ISI Certification (BIS) for
SANITARY NAPKIN IS 5405 in India

BIS CERTIFICATION FOR SANITARY NAPKIN IS 5405

Introduction to Indian Standard IS 5405; Sanitary Napkins

 

·       IS 5405 cover Sanitary Napkins.

·       Raw material should confirm the following points :

a)   The materials of cover/top sheet, absorbent core and bottom sheet shall conform to the requirement of Cl. 3.1 to 3.3 of IS 5405:2019.

b)   Biocompatibility evaluation is an optional requirement for raw material. If the manufacturer intends to cover biocompatibility in the scope of their licence, conformity of raw material to biocompatibility evaluation requirement as per Cl. 7.4 of IS 5405:2019 shall be established.

c)    Conformity of raw materials to the standard may be established through supplier’s test certificate, test report of BIS recognized/empanelled lab or any other NABL accredited lab or through in house testing.

 

·       IS 5405 specifies the quality parameters or characteristics of the  Sanitary Napkins as follows :

 

(i)           Cover / Top Sheet

(ii)         Absorbent Core

(iii)        Barrier and Bottom sheet

(iv)        Types and Shapes

(v)          PH Value

(vi)        Ability to withstand pressure after absorption

 

1.   Mandate for ISI Mark Certification of Sanitary Napkins (IS 5405)

 

·       In exercise of the powers conferred by sub-sections (1) and (2) of section 16 read with section 17 and sub-section (3) of section 25 of the Bureau of Indian Standards Act, 2016 (11 of 2016), the Central Government is of the opinion that it is necessary so to do in the public interest and after consulting the Bureau of Indian Standards, hereby makes the following Order, namely

Medical Textiles (Quality Control) Order, 2023.

·       As per the Medical Textiles (Quality control) order, all the manufacturers of Sanitary Napkins are obligated to obtain ISI Mark Certification.

 

2.   Types of Sanitary Napkins covered under IS 5405                  

 

Licence is granted to use Standard Mark on Sanitary Napkins as per IS 5405 : 2019 with the following scope:
Type/Grade/Variety	Type – Thick /Thin Napkins Shape & Designs – Wings/ No Wings, Tab/Tab less Size Class – Regular / Large / Extra Large/ XXL / Others Optional requirements – With/without biocompatibility of raw material With/without biodegradability and compostability

 

 

3.   Procedure to obtain BIS Certification of  Sanitary Napkins to use ISI mark as per IS 5405

 

·       For Indian Manufacturers (Standard Timeframe – 30 days)

·       For Foreign Manufacturers (Standard Timeframe – 180 days)

 

4.   Requisites to get the BIS license for Sanitary Napkins

 

·       Conformity of Raw Material as per IS 5405

·       In-house testing laboratory for mandatory tests

·       Competent Quality Control Personnel

·       Adherence to the BIS guidelines for  Sanitary Napkins as per Indian standard IS 5405

·       There are 3 major categories of document required to get the BIS license:

a.   Administrative Details

b.   Technical Details

c.    Quality Control Personnel Details

d.   Commercial Details

 

5.   Expenses involved in obtaining BIS certificate for  Sanitary Napkins as per IS 5405 under the Product Certification (Scheme-I) of BIS :

 

For Indian Manufacturers
No.	Major Charges		Amount	Remark
1.	BIS Fee	Application Fees	INR 1000	To be paid in BIS A/c directly. 20% rebate on Marking Fee for MSME units.
		Audit Charges	INR 7000
		License Fee	INR 1000
		Marking Fee	INR 46,000
2.	Testing Charges	Sample Test Fee	As Applicable	To be paid into BIS approved Lab A/c
3.	ERCS Service Fee	Consultancy & others	As per actual, (Depending upon the product and the region of factory)

 

For the Foreign Manufacturers
No.	Major Charges	Particulars	Amount	Remark
1.	BIS Fee	Application Fees	USD 30	To be paid into BIS A/c directly in USD (SWIFT). SAARC countries can pay in INR with GST@18%
		Audit Charges (consolidated)	USD 3200 to USD 5900
		License Fee	USD 30
		Marking Fee	USD 580
2.	Testing Charges	Sample Test Fee	As applicable	To be paid into BIS approved Lab A/c
3.	ERCS Service Fee	Consultancy & other charges	As per actual, (Depending upon the product and the location of mfg.)

 

    

 ·      In the certification process, product testing is the most important stage as it determines whether the quality of the product meets Indian standards.

·       For the same purpose, investments in testing facilities are required to install test equipment for internal factory test laboratories.

·       Apart from charges mentioned above in the table, we may ask you to pay/reimbursement for a Pre-Visit at your Factory Premises to ensure the conformity of your product as per the relevant Indian Standard & BIS guidelines for its BIS certification.

 

 

 

 

6.   Role of ERCS Private Limited in getting your product certified :

 

·       To get BIS certification and produce a standard quality product, the manufacturer must ensure that their product must follow the specified Indian Standard Specifications (ISS) which we directly interpret to you from the BIS officials as per the Indian Standards.

·       ECRS Private Limited will be your friend, philosopher and guide in the whole process of getting your product certified by the concerned authorities/ departments.

 

·       Scope of work by ECRS Private Limited:

 

a.     Ensuring the conformity of your product as per IS 5405

ERCS Pvt. Ltd. has developed a vast network within the Medical

Textile Industry & various BIS departments to assist for ensuring conformity of the product Sanitary Napkins according to according to IS 5405.

 

b.     Effective documentation with the awareness of the BIS guidelines:

In order to facilitate the manufacturing industry in obtaining BIS certifications, guidelines have been developed. Our team has the experience of completing over 450 projects and technically competent acquaintances in various Industries.

We are familiar with the Indian Standard Specifications & BIS guidelines and deliver the most suitable interpretation to the Quality Control Personnel so we can do a reliable and effective documentation of your product in accordance with the BIS guidelines.

 

c.      A pre-visit can be paid at your factory premises:

In the process of getting BIS certification, the officer from BIS authority visits the factory for inspection. In order to get good results, the BIS inspection should go smoothly without any Non-Conformity. By keeping this goal in mind, our team will organize a pre-visit to your factory premises so that required changes can be adapted so as to remove the elements of fallibility.

 

d.     Assistance for BIS audits:

We will explain the whole procedure of conducting a BIS inspection and make you aware of the things which need to be prepared and readily available at the time of inspection.

 

 

 

 

7.   Benefits of getting ISI Mark for  Sanitary Napkins to sell in Indian Market with our help :

 

§  The term “ISI mark" means, that a certain product conforms to the quality standards set up by the government.

§  It is compulsory for Sanitary Napkins to obtain the ISI Mark and the violators are penalized with the material seize and a significant sum as fine.

§  Getting certification improves the probability of your product to survive and compete in the market.

§  Customers have the tendency of buying ISI certified products as it ensured safety and standard quality. Hence, with the certified products you can win the confidence and trust of the buyer.

§  With the word of mouth of such client list, you can establish your credibility in the market.

§  Hence with the renowned brand, you can raise the standard and benchmark the market value of the product.