Which approvals apply
| If you import… | You need | Regulator |
|---|---|---|
| Products under a Quality Control Order | BIS certification (ISI mark or registration) | Bureau of Indian Standards |
| Food and food ingredients | Importer licence, plus clearance of every shipment | FSSAI |
| Cosmetics | Import registration | CDSCO |
| Medical devices and diagnostics | Import licence or registration | CDSCO |
| Pre-packaged goods sold to consumers | Mandatory label declarations | Legal Metrology |
BIS certification
Government ministries issue Quality Control Orders that make a specific Indian Standard mandatory for a product. Once an order takes effect, the product can't be made, imported, sold or distributed in India without Bureau of Indian Standards certification. The list covers many electrical and electronic goods, steel products, chemicals, toys, footwear and more, and it keeps growing. Foreign factories certify under BIS's schemes, which can include a factory audit and product testing. Check the BIS list first.
FSSAI for food
Every food importer needs a central licence from the Food Safety and Standards Authority of India, alongside its IEC. Each shipment is then cleared through FSSAI's Food Import Clearance System (FICS), which is linked to customs: documents and labels are checked, and samples may be tested, before a no-objection certificate lets customs release the goods. Labels must meet FSSAI's packaging and labelling rules, including the importer's details and FSSAI licence number.
CDSCO for cosmetics and medical devices
The Central Drugs Standard Control Organisation registers imported cosmetics (under the Cosmetics Rules, 2020) and licenses imported medical devices (under the Medical Devices Rules, 2017). Applications go through CDSCO's online SUGAM portal, usually by the foreign manufacturer's authorised agent in India.
Labelling for packaged goods
Pre-packaged goods sold to consumers must carry, under the Legal Metrology (Packaged Commodities) Rules, 2011:
- The importer's name and address, as well as the manufacturer's
- The common name of the product
- Net quantity in standard units
- Month and year of manufacture or import
- Maximum retail price (MRP), inclusive of taxes
- Consumer care contact details
Labels can often be applied in India before sale, but agree who does it and where before the goods ship.
Plan the timeline
Some approvals take weeks, others months, especially where factory audits or testing are involved. Start before you sign a distributor or book the first shipment, and agree in writing who applies for and holds each approval. See also India's import duty explained.
Questions
Can I import a product without BIS certification if it's under a Quality Control Order?
No. Once a Quality Control Order applies to a product, it can't be imported, sold or distributed in India without valid BIS certification, unless a specific exemption applies.
Who applies: the foreign manufacturer or the Indian importer?
It depends on the scheme. BIS certification is granted for the manufacturer's product and factory; FSSAI licensing is for the importer; CDSCO applications are made by the foreign manufacturer's authorised agent in India or an importer with the right licence. Agree who holds each approval before you start.
Are there other regulators?
Yes, for particular products, for example wireless and telecom equipment, and producer responsibility rules for some packaging and electronics. Check the rules for your exact product before the first shipment.