The IDA Seal of Acceptance Program began in 1994. It acts as a Gold Standard Acceptance Representation for Public Safety and Efficacy of Dental Products available to the Public & Dental Professionals. The IDA Seal helps people in differentiating and selecting the best available products from all the products at their dispense in the market. The sole purpose of the seal is to help people select the best product for themselves. Similarly, it also helps the dentists to recommend the best products to their patients from the wide range out there.
To bring about Gold standard regulations assuring safety and efficacy of all Oral Health Products in the market. Presence of IDA Seal is a shield which assures that the product is safe for effective oral care and serves the purpose to its mission when used as per the instructions given by the manufacturer and under the guidance of Professional Advice wherever necessary.
IDA will be regularly updating the directory of Oral Health Products as per product classification with all necessary details about the Product’s Seal of Acceptance. The information regarding the same will be accessible to everyone who wishes to learn more about it.
IDA, hereby, advises and encourages people to use Oral Health Products with IDA Seal for most effective oral care. IDA also welcomes any questions and queries by the people about IDA Seal via all our platforms.
What goes in making a Dental Product get IDA Approval Seal:
The IDA Seal of Acceptance is not given away to any Dental Product without an in-depth evaluation process by our Council on IDA Seal. Each Product is independently evaluated and IDA makes sure that the product lives up to the specific IDA Seal claims on the back of every package and is safe to use by the Public. You can count on us that we’ve done completed our evaluation process with complete attention to the smallest of details with precision before adding a product to the program.
Dental product trends come and go. Help the public achieve their best home dental care by recommending personalised products with the IDA Seal of Acceptance. Use IDA free chair-side guide and searchable product database to find safe and effective products to fit your patients’ needs.
Oral health products cleared by the Food Safety and Standards Authority Govt. of India for sale can be marked by IDA Seal. The IDA Council on Seal of Acceptance (CSA) evaluates consumer dental products such as Oral Health Products, Therapeutic agents, Drugs, Chemicals, Materials, Instruments, and Equipment that are used in the treatment or prevention of dental disease. In addition, cosmetic agents may also be eligible for the Seal.
Not every dental product qualifies for the Seal. There are certain requirements that must be met. For example, a company that applies for the Seal must
IDA Seal is usually awarded for a three-year period. Companies must reapply to continue using the Seal. Whenever the composition of an accepted product changes, the company must resubmit the product for review and approval before it is marketed with the Seal.
IDA’s Seal of Acceptance Programme guidelines are provided for informational purposes only and may be modified at any time. These provide a general overview of the programme; they do not govern a company’s rights to use the IDA Seal.
The IDA Seal of Acceptance is a registered certification mark of the association. All rights to use the IDA Seal are governed solely by a separate MOU between the IDA and the manufacturer or distributor of an accepted product. It can be used on or in connection with a product after the Seal of Acceptance has been given by the IDA Council on Seal of Acceptance and a MOU has been signed. Upon termination or expiration of the MOU, all rights of a company to use the IDA Seal cease.
Commercial products are evaluated upon the request of a distributor or manufacturer, or the initiative of the Council. Products which meet the IDA Seal Programme’s Acceptance criteria with respect to public safety, efficacy, composition, labelling, package inserts, advertising, claims made by company and other promotional material will be granted the IDA Seal of Acceptance.
This will be formalised by executing the IDA Seal MOU agreement. The Council may require a company to use an authorised statement in conjunction with its use of the IDA Seal. Acceptance is renewable and may be reconsidered at any time. If there is a change in the manufacturer or distributor of a product, the Seal of Acceptance is withdrawn automatically and the MOU agreement expires.
Products that are obsolete, substantially inferior, ineffective or dangerous to the health of the user will be declared unacceptable and in the best interest of the public or the profession. The Council may submit reports on unaccepted products to the editor for publication in the journal published by IDA or in any other publication of the association.
Unacceptable product names (as determined by, but not limited to, the above criteria) must be revised before Acceptance.
Product Information : A company is required to provide a quantitative statement of composition, including ingredients, to the Council. For Oral Health Products, therapeutic agents, adequate information on the properties of all ingredients must be provided. For materials, instruments and equipment, a description of the materials used in the construction and the method of operation must be provided.
