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Drug Regulatory Affairs Certificate Institutes in India

Yesenia Harris

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Historical Overview of Pharmaceutical Industries and Regulatory Affairs:During 1950s, multiple tragedies i.e., sulfanilamide elixir, vaccine tragedy and thalidomide tragedy have resulted in substantial increase of legislations for drug products quality, safety and efficacy. This has also resulted into stricter norms for Marketing Authorization (MA) and Good Manufacturing Practices (GMPs). To understand the chronological development of the modern era of pharmaceutical industry and regulatory framework, we will glance through the historical evolution of regulations in USA, Europe and India. Let us see what happened in USA, Europe and India.

Basics of DRA (Drug Regulatory Affairs) : Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies responsible for the discovery, testing, manufacture and marketing of these products wanting to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare.A new class of professionals emerged to handle these regulatory matters for companies.

Importance of DRA : Indian pharmaceutical sector is rising very rapidly and there is a need of regulatory affairs professionals to provide the current needs of industries for the global competition. A regulatory affair is a somewhat new profession which has developed from the desire of governments to defend public health. The pharmaceutical companies responsible for the discovery, testing, clinical trials, production, manufacture and marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. They are required to be well versed in the laws, regulations, and guidance of the regulatory agencies. There is a growing need to incorporate the current requirements of pharmaceutical industries. The present article discusses the regulatory education and its need, learning resources, courses available, syllabus contents, and job opportunities in regulatory affairs.

Working profile of DRA : Regulatory affairs professionals obtain essential paperwork and documentation for regulatory filings. All documents that are a part of the regulatory submissions should be of high quality ? and up-to-date. The pharmaceutical sector is a good example of the complexity engaged in regulatory processing. Prior to a drug being officially marketed by a pharmaceutical organization, it must be accepted by the regulatory authorities such as US FDA, MHRA, HSA, CDSCO etc. A regulatory affairs professional who works for a pharmaceutical company generally consults with company researchers and other staff to obtain sufficient data to develop a strong application for regulatory agencies. This data might consist of information on how the drug was developed in a laboratory, how it was analyzed, information about its efficacy and safety profile etc. In some cases, particularly in the case of a new drug, the process takes several years to complete.

The regulatory affairs professionals are responsible to complete all applicable regulatory submission forms issued by the agency, file the forms together with the essential associated documentation and compile a dossier. The particular information requested on submission forms differs significantly based on the type of approval applying for. For instance, the FDA’s Investigational New Drug (IND) application must be presented to the authority by a drug producer prior to the company can perform clinical trials. IND form requests for information concerning the drug protocol, which is basically an explanation of how the drug is designed; data related to the animal studies performed on the drug etc. On the other hand, the FDA’s New Drug Application (NDA) form, which must be submitted before marketing the drug for human use, needs the drug maker to submit additional documentation relevant to the drug’s efficacy and safety in humans, package labeling, manufacturing and other information.

Once submissions have been made the regulatory affairs professionals must monitor the progress of regulatory submissions. It’s important to not only file submissions in a timely manner to start with, but also to follow-up on a periodic basis. Monitoring the progress of submissions is not usually easy. For instance, for a drug company that has a target time frame for getting a new drug on the market, it might be complicated to calculate how much time it will take the regulatory authority to approve NDA application. Sufficient time must be allowed for the regulators to evaluate and approve the application. Usually regulatory agencies will have well published timelines that they take for approvals, so regulatory professionals must anticipate timelines accordingly.

Institute : Jamia Hamdard
Duration : 1 year (2 semester) for both the programs
Location : Delhi
Fees : ADDRA(Rs24,500)
PGDDRA(Rs24,500)
Mode : Distance learning
Ranking : 1st
Course content:
(1) Advance Diploma in Drug Regulatory Affairs(ADDRA 1 year):
The main objective of this Programme is to provide good knowledge of pharmacy and regulatory affairs laws and system as applicable in the field of pharmaceutical regulation at both national and international levels. This course prepares the students to pursue career in pharmaceutical industry, drug licensing and control authorities, and export&import agencies dealing with the pharmaceuticals and medical devices.

An Introduction to Pharmaceutical Drug Regulatory Affairs
General Pharmaceutical Laws and Guidelines
Drug Regulatory Affairs in India
Information and Quality Management
Chemical, Pharmaceutical and Biological aspects of Regulatory Documentation
Clinical Trials and Health Care Policies
International Licensing
Regulatory Considerations in Controlled Drug Delivery and Future Aspects of Biopharmaceuticals

(2) Post Graduate Diploma in DRUG Regulatory Affairs(PGDDRA):
1st Semester: An Introduction to Pharmaceutical Drug Regulatory Affairs
– General Pharmaceutical Laws and Guidelines
– Drug regulatory Affairs in India
– Information and Quality Management
2nd Semester: Chemical ,Pharmaceutical and biological aspects of Regulatory documentation. -Clinical Trials and Health care policies
– International licensing
– Regulatory considerations in controlled Drug delivery and future aspects of Biopharmaceuticals.
Institute : James Lind Institute
Duration : 18 months(Maximum duration)
Location : Bengaluru
Fees : Rs 36000
Mode : Online
Ranking : 2nd

About course:The regulations related to the development, sale and marketing of healthcare products have seen stricter reforms over the last few decades. Regulatory authorities are being set up in an increasing number of nations throughout the globe. Those which are already set up are restructuring their regulations and trying to match with the regulatory authorities of other nations. The regulatory standards related to healthcare products has seen rapid advancement due to changes in product safety, regulatory compliance, technological transformation, enhanced understanding of disease characteristics and customer requirements.
Course content:
Professional Diploma in Regulatory Affairs and Quality Operation
o MODULE 01: GENERAL INTRODUCTION
o MODULE 02: INTRODUCTION TO JUDICIAL SYSTEM IN INDIA, D&C ACT
o MODULE 03: SCHEDULE Y
o MODULE 04: INDIAN REGULATIONS GOVERNING CLINICAL TRIALS
o MODULE 05: REGULATORY REGIME – FDA, EMA & JAPAN
o MODULE 06: SAFETY TOPICS RELATED TO PRE-CLINICAL & CLINICAL STUDIES
o MODULE 07: COMMON TECHNICAL DOCUMENT, IND & NDA REQUIREMENTS
o MODULE 08: CMC INFORMATION & GHTF OVERVIEW
o MODULE 09: MEDICAL DEVICES, VETERINARY PRODUCTS & BIOSIMILARS
o MODULE 10: BIOPHARMACEUTICAL INDIAN REGULATIONS AND REGULATORY STRATEGIC PLANNING

