Cosmeceuticals: A transit state from synthetic to natural

Abstract

Cosmeceuticals are topically applied cosmetic products containing a biologically active ingredient with a pharmaceutical effect that improves, nourishes, and treats the skin appearance. The trend of cosmeceuticals began during the mid-20^th century due to its potent ingredients with therapeutic effects for various skin ailments. Even though there is a great advancement in cosmetics, which shows the risk of cosmetic linked melanoma, endocrine disorders, and birth defects which was one in 1500 people during 1935 have increased to one in 75 people in 2000. Hence, as a part of reducing the harmful effect, natural ingredients were added to the formulation to give the pharmaceutical effect. Thus, natural/herbal cosmeceuticals were introduced. Due to the awareness of the side effects such as photo-toxicity, mutagenicity, irritation by these synthetic products, people started preferring herbal/natural cosmetic products. Moreover, natural cosmeceuticals were proven to be effective against various dermatological conditions as well as have fewer side effects marked the natural/herbal cosmeceuticals in the market. Unlike a drug, cosmeceutical products undergo safety, toxicity, and efficacy tests, but these are not classified under Food and Drug Administration. This review will give an insight into different natural ingredients used in natural/herbal cosmeceutical formulation and their function challenges faced during formulation, advantages of natural cosmeceuticals over regular cosmeceuticals, and regulatory aspects in India.

Introduction

From the ancient times, human mankind always relished external appearance and beauty.[1] The application of cosmetics and cosmeceuticals started a long time back when people started considering beauty as the prime quality that gives pleasure to the senses.[2] People admired being charming, and this appearance was attained by using various substances which were later known as cosmetics.[3] Any product or substance that enhances or changes the appearance of skin or hair is called cosmetic; those cosmetics which contain an active ingredient that acts as a medicine is called cosmeceuticals and studies related to cosmetics are referred to as cosmetology.[4] In ancient times before the knowledge of chemical science, people used natural substances for beautification, later the discovery of various chemical products led to the usage of synthetic products.[5] There are different types of cosmeceuticals used in everyday life such as creams, lotions, gels, oils for skin, hair care products, deodorants, perfumes, shaving products, the list is endless.[6] Cosmeceuticals although give the impression of women using them, but they are used by men and women equally in the form of fairness cream, sun protection cream, hair colouring, etc., therefore, they are the oldest products used by the mankind.[7] Evolution of herbal cosmetics to synthetic is of great interest. As the people evolved so did the regulatory systems as well as the science to produce variety of cosmetic products which is explored at its significant in this review.

Traditional Knowledge of Cosmetics and Cosmeceuticals

The traditional use of herbal cosmeceuticals is in practice ever since the ancient Ayurveda system has started using plant-based medicines, and even the traditional Indian literature well explains the use of herbal cosmeceuticals in the name of “solah shringar” meaning 16 concepts of beautification from head to toe which is single or a mixture of herbs applied externally for beautification.[8] Several herbs such as Rubia cordifolia Linn (Indian madder), Acacia concinna (shikakai), Callicarpa macrophylla, Curcuma amada Roxb (Mango-ginger), Curcuma longa (turmeric), and Emblica officinalis Gartn (amla) were well-known for treating skin and hair problems. Curcuma longa or turmeric is also known as “Indian saffron” is one such traditional medicine used nearly 4000 years ago and distinguished in Vedic culture in India.[9] Among the diverse function of turmeric which includes anti-inflammatory, anti-oxidant, anti-carcinogenic, anti-mutagenic, anti-bacterial, anti-fungal, and many more, it is also found to protect skin against chromosomal damage caused by gamma radiation and hence act as a curative drug for skin disease, graying of hair and for skin nourishment. Hence, turmeric is being used in many of the formulations.[8,10,11,12] There are many other herbs used during ancient times, for example, Aegle marmelos Corr (bitter orange) as lip balm, seeds of Sessamum indicum Linn (sesame) as skin lightening and exfoliating scrub, seeds of Papaver somniferum Linn (opium poppy) in milk as a cure for dandruff, Lens culinaris (lentil) along with honey as a face pack, paste of Coriandrum sativum Linn (coriander), Acorus calamus Linn and Saussurea lappa together for curing pimples, juice of Eclipta alba along with Terminalia chebula and Emblic myrobalan cooked in oil and applied to the scalp is one of the remedies for premature graying of hair.[13]

