IDA Seal of Acceptance

Products cleared by Food Safety and Standards Authority Govt. of India for direct sale, Indian Food and Drug Administration over- the- counter or exclusively through oral health care professionals are eligible to apply for IDA's Seal. The Council on IDA Seal evaluates consumer dental products that are employed in the treatment or prevention of dental disease. In addition, cosmetic agents may also be eligible for the Seal.

The following Products can be applied for IDA Seal of Acceptance:

1. Toothpaste
2. Toothbrush
3. Dental Floss
4. Electronic Toothbrush
5. Mouthwash
6. Sugar-free chewing gum
7. Denture adhesives and cleansers
8. Teeth whitening products
9. White strips and other bleaching products
10. Dental pain relief products
11. Sports Mouth guard
12. Dental materials and equipment
13. for treatment & prevention
14. Nicotine gum

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 If there is a change in the manufacturer or distributor of a product, the Seal of Acceptance is withdrawn automatically and the MOU agreement expires.

• Established or Generic Names: The selection and use of established or generic names must confirm to the requirements of The Drugs and Cosmetics Act.
• Trade Names: Proprietary names will be acceptable to the Council provided the names meet certain professional standards.
• Misleading Names: Names which are misleading or which suggest diseases or symptoms will not be acceptable. This provision may not apply to certain biological products such as serums or vaccines.
• Titles in Names: Products that include titles such as Doctor or Dentist or the designation B.D.S or M.D.S in the name of a product will not be acceptable.

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. 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:

  1. The company must provide evidence that a product demonstrates compliance with its relevant guideline and / or specification.
  2. The Council at any time and without notice to the company, may authorise the testing of such products.
  3. For products which fall under the scope of official IDA Specifications the following information must be submitted: (1) the serial or lot number; (2) the physical properties as obtained by standard test methods and (3) data covering every provision of the official specification. Responsibility for guarantying that the product complies with an official specification lies solely with the manufacturer and not with the Indian Dental Association.
  4. Test samples will be procured at the expense of the manufacturer or can be supplied by company. In the event that an accepted product fails to comply with the appropriate specification, the IDA Seal of Acceptance will be withdrawn from the product. The MOU agreement will terminate immediately and all rights of the company to use the IDA Seal will cease. All products that do not comply with the specification must be removed from the market. If the IDA Seal of Acceptance is withdrawn from a product, the product may be resubmitted at any time, provided adequate evidence of public safety and effectiveness is submitted for Council review.

• Submission of Evidence: Evidence must be submitted pertaining to-actions, public safety and efficacy; and where applicable, mechanical and physical properties. Information on acceptable standard test methods for physical properties may be obtained from the IDA Council on Seal of Acceptance. In general, the data required on physical tests will include: methods, results, names of the observers, and dates of testing.
• Nature of Evidence: The company must provide objective data from clinical and laboratory studies demonstrating safety and effectiveness. Evaluation of a product may also be based on similarity to a previously accepted product. Products that fall under the scope of an official IDA Specification will be tested for compliance by the IDA recommended laboratory. Test samples, unless otherwise indicated, will be procured on the open market at the expense of the manufacturer.
• Supplemental Evidence: All proprietary studies for the product must be submitted. Additionally, the IDA may, through use of different laboratory facilities or use of other facilities, conduct any additional evaluation deemed necessary by the Council.
• Post Marketing Surveillance: Any new information regarding safety and efficacy must be submitted as it becomes available. This evidence may be in the form of new clinical studies, reports of adverse reactions or follow-up investigations of previously submitted clinical studies.
• Renewal of Acceptance: The company may be required to submit evidence demonstrating continued acceptable clinical performance of the product. This evidence may be in the form of new clinical and/or laboratory studies. reports of follow-up investigations of previously submitted clinical studies.

• 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.

Product must abide by all applicable laws and governmental regulations.

IDA is concerned about the negative environmental impact of non-biodegradable materials for the manufacture and packaging of disposable products. Therefore, IDA encourages all dental manufacturers, especially those with accepted products, to use, whenever possible, materials that are biodegradable and/or recyclable.

1. Laboratory Testing
2. Clinical trials
3. Factory Inspection if required

Labelling, Package Inserts, Advertising and Other Promotional Material

1. Name: The established or generic name of a product must be displayed in a prominent manner.
2. Claims: Claims of significance to dentistry for a product must be clear and accurate.
3. Packaging/Labelling: All packaging / labelling must be submitted to the Council for review and approval prior to use.
4. Advertising: Advertising must conform to the IDA’s standards and certification mark usage guidelines. The IDA’s name, Seal and Seal Statement may appear in advertising and promotional materials, to include point-of- purchase. The Seal statement sets forth the basis for acceptance by the Council and must be used whenever the Seal is used, unless otherwise authorised by the Council.
5. Disparagement of other products: Advertising of an accepted product must not result in the disparagement of other products.
6. Implied Acceptance: An accepted product must not be advertised or displayed with unaccepted products in a manner that implies acceptance of the unaccepted product. This provision does not apply to conventional price lists or catalogues.
7. Responsibility: The responsibility of providing substantiation of claims for Public safety and efficacy or claims of compliance with an official standard must reside with the manufacturer and not with the Indian Dental Association.

Changes to the IDA Seal of Acceptance Programme

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.

Withdrawal of Acceptance

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.

Confidentiality of Submission Material

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.

IDA does not treat as confidential any information that:

• Should becomes a part of the public domain through no act or omission of IDA.
• was in IDA’s lawful possession prior to the disclosure.
• is lawfully disclosed to IDA by a third party without restriction on disclosure. or
• is independently developed by IDA without use of or reference to the company’s Confidential Information.