Introduction
The use of colors in drugs and cosmetics is regulated under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945 to ensure safety, stability, and compliance with international standards. The Act mandates that only approved colors can be used in the formulation of pharmaceutical products and cosmetic items to prevent health risks caused by toxic or non-compliant colors.
The Bureau of Indian Standards (BIS) and the Central Drugs Standard Control Organization (CDSCO) regulate the use of permitted colors in India, aligning them with international standards such as the U.S. FDA, EU Regulations, and WHO guidelines.
1. Categories of Permitted Colors
The permitted colors for drugs and cosmetics are classified into the following categories:
- Colors permitted in oral drugs (Tablets, Capsules, Syrups, etc.)
- Colors permitted in external use drugs (Ointments, Creams, Lotions, etc.)
- Colors permitted in cosmetics (Lipsticks, Shampoos, Nail Polish, etc.)
Each category follows specific guidelines to ensure safety and non-toxicity.
2. List of Permitted Colors in Drugs
(a) Colors Permitted in Oral Drugs (Schedule Q)
Only certain synthetic water-soluble and aluminum lake colors are allowed in oral drugs (e.g., syrups, tablets, capsules). These colors are approved by BIS and the U.S. FDA.
| Color Name | Common Use |
|---|---|
| Ponceau 4R (INS 124) | Tablets, Syrups, Capsules |
| Tartrazine (INS 102) | Capsules, Liquid Medicines |
| Sunset Yellow FCF (INS 110) | Tablets, Oral Suspensions |
| Erythrosine (INS 127) | Syrups, Oral Drops |
| Brilliant Blue FCF (INS 133) | Liquid Medicines, Gelatin Capsules |
| Indigo Carmine (INS 132) | Coated Tablets, Capsules |
| Fast Green FCF (INS 143) | Pediatric Formulations, Syrups |
| Allura Red AC (INS 129) | Suspensions, Chewable Tablets |
(b) Colors Permitted in Drugs for External Use (Schedule Q)
Drugs applied externally (ointments, creams, lotions, eye drops, etc.) must only contain permitted colors that are non-toxic and safe for dermal or mucosal application.
| Color Name | Common Use |
|---|---|
| Titanium Dioxide (INS 171) | Ointments, Creams, Sunscreens |
| Iron Oxides (INS 172) | Creams, Lotions, Makeup Products |
| Chromium Oxide Green | Ointments, Medicated Cosmetics |
| Ferric Ammonium Ferrocyanide | Medicated Powders |
| Carbon Black (INS 153) | Eyeliners, Kajal, Mascara |
3. List of Permitted Colors in Cosmetics (Schedule Q)
Cosmetic products such as lipsticks, eye shadows, nail polishes, shampoos, and fairness creams require FDA-approved colors to ensure safety and non-toxicity. The permitted colors are divided into two groups:
(a) Colors Permitted in All Cosmetics
These colors can be used in all types of cosmetic formulations, including lip, eye, and skin products.
| Color Name | Common Use |
|---|---|
| Tartrazine (INS 102) | Lipsticks, Shampoos, Foundations |
| Sunset Yellow FCF (INS 110) | Lipsticks, Nail Polish |
| Brilliant Blue FCF (INS 133) | Shampoos, Hair Dyes |
| Fast Green FCF (INS 143) | Lotions, Creams, Face Masks |
| Allura Red AC (INS 129) | Lip Balms, Lip Glosses |
(b) Colors Permitted in Cosmetics for External Use Only
Some synthetic and inorganic colors are permitted only for external application and cannot be used in lip or eye cosmetics.
| Color Name | Common Use |
|---|---|
| Ferric Ferrocyanide | Eyeshadows, Nail Polish |
| Chromium Hydroxide Green | Blushers, Face Powders |
| Titanium Dioxide (INS 171) | Sunscreens, Skin Whitening Creams |
| Iron Oxides (Red, Yellow, Black) | Hair Dyes, Eyeliners |
| Carbon Black (INS 153) | Mascara, Kajal, Eyeliners |
4. Regulatory Guidelines for Using Permitted Colors
- Colors used in drugs and cosmetics must comply with Schedule Q of the Drugs and Cosmetics Rules, 1945.
- Color purity standards must meet BIS and FDA regulations.
- Non-permitted or unapproved colors are strictly prohibited and can result in penalties.
- All synthetic colors must be free from toxic metals such as lead, mercury, and arsenic.
- Labels must indicate the use of permitted colors (e.g., “Color Added: Tartrazine”).
5. Prohibited Colors in Drugs and Cosmetics
Certain harmful and toxic colors are strictly banned in pharmaceutical and cosmetic products due to their potential health hazards.
(a) Banned Colors in Drugs
The following colors are not allowed in any drug formulations due to their carcinogenic or toxic nature:
| Banned Color | Reason for Ban |
|---|---|
| Auramine O | Potentially Carcinogenic |
| Sudan I, II, III, IV | Causes Liver Toxicity |
| Rhodamine B | Associated with Skin Allergies |
| Methyl Violet | Linked to DNA Damage |
| Malachite Green | Toxic to Internal Organs |
(b) Banned Colors in Cosmetics
Several colors are prohibited in cosmetic formulations due to toxicity, allergic reactions, and contamination risks.
| Banned Color | Reason for Ban |
|---|---|
| Lead-based Colors | Neurotoxic, Affects Brain Development |
| Mercury-based Pigments | Causes Skin Disorders |
| Arsenic-containing Colors | Highly Toxic |
| Coal Tar Dyes | Potentially Carcinogenic |
| Chromium VI Compounds | Allergic Reactions, Skin Irritation |
6. International Comparison of Permitted Colors
Different countries have varied regulations for color use in drugs and cosmetics:
| Country | Regulatory Body | Permitted Colors |
|---|---|---|
| India | CDSCO (Schedule Q) | Synthetic Colors, Iron Oxides, Titanium Dioxide |
| USA | FDA (21 CFR 74) | Certified FD&C Colors |
| EU | European Medicines Agency | E-Number Approved Colors |
| Japan | MHLW | Natural & Synthetic Colors |
| WHO | WHO GMP Standards | Non-toxic, GMP-Compliant Colors |
Conclusion
The use of permitted colors in drugs and cosmetics is crucial for ensuring safety, compliance, and consumer trust. Regulatory authorities such as CDSCO, BIS, and the FDA strictly monitor the use of synthetic and natural colors in pharmaceutical and cosmetic products.
Strict quality control, labeling, and compliance with Schedule Q of the Drugs and Cosmetics Rules, 1945, help prevent the use of toxic or non-approved colors, thereby safeguarding public health and safety.
