Adequate facilities exist in our laboratory and animal house to perform various toxicological and efficacy studies of drugs, pharmaceuticals and neutraceutical formulations.

The facilities in the Toxicology Department are;

Animal house

• CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals, under Govt. of India) registered laboratory animal house facilityto conduct research on various experimental animals like rodents and rabbits.
• Well-maintained and spacious animal rooms with 24hr air conditioning facility
• Separate rooms for different laboratory animal species.
• Animals maintained under hygienic conditions
• Individually Ventilated Caging (IVC) System - for housing laboratory animals

Laboratory

To perform analyses on various samples collected from the experimental animals. Major equipments available in the toxicology laboratory include;

• Auto Analyzer - for Serum Biochemistry
• Haematology cell Counter
• Lyophilizer or Freeze Dryer – freeze-dry system used to remove solvent from frozen samples, (eg. plant extracts)and it can be preserved for long
• Histopathology Processing Unit for the microscopic examination of tissues

Institutional Animals Ethics Committee (IAEC)

• A committee recognized and registered by the CPCSEA
• To review and approve all types of research proposals of lab animal experimentation before the start of the study.

Institutional Scientific Advisory Committee (ISAC)

• A committee of in-house scientific personals and one external expert advisor
• To review and modify the research proposals before submitting to the IAEC.

Chronic Toxicity Studies

Chronic toxicity adverse effects are observed following repeated exposure to a chemical during a substantial fraction of an organism's lifespan (usually more than 50%). For humans, chronic exposure typically means several decades; for experimental animals, it is typically more than 3 months. Chronic exposure to chemicals over periods of 2 years using rats or mice may be used to assess the carcinogenic potential of chemicals.

IPreclinical studies -An overview

Toxicological Studies:

• Acute (single dose) toxicity studies
• Sub-acute and sub-chronic (repeated dose) toxicity studies
• Chronic (repeated dose) toxicity studies
• Irritation studies
• Allergic sensitization
• Reproductive toxicity studies

Efficacy studies conducted in our Lab:

• Analgesic and Anti-inflammatory activity
• Hypolipidemic activity
• Hepatoprotective activity
• Anti-ulcer activity
• Wound healing activity
• Cardio protective activity
• Immunomodulatory activity
• Anti convulsant activity
• Other pharmacological studies

Facilities for students

Small Animal Research Centre (Department of Toxicology & Pharmacology) at CARe Keralam Ltd. offers a good opportunity to students/research scholars in life science/related fields,

• To carry out their dissertation and project works in Pharmacological/Toxicological studies by utilizing the superior facilities present in the department.
• Training on laboratory animal handling and experimentation techniques

Main toxicological Study Designs

1.ACUTE TOXICITY STUDY

Single-Dose Toxicity Study based on OECD Guideline 420

2.REPEATED DOSE TOXICITY STUDIES

a)Subacute Toxicity Study based on OECD Guidelines

Main study	Recovery
	Groups	Males	Females	Males	Females
Laboratory rodents	Control	5	5	5	5
	Low	5	5	0	0
	Mid	5	5	0	0
	High	5	5	5	5
Total no. of animals		N = 40		N = 20
Dose Route	To be specified (ex. oral, bolus iv, infusion, subcutaneous injection,intraperitoneal injection, topical ocular, etc.)
Dose Frequency	Daily for 28 days
In-life Study Duration	28 days dosing, plus Recovery Period (i.e. 14 days)
Dose formulation	As specified by Sponsor—additional charges may apply

Evaluation parameters

b)Subchronic Toxicity Study based on OECD Guidelines

Evaluation parameters

Study sample processing

• Identify the category of your “Product” and its potential by Business Development Executive CARe Keralam
• BD Communicates to Department
• Cost of Study, Duration, Volume of Samples, Certificates needed will be informed
• Sign work order
• 50% of Study Cost as Advance
• Preparation of Protocol (Form B) by Scientific Committee, CARe Keralam.
• Approval from Institutional Scientific Advisory Committee (ISAC)
• Approval from Institutional Animal Ethics Committee (IAEC)
• Study conduction
• Recording of Observations and Statistical Analysis of Data
• Interpretation of results and report preparation
• Release of Study Report on final payment

With advent of modern machines and the need to produce on a commercial scale increasing in Ayurveda,there exists a lacunae in uniformity in method of manufacturing. A trial and error method is being followed , which may even compromise the core ingredient of the formulation.