Institute: Indian Biological Sciences And Research Institutes (IBRI):
Duration: 3 months,6months & 12 months Location: Noida
Fees structure:
3 months: Rs 7500
6 months: Rs 10500
12 months: Rs 16500
Mode:Classroom
Ranking: 3rd
Course content:
3 months course:
Certificate Program in Regulatory Compliances and Affair
Paper-I: Introduction to Regulatory Affairs
Paper-II: International Licensing and Drug Regulatory Affairs
Paper-III: Regulatory Documentation for Biologics /Medical Diagnostics and Pharmaceutics (Submission of DMF, Dossiers etc.)
Paper-IV: Global Regulatory Compliance Systems
6monthscourse :
o Certificate Program in Regulations for Biologics and Pharmaceutical Product
o Paper-I: Introduction to Regulatory Affairs
o Paper-II: International Licensing and Drug Regulatory Affairs
o Paper-III: Regulatory Documentation for Biologics /Medical Diagnostics and Pharmaceutics (Submission of DMF, Dossiers etc.)
o Paper-IV: Global Regulatory Compliance Systems
12monthscourse :
Comprehensive Program in Regulatory Affairs for Pharmaceutics:
Paper-|: Introduction to Regulatory Affairs
Paper-II: International Licensing and Drug Regulatory Affairs
Paper-III: Regulatory Documentation for Biologics /Medical Diagnostics and Pharmaceutics (Submission of DMF, Dossiers etc.) Paper-IV: Global Regulatory Compliance Systems
Paper-V: Regulations for Clinical Trials, GMP, GLP and ICH Guidelines
Paper-VI: Regulatory Strategy and Quality Assurance Systems
Paper-VII: Future of Biopharmaceuticals
Paper-VIII: Research Study

Institute: GITAM Institute of Pharmacy, Visakhapatnam campus :
GITAM Institute of Pharmacy, GITAM Deemed to be University is offering a certificate course in Drug Regulatory Affairs. The course is designed to contain global regulatory requirements and practices of drugs, pharmaceuticals and medical devices. After completion of the course, the participants are expected to have in-depth knowledge and understanding of concept of global regulatory agencies and regulations on drugs and pharmaceuticals, Drug discovery and development process, Innovator and generic drug regulatory filing and approval process. The participants will be trained in GMP, GLP, GCP and quality management systems.
Duration:3 months
Location: Visakhapatnam
Fees: Rs 15000/-
Mode: Offline
Ranking: 4th
Eligibility for admission: Pass in B.Pharm,M.Pharm, M.Sc. and B.Pharm final year students.
Course content:
o The course is designed to contain global regulatory requirements and practices of drugs, pharmaceuticals and medical devices.
o After completion of the course, the participants are expected to have in-depth knowledge and understanding of concept of global regulatory agencies and regulations on drugs and pharmaceuticals, Drug discovery and development process, Innovator and generic drug regulatory filing and approval process.
o The participants will be trained in GMP, GLP, GCP and quality management systems.
Institute: Institute of Good Manufacturing Practices India(IGMPI):
Duration: 1 year & 6 months
Location: New Delhi
Fees:1,50,000-Post graduate Diploma in Pharmaceutical Regulatory Affairs.
1,20,000- Course-Executive Diploma in Regulatory Affairs (Medical Device as major)
Mode:Regular/Online /Part time
Ranking: 5th
Course content(1 year):
o Post graduate Diploma in Pharmaceutical Regulatory Affairs:
o Module 1 : Introduction to Global Regulatory Authorities for pharma and healthcare industries Module 2 : Drug Development Process, Clinical Trials and related norms and regulations.
Module 3 : GMP and other good practices (International perspective of USA, WHO, ICH & Europe
/ Australia & New Zealand / Gulf Countries (GCC) / Canada / Africa/India etc)
Module 4 : Documentation of drug trials and regulatory filings in US,Europe, UK, India, Japan, Canada, Australia, South Africa, etc.
Module 5 : Quality Assurance and Drug Regulations, ICH and WHO guidelines
Module 6 : Dossier preparation in CTD format, eCTD submissions
Module 7 : Pharma and Healthcare industries IPR, Patents, Copyrights and Trademarks
Module 8 : Pharma and Healthcare products- Marketing, Import and Export regulations
Module 9 : Compliance guidelines, Govt. Audits (FDA, MHRA, PMDA, TGA, DCG, etc) and
Breach reports
Module 10 : Indian GMP Regulations.
o Module 11 : Drug Registration in African Countries.
o Module 12 : Drug Registration in Gulf (GCC) Countries.
o Module 13 : AYUSH Regulatory Affairs(Ayurveda, Unani, Siddha, Homeopathy, Yoga and Naturopathy)
o Module 14 : Industry specific case studies

Course – Executive Diploma in Regulatory Affairs (Medical Device as Major) 6-12months
o Module 1: Introduction to Global Regulatory Authorities for Medical Device Industry
o Module 2: Medical Devices, In -vitro devices, Biologics & Combination Products: Introductory Module
o Module 3: FDA Regulations and Guidelines on Medical Devices
o Module 4: European Union Regulatory Guidelines on Medical Devices
o Module 5: Medical Device Regulations from Indian perspective
o Module 6: Management of the risks associated with Medical devices
o Module 7: Bio-compatibility Studies and Medical Devices
o Module 8: Clinical Trials: Medical Devices
o Module 9: Overview of In – Vitro Device Regulation
o Module 10: Overview of Combination Products Regulation
o Module 11: Dossier preparation in CTD format, eCTD submissions