Cosmeceuticals versus Pharmaceuticals

Cosmeceuticals are cosmetics having active ingredients similar to a pharmaceutical but at reduced concentrations of actives. They improve appearance by supplying essential nutrients for maintaining healthy skin and hair.[14] Pharmaceuticals, on the other hand, are the products that contain an active ingredient in a specific concentration that is promised for changing from abnormal or pathologic conditions.[15] Although cosmeceuticals are cosmetics with medicinal properties, they are not categorized as drugs that can cure or heal a disease condition.[16] According to the European Commission, any formulations that are designed for external use such as applying on skin, hair, nails, lips, external genital organ, mouth, are defined as cosmetics. These are exclusive to cleanse, perfuming, or changing their appearance or to provide odors or maintain good condition.[17] Pharmaceuticals are supervised under stringent regulations by regulatory bodies of the respective countries such as Central Drug Standard Control Organization (CDSCO) in India, Food and Drug Administration (FDA) in the USA; Federal Institute for Drugs and Medical Devices in Germany.[18]

Importance of Herbal Cosmetics and Their Demand in the Market

In the history of cosmetics, Egyptians were known to recognize the benefits of cosmetics in the early days. Earlier natural and herbal products were predominantly used to enhance skin tone, radiance, hair growth, fragrance, and various dermatological conditions.[19] Later in the 19^th century, the chemical formulation known as cosmetics became popular over time since it was proven to give the same effect as that of natural products for improving beauty and appearance.[20] The Discovery of hydroxyl acids used against wrinkles marked the rapid expansion of the cosmeceutical industry. Raymond Reed, the founder of the United States Society of Cosmetic chemists coined the term cosmeceuticals. Albert M Kligman in 1970, used retinoic acid in a formulation to improve the appearance of skin damaged by ultraviolet (UV) radiation and wrinkles.[21,22] Although the cosmetics improved the appearance, their extensive use leads to severe side effects such as endocrine disorders, cosmetic-linked melanoma, stillbirths, birth defects, even severe lung diseases,[23] which led to change over from chemicals to natural or herbal extracts.[17] Considering these side effects, the cosmeceutical industries started working on a stable formulation containing natural and herbal extracts (ingredients) in place of chemicals that had mere side effects compared to cosmetics, hence herbal cosmeceuticals became a current trend again in the market.[16] The zero or mere side effects from the herbal cosmeceuticals gained the trust of customers and hence boomed in the market.[24] Now the herbal cosmeceuticals used are in more demand worldwide compared to synthetic cosmeceuticals.[25]

Synthetic versus Herbal Cosmeceuticals

Cosmeceuticals may be synthesized chemically or derived from the natural sources. Regardless of whether it is synthetic or natural cosmeceuticals, the ingredients used in it must be safe, effective, stable, cost-effective, and metabolized within the skin.[26] In synthetic cosmeceutical, the active ingredient can be derived artificially through chemical reaction or it can also be a chemical modification of any naturally derived compound.[27] Whereas herbal cosmeceutical formulation consists of herbal ingredients as active components in a cosmetic base providing the cosmeceutical effect.[7]

It was evident that constant exposure to the chemicals used in synthetic cosmeceuticals such as hair sprays, perfumes, lipstick, gave adverse effects such as lung irritation, and cancer. The chemicals such as paraformaldehyde, 1,4-dioxane formaldehyde, paraben derivatives, benzalkonium chloride, phthalate, phenoxy-ethanol, Diazolidinyl urea, and imidazolidinyl urea, used in cosmeceuticals were claimed to be carcinogenic, pesticides, reproductive toxins, endocrine disruptors, degreasers, and surfactants which in turn imbalanced the body mechanism.[23,28] Alkyl esters of para hydroxybenzoic acid also known as paraben are known for their antimicrobial and preservative effects against mold and yeasts. They are claimed to be nonirritant, nonsensitizers with low acute toxicity at stable pH.

