Cosmetics Regulatory FAQs

All non-SAARC countries require a COS-1 (Cosmetic Import Licence) under Rule 13 of the Cosmetics Rules, 2020. SAARC nations are exempt from COS-1 but still require Form COS-2 registration for each product prior to import. [Cosmetics Rules 2020, Rule 13]

Legal Metrology Packaged Commodities (LMPC) registration is mandatory for any importer, manufacturer, or packer of pre-packaged cosmetics under Rule 27 of the Legal Metrology (Packaged Commodities) Rules, 2011. It is issued by the Controller of Legal Metrology in the state of business registration. [Legal Metrology (Packaged Commodities) Rules 2011, Rule 27]

A COS-8 (Cosmetic Manufacturing Licence) is mandatory for all cosmetics manufacturers under Rule 55 of the Cosmetics Rules, 2020. This licence is issued by the State Licensing Authority (SLA) of the state where the manufacturing premises are located. [Cosmetics Rules 2020, Rule 55]

The COS-1 licence is issued to the Indian Authorised Agent, not the foreign manufacturer. The agent assumes full regulatory responsibility for the imported product under Rule 14 of the Cosmetics Rules, 2020, and must be named in the manufacturer's Letter of Authorization. [Cosmetics Rules 2020, Rule 14]

Yes. The Cosmetics Rules, 2020 require that ingredients be listed using INCI (International Nomenclature of Cosmetic Ingredients) names as prescribed under Rule 134(i)(xii). Common or trade names are not acceptable substitutes. The list must be in descending order of concentration. [Cosmetics Rules 2020, Rule 134(i)(xii)]

LMPC registration for importers is issued by the Controller of Legal Metrology of the state in which the importer's registered business address is located, under Rule 27(2) of the Legal Metrology (Packaged Commodities) Rules, 2011. Importers with operations in multiple states may require registration in each state. [Legal Metrology (Packaged Commodities) Rules 2011, Rule 27(2)]

The COS-8 licence is issued by the State Licensing Authority (SLA), typically the State Drug Controller or an equivalent designated authority, as prescribed under Rule 56 of the Cosmetics Rules, 2020. CDSCO has central oversight but does not issue manufacturing licences directly. [Cosmetics Rules 2020, Rule 56]

Mandatory documents include the Covering Letter for SUGAM, a completed Second Schedule (Annexure A), a notarized Letter of Authorization from the foreign manufacturer, GST registration certificate of the Indian agent, and a Certificate of Free Sale or equivalent from the country of manufacture. CDSCO rejects applications missing any of these without exception. [Cosmetics Rules 2020, Second Schedule; SUGAM portal SOP]

Yes. The date of manufacture or import and the best before date (period after opening or shelf life, as applicable) are mandatory declarations under Rule 134 of the Cosmetics Rules, 2020. Products with a shelf life exceeding 30 months must still carry a 'period after opening' (PAO) symbol. [Cosmetics Rules 2020, Rule 134]

Pre-packaged cosmetics must declare net quantity by net weight for solids (in grams/kilograms), net volume for liquids (in millilitres/litres), or by count where weight/volume is not applicable, as required under Rule 6 of the Legal Metrology (Packaged Commodities) Rules, 2011. [Legal Metrology (Packaged Commodities) Rules 2011, Rule 6]

Manufacturing premises must comply with Schedule M (Part III) of the Cosmetics Rules, 2020, which specifies requirements for premises, equipment, personnel, quality control, and documentation. Schedule M Part III is India's principal GMP standard for cosmetics and forms the basis of SLA inspection. [Cosmetics Rules 2020, Schedule M, Part III]

The statutory processing time is 60 days from the date of complete receipt of the application. If CDSCO raises a deficiency query, a stop-clock notice is issued and the 60-day clock restarts only upon receipt of a complete response. [Cosmetics Rules 2020, Rule 16]

