Cosmetics Rules 2020 — What Changed, What Remains Confused, and What Companies Get Wrong

When the Government of India notified the Cosmetics Rules, 2020 under the Drugs and Cosmetics Act, 1940, it marked the first time cosmetics in India had their own dedicated regulatory framework — separate from the combined drugs and cosmetics rules that had governed the industry since 1945. Four years into implementation, Advocate Srijan Tiwari — drug and cosmetics law specialist at the Delhi High Court — observes that many companies are still making the same critical compliance mistakes. Here is the complete picture.

What the Cosmetics Rules, 2020 Actually Changed

Before the 2020 Rules, cosmetics were regulated under the Drugs and Cosmetics Rules, 1945 — a set of rules primarily designed for drugs, with cosmetics somewhat awkwardly fitted in. The 2020 Rules created a separate, standalone regulatory framework for cosmetics. Key changes include:

• Dedicated cosmetics licensing: Separate licences for cosmetics manufacture and sale, distinct from drug manufacturing licences.
• BIS certification requirements: Certain cosmetics categories now require Bureau of Indian Standards (BIS) certification — meaning they must carry the ISI mark before they can be manufactured for sale.
• Import cosmetics registration: All cosmetics imported into India must be registered with CDSCO under a dedicated registration procedure before import.
• Labelling requirements: Updated, more specific labelling requirements including full ingredient disclosure (INCI names), country of origin, and warnings for specific ingredient categories.
• Prohibited ingredients list: An updated list of substances prohibited in cosmetics, aligned more closely with international standards.
• Manufacturer competence requirements: Requirements for the technical staff qualifications at cosmetics manufacturing facilities.

The Drug-Cosmetic Boundary: India's Most Litigated Classification Question

One of the most persistent compliance challenges that Advocate Srijan Tiwari sees in his cosmetics law practice involves products that straddle the boundary between drugs and cosmetics. This is India's most litigated cosmetics classification question — and getting it wrong leads to prosecution.

Under the Drugs and Cosmetics Act, the key distinction is one of purpose and claims:

• A product intended for external application that beautifies, cleanses, or alters appearance — without therapeutic claims — is a cosmetic.
• A product that makes therapeutic or medicinal claims (treating dandruff, preventing hair loss, treating acne, reducing dark circles through medicinal action) crosses into drug territory and must comply with drug regulations.

The problem arises with products like medicated shampoos, fairness creams with UV filters, anti-acne formulations, and hair care products with active pharmaceutical ingredients. State drug authorities have prosecuted companies for manufacturing and selling these products as cosmetics when — based on their formulation or labelling claims — they are legally drugs.

Advocate Srijan Tiwari has successfully defended multiple cosmetics companies at the Delhi High Court against such prosecutions by arguing that their products fall within the cosmetics category based on the specific claims made and the actual pharmacological action (or lack thereof) of the ingredients. This is a technically complex argument that requires both scientific and legal expertise.

BIS Certification — What Companies Get Wrong

BIS certification under the Quality Control Orders issued for cosmetics is mandatory for specified categories — and non-compliance is a criminal offence. Yet Advocate Srijan Tiwari regularly encounters companies that have made one of three critical errors:

1. Not knowing if their product category is covered: BIS certification requirements have been expanded progressively since 2020. Companies must regularly check whether their product category has been brought under Quality Control Order (QCO) coverage. Many companies are not tracking these notifications and are unknowingly manufacturing non-certified products.
2. Assuming existing cosmetics licences cover BIS requirements: A cosmetics manufacturing licence and a BIS certificate are separate — having one does not give the other. Both are mandatory where required.
3. Getting BIS certification for one variant but not others: BIS certification is product-specific. A company certified for one shade of a foundation product is not automatically certified for another shade if the formulation differs.

Import Cosmetics Registration — A Growing Source of Prosecutions

Since the Cosmetics Rules, 2020, all cosmetics imported into India must be registered with CDSCO under a dedicated registration procedure (separate from, and in addition to, the import cosmetics application under the old rules). Customs authorities and drug inspectors have been increasingly vigilant about compliance with this requirement.

The registration requirement applies to the importer — not to the foreign manufacturer. This means Indian cosmetics importers and trading companies are legally responsible for ensuring their imported products are registered before import. Advocate Srijan Tiwari advises cosmetics importers on the registration process and handles prosecutions where registration requirements are alleged to have been violated at Delhi courts.

One common defence that has succeeded in Delhi courts involves challenging whether a product is truly a cosmetic requiring registration, or whether it is a personal care product that falls outside the scope of the Drugs and Cosmetics Act altogether. The classification of personal care products, wellness products, and beauty supplements remains contested — and Advocate Srijan Tiwari has a track record of success in these classification challenges.

Labelling Violations Under Cosmetics Rules 2020

Cosmetics labelling non-compliance is the single most common ground for prosecution under the Cosmetics Rules, 2020 that Advocate Srijan Tiwari encounters in his practice. The labelling requirements under the 2020 Rules include:

• Full INCI name ingredient list in descending order of concentration
• Batch number, manufacturing date, and best before date
• Name and address of the manufacturer (not just the brand owner)
• Country of origin for imported cosmetics
• Instructions for use and safety warnings for specific ingredient categories
• Net weight or volume

Companies regularly violate these requirements through incomplete INCI disclosure, using trade names instead of INCI names, or failing to update labels when formulations change. Prosecutions for labelling violations can be defended — particularly by demonstrating that the non-compliance was a technical violation without consumer deception — but prevention through a systematic label review process is strongly recommended.

Prohibited Ingredients Enforcement — A New Frontier

CDSCO's market surveillance of prohibited ingredients in cosmetics has increased significantly since 2023. The prohibited substances list in the 2020 Rules includes numerous ingredients commonly used in skin lightening products, hair dyes, and anti-ageing formulations. Companies that are using ingredients without checking the current prohibited list face serious prosecution risk.

Particularly at risk are companies that reformulated during the COVID-19 period and may not have conducted a thorough legal review of the new formulation against the 2020 Rules prohibited ingredients list. Advocate Srijan Tiwari's practice has seen a significant increase in prohibited ingredient prosecution matters since 2024 — and this trend shows no signs of reversing.

How Advocate Srijan Tiwari Helps Cosmetics Companies

From his Delhi High Court practice, Advocate Srijan Tiwari provides cosmetics companies with three levels of legal support:

Preventive Compliance Advisory: Reviewing product portfolios against the Cosmetics Rules 2020, identifying compliance gaps, advising on BIS certification status, and reviewing import registration requirements — before enforcement actions arise.

Show Cause Notice Response: When a state drug authority or CDSCO issues a show cause notice alleging Cosmetics Rules violations, Advocate Srijan Tiwari drafts and files the company's response — technically sound, legally comprehensive, and strategically calibrated to avoid escalation to criminal prosecution.

Criminal Defence: For companies already facing prosecution for Cosmetics Rules violations at Delhi trial courts or Delhi High Court, Advocate Srijan Tiwari provides full courtroom representation — bringing his 14+ years of exclusive drug and cosmetics law expertise to bear on every aspect of the defence.

Contact Advocate Srijan Tiwari: 9899966225 | srijantiwari@hotmail.com | Delhi High Court