Phthalates, another ingredient used as adherent in cosmetics are salts or esters of phthalic acid that are reported to cause birth defects and long-term reproductive impairment when tested in animals.[23] Similar adverse defects were reported for the chemicals used in cosmetics.

Herbs are known to enhance physical and mental well-being, strengthen the immune system, detoxify, help in sleeping, increase stamina, and reduce fatigue.[29] The mere side effects of herbal cosmeceuticals gained the attention of customers, hence they preferred natural cosmeceuticals over synthetic. Herbal cosmeceuticals were proved to be hypo-allergic and safe to use anytime.[30]

Potential Herbs Used in Cosmeceuticals

As discussed in previous sections, several herbs are used for beautification which primarily includes skin and hair care. The climate change causes skin dryness which is naturally treated with oils such as coconut oil, sunflower oil, and jojoba oil aloe vera.[19] As a part of basic skincare and protection cleansing agents, toners, moisturizers are used which help in removing the dead cells and dirt, clear clogged pores on the skin, remove exposed toxic substances from the environment, also softens the skin, and gives a healthy glow. Normally, coconut oil, milk, curd, honey, and aloe vera, can be used as a cleansing agent, toner as well as a moisturizer. Rosewater, on the other hand, is well known for its toning property.[31] The ultimate aim of basic skincare and protection as well as retaining the charms is to prevent aging. Hence, herbs with age-defying activity, which increases youthful radiance, protects from normal damages, and enhances the glow of the skin are considered majorly.[32] Usually, a different combination of herbs is used for different skin types, for instance, (a) for dry skin, a mixture of Rubia cardifolia (manjista), triphala, Ocimum tenuiflorum (tulsi), and Glycyrrhiza glabra (licorice) in sesame oil is used; (b) For sensitive skin, herbs such as Vetiveria zizanioides (Usheero), Curcuma longa (turmeric), triphala, and Azadirachta indica (neem), are used; (c) for oily skin, tulsi, neem, turmeric, and papaya are used.[29] For anti-aging treatment herbs such as roseroot (Rhodiola rosea), carrot, ginko biloba, neem, tamarind are used which are enriched with Vitamin A and antioxidant activity.[7,17,19,33] Exposure to dirt leads to roughness, dandruff, and other diseases are the main issues in blocking the hair growth that leads to devoid of hair.[2] Amla, Brahmi, aloe vera, tulsi, and henna are some of the herbs that are used to treat dandruff, lice, hair, and scalp problem. Shikaka and reetha powder aka soap nut have a cleansing property which is usually used as a replacement for shampoos. Shikaka is also known to promote hair growth and prevent dandruff.[7] Medicinal properties of these herbs are due to the actives present in them for example, amla contains phyllembic acid, trigalloylglucose, terchebin, corilagin, ellagic acid, as well as it is a rich source of Vitamin C, hence can be used in hair care products. Pods of shikaka which are typically used as detergent are rich in saponins mainly the mixture of acacinin-A and acacinin-B. Turmeric is found to have D-α-phellandrene, D-sabinene, cineol, borneol, and zingiberene and it is preferably to be used in skincare products.[8] Various herbs used in everyday life are aloe vera, henna, gooseberry, almond, avocado, sandalwood, saffron, neem, lavender, and elder tree.[29] The benefits of some of the herbs are described in Table 1.

Table 1.