Institute : RoyedTraining (Distance learning Centre) :
Royed Training is online, onsite training provider catering to FMCG, Cosmetic, Food, Pharmaceutical, Biopharmaceutical and Medical Devices industry.
Duration: 1 year
Location: Kolkata, West Bengal
Fees:35,500/-
Mode: Online
Online Ranking : 6th
PG Certification in Drugs, Biologic and Medical Devices Regulatory Affairs.
Course content :
Section 1: Fundamental of Drug Discovery and Development Section 2: Innovation/Intellectual Property Management
Section 3: Regulatory Strategic Management and Planning
Section 4: Good Manufacturing Practice
Section 5: Submission Dosier: DTC|ACTD |DMF-SMF-ANDA|505 (B)(2)|NCE|PETITION|PRIOR APPROVAL SUBMISSION
Section-6:Quality issue , Warning letter CAPA and Data Integrity
Section-7: Biopharmaceutical (Biologics and Biosimilar)
Section-8: Medical Devices Regulation

Institute : Universal School of Biosciences :
Duration: 6 months
Location: Delhi
Fees: 90,000
Mode: Online
Ranking: 7th

Course content: Module I: Introduction to Intellectual Property Rights
o Module II: Patent Law, Practice and Procedure
o Module III: Industrial IPR Design &Trademark
o Module IV: Indian Drug Regulations
o Module V: International Drug Regulations
o Module VI: WTO, GATT, IPR, TRIPS, Orange book guidelines, EMR, GMP, GLP, US-FDA & ICH Guidelines.
o Introduction to Drug Regulatory Affairs and functions of Drug Regulatory Authorities.
o Comparison of Indian Regulatory requirements with Global standards

Institute: Physis Learning Academy
This is a self-paced certificate course will provide you a comprehensive training on the concepts & processes in drug regulatory affairs in compliance with applicable guidelines.
Duration : 6 months
Location : Delhi
Fees : 7600/-
Mode : Online/Distance
Ranking : 8th
Certificate program in Drug Regulatory Affairs:
Course content :
o Module 1: Introduction to Drug Regulatory Affairs (Evolution, Scope and Role of DRA)
o Module 2: Regulatory Authorities (USFDA, Canadian, EU, CDSCO, ICH, WHO)
o Module 3: Regulatory Requirements in Pharmaceutical (Drug Product Lifecycle – Development, Regulatory Submission, Regulatory Compliance etc.)
o Module 4: Medical Device Regulation (Definition and Classification, Steps in Development, Product Lifecycle)
o Module 5: Applicable ICH Guidelines in DRA (Q1A, Q1B, Q1C, Q1D, Q1E, Q1F, Q2, Q3, Q6, Q7)
o Assessment and Evaluation through Exam.
o Section-9: European Drug Regulatory Affairs.
o Section-10: Asian Regulatory Affairs
o Section-11:African Regulatory Affairs
o Section-12:Lattam Regulatory Affairs
o Section-13:GCC Regulatory Affairs
o Section-14:China Regulatory Affairs
o Section-15: Russia Regulatory Affairs

Institute

Location

Mode of learning

Duration

Fees

RAPS


Online

6 months

https://www.raps.org/education/course-catalog?type=course

Karnataka Clinical

Research Institute

(KCRI)

Karnataka

Offline/Online

2 months

Rs 30,000/-

Institute of

Pharmaceutical

Management

Maharashtra

Online

4 months

Rs 15,340/-

Rajiv Gandhi

Paramedical

Institute

New Delhi

Offline

1 year

_

Rajshri Institute of Medical Sciences

New Delhi

Offline

1 year

_

Cliniminds

Kolkata and Bangalore

Online

6 months

Rs 21000/-

Covalent training

Hyderabad

Online

3 months

Rs 15000/-

Institute

Location

Mode of Learning

Duration

Fees

Udemy

New Delhi

Online

3 months

Rs 3499/-

Physis learning

Academy

Delhi

Online/Distance

6 months

Rs 7600/-

Institute of Para

Medical Technology

Delhi

Online

1 year

_

QREC clinical research institute

Jaipur

Offline

6 months

Rs 11000/-

Avigna Clinical

Research

Institute(ACRI)

Bangalore

Online

3 months

Rs 25000/-

JS University

Shikohabad, Uttar Pradesh

Offline

1 year

Rs 30,000/-

Coursera

Gurugram

Online

6 months


Article by : Sohail Ahmad, B.Pharm, INDIA
Mentor: Mohit Khandelwal, Expert Regulatory Professional, INDIA

Read More

Source: pharmatutor.org

Pharma

HERBAL / NATURAL INGREDIENTS for SKIN NOURISHMENT FROM a to Z

Yesenia Harris

Published

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By

About AuthorsAvdesh Thassu
MPharm (Nat. Chem.); MBA(Mkt.)
Associate Vice President
Global Regulatory Affairs,
Emami Limited,athassu@hotmail.com

Chandra Mohan Nandi
MSc. (Organic Chem.)
Deputy Manager,
Global Regulatory Affairs,
Emami Limited,
chandramohannandi@yahoo.in

Abstract
Human beings especially womans are obsessed with looking beautiful. Hence, various beauty products have been in use to look charming and young. Herbal ingredients are popular worldwide for use in cosmetics.The word cosmetic was obtained from “Kosmtikos,” a Greek word, means having the influence, arrange, and ability in decorating The demand for herbal cosmetic is growing in the world market and is a valuable gift of nature. Herbal cosmetics are formulated using different herbal active ingredients, which are further incorporated in cosmetic bases to nourish and cure various skin ailments. Herbal cosmetics are natural and are found to be safe to use as compared to chemical-based cosmetics. Herbal formulations have always attracted considerable attention because they are free from all the harmful synthetic chemicals which otherwise may prove to be toxic to the skin. The bioactive ingredients from plants include antioxidants, vitamins, essential oils, tannins, alkaloids, dyes, carbohydrates, and terpenoids, which are used as cosmetics for care of skin, body, and its other parts. Cosmetics based on herbal ingredients possess desirable physiological activity such as smoothing appearance, healing, enhancing, and conditioning properties. Various herbal active ingredients which are particularly used for skincare are being discussed in this article.

Introduction
Herbal cosmetics are the composition incorporating phytochemicals from various botanical sources, impacting the skin functions, and allocate nutrients which are beneficial for the healthy and glowing skin or hairs. These phytochemicals of various sources have dual functions, they can be utilized as a cosmetic product for the skincare purpose, and the botanical components imparting biological activity to the skin and furnish nutrients beneficial for the nourished skin or hair.

Anatomy of Skin : The skin is the largest organ of the body. It has three main layers, the epidermis, the dermis and the subcutaneous layer.