Yes. The name and complete address of the Indian importer or Authorised Agent must appear on the label under Rule 134(i)(ii) of the Cosmetics Rules, 2020. The foreign manufacturer's name and country of origin must also be declared. Both declarations must be in English. [Cosmetics Rules 2020, Rule 134(i)(ii)]

Yes. Maximum Retail Price must be declared on all pre-packaged cosmetics sold in India under Rule 6(1)(f) of the Legal Metrology (Packaged Commodities) Rules, 2011. The declaration must read 'MRP ₹___ (inclusive of all taxes)' and must be printed clearly on the principal display panel. [Legal Metrology (Packaged Commodities) Rules 2011, Rule 6(1)(f)]

Required documents include the completed Form COS-8 application, site master file describing premises layout and manufacturing operations, equipment list, qualified person (QP) details, Schedule M compliance declaration, and applicable state fee challan. Document requirements vary by state SLA. [Cosmetics Rules 2020, Rule 55 & Schedule M Part III]

The fee for a COS-1 import licence is ₹1,000 per product variant as prescribed in the Second Schedule to the Cosmetics Rules, 2020. Fees are paid online through the SUGAM portal at the time of application submission. [Cosmetics Rules 2020, Second Schedule (Fee Schedule)]

The Cosmetics Rules, 2020 do not prescribe a single universal minimum font size. However, the Legal Metrology (Packaged Commodities) Rules, 2011 — which apply concurrently — require MRP and net quantity declarations to be in a minimum font height of 1 mm for packages with a principal display panel below 100 cm². [Legal Metrology (Packaged Commodities) Rules 2011, Rule 7; Cosmetics Rules 2020, Rule 134]

Yes. The MRP must be declared or affixed before the goods are cleared for home consumption from Customs. Rule 6(1)(f) of the Legal Metrology (Packaged Commodities) Rules, 2011 requires MRP to appear on the package at the point of sale; stickering at the importer's bonded warehouse is the standard procedure. [Legal Metrology (Packaged Commodities) Rules 2011, Rule 6(1)(f); Customs Act 1962]

Schedule M Part III of the Cosmetics Rules, 2020 requires the manufacturing facility to have a qualified Competent Technical Staff member with a degree or diploma in pharmacy, chemistry, or a related discipline. The SLA verifies CTS qualifications at the time of licence grant and renewal. [Cosmetics Rules 2020, Schedule M Part III, Clause on Personnel]

No. Each product variant requires a separate COS-1 licence application and a separate fee payment. A single Letter of Authorization may cover multiple products, but each product's SUGAM submission is distinct. [Cosmetics Rules 2020, Rule 13 & Second Schedule]

Cosmetic claims must not imply medicinal or therapeutic action. 'Whitening' and 'brightening' are acceptable cosmetic claims; claims implying cellular regeneration or structural skin change may trigger reclassification as a drug under Rule 36 of the Cosmetics Rules, 2020. UV protection claims must align with the SPF testing method specified in IS 16248. [Cosmetics Rules 2020, Rule 36; BIS IS 16248]

Rule 6 of the Legal Metrology (Packaged Commodities) Rules, 2011 requires: name and address of the manufacturer or importer, country of origin (for imports), net quantity, MRP, month and year of manufacture or import, best before date (where applicable), and customer care contact details. [Legal Metrology (Packaged Commodities) Rules 2011, Rule 6]

The COS-8 licence endorses specific product categories. Expanding into a new category — for example, adding aerosol products to a skin care operation — requires an amendment to the existing licence from the SLA under Rule 59 of the Cosmetics Rules, 2020. [Cosmetics Rules 2020, Rule 59]

A COS-1 licence is valid for 3 years from the date of grant. Renewal must be applied for before expiry through the SUGAM portal; the fee is the same as the original grant fee under the Second Schedule. Importing after licence expiry is a violation under the Drugs and Cosmetics Act, 1940. [Cosmetics Rules 2020, Rule 18; Drugs & Cosmetics Act 1940]