List of herbs used in herbal cosmeceuticals and their benefits

Herbs	Treatment	Function	References
Aloe vera, turmeric, rose, papaya, cucumber, Rhodiola-Rosea, carrot, gingko, neem, tamarind, grapeseed, wheat germ oil, palm oil	Smooth and soft skin, restore cracked heels, removes dark circles, tans, removes freckles	Moisturizer and anti-aging	[12,14,19,20,29]
Sandalwood, turmeric	Skin glow, prevent wrinkles	Anti-bacterial and anti-fungal	[12,14,19,20,29]
Jasmine, green tea, amla, eucalyptus, almond oil, henna, shikakai, aloe vera, brahmi, lemon, reetha powder	Strengthens hair root	Anti-deodorant, hair care	[12,14,19,20,29]
Coffee, coconut oil, jojoba oil, sunflower oil, olive oil, aloe vera, green tea, calendula, turmeric	Protects skin from UV	Regulates cell regrowth, skin care and protection	[12,14,19,20,29]

UV=Ultra violet

The scientific reason behind the medicinal activities of every herb depends on its chemical composition. A few of the functional groups considered are explained below:

1. Lipids: Are lipophilic, highly hydrogenated organic compounds with the least solubility in water. Various plants yield lipid material in the form of saturated or unsaturated fatty acids. The cocoa butter extracted from Theobroma cacao (cocoa plant) and oil extracted from mango kernel contains a high amount of stearic acid, saturated palmitic acid, monounsaturated oleic acid, triglycerides, and free fatty acids

2. Terpenoids: Also known as volatile oils are the major content in the mixture of hydrophobic aroma compounds

3. Flavonoids: Are polyphenolic compounds with phenylbenzopyrane structure having 15 carbons in two aromatic rings connected by a three-carbon bridge, that are mainly found in fruits, seeds, stems, and flowers

4. Alkaloids: Are secondary metabolites that have heterocyclic rings with basic nitrogen inserted in them, and are destined to fight against predators and parasites

5. Carbohydrates: Are abundantly found hydroxylated compounds of carbon which exists as monosaccharide, disaccharide, and polysaccharides. Acemannan is a strong immune activator and the major carbohydrate fraction extracted from aloe vera. Gums, mucilage are also mixtures of polysaccharides that are used as additives for topical application. Ascorbic acid is a simple sugar acid that is well known for its antioxidant activity

6. α-hydroxy acid: Citric acid, malic acid, glycolic acid, and lactic acids, are also known as fruit acids, which are important ingredients in skincare and dermatological therapy.

The therapeutic effects of herbs depend on the presence of either of these compounds or their synergistic activity.[34]

Tables 2 and 3 describe the various herbs used in the formulation for skin and hair care and protection, the actives present in them, and their uses.

Table 2.

List of herbs used in skincare formulation and its medicinal uses

Common name	Botanical name	Herb actives	Medicinal use	References
Mango	Mangifera indica	Isomangiferin, Mangiferin, gallic acid, catechin, protocatechic acid, tannins, shikimic acid, γ-aminobutyric acid, alanine, Kinic acid, glycine	Antioxidant properties	[33,35]
Amla	Phyllanthus emblica Euphorbiaceae	Ellagitannins, emblicanin A/B, gallic acid, punigluconin, pedunculagin, punicafolin, phyllanemblin	Antioxidant properties	[36,37]
Aswagandha	Withania somnifera Solanaceae	Withanolides, withanolide R, sominolide, corydaldine, corlumine, juziphine, mindabeolide-1, flabelline, fumariline, fumaritine, Oxyhydrastine, protopine, tetrahydropalmatine, N- feruloy1tyramine, bicuclline	Skin cleansing	[38,39]
Almond	Prunus amygdalus Rosaceae	3-O-methylquercetin 3-O-β-d- glucopyranoside, 7-O-β-d- glucopyranoside, naringenin, catechin, protocatechic acid, vanillic acid, p- hydroxybenzoic acid	Skin protection and antioxidant	[40,41]
Sandal	Santalum album Santalaceae	α and β santalol, cedrol, esters, aldehydes, phytosterols, squalene	Face pack, skin beautification antioxidant	[42,43]
Garlic	Allium sativum Alliaceae	Licin, phytoncidea, alliin, isoalliin, ajoene, methiin	Manage sores, pimple, and acne	[44]
Turmeric	Curcuma longa Zingiberaceae	Curcumin, zingiberene, and turmerone; cineole, p-tolylmethyl carbinol, α- phellantrene, terpinolene, 1,8-cinceole, undecanol, and p-cymene	Anti-inflammatory antioxidant	[45]
Coconut	Cocos nucifera Arecaceae	Sugars, vitamins, minerals, amino acids, and phytohormones	Skincare	[46]
Neem	Azadirachta indica	Di-n-propyl disulfide, 1- cinnamoylmelianolone, nimolicinoic acid, Isonimolicinolide	Antioxidant anti-septic treatment for skin diseases	[47]
Lemon	Citrus limon Rutaceae	Limonene, decanal, and β-myrcene	Skin nourishment	[48,49,50]
Sunflower	Genus Helianthus	Vitamin F and polyphenols	Skin and hair care	[51]
Tulsi	Ocimum sanctum Lamiaceae	Eugenol, γ-cadinene, epi-α-cadinol, α- bergamotene	Manage skin infection and rejuvenation	[52,53]