The epidermis is an elastic layer on the outside that is continually being regenerated. It includes the following:
o Keratinocytes – the main cells of the epidermis formed by cell division at its base. New cells continually move towards the surface. As they move they gradually die and become flattened.
o Corneocytes – the flattened dead keratinocytes that together make up the very outer layer of the epidermis is called the stratum corneum or horny layer. This protective layer is continually worn away or shed.
o Melanocytes – produce the pigment melanin that protects against UV radiation and gives skin its colour.

The dermis is the inner layer that includes the following:

o Sweat glands – produce sweat that travels via sweat ducts to openings in the epidermis called pores. They play a role in temperature regulation.
o Hair follicles – are pits in which hairs grow. Hairs also play a role in temperature regulation.
o Sebaceous glands – produce sebum (an oil) to keep hairs free from dust and bacteria. Sebum and sweat make up the ‘surface film’.
The subcutaneous layer under the dermis is made up of connective tissue and fat (a good insulator).

Natural Ingredients in Cosmetics : Skin constitutes the largest living organ that protects the body from the external environment, helping to regulate temperature and fluid balance, keeping out harmful microbes and chemicals and offering some protection against sunlight. The outermost layer of the skin is the stratum corneum, a selectively permeable, heterogeneous layer of the epidermis, which protects against desiccation and environmental challenge and retains sufficient water to allow it to function. Impairment in skin barrier function is often demonstrated by an altered integrity of the stratum corneum, with a consequent increase in transepidermal water loss and decrease in skin hydration. The term “natural” is defined as something or an ingredient that is produced by the nature or found in nature and is directly extracted from plants or animal products. Sources of natural ingredients can include herbs, fruits, flowers, leaves, minerals, water and land . The effect of natural ingredients in skin care products depends on their in vitro and in vivo efficacy and the type of dermatological base where they are incorporated.
Benefits of Plant Extracts: The use of bioactive extracts or phytochemicals from a variety of botanicals in cosmetics accomplishes two functions: care of the body and as ingredients to influence the biological functions of the skin, providing the nutrients for healthy skin. According to their composition, these extracts can provide different properties:

A) Antioxidant activity : The oxidative stress is one of the major mechanisms for skin aging and dermatological conditions. Ultraviolet radiation from sunlight is the most common exogenous factor harmful to the skin. The continuous exposure to environmental factors leads to alterations in the connective tissue due to the formation of lipid peroxides and reactive oxygen species (ROS), as well as enzymes action, which results in several skin disorders. Free radical formation is naturally controlled by various beneficial compounds known as antioxidants. These are radical scavengers providing protection to the human body by inhibition of various oxidizing chain reactions. ROS generated exogenously react with various biomolecules present in the skin and play an important role in skin disorders. Phenolic compounds are bioactive substances widely distributed in plants, being important constituents of the human diet. Plant phenolics comprise a great diversity of compounds, such as flavonoids (anthocyanins, flavonols, flavones, etc.) and several classes of non-flavonoids (phenolic acids, lignins, stilbenes). Natural antioxidants are effective in preventing free radical formation by scavenging them or promoting their decomposition and suppressing disorders.

B) Tyrosinase Inhibition Effect : Melanin is a human pigment responsible for the colour of eyes, hair and skin. It is produced and secreted, through a physiological process called melanogenesis, by the melanocytes, which are distributed in the basal layer of the dermis. There are two types of melanin pigments produced by the melanocytes: eumelanin, black or brown, and pheomelanin, red or yellow. The colour of human skin and hair is determined by the type and distribution of melanin pigment. Upon exposure of the skin to sun radiation, melanogenesisis enhanced by the activation of thyrosinase, a melanogenesis key enzyme. Tyrosinase, a polyphenol oxidase, can catalyze two distinct reactions (Figure 1): the oxidation of L-tyrosine to L-dihydroxyphenylalanine (L-DOPA) (first reaction) and the oxidation of L-DOPA to dopaquinone (second reaction). Then, dopaquinone, through a non-enzyme-catalysed process, is transformed into leukodopachrome (third reaction). This compound is oxidized into dopachrome (fourth reaction), which is an extremely fast and non-enzyme-catalyzed process. Then, dopachromeis transformed to melanin through a series of chemical- and enzyme-catalyzed reactions. Thus, the referred process shows that dopachrome synthesis can be suppressed when any of the steps are inhibited.

Melanin protects the skin against UV light damage by absorbing UV sunlight and removing the reactive oxygen species.

Ingredients A to Z of Skin Care Products

Avocado Oil :Avocado oil is loaded with omega-3 fatty acids and vitamins A, D, and E. In addition to vitamin E, avocado oil contains potassium, lecithin, and many other nutrients that can nourish and moisturize the skin.The outermost layer of skin, known as the epidermis, easily absorbs these nutrients, which also help to form new skin.The antioxidants in avocado oil may help to ease the symptoms of a sunburn. The vitamin E, beta carotene, vitamin D, protein, lecithin, and essential fatty acids in the oil can support healing and soothe the skin.

Bhibhitaki/Baheda :This ingredient helps in getting a smooth, acne free face. The antibacterial astringent and rejuvenating properties of Bibhitaki helps in attaining a brighter skin tone.

Chestnut : Chestnut, particularly chestnut fruits and leaves are important sources of phenolic compounds. Apart from that its flower has antioxidant properties. In a study developed by Almeida et al., a surfactant-free topical formulation containing an ethanolic C. sativa leaf extract was characterized. No changes in pH and 1,1-diphenyl-2-picrylhydrazyl (DPPH)-scavenging activity were observed after a 6 months storage period at 20 ?C and in vivo moisturizing effect was demonstrated that, lasted at least 4 h after products application. The safety and stability of this formulation for topical use was verified. It could be relevant in the prevention and treatment of oxidative stress-mediated diseases and photo-ageing.

Diamond Powder :Popularly known as natural exfoliator, it is not only helps in preventing the skin aging, but also improves skin complexation. It helps protect collagen and reduce sun damage.

Eucalyptus oil : The most effective and well-proven benefits of eucalyptus oil are its antibacterial, moisturizing, and anti-inflammatory properties. Further, it has also been shown to treat eczema and acne flare-ups, as well as promote wound healing and provide pain relief for minor cuts and scrapes.