For imported cosmetics, the COS-1 licence number must appear on the label under Rule 134 of the Cosmetics Rules, 2020. For domestically manufactured cosmetics, the COS-8 manufacturing licence number must be declared on the label. [Cosmetics Rules 2020, Rule 134]

No. Rule 10 of the Legal Metrology Act, 2009 mandates exclusive use of the metric system (SI units) for all commercial transactions and packaged commodity declarations in India. Non-metric units may appear supplementarily on labels intended for export but must not appear alone or prominently on packages sold domestically. [Legal Metrology Act 2009, Section 10; PC Rules 2011, Rule 6]

A COS-8 licence is valid for 5 years from the date of issue. Renewal applications must be submitted to the SLA before the expiry date; failure to renew before expiry renders the manufacturer liable under Section 17B of the Drugs and Cosmetics Act, 1940. [Cosmetics Rules 2020, Rule 58; Drugs & Cosmetics Act 1940, Section 17B]

Form COS-2 is required for registration of cosmetics imported from SAARC countries under Rule 32 of the Cosmetics Rules, 2020. It follows a simplified document set compared to COS-1 but still requires a valid Letter of Authorization and Second Schedule declaration. [Cosmetics Rules 2020, Rule 32]

Mandatory label declarations under Rule 134 of the Cosmetics Rules, 2020 must be in English. Additional languages may be used, but no mandatory declaration may appear only in a foreign language without an English equivalent. For Legal Metrology declarations, Hindi is acceptable alongside English. [Cosmetics Rules 2020, Rule 134; Legal Metrology Act 2009, Section 10]

No. LMPC registration is entity-specific and is not transferable on change of ownership. The new entity must apply for fresh registration under Rule 27 of the Legal Metrology (Packaged Commodities) Rules, 2011 before importing pre-packaged commodities. [Legal Metrology (Packaged Commodities) Rules 2011, Rule 27]

Yes. A Loan Licence (Form COS-9) allows one manufacturer to use the approved premises and equipment of another licence holder under Rule 62 of the Cosmetics Rules, 2020. The licensed premises holder remains responsible for GMP compliance; the loan licensee is responsible for product quality and labelling. [Cosmetics Rules 2020, Rule 62, Form COS-9]

Yes. The Letter of Authorization must be notarized in the country of the foreign manufacturer. For countries party to the Hague Apostille Convention, apostille authentication is required. For non-Apostille countries, the document must be attested by the Indian Embassy or consulate. [CDSCO Import Guidelines; Hague Convention 1961]

Yes. Hair colourants containing PPD must carry a mandatory warning label per IS 4707-1 and the Cosmetics Rules, 2020 First Schedule. The warning must instruct the consumer to conduct a patch test 48 hours before use. Products without this warning are non-compliant at the import registration stage. [Cosmetics Rules 2020, First Schedule; BIS IS 4707-1]

Permissible tolerance on net quantity is prescribed in Schedule II to the Legal Metrology (Packaged Commodities) Rules, 2011. For liquids up to 100 ml, the tolerance is ±4.5%; for volumes between 100 ml and 200 ml, it is ±4.5 ml. Products outside these tolerances at point of sale constitute an offence. [Legal Metrology (Packaged Commodities) Rules 2011, Schedule II]

IS 4707 (Parts 1 and 2) is the Bureau of Indian Standards specification for cosmetics, covering quality parameters and test methods. While BIS certification is not a condition of the COS-8 licence itself, products must meet IS 4707 standards for import registration (COS-1) and for CDSCO market surveillance. [BIS IS 4707-1 & IS 4707-2; Cosmetics Rules 2020]

Yes. Any change to a registered detail — formulation, pack size, label, or Authorised Agent — requires a formal Endorsement & Amendment application through SUGAM under Rule 19 of the Cosmetics Rules, 2020. Importing an amended product under an unamended licence is non-compliant. [Cosmetics Rules 2020, Rule 19]