Any change in the composition, nature or function of an accepted product must be submitted to the Council for review and approval before a modified product is marketed. A modified product is prohibited from using the IDA Seal unless and until it is approved by the Council.
Manufacturing Standards: The Company must provide evidence that manufacturing and laboratory control facilities are under the supervision of qualified personnel, assure purity, uniformity of products and are in compliance with Good Manufacturing Practices.
The company must agree to permit representatives of the Council to visit laboratories and factories upon request If required. For products, guidelines of Indian Dental Association are required. The manufacturer must conduct testing on a regular basis to determine continued compliance with the specification. Upon request of Council, the company must make these test records available to the Council.
Complying with Guidelines and /or Specifications:
Disclosure: The company must disclose any past, present or anticipated financial arrangements between the investigators and the company, its affiliates or subsidiaries, including, but not limited to, consulting agreements, speakers’ fees, grants or contracts to conduct research, or membership on the company’s advisory committees including remuneration policies, or in the product that is the subject of the investigation.
If the Council determines that the financial interests raise a question about the integrity, the Council may take any action it deems necessary to ensure the reliability of the data, including but not limited to requesting that the company submit further analysis; conduct additional independent studies.
The IDA reserves the right to make changes to the IDA Seal of Acceptance Programme at any time at its sole discretion. Such changes may include: Changes to the guidelines or specifications, testing criteria, license agreement or advertising standards. Note that in some instances, changes to the Programme may result in the permanent withdrawal of the IDA Seal from a product or product category. If the foregoing circumstance occurs, IDA will determine the date by which the MOU agreement will terminate and will notify affected companies accordingly. All rights of a company to use the IDA Seal will cease upon termination of the MOU agreement.
The Council may on occasion find it necessary to permanently withdraw the IDA Seal of Acceptance from a product or product category. Such decisions may be made at any time at the sole discretion of the Council.
Any violation of the IDA Seal MOU agreement is grounds for Council’s withdrawal of the IDA Seal of product acceptance.
It is the policy of the Indian Dental Association to treat the material submitted for Council review as confidential. Any confidential information submitted by a company should be marked as “confidential,” “proprietary” indicating it's confidential nature.
Although IDA utilises outside consultants in its review of products, IDA Seal Programme consultants are required to sign the IDA’s Code of Conduct. The Code of Conduct requires the consultants to refrain from disclosing confidential product submission materials to anyone outside IDA. IDA refrains from voluntarily disclosing properly marked product submission materials to any third party without the prior consent of the manufacturer. IDA also takes steps to ensure that such materials are not disclosed or distributed by its employees, consultants or other agents. However, IDA will not be liable for any damages resulting from the acts or omissions of IDA consultants, including but not limited to their failure to abide by the Code of Conduct.
Participation in the IDA Seal program is voluntary. Commercial products are evaluated upon the request of a distributor or manufacturer. Any company may submit appropriate products to the Council for consideration for Acceptance.
Companies pay administrative fee when they apply for the Seal to help to take care of the cost of evaluation. It may vary product to product.
Submission fees are a one-time, non-refundable fee required with the application.
Annual maintenance fees every year till three years by company every year January.
Products which meet the IDA Seal Program’s criteria for Acceptance with respect to public safety, efficacy, composition, labelling, package inserts, advertising and other promotional material will be granted the IDA Seal of Acceptance.
Notification of a product’s Acceptance into the IDA’s Seal Program will be made in writing by the Council. A company may not begin use of the IDA Seal of Acceptance unless and until it has executed the IDA’s standard IDA Seal MOU agreement and complied with the IDA’s advertising requirements.
The Council may require a company to use an authorised statement in conjunction with its use of the IDA Seal. Acceptance is renewable and may be reconsidered after three year time. If there is a change in the manufacturer or distributor of a product, the Seal of Acceptance is withdrawn automatically and the MOU agreement expires simultaneously.
Products that are obsolete, substantially inferior, ineffective or dangerous to the health of the user will be declared unaccepted. When it is in the best interest of the public or the profession, the Council may submit reports on unaccepted products with proper justification to the Executive Editor for publication in The Journal of Indian Dental Association or in another Association medium.