Reference

India Cosmetics Regulatory Glossary

Plain-language definitions of regulatory terms used in Indian cosmetics compliance — sourced from the Cosmetics Rules 2020, BIS standards, CDSCO guidelines, and the Legal Metrology Act.

A B C D EFGHIJKL M NOPQR S T U V WXYZ

A

Amendment: A modification to an existing COS-1 or COS-2 registration to update product details, manufacturer information, or authorised agent particulars. Amendments are filed through the SUGAM portal and require supporting documentation for each change requested.; Source: Cosmetics Rules 2020, Rule 21
Apostille: An authentication certificate issued under the Hague Convention that validates the origin of a public document—such as a manufacturer's power of attorney—for use in a member country. India requires apostille or notarisation of foreign-origin documents submitted with COS-1 applications.; Source: Hague Convention (Apostille) Act, 1961; Cosmetics Rules 2020, Second Schedule
Authorised Agent: An Indian entity—individual or company—appointed by a foreign manufacturer to hold a COS-1 import registration and act as the responsible party for the product in India. The Authorised Agent's name, address, and registration must appear on the product label.; Source: Cosmetics Rules 2020, Rule 2(b) and Rule 13

B

BIS (Bureau of Indian Standards): The national standards body of India responsible for formulating and publishing IS standards, including IS 4707 series for cosmetics. BIS certification or compliance with IS standards may be mandatory for specific cosmetic categories sold in India.; Source: Bureau of Indian Standards Act, 2016
Batch Number: A unique alphanumeric identifier assigned to a specific production lot that enables traceability of a cosmetic product. Every cosmetic imported or manufactured in India must display a batch number on its primary and secondary packaging.; Source: Cosmetics Rules 2020, Rule 19, Schedule VI

C

CDSCO (Central Drugs Standard Control Organisation): The central regulatory authority under the Ministry of Health and Family Welfare responsible for granting import and manufacturing licences for cosmetics in India. All COS-1, COS-2, and COS-8 applications are processed and approved by CDSCO.; Source: Drugs and Cosmetics Act, 1940, Section 3(b)
COS-1: The import registration licence required for any cosmetic product originating from a non-SAARC country to be imported and sold in India. COS-1 is granted to the Authorised Agent in India on behalf of the foreign manufacturer and is product-specific.; Source: Cosmetics Rules 2020, Rule 13, Form COS-1
COS-2: The import registration licence issued for cosmetic products originating from SAARC member countries—Afghanistan, Bangladesh, Bhutan, Maldives, Nepal, Pakistan, and Sri Lanka. The documentation requirements differ from COS-1, particularly regarding attestation of foreign documents.; Source: Cosmetics Rules 2020, Rule 14, Form COS-2
COS-8: The manufacturing licence issued to Indian cosmetics manufacturers authorising them to produce cosmetic products at a specified facility. COS-8 is granted by CDSCO after inspection and verification of GMP compliance with Schedule M.; Source: Cosmetics Rules 2020, Rule 30, Form COS-8
Certificate of Analysis (CoA): A document issued by the manufacturer or a third-party laboratory confirming that a cosmetic product meets its specification for physical, chemical, and microbiological parameters. CDSCO requires a CoA per IS 4707-2 Annex C as part of the COS-1 dossier.; Source: IS 4707-2; Cosmetics Rules 2020, Second Schedule
Country of Origin: The country where a cosmetic product is manufactured or substantially transformed, as required to be declared on the product label. For imported cosmetics, the country of origin must match the manufacturer's details in the COS-1 registration.; Source: Cosmetics Rules 2020, Rule 19, Schedule VI; Legal Metrology (Packaged Commodities) Rules 2011, Rule 6

D

Date of Expiry: The date up to which a cosmetic product is guaranteed to remain stable, safe, and efficacious under specified storage conditions. Products whose date of expiry cannot be determined are required to display the Period After Opening (PAO) symbol instead.; Source: Cosmetics Rules 2020, Rule 19, Schedule VI
Date of Manufacture: The date on which a cosmetic product or batch is produced, required to appear on all primary and secondary packaging. The date of manufacture is used in conjunction with shelf life to determine a product's date of expiry.; Source: Cosmetics Rules 2020, Rule 19, Schedule VI

E

Endorsement: An addition to an existing COS-1 or COS-2 registration to include new product variants—such as additional shades, sizes, or fragrances—under the same licence. Endorsements are processed through the SUGAM portal and require product-specific supporting data.; Source: Cosmetics Rules 2020, Rule 21