These have resulted in batch to batch variation in final products . At our validation lab we will help you, through our pilot scale production, to arrive at a documented ,uniform, manufacturing process, scaling up process, economic process development.

We also provide consultancy on new product development of Arishtas, Asavas, Grhithams, Tablets, Liquids, Syrups, Powders, Creams & Ointments. A trial pilot batch will be take in presence of the client, as the last stage of consultation.

Production

Our plant comprising of 5894 sq. ft. is designed taking into account man, material and process flow and as per GMP and WHO specifications. It is equipped with high end machineries for softgel encapsulation, tableting and blistering of multi vitamin, mineral, nutraceutical and ayurvedic products.

• Herbal Ayurveda Preparations
• Cosmeceuticals Development
• Formulations
• Contract Manufacturing
• Process & Product Standardization
• New Product Development
• High Quality Rawmaterials
• Tablet Coating

Encapsulation Facility

We have a state of art encapsulation facility. The floor is polyurethane coated and the walls are puff insulated. Our encapsulation machine is a jumbo model of Chang Sung make, with a capacity to encapsulate 100000 capsule/hr. This a boon to the ayurvedic Industry as many dosage forms in oil phase can be converted into aesthetic soft gel capsules.

Tablets/Coated Tablets/Extract’s Tablets

A 16 station granulation machine takes care of all the compression requirements when the granules are provided to us as per the pre-approved validated formula.

Blister Packing

Packing, which is one of the important criteria that adds to shelf life of a product, is taken care by our blister packing machine with a capacity of 240 packs/minute.

Softgel Encapsulation

The medicine in a liquid or semi-solid state supplied by the entrepreneur is converted into soft gelatin capsule form. Applications: Traditional oil, ghee, ghritham fillingNeutraceuticalsMultivitamins, Vitamin E, Honey etcTableting

The medicine supplied as dust or granules is compressed into tablets along with excipients and lubricants to ensure efficient tableting.Applications:Extract tablets, Herbal tablets,Coated tablets, Various patented tablets, Clasical tablets

Range of Size & Shape of Tablet:75mg to 750mg, round and oblong

Blistering & Bottling

Facility for Blister packing and Bottle packing of Soft gelatin capsules and tablets.Range of Blister Dye: 6, 8, 10, 11.5, 12.5,15 mm tablets and 4, 10 oval soft gel capsule and 22 oblong and zero size hard gel capsule

Semi Solid Formulations

• Creams
• Lotions
• Gels
• Ointments
• Balms
• Lip balm

CARe Keralam is a pioneering research institution in the field of Ayurvedic research, with all of the necessary infrastructure and experience to bring innovative Ayurvedic medications from concept to market. It is critical to the advancement of Ayurveda in the country. Research and development is the brain and backbone of any Life science companies. Our R&D department has been involved in the research, development, and commercialization of ayurvedic health products based on Ayurveda and current scientific approaches. The process includes a wide spectrum of activities ranging from identification of raw materials to formulation of Ayurvedic products with reproducible efficacy.

Despite the good intentions of government organisations, research in ayurveda and herbal medicines of Indian origin, as well as converting that research into commercial medicine, is languishing in the country. In an era of rising consumer awareness of quality and efficacy as well as market competitiveness, we believe that existing products must be strengthened utilising an innovative approach as well as new advancements. It is active in a variety of operations connected to Ayurveda research, herbal pharmaceuticals, nutraceuticals, and phytochemicals employing current scientific and technological approaches while retaining efficacy, safety, and Ayurveda principles.

CARe Keralam Ltd seeks to provide technical assistance in a variety of areas of healthcare research, including the creation and validation of herbal and phytopharmaceuticals, as well as the application of advanced techniques in the plant, microbial, and healthcare industries. We offer technical assistance with pre-clinical compound screening, formulation development, and clinical validation. We also provide professional, student, and researcher skill development through training / internships.

The R&D unit has a team of Doctors, Scientists, and experts from Ayurveda, Botany, Pharmacognosy, Biotechnology, Microbiology, Pharmacology, Chemistry, Herbal Drug Discovery, etc.

Herbal Garden

We are establishing a herbal garden of various types of plants to popularize the usefulness of Medicinal Plants among the research community. Our supreme aim is conserving rare, endangered and threatened species of medicinal plants. The herbal garden of CARe Keralam is spread out in an area of 1 acre of land where more than 250 species of medicinal plants are grown. A part of the herbal garden has been earmarked exclusively for growing herbs required for the research division of Institution.