Frankincense (Boswellia): The oil of the famous resin frankincense has been used in cosmetics for centuries for its antiseptic and astringent properties. This makes it brilliant for preventing wounds from developing infections, but it can also be used to protect against hair loss, to tone the skin and to reduce the appearance of wrinkles. It helps to promote the regeneration of cells, creating potent anti-ageing qualities when found in scientifically tested skin creams.

Glycyrrhizaglabra (Licorice): Licorice is good for skin eruptions, including dermatitis, eczema, pruritus and cysts. Anti-inflammatory, antiseptic and antibacterial properties. Licorice contains glycyrrhizin, glycyrrhetinic acid, flavonoids, asparagine, iso-flavonoids and chalcones. Glabridin is the main ingredient of the hydrophobic fraction of licorice extract and has been shown to inhibit tyrosinase activity in B16 murine melanoma cells.

Holy basil :Holy basil has been found to have antibacterial, antiviral, antifungal, anti-inflammatory and analgesic (painkilling) properties. It can help kill bacteria that can cause breakouts and skin infections, so it’s a great natural remedy for wounds, plus a home remedy for acne and other skin irritations. It’s believed to benefit the skin and treat skin infections both internally and externally. The primary active compound of holy basil oil is eugenol, also the active ingredient in the powerful antimicrobial clove oil, which is widely believed to help combat many skin disorders. Holy basil also contains other therapeutic components, including gamma-caryophyllene and methyl eugenol.

Indian Madder : The presence of bioactive constituent like purpurin, munjistin, xanthopurpurin, pseudopurpurin and glycosides like rubiadin, etc, helps in purifying the blood and increasing blood flow. As a result, Indian Madder prevents acne breakout and brightens skin texture.

Jujube : Jujubes bestowed with vast reserves of vitamin C and antioxidants combat free radicals and prevents oxidising of healthy skin cells, thereby reverse the effects of ageing. Imbued with a myriad of skin-boosting nutrients, ber fruits can do wonders for your skin by treating acne, blemishes, and scars and makes the skin look radiant and flawless. It also slows down premature ageing of the skin, fades wrinkles, pigmentation and helps in improving skin complexion and natural glow. In addition, jujube has been found to heal skin woes like eczema, psoriasis and also has the potential to avert the spreading of melanoma (skin cancer).

Kiwi seed oil : The oil of kiwi seeds is not a commonly known skincare ingredient, but it actually has a lot of uses. Whether it be controlling sebum production to reduce the presence of blackheads or firming the skin through the presence of collagen-inducing vitamin C, kiwi seed oil is an unsung saviour of the natural skin care catalogue.

Lavender oil : A natural skin care superhero, lavender oil has more uses than you could count. Whilst it is essential to use this ingredient in the correct quantities (otherwise it can irritate the skin), lavender is incredibly healing. Its powerful antiseptic and anti-inflammatory properties while lavender is also a brilliant cure for acne, as well as for reducing the itchiness of eczema. It is perhaps the most effective ingredient for healing burns and reducing the appearance scars.

Marshmallow root :Marshmallows are one of the world’s favourite sweet treats, but its natural form can also be a treat for your skin! Marshmallow roots, otherwise known as Althaea, has healing, moisturising and soothing properties, high in mucilage, which can coat the skin and prevent irritation. This makes the ingredient brilliant for revitalising the skin.

Neroli oil :Neroliis derived from orange blossom. In ancient times, it was allegedly used to treat the plague. Today, however, it is applied topically to improve the skin’s elastic, preventing the development of stretch marks, along with reducing acne due to its anti-bacterial features.

Olive oil : Olive trees, fruits, olive oil and olive mill waste contain hydroxytyrosol (2-(3,4-di-hydroxyphenyl) ethanol) and tyrosol (2-(4-hydroxyphenyl)ethanol). These phenolic compounds present antimicrobial, anticarcinogenic, anti-inflammatory and antioxidant activities. Due to the beneficial properties of these compounds, the use of olive extracts as raw material in the manufacture of cosmetic products seems to be an interesting innovation approach for cosmetic industries.

Patchouli : Patchouli is a member of the mint family. Besides being used in perfumes and soaps, the essential oil can be applied topically with a carrier oil or in a cream to soothe inflammation in infections and even in arthritis. Its astringent properties also make it good for preventing sagging and wrinkling skin.

Quince seed : It is a herb that is rich in vitamins and minerals. It contains certain nutrients which contribute to the health as well as the vitality of the skin. It further helps in retaining skin moisture and retaining its glow.

Rose absolute : One of the most precious essential oils in the world, rose absolute has an incredible array of skin-healing properties. Its astringent properties make it great for treating wounds, as it causes the blood vessels to contract, slowing the blood flow caused by cuts and small wounds. It is also anti-inflammatory and soothing, making it the perfect toner for dry, inflamed or itchy skin. It also helps to tone and strengthen the skin for a youthful appearance.

Sandalwood :Another antiseptic and anti-inflammatory ingredient, sandalwood treats everything from insect bites to boils. However, it is also a cicatrizant, meaning that it can help the skin to heal scars much quicker. Sandalwood has long been used as a disinfectant, which, mixed into bathwater, can both prevent infections and repel insects due to the oil’s fragrance

Tea Tree oil : A famous remedy for acne, tea tree oil is a powerful antiseptic that can help reduce excess sebum production to clear out the skin. This Australian ingredient is also anti-fungal, making it effective in removing athlete’s foot and other fungal ailments. However, it can also soothe dandruff and relieve the itching of insect bites. Tea tree oil can also treat minor wounds, encourage healing, and prevent infection.

Ulmusdavidiana root extract : The bark of the root and stem of the Ulmusdavidiana japonica tree has been used in traditional Korean medicine for many years as an anti-inflammatory ingredient. many scientists believe it can be beneficial in the conditioning of the skin, and potentially as an anti-wrinkle agent to treat sun-induced premature ageing.

Viniferafruit(Grape seed): Grape seed extract has the ability to release endothelial growth factor and its topical application results in contraction and closure of the skin wound. Furthermore, it possesses antioxidant and antibacterial properties, which help for our skin care.

Witch Hazel : Witch hazel is another favourite for those suffering from spot-prone skin. Derived from the bark, twigs and leaves of plants native to North America and some parts of Asia, the active ingredients are mixed to create witch hazel water. Used topically, witch hazel is a fantastic astringent and antioxidant, naturally reducing acne, blisters and insect bites. As an astringent, it helps to shrink the pores, reducing the number of bacteria that can enter the pores and cause blemishes.

