India: Health Insurance Regulations & Guidelines: The Recent Overhaul

Last Updated: 6 September 2016
Article by Celia Jenkins, Damini Ghosh and Priya Misra

Health insurance business in India has, traditionally, been regulated by the framework governing general insurance business as issued by the Insurance Regulatory and Development Authority of India (IRDAI) from time to time. However, due to a series of developments, a need was felt for creating a specific framework for the development and operation of health insurance products. In 2013, the IRDAI issued the IRDA (Health Insurance) Regulations 2013 (Health Regulations 2013) along with the Guidelines on Standardization in Health Insurance of 20th February 2013 (Standardization Guidelines 2013) which set out the procedures and requirements for filing health insurance products and certain follow through operational requirements.

Recently, following a number of representations made by various stakeholders (including Insurers) on a multitude of issues as well as to update the existing framework, the IRDAI, by way of a notification of 18th July 2016, issued the IRDAI (Health Insurance) Regulations 2016 (Health Regulations 2016) replacing the Health Regulations 2013. The IRDAI also replaced the Standardization Guidelines 2013 with the Guidelines on Standardization in Health Insurance of 29th July 2016 (Standardization Guidelines 2016) and the Guidelines on Product Filing in Health Insurance Business of 29th July 2016 (Product Filing Guidelines).

Some of the key features of the Health Regulations 2016 include the following:

  • Pilot Products: The Health Regulations 2016 have introduced the concept of "Pilot Products" aimed at encouraging innovation in the design of products for covering risks that have not been offered before. Pilot Products may be offered by General Insurers and Health Insurers for a policy tenure of one year, but not exceeding five years. Further, the sales and publicity material of such products are required to provide certain specific disclosures as set out under the Health Regulations 2016.
  • Wellness and Preventive Aspects of Health Insurance Policies: The Health Regulations 2016 have introduced norms aimed at encouraging the inclusion of "Wellness and Preventive" aspects as part of the product design. Insurers may now promote wellness amongst health insurance policyholders by offering them health specific services which are to be provided only by their network providers, such as, outpatient consultations or treatment, pharmaceuticals, and health check-ups. Moreover, Insurers are prohibited from offering discounts on products of third parties either as part of the policy or otherwise.
  • Restrictions on Life Insurers offering Health Insurance Policies: Life Insurers are prohibited from offering indemnity based health insurance products either as an individual or a group policies. Consequently, all such existing indemnity based products offered by Life Insurers are now required to be withdrawn in accordance with the prescribed procedure.
  • Group Health Insurance Policies: Per the Health Regulations 2016, Insurers can offer group health insurance products for a term of one year except credit linked products where the term can be extended up to the loan period which shall not be more than five years. Moreover, these regulations mandate that the minimum size of the group shall be 7.

Key features of the Standardization Guidelines 2016

The Standardization Guidelines 2016 set out the revised set of standard definitions of terminology and standard nomenclature and procedure for critical illnesses which are required to be used in health insurance policies. These guidelines also prescribe the standards and benchmarks required to be met by network providers or hospitals. In addition, the Standardization Guidelines 2016 also set out the various health insurance returns required to be submitted by Insurers in a periodic manner. 

Key features of the Product Filing Guidelines

  • The Product Filing Guidelines set out the procedure and the requisite forms for filing various types of health insurance products, such as, new health insurance products, Pilot Products, Health Package Products and Non-Life Package Products under the File & Use Procedure. The provision for submitting a lawyer's certificate while filing such products with the IRDAI has now been omitted.
  • The Product Filing Guidelines also mandate setting up of a "Product Management Committee" (PMC) by General Insurers and Health Insurers. The PMC is, among other functions, required to carry out a due diligence process and record its concurrence on various product related risks for all product filings under File & Use before any application for a product is sent to the IRDAI for approval.
  • A significant change brought about by the Product Filing Guidelines is the introduction of the Use & File procedure for group health insurance products. Per this procedure, a group product may be launched without the prior approval of the IRDAI subject to the following stipulations:

    • The product must be approved by the PMC;
    • The Insurer shall obtain a Unique Identification Number for every insurance product from the IRDAI by duly informing them of the name of the product proposed to be launched; and
    • The product shall be filed with the IRDAI within seven days from the date of approval by the PMC in the prescribed form.
    Life Insurers are not permitted to file group health insurance products under the Use & File Procedure and are required to follow the procedure of File & Use as prescribed under the Product Filing Guidelines for these products.
  • In addition, the Product Filing Guidelines provide detailed guidance on Wellness Features and Benefits that an Insurer may offer in a health insurance product. The Product Filing Guidelines also provide an extensive procedure for the withdrawal of products.

The revised regulatory framework governing health insurance products seeks to bring greater accountability internally within Insurers to the extent that the PMC of an Insurer is required to ensure that the products proposed to be launched in the market are in compliance with applicable laws and regulations. Further, there is an apparent encouragement to bring innovation in the product design and promote wellness through allowing pilot products and wellness features as part of health insurance products.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Celia Jenkins
Damini Ghosh
Priya Misra
In association with
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.