Recognition of R&D Laboratory

In realisation of the achievements of our R&D Laboratory, the Department of Scientific and Industrial Research (DSIR), Government of India has granted it recognition and formal certification to our laboratory.

Completed Projects:

Ongoing Projects

R&D Capabilities

Our R&D laboratory is well equipped to carry out modern research in various areas of life Sciences. We follow the standard guidelines and protocols for all the scientific studies. Some of the areas of our R&D activities are:

1. New Product development
   • Drug selection, Identification, Extraction, Isolation and Characterisation
   • Chemical/Spectral/ Analytical studies
   • Clinical trials, Pilot studies, Randomized clinical trials, Post Marketing (PMS) study
   • In vitro studies ,Cell line studies
   • Preclinical studies, Toxicology Pharmaceuticals, Cosmeceuticals, Nutraceuticals & Others
   • Development and evaluation of pharmaceuticals, Cosmeceuticals, Nutraceuticals & Others
   • Process validation & optimization
   • Characterization and identification of biomarkers
   • Fingerprinting studies with HPTLC, HPLC, etc.
   • Standardization of herbal as well as ayurvedic medicines.
2. Process Development
   • Development of herbal and modern ayurvedic formulations
   • Preformulation Process
   • Formulations Process
   • Packing and Storage process
   • Economic Process Development
3. Technology Development
   • Industry set up
   • Fabrication of Machines
   • Customised Machines & Equipments
   • Economic and Viable Technology development
4. Problem Solving
   • Existing Product /Formulation/Process related problems
   • Conversion of existing products to new formulations
   • Stability, Palatability, Aesthetic improvement
   • Packaging, Storage, Shelf life Modifications
   • All type of running problem solving
5. Project development
   • Assisting funded/Non funded projects
   • Dealing new projects
   • Completion of Existing projects
6. Academic Services
   • Research support for UG, PG & PhD scholars.
   • Training program for Professionals, Industrialists, and Students.
   • Seminars
   • Publications
   • Intellectual Property Registration
   • Projects
7. Professional Services
   • New Formulations
   • Customized products
   • Process development
   • Process & Product Standardization
   • Advanced technology
   • Regulatory services
   • Licensing services
   • Patenting
   • Copyright& trademark
8. Standardised Raw materials Supply
   • Certified
   • Standardised
   • Genuine
   • Authentic
   • Pesticide & Heavy metal free reference materials
   • At Affordable price Ready to use – No need to rewash or redry.
9. Medicinal Garden/ Herbarium
   • Plant authentication
   • Botanical/ taxonomical identification
   • Pharmacognostic studies
   • Agronomy/Agricultural services
   • Plant Tissue culture studies
   • Taxonomically identified spices. more than 200 species on display

The Cluster Innovation Centre (CIC) supported by the National Innovation Council (NInC), Government of India, promotes innovation leading to entrepreneurship which will benefit to the people at large having potential for successful marketing. CIC in CARe KERALAM is the only Ayurveda cluster in the country, selected by NInC, for the promotion of ayurveda products and services to the global market, at international standards. The Cluster Innovation Centre (CIC) provides a platform for CARe KERALAM and its partners to forge linkages between various stakeholders from industry, academia, research institutions, professional service organizations, Government & non-Government agencies and society on a need basis. With a team management structure, this centre will aid the cluster and its ecosystem by providing guidance to various start-ups on all aspects of the innovation process including training and support, organize initiatives to promote innovations, knowledge/technology transfer, channel various incentives that benefit the cluster and act as an incubating body managing the growth of innovation in the ecosystem.The Centre will serve as a networking hub of the cluster, acting as a catalyst and a facilitator to initiate and assist innovation activities the 'decade of innovation' 2010-2020.

Objectives

• Promote Innovation
• Support Entrepreneurs

Beneficiaries

• Potential entrepreneur
• Investor
• Inventor
• Innovator
• Students
• To act as a connecting point Establish any new entrepreneur ventures by supporting in the following areas.
• Identifying investment area
• Development of product
• Detailed Project Report (DPR)
• Intellectual Property Rights (IPR)
• Funding
• Plant Establishment
• GMP Certification
• Product Registration
• Marketing
• Investor
• Inventor

Activities

Role of the Cluster Innovation Center (CIC)

• Research
• Finance
• Industry &Professional Bodies
• Finance
• Government
• Agencies
• Sectoral Experts

CIC - The connector

• All "internal" units
• All "External" orgs
• Collaboration, Coorperation, Networking