Table 3.

List of herbs used in hair care formulation and its medicinal uses

Common name	Botanical name	Herb actives	Medicinal use	References
Walnut	Juglans regia Juglandaceae	Oleic acid, linoleic acid, macadamia, linolenic acid, tryptophan, methionine, cysteine, threonine	Hair dying	[54,55]
Aloe vera	Aloe vera Liliaceae	Salicylic acid	Contains enzymes that remove dead cells and clears excess sebum	[51]
Amla	Phyllanthus emblica Euphorbiaceae	Gallic acid, ellagic acid, 1-O-galloyl-β-D-glucose, 3,6-di-O-galloyl-D- glucose, chebulinic acid, quercetin, chebulagic acid, corilagin, 3- ethylgallic acid isostrictinin.	Promotes hair growth	[56]
Henna	Lawsonia inermis Lythraceae	Lalioside, lawsoniaside, uteolin-7-O-β- d-glucopyranoside, awsonicin, lawsonadeem, vomifoliol	Hair dyeing and nourishment	[57,58]
Ritha	Sapindus mukorossi Sapindaceae	Saponins, mucilages, sugars	Shampoo, hair cleanser	[59,60]
Safflower	Carthamus tinctorius Asteracea	Benzyl-O-β-D-glucopyranoside, syringarenol, lirioresinol-A, β- sitosterol, stigmasterol	Hair tonic	[61]
Shikaka	Acacia concinna Mimosaceae	Lupeol, spinasterol, lactone, hexacosanol, spinasterone, calyctomine, racimase-A oleanolic acid, lupenone, betulin, betulinic acid, betulonic acid	Hair cleanser manages dandruff	[62]

Types of Herbal Cosmeceuticals

A wide range of herbs is used in the formulation of herbal cosmeceuticals. When it comes to the products, there are various categories of cosmeceuticals which include creams, emulsions, lotions, gels, oils for both hair and skin, soaps, shampoos, deodorants, hair tints and bleaches, cleansing products, anti-wrinkle products, skin whitening products, nail care and makeup, lip care products, and so on.[63] The forms of cosmeceuticals based on the site of application are categorized as skincare, haircare, oral care, nail, and eye care.[29] Table 4 depicts some of the current herbal cosmeceuticals in the market.

Table 4.