Xanthine : Xanthine might not sound like a particularly ‘natural’ substance, but don’t worry – this is simply a chemical component of some nourishing natural plants such as cacao beans and cola nuts. Plant extracts containing xanthine are known by scientists to prevent photo-damage from sun exposure when applied topically, reducing wrinkle formation. Look for creams containing xanthine in skin creams for daily protection against premature ageing.

Ylangylang : Ylang-ylang essential oil is notable for its anti seborrhoeic qualities. This means that it both reduces inflammation and regulates the sebum production in skin infections. The substance is thought to help balance the hormones, reducing acne and other complaints often provoked by hormonal fluctuations. It is also a great oil to massage into the scalp to keep the skin moisturised and the hair looking healthy.

Ziziphusmauritiana fruit pulp : Its components and properties treat dry skin, relax sunburn and reduce wrinkles, giving your skin a glowing and silky texture.

Conclusion : Nowadays, consumers have an increasing interest in natural products, namely in the case of cosmetic products. On the other hand, several works refer to the advantages of plant extracts, such as antioxidant capacity, tyrosinase inhibition and antimicrobial activity, which can be beneficial for attenuation and prevention of various skin conditions.In summary,many plant extracts, after being duly studied, can be a safe, efficacious and cost effective alternative to synthetic products. Our main aim of this article to review the efficacy of the plant based ingredients in Cosmetic category.

References :
o Rawlings, A.V.; Scott, I.R.; Harding, C.R.; Bowser, P.A. Stratum corneummoisturization at the molecular level. J. Investig. Dermatol. 1994, 103, 731-740
o Hardin, C.R.; Watkinson, A.; Rawlings, A.V. Dry skin, moisturization and corneodesmolysis. Int. J. Cosmet. Sci. 2000, 22, 21-52
o Draelos, Z.D. The cosmeceutical realm. Clin. Dermatol. 2008, 26, 627-632
o Mukul, S.; Surabhi, K.; Atul, N. Cosmeceuticals for the skin: An overview. Asian J. Pharm. Clin. Res. 2011, 4, 1-6
o Dweck, A.C. Botanicals–Research of actives. Cosmet. Toilet. 1996, 111, 45-57
o Dureja, H.; Kaushik, D.; Gupta, M.; Kumar, V.; Lather, V. Cosmeceuticals: An emerging concept. Indian J. Pharm. 2005, 37, 155-159
o Chaudhari, P.M.; Kawade, P.V.; Funne, S.M. Cosmeceuticals–A review. Int. J. Pharm. Technol. 2011, 3, 774-798
o Anitha, T. Medicinal plants used in skin protection. Asian J. Pharm. Clin. Res. 2012, 5, 35-38
o https://www.medicalnewstoday.com/articles/321543
o Calliste, C.A.; Trouillas, P.; Allais, D.P.; Duroux, J.L. Castaneasativa Mill. leaves as new sources of natural antioxidant: An electronic spin resonance study. J. Agric. Food Chem. 2005, 53, 282-288
o Ribeiro, B.; Rangel, J.; Valent?o, P.C.; Andrade, P.B.; Pereira, J.A.; B?lke, H.; Seabra, R.M. Organic acids in two portuguese chestnut (Castaneasativa Miller) varieties. Food Chem. 2007, 100, 504-508
o Barreira, J.C.M.; Ferreira, I.C.F.R.; Oliveira, M.B.P.P.; Pereira, J.A. Antioxidant activities of the extracts from chestnut flower, leaf, skins and fruit. Food Chem. 2008, 107, 1106-1113
o Almeida, I.F.; Maleckova, J.; Saffi, R.; Monteiro, H.; Goios, F.; Amaral, M.H.; Costa, P.C.; Garrido, J.; Silva, P.; Pestana, N.; et al. Characterization of an antioxidant surfactant-free topical formulation containing Castaneasativa leaf extract. Drug Dev. Ind. Pharm. 2015, 41, 148-155
o Beneficial and Healthy Properties of Eucalyptus Plants: A Great Potential Use Article in The Open Agriculture Journal o August 2016 DOI: 10.2174/1874331501610010052
o Leung, A.T.; Foste, S. Encyclopedia of Common Natural Ingredients Used in Food, Drugs and Cosmetics; Wiley: New York, USA, 1996
o https://draxe.com/nutrition/holy-basil-benefits
o https://www.titanicspa.com/blog/a-z-of-natural-skincare-ingredients-and-their-uses
o P?rez-Bonilla, M.; Salido, S.; van Beek, T.A.; Altarejos, J. Radical-scavenging compounds from olive tree (Oleaeuropaea L.) wood. J. Agric. Food Chem. 2013, 62, 144-151

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Rice Ferment Filtrate in Cosmetics

Yesenia Harris

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About Author

Vinay Kumar Singh.

Head-Formulation

Kumar Organic Products Research Centre Pvt. Ltd., Bengaluru

Rice water is nothing but cloudy-milky water that you throw away after soaking the rice for a few hours or boiling them. You would be surprised to know that rice water contains a lot of minerals and vitamins like amino acids and vitamin B6, which might benefit your skin and hair by increasing shininess, enhancing softness, strengthening the hair while protecting against the various damages to your skin & health goes through.

Rice is part of India’s beauty legacy, which contains ferulic acid, a powerful antioxidant, and allantoins, anti-inflammatory properties. So, whether you eat rice or not, use it in your face pack for glowing skin. The starch in rice water soothes the skin in conditions like eczema.

Rice water has been used in Asian beauty rituals for centuries to achieve glowing and smooth skin. Using rice water for the skin is a natural home remedy in treating and preventing acne, removing acne scars, and getting rid of hyperpigmentation.

Rice water contains amino acids, vitamins B and E, and minerals that promote cell growth, stimulate blood flow and keep the skin smooth, youthful, and bright in chilly weather conditions. It’s a beauty booster used by more and more people worldwide.

Rice is, of course, delicious as one of the vital culinary ingredients worldwide, so we all know how to make it, but when we are using it for beauty purposes, it’s a different process, very simple, by the way.