Yes. IS 4707-1 prescribes additional product-specific label requirements — for example, specific caution statements for eye cosmetics, aerosol products, and exfoliating preparations. CDSCO cross-checks IS 4707-1 requirements during COS-1 label review; non-compliance results in an objection letter. [BIS IS 4707-1; Cosmetics Rules 2020, Rule 134]

Yes. The Legal Metrology (Packaged Commodities) Amendment Rules, 2017 introduced a mandatory customer care number or email declaration on all pre-packaged commodities, including cosmetics. Packages manufactured or imported after the amendment's commencement date without this declaration are non-compliant. [Legal Metrology (Packaged Commodities) Amendment Rules 2017]

The COS-8 licence issued under the Cosmetics Rules, 2020 is the primary registration under the Drugs and Cosmetics Act, 1940. There is no separate Act-level registration. However, the manufacturer must also comply with state-level shops and establishments and pollution control requirements, which are outside the Act's scope. [Cosmetics Rules 2020, Rule 55; Drugs & Cosmetics Act 1940]

Customs operates under the Drugs and Cosmetics Act, 1940, which requires production of a valid import licence on demand. The importer must produce the COS-1 licence or its SUGAM acknowledgement. Repeated detention can trigger a CDSCO show-cause notice under Section 10A of the Act. [Drugs & Cosmetics Act 1940, Section 10A; Cosmetics Rules 2020, Rule 13]

The principal display panel (PDP) is the portion of the package most likely to be seen by the consumer at point of sale. Under the Legal Metrology (Packaged Commodities) Rules, 2011, the MRP, net quantity, and product name must appear on the PDP. CDSCO additionally requires the product name and COS-1 number to appear on the PDP under Rule 134. [Legal Metrology (Packaged Commodities) Rules 2011, Rule 2(k); Cosmetics Rules 2020, Rule 134]

One LMPC registration per importer or packer entity covers all SKUs handled by that entity. There is no per-product or per-SKU registration requirement under the Legal Metrology (Packaged Commodities) Rules, 2011. The registration must, however, be kept current with accurate business details. [Legal Metrology (Packaged Commodities) Rules 2011, Rule 27]

The SLA conducts a premises inspection against Schedule M Part III checklist items covering facility layout, air handling, water quality, equipment qualification, and documentation. Deficiencies are reported in an inspection report; a corrective action response is required before the licence is granted. [Cosmetics Rules 2020, Schedule M Part III; Rule 56]

Personal imports in small quantities may be cleared under the baggage rules without a COS-1 licence. However, any commercial import — including samples, gifts to distributors, or trial shipments — requires a valid COS-1 licence under Rule 13 of the Cosmetics Rules, 2020. [Cosmetics Rules 2020, Rule 13; Baggage Rules 2016]

Yes, stickering is permitted provided the sticker does not obscure any information on the original label that is also required under Indian regulations. The sticker must be durable, legible, and permanently affixed. CDSCO and Legal Metrology inspectors verify that stickered declarations match the approved label on record. [Cosmetics Rules 2020, Rule 134; Legal Metrology (PC) Rules 2011, Rule 6]

Selling a pre-packaged commodity without a mandatory MRP declaration is an offence under Section 36 of the Legal Metrology Act, 2009, punishable by a fine of up to ₹25,000 for the first offence and up to ₹1,00,000 or imprisonment for subsequent offences. [Legal Metrology Act 2009, Section 36]

Yes. The COS-8 licence issued by the state SLA covers manufacturing operations at that facility. Products may be sold nationwide; no state-specific selling licence is required for cosmetics. Labelling must comply with the Cosmetics Rules, 2020 regardless of the destination state. [Cosmetics Rules 2020, Rule 55 & Labelling Rules]

