G.S.R. 346(E) was notified on 21 May 2014 and came into operation approximately 4 July 2014. Rule 148-C prohibits any person from using any animal for testing cosmetics. G.S.R. 718(E) was notified on 13 October 2014 and came into operation approximately mid-November 2014. Rule 135-B prohibits import of any cosmetic tested on animals after the commencement date of the Fifth Amendment Rules. The Ministry of Health and Family Welfare’s November 2014 PIB release confirms both prohibitions as implemented. CDSCO and state drug control authorities are responsible for enforcement at manufacturing sites and ports of entry. The consolidated Drugs and Cosmetics Rules, 1945 (accessible via IndiaCode) continues to include rules 148-C and 135-B without subsequent repeal or amendment. No court decisions or administrative orders overturning the rules are documented in sources consulted. HSI India and PETA India have continued to cite India’s cosmetic animal testing and import bans in their advocacy communications, indicating continuing operative status.

Anticipated Effects

If rule 148-C is implemented as written and consistently enforced by CDSCO and state drug control authorities, the use of animals for testing cosmetics by Indian manufacturers and contracted laboratories would be expected to cease, with companies shifting to non-animal methods or relying on existing safety data.

If rule 135-B is implemented as written and consistently enforced at ports of entry, cosmetics tested on animals after the October 2014 commencement date would be excluded from the Indian market, requiring multinational cosmetic companies seeking access to the Indian market to ensure their products and supply chains do not involve post-November 2014 animal testing.

Whether the two rules have produced a measurable reduction in the number of animals used for cosmetic testing globally — versus redirection of testing to markets without equivalent bans — is not established in available sources.

Significance Rationale

Assigned Reduces Exploitation (impact direction) because the two rules remove the legal basis for cosmetic animal testing within India and restrict market access for cosmetics tested on animals internationally. If implemented as written, the domestic testing ban eliminates animal experimentation for cosmetics within India’s regulatory jurisdiction, and the import ban restricts entry of animal-tested cosmetics into one of the world’s largest cosmetic markets.

Assigned Alters Legal Basis (impact type) because the primary mechanism is the creation of explicit categorical prohibitions in the Drugs and Cosmetics Rules, 1945 — rule 148-C and rule 135-B — defining what is now legally impermissible for cosmetic manufacturers and importers operating in India.

Assigned High significance because the rules apply nationally across all cosmetic manufacturers and importers in India — a national market of continental scale — and address the cosmetic testing system comprehensively: the domestic testing ban removes legal authorisation for all animal testing of cosmetics within India; the import ban restricts market access for animal-tested cosmetics from any origin. This is a categorically broader scope than the Brazil state-level cosmetic testing bans (Moderate), which were limited to individual states. India’s rules apply to the entire national regulatory jurisdiction simultaneously.

The duration and persistence of the scale change is not established in available sources; no quantified data on animals previously used in cosmetic testing in India or on post-ban reductions are reported in sources consulted.