Category of herbal cosmeceuticals in the market

Purpose	Type of herbal cosmeceuticals	References
Skincare	Soap, lotion, cream, body powder, moisturizer	[6,7,51,63,64]
Haircare	Shampoo, oil, conditioner	[6,7,51,63]
Lip care	Lipstick, lip balm	[6,7,51,63]
Eyecare	Eye makeup, eye shadow, eye gloss, liquid eyeliner	[6,7,51,63]
Oral care	Dentifrices and mouthwashes, toothpaste	[6,7,51,63]

Developing a stable herbal cosmeceutical is challenging compared to synthetic compounds, due to the less stability of herbal extracts added in the formulation. The actives present in the herbal extracts are easily degradable by many physiochemical processes, hence deterioration can happen easily during storage leading to loss of the active ingredients or production of toxic metabolites. Therefore, there are stability issues reported both before and after formulation.[7] Moreover, during the cultivation of the herbs, factors such as light, temperature, atmospheric humidity, altitude, rainfall, soil can alter the nature of the actives present in the herbs. Hence, all these factors should be taken care of while propagating the herbs.[65] Once the herbs are cultivated in their appropriate environment, the next challenge is in the extraction process. Proper drying conditions should be followed, flaws in this process can lead to unintentional adulteration.[19] Every cosmeceutical consists of vehicles and preservatives which are of great importance because of their vital role in skincare. Most of the vehicles and preservatives used are various oils that imitate sebum-like fatty substances which provides an additional benefit of cleansing, smoothening. An ideal vehicle is supposed to enter the stratum corneum layer of the epidermis and deliver the appropriate amount of active ingredient to the lower epidermal, dermal, or sub-dermal site, where the actual process is carried out. Phytoalexins, natural preservatives in plants have other biological activities besides anti-microbial properties. The phytocompounds such as terpenoids, organic acids, oxygenated fatty acids, aliphatic alcohols, polyphenols, β-carotene, flavonoids, anthocyanins, catechins, and phenolic acids that shows anti-microbial and anti-oxidant properties are considered to be natural preservatives.[34] An interesting study on mushroom extracts revealed that a wide range of bioactive compounds present in mushrooms played vital roles in biological functions such as antioxidants, antimicrobial, anti-tumor, anti-inflammatory, antiatherogenic, hypoglycemic activities, and immunomodulatory.[66] Based on these studies, there are cosmetics with mushroom-based ingredients available commercially. Some of them are (a) Mega-mushroom (Dr. Andrew Weil for Origins^TM) – launched in 2006 as a face mask to relieve skin from aging, as well as aiming to calm, soothe, and maintain the skin. The formulation contains Hypsizygus ulmarius mycelium, Ganoderma lucidum, and Cordyceps sinensis. (b) Menard is a cosmetic product that contains Ganoderma lucidum extract, used to eliminate toxins and skin repair after exposure to UV radiation.[67]

Nutricosmetics

The use of natural ingredients has become a trend now, with new ideas implemented to bring about demand in the market. In this evolution, there is an emerging market called nutricosmetics, the combination of nutraceuticals and cosmeceuticals, or simply cosmeceuticals with nutritional benefits.[68] According to Stephen DeFelice, a nutraceutical is a dietary ingredient that has medicinal o health benefits, such as disease prevention or therapy.[69] Unlike cosmeceuticals that are topically applied, these nutricosmetics are palatable. Therefore, it is often described as “beauty pills.”[70] The idea of nutricosmetics is to improve the appearance of the skin and hair by providing micronutrients, for example, isoflavone protein, lutein, lycopene, Vitamin A, Vitamin B6, Vitamin E, omega-3-fatty acids, β-carotene, sterol esters, chondroitin, and coenzyme Q10 in the diet as nutritional supplements.[71] For instance, ascorbic acid (Vitamin C) is a potent antioxidant that helps in reducing the free radicals generated during exposure to UV radiation.[67] The cosmetic industries are focusing on developing nutricosmetics containing high amounts of collagen, hyaluronate, elastin, and ceramide along with other micronutrients to boost skin’s water holding capacity for maintaining skin structure and function.[72] Most of the nutricosmetic products in the market are in the form of pills/capsules or liquid.[73] Table 5 given describes some of the natural ingredients and their functions used as nutricosmetics.

Table 5.