Yes. Each shade is treated as a distinct product variant requiring an individual COS-1 application and fee under the Cosmetics Rules, 2020, Second Schedule. CDSCO does not permit a single licence to cover multiple shades under a common product name. [Cosmetics Rules 2020, Second Schedule]

Perfumes and alcohol-based cosmetics must carry the standard declarations under Rule 134 of the Cosmetics Rules, 2020. Additionally, where the product contains alcohol above a prescribed threshold, the label must carry a declaration per the Alcohol Duty Rules applicable in the state of manufacture or import. Fragrance ingredients may be declared collectively as 'Parfum' in the INCI list. [Cosmetics Rules 2020, Rule 134; BIS IS 4707-1]

No. The LMPC registration number does not need to appear on the product label. Rule 6 of the Legal Metrology (Packaged Commodities) Rules, 2011 specifies all mandatory label declarations; registration number is not among them. [Legal Metrology (Packaged Commodities) Rules 2011, Rule 6]

Schedule M Part III of the Cosmetics Rules, 2020 applies to all cosmetics manufacturers regardless of product category. There is no category-based exemption. Small-scale manufacturers must meet the same Schedule M standards as large facilities. [Cosmetics Rules 2020, Schedule M Part III]

Yes. A single Indian entity can hold COS-1 licences as Authorised Agent for multiple foreign manufacturers. Each manufacturer must issue a separate, product-specific Letter of Authorization, and each product must have its own SUGAM application. [Cosmetics Rules 2020, Rule 14]

CDSCO's reviewing officer checks the submitted label against the Second Schedule declarations and Rule 134 of the Cosmetics Rules, 2020. Specific checks include: INCI ingredient list completeness, presence of mandatory warnings per IS 4707-1, licence number placement, and consistency of product name across the application and label. Discrepancies result in a deficiency query under the stop-clock procedure. [Cosmetics Rules 2020, Rule 134 & Second Schedule; BIS IS 4707-1]

A combination package must declare the net quantity of each individual item and the combined retail price on the outer packaging under Rule 18 of the Legal Metrology (Packaged Commodities) Rules, 2011. The MRP of the combo must not exceed the sum of the individual MRPs. [Legal Metrology (Packaged Commodities) Rules 2011, Rule 18]

Schedule M Part III requires the manufacturer to have adequate quality control arrangements, but does not mandate that the QC laboratory be physically within the manufacturing premises. The SLA accepts in-house or accredited third-party laboratory arrangements, provided testing is conducted under defined SOPs. [Cosmetics Rules 2020, Schedule M Part III, QC Clause]

CDSCO can cancel or suspend a COS-1 licence under Rule 20 of the Cosmetics Rules, 2020 for misrepresentation in the application, failure to comply with labelling requirements, adverse safety findings, or failure to respond to a show-cause notice within the stipulated period. [Cosmetics Rules 2020, Rule 20]

The Cosmetics Rules, 2020 do not yet have a specific provision for QR-linked digital claims. However, any claim accessible via a QR code linked from the label is treated as part of the label for enforcement purposes under the Drugs and Cosmetics Act, 1940. Claims via QR codes must therefore comply with Rule 134 and must not imply medicinal action under Rule 36. [Cosmetics Rules 2020, Rule 36 & Rule 134; Drugs & Cosmetics Act 1940]

A registered LMPC importer must maintain records of all packaged commodity imports, including declarations made, consignment details, and inspection reports, for a minimum of 2 years from the date of sale as required under the Legal Metrology (Packaged Commodities) Rules, 2011. These records must be produced on demand by the Controller. [Legal Metrology (Packaged Commodities) Rules 2011, Rule 29]

Manufacturing cosmetics without a valid COS-8 licence is an offence under Section 17B of the Drugs and Cosmetics Act, 1940, punishable by imprisonment of up to 3 years and/or a fine. Products manufactured without a licence are also liable to seizure and forfeiture under Section 18A. [Drugs & Cosmetics Act 1940, Sections 17B & 18A]