A Chinese Village in Huangluo was named as the ‘Long Haired Village’. This is because the Yao women out there have the most beautiful, shiny and long hair. And guess the length of their hair? The majority of the women have hair longer than 1.4 meters, and they even made a place in the Guinness Book of World Records as the “world’s longest hair village”.

Yao women have a belief that long hair signifies prosperity, good fortune, longevity, etc. Thus their long hair is undoubtedly their prized possession! Also, they do not have grey hair till their late 80s.

The Yao women believe that the fermented rice water, which they use to cleanse their hair, is what helps to keeps their hair long, dark and clean.

Furthermore, female rice farmers in China, Japan, and other Southeast Asian countries used to bathe and wash, in the water used for cleaning rice. Rice water is the secret recipe of flawless-skinned Japanese geishas for centuries.

In Korean cuisine, rice water has been used for a long time to cook dishes like stews. They also use rice water for braising fish or to wash it, which further takes away all the smell of the fish. Korean people also use rice water for deodorizing their plastic containers. You will be surprised to know that it can also be used for cleaning dishes and as a natural fertilizer for plants as it’s loaded with minerals and vitamins.
Benefits of Rice water for hair and skin

1. Promotes hair growth

The fascinating length of the Yao women proves that rice water inevitably has a significant role in the hair growth. This magical potion is rich in Amino Acids, Vitamin B, Vitamin C and Vitamin E, which encourages hair growth to a great extent. The Amino Acids are an excellent ingredient for hair growth. It boosts

protein and keratin production, which are the basic necessities for your hair. Vitamin B is significant to maintain your hair’s strength, and Vitamin C keeps the sebum production in check to an optimum mark. Vitamin E prevents hair loss and keeps your hair hydrated so that it doesn’t feel dry or dull.

2. Prevents Split Ends

The problem of Split ends is pretty common, and this is a real nuisance. The amount of effort and time invested in making your hair long gets wasted completely when you chop off your hair length to eliminate the split ends. This is simply heart breaking. Rice water is an excellent remedy to prevent split end.

3. Cures Dandruff

There is simply no individual on earth who hasn’t dealt with the struggle of dandruff. Rice water has been proven to help with dandruff by fighting the fungi, which causes dandruff and eliminates those dry white flakes to a large extent. It also helps maintain the pH level of your hair.

4. Gives damage protection

Styling tools are common in our everyday life. Perfect straight hair is one of the ongoing trends right now. Investing in a damage protectant or protectant serum is essential but can be costly. The carbohydrate present in the rice water is a great damage protectant. It can be used before applying any styling tools. It reduces the surface friction and also increases the elasticity of your hair. Thus, making it less prone to damage by those heating tools.

5. Has Inositol, a carbohydrate to help

A recent research showed that rice water exhibits hair care properties, such as decreasing surface friction and improving hair elasticity. Rice water has inositol, a carbohydrate that can repair damaged hair, as well as protect it from further damage. Specialized imaging technique shows that inositol stays inside the hair even after rinsing, offering continuing hair protection and beautifying effects. These remarkable benefits explain the 6 feet, healthy, long and beautiful hair of the Yao women.

6. Skin benefits.

Due to its cooling and soothing effects on skin, it is often prescribed as an effective ointment to cool off inflamed skin. Rice water also has moisturizing, antioxidant, and healing properties that help to improve circulation, prevent or fade age related spots, and ease inflammation to give you a healthy, better moisturized and clear skin. As long as it’s left on the skin, rice water is even believed to offer mild protection from the sun.

Rice water illuminates, firms, and tightens skin to create a porcelain finish. It reduces pore size, leaving a powdery, soft feeling behind. Rice water is also good for acne since it reduces redness and blemishes.

Black rice is indigenous to Northeast India, and is extensively grown in Odisha, West Bengal and Jharkhand. Commonly eaten in Manipur, the dish is called chak-hao, which translates to rice (chak) which is delicious (ahaoba). It’s a medium-grain rice that originated in China and other parts of Asia some 10,000 years ago.

Varieties of black rice is grown everywhere from Thailand and Indonesia to China, Japan, and India. This rice also grows in countries all across the world. Some varieties are short-grained, and some are long-grained. Long-grained rice is slightly healthier since it has less starch, giving it a lower glycemic index.

Kavuni Arisi (Black Rice): Almost unique to the Chettinad region in Tamil Nadu and evidence of the Chettiar community’s strong links with Burma, black rice is prevalent across South East Asian cultures and is a rich source of Iron and Vitamin E. The bran hull of black rice has one of the highest levels of anthocyanin antioxidants found in any food (even more than blueberries).

Black rice has a spectacularly high level of anthocyanin, which might be why it’s revered in, for example, China as an extremely healthy food as they help to protect your cells against damage. These pigments are also known for reducing inflammation and helping reduce the risk of cardiovascular conditions. Eating black rice can give you a worthwhile boost on your heart health and overall fitness.

It also is fairly tricky to grow, at least in terms of yield, which is often as low as 10 percent of other rice varieties. It’s occasionally called “emperor’s rice” or “forbidden rice” for that very reason but oral history suggests that only the richest of the rich were able to afford the delicacy. Chinese emperor to ensure his health and longevity, had forbidden it to all others. In fact, it has more fiber and protein than red, brown, or white rice.

Black rice also provides these health benefits :

Improved Eye Health: Along with protective anthocyanins, black rice contains high amounts of lutein and zeaxanthin, two carotenoids known for their role in supporting eye health. These antioxidants help to protect the cells in your eyes and to reduce the effects of ultraviolet (UV) radiation.

Diabetes Management: Flavonoids like anthocyanins also influence blood sugar levels and diabetes management. Phytochemicals have a positive influence on our body, improving insulin sensitivity. They also help by reducing sugar digestion in your small intestine, which lowers sugar levels in your blood.

Nutrition : Black rice is rich in amino acids, fatty acids, antioxidants, flavonoids, anthocyanins, and other phenolic compounds. There are 18 amino acids in black rice, with a mix of essential and non-essential types. Amino acids are crucial to many of your body’s functions, from helping repair skin and tissues to improving your energy levels and digestion.

At KOPL Biotech Centre, we explored The SCIENCE behind Rice Water. We believe in innovation so we have launched Kopryza- A black rice ferment filtrate.

