Introduction
India’s BIS (Bureau of Indian Standards) certification system is often considered one of the most complex market-access requirements in Asia—especially for overseas manufacturers dealing with diverse schemes such as CRS, FMCS, Scheme X, and various product-specific Orders.
Questions frequently arise around license renewal, customs intervention, mandatory vs. voluntary schemes, and how BIS interacts with other Indian regulations, such as plastic labelling or hazardous chemical import rules.
To help global manufacturers navigate these challenges with clarity, we have compiled the following BIS Certification FAQ. These questions were gathered from our latest industry webinar, covering practical issues faced by foreign factories, exporters, and global brands.
If you require case-specific guidance or are facing a time-sensitive BIS issue, our experts are available for a one-on-one discussion.
FAQ
Q1: I think that the application list for OTR on the website is only for local manufacturers, not foreign manufacturers.
A1: Yes, you are right, as the domestic OTR portal is in working mode as of now, but if I give a rough idea about the pre-registration of OTR by foreign manufacturers, it’s around 2000+.
Q2: Is it important to put the ISI mark on infant formula now for foreign food manufacturers, as Infant formula or dairy products are exempted
A2: Only IS 14433: 2007/2022 INFANT MILK SUBSTITUTES - SPECIFICATION (SECOND REVISION OF IS 14433) is under the mandatory certification; the rest are exempted, therefore, there is no such requirement needed; it is on a voluntary basis as of now.
Q3: If we cannot renew our license in time, does BIS have a grace period that still allows manufacturers to send products to India?
A3: No, there is no such grace period given by the BIS. If you are struggling with such issues, this needs to be solved within the week, so your business will not be hampered. Please schedule a one-on-one meeting with our expert for a more case-by-case evaluation.
Q4: What are the obligations of overseas manufacturers and suppliers whose customers in India are the importers for the India BIS regulations?
A4: If the product falls under the mandatory scope, the manufacturer needs to get a License from the BIS department to continue their business in India. If you need more clarification, please schedule a one-on-one meeting with our expert for a more case-by-case evaluation.
Q5: Is it only the manufacturing products that require registration, or do all industries using the product need to register for BIS certification?
A5: Only the original manufacturer (Domestic & Foreign) comes under the purview of the BIS certification scope.
Q6: For Scheme X, how to check which overseas manufacturer registrations have been submitted or completed?
A6: As of now, no single manufacturer from a foreign manufacturer site has received the License. However, 2000+ initial pre-registration have been recorded by the department.
Q7: For a local or foreign manufacturer, is it mandatory for the factory to apply for/obtain a BIS certification first, so that they can proceed production of the products for sale in the Indian market? Can they just apply certification for their product only if they don't have a BIS/FMCS certification from the manufacturer?
A7: If the product falls under the mandatory scope, the manufacturer needs to get a License from the BIS department to continue their business in India. If you need more clarification, please schedule a one-on-one meeting with our expert.
Q8: I would have a question about the regulation: if a product would fulfil all properties but one, e.g., the viscosity is outside the given boundaries. Can this product still be imported into India? If so, what has to be done to prevent the product from being stopped at customs?
A8: You need to provide proper justification for the product, like why this parameter is going beyond the limit. Such complex cases are resolved by the REACH24H team on a priority basis after discussion with internally in BIS department.
Q9: Will customs hold shipments for imports where BIS certification is missing? Are foreign manufacturers responsible for obtaining a BIS certificate?
A9: Yes, the Customs department could recall, detain, penalize, or hold the consignment as per the BIS Act & Regulation if the product comes under the BIS certification scope. It is necessary for a foreign manufacturer to check the product scope under the BIS mandatory certification scope. If it does not come under the mandatory list, then there will be no challenge faced by the manufacturer.
Q10: I've heard that earlier this year, India stopped issuing new BIS certificates to factories located in China. Do you know if this is expected to change anytime soon?
A10: Correct, the restriction or unnecessary delay could be resumed soon, as both country' relations going better day by day. However, there is no such public/official announcement published. This statement is provided through our internal resources.
Q11: How does India's plastic management and labelling regulation connect to the other requirements under BIS?
A11: Plastic Management is mostly done by the Extended Producer Responsibility regulation; however, the BIS certificate for plastic products ensures the product quality. However, please note that there is no such public/official announcement published. This statement was provided through our internal resources.
Q12: What are the obligations of US manufacturers shipping hazardous chemicals into India?
A12: First, verify whether the chemical falls under the scope of the BIS (Bureau of Indian Standards) certification. If it does not come under the BIS purview, then check whether it is classified as a hazardous chemical under the MSIHC (Manufacture, Storage and Import of Hazardous Chemicals) Rules of India.
If the chemical is not listed there either, the next step is to review its status on the DGFT (Directorate General of Foreign Trade) website using the HS code, to determine whether any special permission or license is required for import.
If none of these restrictions apply, the chemical can be freely exported to India. In that case, ensure you provide the Safety Data Sheet (SDS)—the UN-GHS version is acceptable—and share basic information such as the CAS number and IUPAC name of the chemical with the Indian importer for declaration during customs clearance.
Q13: List of Equipment that are under the mandatory registration Scheme.
A13: Please access this link for the mandatory certification required for products.
Contact Us
For more information and inquiries on India BIS certification, please feel free to contact us at customer@reach24h.com.