CIC - The chaneel

• R & D, Skills, Mentors, Financiers, Experts

CIC - The leadership

• Catalyze, Facilitate and manage innovation activities on daily basis

Innovation Promotion Units (IPU)

Innovation Promotion Units are aimed at giving support needed to students and faculty in fostering an ecosystem of innovation as well as connecting research and curriculum with applications for the benefit of industry and society. Thus the centre shall provide a platform for taking up innovation-driven projects. This centre will provide guidance in all aspects of the innovation process including training and support, organize initiatives to promote innovations, knowledge/technology transfer, channel available resources and act as an incubating body, managing the growth of innovation in the ecosystem. It will therefore act as a hub for Innovation activities that could lead them into Entrepreneurship, by facilitating and guiding development of ideas into innovative applications that can be marketed successfully.

In an effort to promote entrepreneurship and innovation among students, the Kerala government has announced its Student Entrepreneurship Policy. On this occasion Honourable Chief Minister of Kerala said "Any student who works to create knowledge, innovation, wealth and jobs in our Society through any Government of India recognised Incubators will be given 20% attendance and 4% Grace Marks in the Academic Courses" similar to what is being given to Sports and NCC. We expect this will give the students time to pursue innovation leading to entrepreneurship during their studies and the best of talent now flows into the proposed Innovation Promotion Unit. To emerge as a strong and vibrant economy, Kerala has to emerge from within and empower our talented youngsters to be job-creators and not job-seekers". This could also provide colleges with an opportunity to involve themselves in projects, research and development with industry thereby strengthening their institution and providing industry with value addition in the form of academic research.

CIC functioning at CARe KERALAM can provide complete solutions for all the innovative ideas/entrepreneurs.

Our clinical trial centre can help you with all aspects of medication development. We specialize in Phase I to Phase IV clinical trials of herbal pharmaceuticals and other alternative therapies, as well as their strategy planning, management, execution, and analysis. Our department is prepared to carry out post-marketing surveillance, human clinical research, and all other clinical research and studies in an efficient, ethical, and scientific manner in order to improve medical treatment for the entire world.

Our experts focus on

• Drug development
• Preclinical studies (Toxicology, Safety & Efficacy studies) Bioavailability -Bioequivalence ((BA/BE) studies Pharmacokinetic- Pharmacodynamic (PK/PD) studies
• Clinical Research
  • Clinical Trials - Phase I to Phase IV, BA/BE studies, (PK/PD) studies. Adverse drug events/ Adverse drug reactions (ADE/ADR), Pharmacovigillance. API (Active Pharmaceutical ingredient) clinical trials.
  • Post marketing surveillance (PMS), Post marketing requirement (PMR), Pharmacoeconomic studies, Cost analysis.
  • Pilot Studies, Case Studies, Case/Control Studies, Cohort studies, Systematic Scientific Studies, Blinded studies.
• Clinical studies (as per ICH-GCP guidelines) on Ayurvedic Proprietary Medicines, Classical Ayurvedic Medicines, Herbal formulations, Allopathic medicines, Functional Food / Supplements, Nutraceuticals, Cosmetic products and Homeopathic, Sidha,Unani medicines.
• Clinical Trial Budgeting/ Project/Protocol Preparation.
• Clinical Validation of traditional/Folk medicine

Biostatistics service

• Preparation of Study Design
• Determination of sample size
• Interim Analysis
• Final Analysis & Report
• Data Management / Processing

Medical writing

• Preparation of Protocol
• Investigator Brochure (IB)
• Collaboration, Coorperation, Networking
• Case Report Forms (CRFs)
• Informed consent form (ICF)
• Subject Diaries
• Study logs (delegation log, IP logs etc.)
• Manuscript Preparations
• Publications

Regulatory submissions

• Drugs Controller General of India (DCGI) Submissions
• AYUSH Submission
• Ethics Committee (EC)submissions
• CTRI (Clinical Trials Registry-India) Registration
• Clinical Trials Registry- US
• Clinical Trials government Registration
• Clinical Trial Presentation
• Repurposing Process

Documentation

• Documentation of clinical trial (TMF, PMF, SMF)
• Quality System Management
• Case Report Forms (CRFs)
• DSOP Development
• Data Collection, Retrieval, Auditing

Operations

• Site selection, Site management & Site closing
• Trial Management
• IP and Trial Material Management
• Data Management
• Monitoring
• Clinical Study Report
• Investigator’s Training
• ICH- GCP Training