The pH level of rice water is slightly harsh on our hair. However, Fermentation process reduces the pH level of rice water and equal to the pH level of the Hair, and nourishes it better due to the effective penetration of vitamins into the scalp and hair structure. Its purported benefits include “promotes hair growth, protects and repairs hair, increases shine and smoothness, detangles the hair, reducing hair fall and makes hair stronger”

Fermented rice water contains “Vitamins, proteins, minerals, keratin and antioxidants”. Once fermented, rice water nutrition is magnified, it is found to produce additional nutrients such as niacin and biotin, which are ingredients in most of the hair growth supplements. Fermented rice water has a natural carbohydrate called Inositol. Inositol penetrates and lingers in the hair shaft to provide repair and lasting protection.

Among the various rice varieties researched at our Biotech Centre, Black Rice was found to possess significantly higher levels of different carotenoids like ?-carotene, lutein and phenolics. It is rich in 18 amino acids, minerals and vitamins like Copper, Iron, Zinc. It is also reputed for having high anthocyanin content and hence, high antioxidant activity, which protects, the skin and hair from damages caused by free radicals.

KOPRYZA is the new hair care ingredient developed at KOPL Biotech Centre where all the benefits of Karuppu, Kavuni Rice are scientifically captured for the benefit of the hair & skin. They are highly recommended for all kinds of shampoos and conditioners and for all types of hair. The best thing is that the goodness imparted onto the hair stays even after multiple washes. The original goodness of black rice water further gets augmented by fermentation.

Inositol content of Kopryza was estimated by HPLC method as 48.45mg Inositol /100g

Bioactives(Peptide) in Kopryza: Oligopeptide is a small molecule of protein, which is also known as a peptide. Oligopeptide content of Kopryza is found to be 5.81 g/L. The molecular weight of this peptide is found to be 10 KDa.

Keeping in mind, the attribute it offers, we have developed many formula. One such formulation of 2 in 1 Conditioning Shampoo, as described below which will help repair hair damage. It will wash away hair woes with the natural goodness of Fermented Black Rice Water and put a full stop to deteriorating hair quality.It improves hair texture by adding elasticity, increasing volume, and giving it a healthier appearance, while also shielding it from further damage being rich in vitamins and minerals.

FORMULATION

2 in 1 Conditioning Shampoo

This Shampoo tends to clean the hair by removing dead cells and sebum from scalp. Kopryza present in the shampoo conditions, helps in detangling the hair & making them smooth and shiny.

Phase

Sr.No

Ingredient/INCI

Wt.%

Trade name /supplier

Uses

A

1

Aqua

QS to 100

In-house

Solvent

2

Acrylates/C10-30 Alkyl Acrylate Cross polymer

0.3

Lubrizol

Rheology modifier

3

Sodium Lauryl Ether Sulfate

45

Godrej

Surfactant

4

Guar Hydroxy Propyl Trimonium chloride (GHPTC)

0.3

Akzo nobel

Rheology modifier

5

Dimethicone

0.75

Dow corning

Conditioning & Shining agent

6

Disodium EDTA

0.1

S.D.Fine

Chelating agent

7

Cocoamidopropyl Betaine

6

Delta Green

Surfactant

B

8

Cetyl Alcohol

0.6

S D Fine

Emulsifier

9

Cocomonoethanol amine

2

Otto Chemicals

Foaming agent

10

Ethylene Glycol Distearate

0.3

Croda

Pearlizing agents

C

11

Polyquaternium 44

1

Delta Green Science

Conditioning agent

12

Rice ferment Filtrate

2

Kopryza/ KRC

Conditioning agent

13

D Panthenol

0.6

Delta Green Science

Conditioning agent

D

14

Green Infusion

0.5

Ultra International

Perfume

15

Triethyl citrate, Benzoic acid, Caprylyl glycol

1

KOPTBC/ KRC

Preservative

E

16

pH adjuster (18% NaOH)

~0.5*

S.D Fine

pH Adjuster

*pH range- 6.0-7.0

Procedure :

1. Weigh phase A & phase B ingredients separately and heat to 70-80?C.

2. Add phase B at 75?C to Phase A at 75?C slowly under stirring, maintain temperature of 75?C for 5-10mints.

3. Add phase C to phase AB at 45?C.

4. Add phase D at Room temperature (RT) to phase ABC at 35-40?C under mixing. Mix it well and allow to cool to RT.

5. Adjust pH with phase E and fill the product in suitable container.

Product Specification :

Parameter

Specification

Results

Appearance

White/off white Viscous liquid

Off White viscous liquid

Odour

Characteristic

Characteristic

pH

4.0-9.0

6.01

Viscosity*

Min.3000cps

4500cps

*Note: Viscosity determined by using Brookfield viscometer, Model LVDV II+PRO,

Spindle no: S6.3 @ 50RPM, 26?C

Ref : FD/AT/10/023A

Stability: Passes 12weeks at 45?C and passes 3 freeze/thaw cycles

Conclusion: Product was observed to be stable without any colour change or separation. Thus it was found to be stable.

KOPL Products :

Kopryza : Rice ferment filtrate Obtained by fermentation of Black Kavuni, Rice a rare variety of rice from south India using Bacillus bacteria, Suitable in skin care & hair care products

KOPTBC : This is a preservative blend of Caprylyl glycol, Triethyl citrate, Benzoic acid which is used in skin care, hair care Color cosmetics products.

Directions for Use :

Wet hair thoroughly with warm water. Take shampoo in your hand and rub it to generate foam. Apply on your scalp and hair length. Massage the shampoo into your scalp for 2-3 minutes. Rinse your hair with plenty of water. Use conditioner for better result

Fermented Black Rice Filtrate has lingering effective conditioning effect for hair and soothing & moisturizing effect on skin, making it useful for Hair care, Skin care & Colour cosmetics alike and truly Rice water just might be Asia’s best kept beauty secret, which is also confirmed by The Health Science Journal.

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Pharma

Inauguration of Pharmacy Council of India: First Step in Implementation of Pharmacy Act, 1948

Yesenia Harris

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Inauguration of Pharmacy Council of India: First step in Implementation of Pharmacy Act, 1948

About Authors
Dr. R. S. Thakur
Chief Editor, Journal of Pharmaceutical Research
Krupanidhi College of Pharmacy, Bengaluru-560035.
Email: drramsthakur@gmail.com

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Thu, 01/13/2022 – 17:31

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