Natural ingredients used in nutricosmetics and their biological function

Natural ingredients	Function	References
Green tea, black tea, carotenoids, Coenzyme Q10, pomegranate, goji berry, acai, grape seed extract, phytosterol, cucumber, Vitamins (Vitamin A, Vitamin C, and Vitamin E)	Anti-oxidant	[74,75]
Black tea, green tea, carotenoids, collagen, curcumin	Skin softness, skin glowing, skin whitening	[74,75]
Coenzyme Q10, pomegranate, goji berry, acai, cocoa	Anti-aging	[74,75]
Omega-3 and Omega-6 fatty acids	Anti-inflammatory	[74,75]
Collagen, Hyaluronic acid, olive oil, papaya	Anti-wrinkles, skin moisturizer	[74,75]
Dates	Nourishing agent	[74,75]
Vitamin A, Vitamin C, Vitamin E	Wound healing	[74,75]
Papaya, aloe vera	Anti-acne	[74,75]

Regulations for Cosmeceuticals in India

Unlike drugs, cosmeceuticals do not follow stringent regulations yet the regulatory systems ensure the safety and efficacy of the products.[19] The true difference between a cosmeceutical and the drug is determined by the purpose of the product and it differs by the country. For example, in the European Union, cosmeceuticals are considered cosmetics, whereas, in the U. S, cosmeceuticals are the medication that does not require U. S FDA approval.[16] In India, the cosmetic industry is categorized into skincare, haircare, oral care, fragrances, and color cosmetics.

According to a report, the global cosmetic market is expected to reach 20 billion USD which is currently around 6.5 billion USD.[16] It is also said that India will contribute up to 5% of the global cosmetic market and will enter the top 5 in the list of leading global markets in terms of revenue by the year 2025.[16]

According to the Drugs and Cosmetics Act, 1940, “any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applicated to, the human body or any body part thereof for cleansing, beautifying promoting attractiveness or altering the appearance, and includes any article intended for use as a component of cosmetic can be claimed as cosmetics.”[76] As per amended rule 129 of the Drugs and Cosmetic Act of 1945, cosmetics can be imported into India only if it is registered under the rules by the licensing authority. Before importing into the country, the pack size and manufacturing location should be specified during the registration process.[77] Import of cosmetics which are not of standard quality, misbranded or spurious, containing injurious or harmful or unsafe ingredients like coal tar other than the prescribed one, hexachlorophene, lead (20 ppm allowed) or arsenic (2 ppm as arsenic trioxide allowed), mercury compound are prohibited under section 10 of the Act and well explained in rules 134A, 135, 135A of Drug and Cosmetics Rules 1945.[78] Products can be labeled as misbranded if it contains a color that is not prescribed or not labeled according to the recommendation or if the label or the container contains any inaccurate or deceptive statements. The products imported under the name of another cosmetic or imitates or substitutes another cosmetics, label bearing the name of individual or company (which does not exist) purporting to be the manufacturer of cosmetics are categorized as spurious cosmetics.[76]

Manufacturing cosmetics in India requires a license issued by the state regulatory authorities (State Food and Drugs administration). The license application must be submitted with all relevant documents, including a layout design of the factory premises, a list of equipment and machinery to be installed, a document demonstrating the firm’s constitution, and a document proving the applicant’s possession of the proposed premises. The license will be issued after a detailed inspection of the factory premises by the officer of the state regulatory agency.[78] Licensing authority inspects the following:

1. General requirements: Location and surroundings, building, water supply, water disposal, staff health clothing and sanitary requirements, medical devices, and cosmetics working benches.