G

GMP (Good Manufacturing Practice): A system of manufacturing controls ensuring cosmetics are consistently produced and controlled according to quality standards. In India, GMP requirements for cosmetics manufacturers are defined in Schedule M of the Cosmetics Rules 2020.; Source: Cosmetics Rules 2020, Schedule M

I

INC Nomenclature: The International Nomenclature of Cosmetic Ingredients (INCI) system for naming cosmetic raw materials using standardised Latin or English designations. Indian regulations under IS 4707 require ingredient labelling using INC names listed in the INCI dictionary.; Source: IS 4707-1; Cosmetics Rules 2020, Schedule VI
IS 4707: The Bureau of Indian Standards specification series for cosmetics, encompassing labelling requirements, safety testing, and product-specific standards across multiple parts. Compliance with relevant parts of IS 4707 is a prerequisite for CDSCO registration.; Source: IS 4707 (multiple parts); Cosmetics Rules 2020
IS 4707-2: The part of the IS 4707 series that specifies safety evaluation and testing requirements for cosmetic products intended for the Indian market. Annex C of IS 4707-2 details the required format and content of the Certificate of Analysis.; Source: IS 4707 Part 2 (BIS)

L

LMPC (Legal Metrology Packaged Commodities) Registration: A registration certificate issued under the Legal Metrology (Packaged Commodities) Rules 2011 that authorises an importer or manufacturer to sell pre-packaged commodities in India with mandatory declarations. Every cosmetic importer must obtain LMPC registration before their products can be cleared at customs.; Source: Legal Metrology (Packaged Commodities) Rules 2011, Rule 27
Letter of Authorization (LoA): A notarised document executed by a foreign manufacturer authorising a specific Indian entity to act as its Authorised Agent for the purpose of obtaining a COS-1 registration. The LoA must be signed by a registered representative of the manufacturer and authenticated per CDSCO requirements.; Source: Cosmetics Rules 2020, Second Schedule

M

MRP (Maximum Retail Price): The highest price at which a packaged cosmetic product may be sold to the end consumer in India, inclusive of all taxes. MRP declaration is mandatory on all pre-packaged cosmetics under the Legal Metrology (Packaged Commodities) Rules 2011.; Source: Legal Metrology (Packaged Commodities) Rules 2011, Rule 6(1)(h)

N

Net Quantity: The declared quantity of product in a package, expressed in standard units of weight (grams/kilograms) or volume (millilitres/litres) as applicable, excluding packaging weight. Net quantity declarations must comply with the tolerances specified under the Legal Metrology (Packaged Commodities) Rules 2011.; Source: Legal Metrology (Packaged Commodities) Rules 2011, Rule 6(1)(c)
Notarisation: The authentication of a document by a notary public confirming the identity of the signatory and the validity of their signature, required for foreign-origin documents submitted in Indian regulatory applications. Documents from non-Hague Convention countries must be notarised; those from member countries may instead be apostilled.; Source: Cosmetics Rules 2020, Second Schedule; Indian Evidence Act

P

Packaged Commodities Rules: The Legal Metrology (Packaged Commodities) Rules 2011, which govern mandatory declarations on all pre-packaged goods sold in India, including cosmetics. Key requirements include MRP, net quantity, importer name and address, country of origin, and customer care details.; Source: Legal Metrology (Packaged Commodities) Rules 2011
Period After Opening (PAO): A symbol indicating the number of months a cosmetic product remains safe and fit for use after its packaging has been opened, used where a fixed expiry date is not applicable. The PAO symbol—an open jar with a number and 'M'—is recognised under Cosmetics Rules 2020 labelling requirements.; Source: Cosmetics Rules 2020, Schedule VI; IS 4707-1
Product Master File (PMF): A confidential dossier maintained by the manufacturer containing complete formulation, safety, stability, and manufacturing data for a cosmetic product. The PMF is referenced but not fully submitted during CDSCO registration; CDSCO may request access during audits or post-market surveillance.; Source: Cosmetics Rules 2020, Rule 18

R

Rule 36: A provision under the Drugs and Cosmetics Act that classifies products falling within the dual definition of cosmetics and drugs as drugs when they carry therapeutic or medicinal claims. Products with depigmenting, anti-acne, hair regrowth, or similar claims frequently trigger Rule 36 classification, requiring drug registration rather than cosmetics registration.; Source: Drugs and Cosmetics Act, 1940, Rule 36

