Menstrual hygiene has been discussed more than ever before today in India. Government, NGOs and campaign groups are working rigorously to ensure Indian women manage their periods in happy, safe and confident ways. Disposable sanitary pads, liners, tampons, labia pads, cloth pads and menstrual cups are some of the products that are used by women. Whilst the government is making progressive changes in ensuring that these products reach rural and urban poor women, it must also ensure that these products are regulated appropriately. In this series on feminine hygiene products, we focus how to ensure these products meet quality and safety standards.

In this article, we focus on the menstrual cup, a product that is gaining popularity among urban educated women because of the freedom it offers and the low ecological footprint. The online platforms have suddenly seen a spurt in different brands of menstrual cups. As with any product of feminine hygiene there are concerns and questions raised by women on the safety and quality of these brands.

This article focuses on the requirements of product standards for menstrual cups to ensure safety and quality.

 

What is a menstrual cup?

Food and Drug Administration (FDA, US) defines a menstrual cup as a receptacle placed in the vagina to collect menstrual flow.

Menstrual cups are made up of silicone, often claimed as medical grade silicone or thermoplastic elastomers (TPE). Cup stays in the body up to 3 – 5 days depending on the user’s menstrual flow days. Users are advised to empty the cup every 4 to 6 hours.

 

How is menstrual cup regulated in other countries?

In the US, the menstrual cup is classified as Class II medical device exempt from the premarket notification [510(k)] requirements subject to the limitations on exemptions. This means that once the product is registered with the FDA they can enter in to the consumer market. However, these devices are not exempt from other general controls. All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labelled, and have establishment registration and device listing forms on file with the FDA.

In Australia, menstrual cups are therapeutic devices and need to be listed on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. The Therapeutic Goods Administration (TGA) regulates menstrual cups as ‘Other Therapeutic Goods’.

In the Europe, cups are categorised as a hygiene product and should comply with the general product safety directives. Any markings like eco-label or CE markings on the product are purely voluntary.

 

What is the appropriate categorisation of menstrual cup in the Indian context?

In the Indian context, menstrual cups are not regulated currently. In a welcome move the Bureau of Indian Standards have initiated the process of revising the standards for feminine hygiene products.

In the view of SMRF, a menstrual hygiene alliance member, we recommend the cup to be regulated as a medical device. Classifying the cup as a medical device will be consistent with the FDA and TGA regulatory practices. A menstrual cup should be classified as a Class B medical device i.e low moderate risk device under the Medical Device Rules 2017, available under the provisions of the Drugs and Cosmetics Act, 1940.

 

What is the rationale behind recommending menstrual cup to be classified as a medical device?

Menstrual cup’s intended function and use time period meets the criteria listed in the clauses defining “medical devices” under the medical device rules 2017.

Function:

The medical device rule, (zb) defines “medical device”,-

(A) Substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i),

(B) Substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified in the Official Gazette under sub-clause (ii).

Based on the above definitions, a menstrual cup is a mechanical barrier (device) placed in the vagina to collect the menstrual blood. Although this device is not a contraceptive given the fact it stays in a women’s reproductive part for approximately 4- 5 days every month should be considered.

Use exposure period:

Medical device rules, 2017 define a medical device in to two types based on the use exposure.

(za) “long term use” means intended continuous use of a medical device for more than thirty days.

(zr) “short term use” means intended continuous use of a medical device for not less than sixty minutes but not more than thirty days;

Based on the above definition, a menstrual cup can be termed as a short-term device.

Classification:

Menstrual cup can be classified as class B medical device consistent to the FDA. Class B device under the medical device rules, 2007, means low moderate risk based on its function as a menstrual blood collector or a mechanical barrier. It may also be noted that this short-term implant stays in the body for approximately four days every month during her active birthing years. Considering the reproductive factor, a menstrual cup can also be considered as a Class C device i.e. moderate to high risk.

 

What happens if the cup is regulated as a Class B device under the Medical device rules, 2017?

Menstrual cup will be regulated by the state licensing authority, or by a national accreditation body. Manufacturers will conform to the following:

  1. Notified body under the sub-rule (1) shall be competent to carry out audit of manufacturing sites to verify conformance with the Quality Management System (QMS) and other applicable standards as specified under these rules.
  2. In case the Central Licensing Authority or the State Licensing Authority has reason to believe or it has been alleged or suspected that the medical device does not conform to the standards of quality, or the QMS are not complied, based on rule 23 can inspect the licensed facility.
  • Manufacturer should possess safety and performance reports on the product conforming to the standards notified by the Bureau of Indian Standards (BIS). In the case of absence of relevant standards the device shall conform to the standard laid down by the International Organisation for Standardisation (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeia standards.
  1. About 2% of the licensed facilities (Class A and B) will be inspected without notification on a random basis.
  2. Import of menstrual cups will be regulated which may be issuing licence without clinical investigation or after investigation of the safety and performance published data depending on the country of origin.

 

What does it mean to women’s health?

Safety:

Ensures that the raw materials are of medical grade and are biocompatible to the body.

Performance:

Product performance will be consistent due to QMS which will reduce product failure issues such as cup not opening up, leakages etc.

Packaging and labelling:

Regulating the cup will ensure all the necessary instructions, which includes how to use the product, warning/caution signs, cleaning instructions; shelf life and product suitability are given.

Currently, there is inconsistency in providing information about a product. For example: There is a possibility that a cup can break the hymen. This information should be available to the user in order to choose based on her cultural preferences. Another important instruction that is missing is the appropriate age for an adolescent to start using the cup and that it is best to seek the advice of a medical professional before doing so. Warnings such as cup to be used only during the menstrual cycle, not to be used for post-partum bleeding and when they have UTI etc. are needed.

There are about 335 million menstruating women and girls in India (FSG, 2016). A significant number of women still do not have access to menstrual management products due to various reasons, affordability being one of them. Menstrual cup if regulated as medical device can become a safe, affordable, comfortable and environmentally friendly option for women.

 

Bibliography

  1. Ministry of health and family welfare notification (2017). Medical device rules, Gazette of India, Part II, Section 3 (i).
  2. WHO India and National Health System and Resource Centre (2015). Biomaterial and biocompatibility testing laboratory.
  3. WHO Geneva (2003), Medical device regulations: Global overview and guiding principles.
  4. US Food and Drug administration (US).
  5. Australian Register of Therapeutic Goods (ARTG).
  6. FSG (2016), Menstrual Health in India: Country landscape analysis.