2. Requirements of Plant and Equipment: Example 1: In the lipstick and lip gloss sector, equipment like a vertical mixer, jacketed kettle, mixing vessel, triple roller mill, moulds with refrigeration, weighing, and measuring instruments are required are all required in a minimum of 15 square meters. Example 2: Hair dye industry requires stainless steel tanks, mixers, filling units, weighing, and measuring equipment in an area of 15 m²with proper exhaust and the staff must wear masks, gloves, and goggles while working.[79]

The label of cosmetic product should contain:

1. Name of the cosmetic

2. Name and address of the manufacturer as well as the country in which the product was manufactured. If the product was not made at the manufacturer’s factory, the name and address of the actual manufacturer, or the name of the country where it was made, shall be mentioned on the label as “Made in ….(name of country)”

3. For a very small size container where the manufacturer’s address cannot be provided, the name of the manufacturer and his major site of manufacture as well as the pin code must be provided

4. Expiry date

5. Direction for safe use/caution

6. Batch number

7. Manufacturing License Number (if any)

8. Registration Certificate Number and R. C holders name and address.

As per the Drugs and Cosmetics rules, 1945, a label should be legible and original for the proposed product and its variants.[80]

Until 2014, the rules did not mention the cosmetics tested on animals. On October 15, 2015, this rule was added to the existing guidelines which say, “The manufacturer either legal or actual/brand owner of the products/Indian subsidiaries can submit a one-time self-declaration that the applied products have not been tested on animals on and after November 12, 2014 along with import registration dossiers to CDSCO. The acknowledgment copy of submission of this undertaking as received by the applicants from CDSCO can be produced at port offices in future for clearing their future consignments.”[81]

Current Trend and Future Perspective of Herbal Cosmeceuticals

The herbal cosmeceutical industry is expanding at a faster pace than an estimated 20% increase in the market value annually.[82] The changing lifestyle of the customers and the awareness about the side effects of chemical-based cosmetic product has marked a significant demand for natural cosmeceuticals.[25] Although India currently holds a small share of the global market, it is expected to grow significantly over the next 5 years due to (a) macroeconomic innovations such as improving demographics, rising disposable income, expansion of organized retail, changing consumer preferences, and large youth population (b) markets that are already developed, such as U. S., China, and Europe are reaching saturation levels and hence are only expected to increase modestly in future. The global cosmeceutical, cosmetics, and personal care markets are predicted to increase at a compound annual growth rate of over 3.5% during the next several years.[83]

India and China hold the lead to introduce herbal cosmetics to the world as they are well known for traditional knowledge of the medicinal effects of herbs.[84] According to the Export-Import bank report, although traditional Chinese medicines use over 5000 plant species and India uses about 7000, in the world herbal market China shares about US$6 billion while India shares only about US$1 billion.[82] According to 2019 report, APCOS NATURALS Pvt Ltd, Emami Ltd, L’Oreal SA, Patanjali Ayurved Ltd, The Himalaya Drug Co, Three-N-Products Pvt Ltd, The Hain Celestial Group Inc, The Procter and Gamble Co, Arbonne International LLC, and Weleda AG are some of the leading companies in the herbal cosmetic market with the constant growth of about 15%.[85]

Conclusion

Cosmeceuticals are products that share the properties of both cosmetics and a drug. Herbal cosmetics exist since people acknowledge to be aesthetic. The traditional knowledge about herbs and their medicinal values has eased the preparation of herbal cosmeceuticals. They are made using the base of approved cosmetics and one or more herbal substances that are used to treat a variety of skin and hair conditions. Every cosmetics cannot be classified as cosmeceuticals, but all cosmeceuticals can be considered as cosmetics. Compared to synthetic cosmeceuticals, herbal cosmeceuticals are cost-effective, have fewer side effects, are eco-friendly, and are safe to use. In India, herbal cosmeceuticals also follow the guidelines the same as cosmetics designed under the Drugs and cosmetics Act, 1945 regulated by the CDSCO. There is no standard protocol to study the effectiveness and safety of the natural product to date. Hence, the active ingredients in herbal cosmetics and cosmeceuticals should be defined and tested using sophisticated technologies to ensure their use in cosmeceutical products is efficient and safe. The new developments in cosmeceuticals concentrate on nonirritating, stimulating, and protective ingredients to improve hair and skin appearance. The metabolites present in the herbal cosmeceuticals impart their role in several biological functions along with the advantage of their natural origin and fewer side effects. Hence, their demand in the current market is rapidly increasing and will have significant growth in future.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.