Cosmetic Compliance in South Asia
Cosmetic compliance in South Asia, led by India's Cosmetics Rules 2020: CDSCO import registration on Form COS-1 through the SUGAM portal, the perpetual registration certificate, BIS standard IS 4707, and the line between cosmetics and drugs.
Regulatory framework
- Regulator
- CDSCO (India); DRAP (Pakistan); national authorities elsewhere
- Primary regulation
- Drugs and Cosmetics Act 1940 and the Cosmetics Rules 2020 (India)
- Notification
- CDSCO Import Registration Certificate via the SUGAM portal (India)
- Region
- Asia-Pacific
India
South Asia’s principal market is India, regulated under the Drugs and Cosmetics Act 1940 and the Cosmetics Rules 2020, administered by the Central Drugs Standard Control Organization (CDSCO). The Drugs Controller General of India, acting as Central Licensing Authority, grants the Import Registration Certificate that an imported cosmetic must hold before it can be sold.
The application is made online on Form COS-1 through the CDSCO’s SUGAM portal, by the manufacturer or by an authorised agent or importer established in India, and the certificate is issued on Form COS-2 under Rule 13. A point the older guidance gets wrong: under the 2020 Rules the certificate no longer expires after a fixed term. It remains valid in perpetuity, subject to payment of a retention fee before the end of each five-year period, unless it is suspended or cancelled. The application is supported by a Free Sale Certificate from the country of origin, and India does not permit the import of cosmetics tested on animals.
Ingredient safety is set by the Bureau of Indian Standards, principally IS 4707, which carries the lists of prohibited and restricted substances, preservatives, colorants and UV filters, and which mirrors the EU fragrance allergen labelling thresholds of 0.001 per cent in leave-on and 0.01 per cent in rinse-off products. The boundary that catches brands out is the line between a cosmetic and a drug: a therapeutic or medicinal claim pulls a product into the far heavier drug-licensing pathway.
Pakistan, Bangladesh, Sri Lanka and Nepal
The other markets each run their own national regime. In Pakistan cosmetics are overseen by the Drug Regulatory Authority of Pakistan (DRAP); Bangladesh, Sri Lanka and Nepal each operate registration through their national medicines or health authorities. None is harmonised with India, so a regional approach means meeting each framework separately.
How Oxford Biosciences helps
The Indian dossier draws on the same safety science as an EU or UK assessment, so the work is to map the existing evidence onto the Cosmetics Rules 2020, prepare the Form COS-1 application and the supporting documentation, and coordinate with the authorised Indian agent. We also check the formulation and claims against the cosmetic-drug boundary before it becomes a registration problem. South Asian engagements are quoted on application.
Our services for South Asia
Global Markets
From £149
Cosmetic regulatory documentation for markets beyond the EU and UK: Canada, Australia, New Zealand, ASEAN, the GCC and Latin America, prepared from the same evidence base by the assessor who signs our CPSRs.
Learn more →CPSR
From £70 · 2 to 3 days
The Cosmetic Product Safety Report is the safety assessment required under Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product may be placed on the UK or EU market. Prepared and signed by a qualified safety assessor.
Learn more →Frequently asked questions
Which international markets does Oxford Biosciences cover?
Beyond the EU and UK, Oxford Biosciences prepares the United States MoCRA Toxicological Risk Assessment (£395), the Canadian Health Canada Cosmetic Notification (£395), the Australian AICIS Compliance Statement (£149), the New Zealand EPA Group Standard Compliance Statement (£179), and the ASEAN Cosmetic Directive Documentation Package (£249), with GCC and Latin American markets (Brazil, Mexico, Argentina and Chile) quoted on application. Where markets share an evidence base, a single Product Information File carries the jurisdiction-specific annexes rather than requiring a separate dossier for each.