India BIS Certification and Implications
What’s India BIS Certification and Implications for companies?
The BIS Act, 2016, Rules and Regulations requires Indian chemical manufacturers and foreign chemical manufactures to obtain a so-called India BIS license for their chemical products placed on the Indian market if they are listed on the Scheme I – commonly named as India BIS list. The Bureau of Indian Standards (BIS) is the national authority in India responsible for India BIS certification. The BIS Act, 2016, Rules & Regulations is a means for providing a third-party guarantee of quality, safety, and reliability of products to the customers. As of today, India has regulated 54 chemicals subject to India BIS license requirement and new chemical substances are expected to be added to the India BIS list.
Under BIS Act 2016 Rules & BIS (Conformity Assessment) Regulations, 2018, foreign manufacturers can also submit India BIS applications to the designated Indian authority through an appointed Authorised India Representative (AIR).
That being said, what are the implications for companies placing chemical substances on the Indian market subject to India BIS certification?
Firstly, companies selling into India need to be aware that once their chemical substances are listed on the India BIS list, they will have only 180 days from the date of their substances inclusion in Quality Control Order (QCO) to apply for India BIS license for their chemical products to the Bureau of Indian Standards (BIS) in India.
Secondly: The application process to obtain the India BIS certification can be tedious and time-consuming if companies don’t know how the application process work or don’t have the information available required to be compiled as part of the India BIS application (e.g., Details of Machinery, Manufacturing Process, Test Equipments, Conformity of Product Quality as per Indian Standard etc.)
Thirdly: Active communication with the Indian authority is also required throughout the whole process and consequently, companies need to be active in this regard. Also, take into account that the India BIS application cannot be submitted electronically to the Indian Authority by Foreign Manufacturers and companies will need to send a hard copy of their application to the right contact at the BIS Foreign Manufacturer Certification Department (FMCD) at New Delhi and follow up on the status of their application
Fourthly: After the India BIS license has been obtained, companies may need to maintain License according to the conditions of the License and thus companies will need to follow up on their granted India BIS licence(s) in case of future updates.
Fifthly, new chemicals are expected to be added to the India BIS list and therefore, companies will need to continue monitoring on that list to avoid disruptions in their supply to the Indian market.
What if the India BIS application period for your substances has passed?
No BIS License, No Market.
Foreign manufacturers are required to initiate the BIS application process as soon as possible and obtain the India BIS license for their chemical products subject to this requirement before they are placed on the Indian market. Chemical products that are not compliant with the India BIS certification requirement are subject to enforcement actions.
More information on the India BIS license can be found here:
General information: https://www.reachlaw.fi/india-bis-regulations-2018/
Link to the India BIS list (Scheme I): https://www.reachlaw.fi/wp-content/uploads/2022/01/india-bis_regulation_list-of-chemicals.pdf
Should you need support with India BIS certification requirement please do not hesitate to contact us at firstname.lastname@example.org. Via our office in India we are happy to provide you with India BIS Authorised Representative services too.