S

SAARC Countries: The eight member states of the South Asian Association for Regional Cooperation—Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, and Sri Lanka—whose cosmetic exports to India are regulated under COS-2 rather than COS-1. SAARC-origin products benefit from a simplified documentation pathway compared to non-SAARC imports.; Source: Cosmetics Rules 2020, Rule 14
SUGAM Portal: The online regulatory submission platform operated by CDSCO (sugam.pharma.gov.in) through which all cosmetics import and manufacturing licence applications are filed electronically. Physical submissions to CDSCO are not accepted; all applications, amendments, and endorsements must be submitted through SUGAM.; Source: CDSCO SUGAM Portal Guidelines; Cosmetics Rules 2020, Rule 13
SUGAM Undertaking: A declaration submitted through the SUGAM portal by the applicant confirming the accuracy of all information and documents filed in a COS-1 or COS-2 application. The undertaking is a mandatory component of every new application and renewal submission.; Source: CDSCO SUGAM Portal Guidelines; Cosmetics Rules 2020, Second Schedule
Safety Data Sheet (SDS): A document providing detailed information on the composition, physical and chemical properties, hazard identification, and safe handling of a cosmetic raw material or finished product. SDS are required as part of the safety dossier and are referenced in IS 4707-2 safety evaluation protocols.; Source: IS 4707-2; BIS Safety Standards
Schedule M: The schedule under the Cosmetics Rules 2020 that prescribes minimum standards for premises, equipment, sanitation, and quality management systems required of licensed cosmetic manufacturers in India. Compliance with Schedule M is verified during CDSCO's manufacturing premises inspection prior to COS-8 grant.; Source: Cosmetics Rules 2020, Schedule M
Second Schedule: The schedule under the Cosmetics Rules 2020 specifying the documentation required for a COS-1 import registration application, including the Covering Letter, Letter of Authorization, product formulation, Certificate of Analysis, and labelling proofs. CDSCO reviewers check each document in the Second Schedule against application completeness before processing begins.; Source: Cosmetics Rules 2020, Second Schedule
Shelf Life: The period during which a cosmetic product, stored under specified conditions, remains stable, safe, and effective as supported by stability testing data. Shelf life is declared as either a fixed date of expiry or, for products with a shelf life exceeding 30 months, a PAO symbol.; Source: Cosmetics Rules 2020, Schedule VI; IS 4707-2
State Licensing Authority (SLA): The state-level regulatory body, typically the State Drugs Controller, responsible for issuing manufacturing licences for cosmetics produced within the state. The SLA works in coordination with CDSCO, and certain manufacturing licences require both central and state approval.; Source: Drugs and Cosmetics Act, 1940; Cosmetics Rules 2020, Chapter IV
Stop-Clock Notice: A formal communication issued by CDSCO suspending the processing clock on a COS-1 or COS-2 application due to deficiencies or missing documentation. The processing timeline restarts only when the applicant submits a complete and satisfactory response to the stop-clock notice.; Source: Cosmetics Rules 2020, Rule 17; CDSCO SUGAM SOP

T

Test Report: A document issued by a BIS-recognised or NABL-accredited laboratory confirming that a cosmetic product has passed the required physical, chemical, and microbiological tests for compliance with IS 4707 or other applicable standards. CDSCO may require test reports from Indian laboratories as a condition of COS-1 grant.; Source: IS 4707-2; Cosmetics Rules 2020, Second Schedule

U

Unique Product Identifier: A code—such as a barcode or QR code—assigned to a cosmetic product to enable tracking from manufacturer to end consumer, increasingly required under India's serialisation and traceability initiatives. While not yet universally mandated, unique product identifiers are required under specific CDSCO pilot programmes and are expected to become standard.; Source: CDSCO Cosmetics Traceability Guidelines (in implementation)

V

Vegan / Cruelty-Free Claims: Voluntary marketing claims asserting that a cosmetic product contains no animal-derived ingredients or has not been tested on animals, regulated as claims compliance under IS 4707-1 and general advertising standards. Claims must be substantiated with supporting documentation; unsubstantiated claims are treated as misleading under the Consumer Protection Act 2019.; Source: IS 4707-1; Consumer Protection Act 2019; ASCI Guidelines

W

Wholesale Importer: An entity that imports cosmetic products in bulk for distribution to retailers or other businesses rather than direct sale to consumers. A wholesale importer must hold an LMPC registration and must ensure all imported products carry compliant labelling before onward supply.; Source: Legal Metrology (Packaged Commodities) Rules 2011, Rule 2(l)