorbency

• Absorption capacity

• Ability to withstand pressure after absorption

• Leakage resistance

2. Material Safety

• pH value within skin-safe limits

• Absence of harmful chemicals (including phthalates)

• Biocompatibility tests (cytotoxicity, skin irritation, sensitization)

3. Hygiene & Microbial Safety

• Bacterial and fungal bioburden limits

• Absence of pathogenic organisms such as Staphylococcus aureus

4. Design & Construction

• Type (with wings / without wings)

• Size and thickness variants

• Cover sheet, absorbent core, and barrier sheet integrity

• Workmanship and finish

Once certified, manufacturers must display the ISI mark clearly on:

• Product packaging

• Labels

• Marketing units

The ISI mark confirms that the sanitary napkins conform to Scheme-I of the BIS (Conformity Assessment) Regulations, 2018.

Step-by-Step Procedure

1. Application Filing

Submit the BIS application through the official portal with product and factory details.

2. Product Testing

Samples are tested at BIS-recognized laboratories as per IS 5405:2019.

3. Factory Audit

BIS officials inspect:

• Manufacturing infrastructure

• Quality control systems

• In-process testing arrangements

• Hygiene and storage conditions

4. Documentation Review

Includes:

• Test reports

• Manufacturing flow chart

• Raw material details

• Quality manuals

5. Grant of BIS License

Upon successful compliance, BIS issues the license authorizing use of the ISI mark.

Manufacturer Type	Approximate Timeline
Indian Manufacturer	30–45 days
Foreign Manufacturer	4–6 months

As per amendments to the Medical Textiles QCO:

• Sanitary napkins manufactured exclusively for export

• Products made by Self-Help Groups (SHGs)

• Declared pre-certification non-marked stock (allowed till 31 December 2025)

All other products must carry ISI marking.

Failure to comply may result in:

• Seizure of non-conforming goods

• Suspension or cancellation of BIS license

• Monetary penalties

• Imprisonment up to 2 years, or both

BIS certification:

• Ensures consumer safety and hygiene

• Builds market credibility and brand trust

• Enables legal sale and import

• Prevents business disruption due to enforcement action

Standphill India is a leading BIS certification consultante with extensive experience in medical textiles and personal hygiene products. We provide end-to-end BIS ISI certification support, including:

• Product gap assessment as per IS 5405:2019

• BIS application filing and documentation

• Coordination with BIS-recognized laboratories

• Factory audit preparation and compliance closure

• Fast-track BIS license approval

Whether you are an Indian manufacturer or foreign exporter, Standphill India ensures a smooth, compliant, and timely certification journey.

BIS certification for sanitary napkins under IS 5405:2019 is no longer optional. With enforcement deadlines already in effect, manufacturers must act immediately to ensure uninterrupted business operations. The 2024 Quality Control Order, along with its amendments, has established a new benchmark for menstrual hygiene product safety in India.

Partnering with an experienced consultant like Standphill India ensures that your products meet all statutory requirements while maintaining the highest quality standards.

Get your BIS certification for sanitary napkins right the first time — contact Standphill India today for expert support and fast approvals.

Q1. Is BIS certification mandatory for sanitary napkins?

Yes, BIS certification under IS 5405:2019 is mandatory in India.

Q2. Which authority enforces IS 5405:2019?

The Bureau of Indian Standards under the BIS Act, 2016.

Q3. Can sanitary napkins be sold without ISI mark?

No. Sale, manufacture, or import without ISI marking is prohibited.

Q4. Does the standard apply to reusable pads?

No. IS 5405:2019 applies only to disposable sanitary napkins.

Q5. Who should apply for BIS certification?

All manufacturers and importers of sanitary napkins intended for the Indian market.