Introduction We pride ourselves on being a completely research oriented company.

Indeed, it is this emphasis on R&D that allows us to produce safe, efficacious and consistent remedies using ayurvedic principles. Our R&D department is focused on product development, quality control and standardization. All our products are derived through rigorous research and produced in state-of-the art facilities. They represent our commitment to continuous investment in the best people, practices and technology. We do not support "Borrowed Science" or the practice of using published literature to substantiate efficacy claims. Each product undergoes years of primary research before it reaches the market.

Recognition In March 2011, we were granted a "Good Manufacturing Practices (GMP)" Certificate, issued by the Licensing Authority, Directorate of Indian Systems of Medicine, Bangalore. We are the only phytopharmaceutical company whose ayurvedic product, Liv.52, a hepato-protective formula, is registered as a 'pharmaceutical specialty' in Switzerland. Our R&D wing has been recognized as a Research Center by the Rajiv Gandhi University of Health Sciences, Karnataka, India.

Quality Assurance Quality covers two areas - Quality Assurance and Quality Control. Pharmaceutical products are designed and developed with the following requirements GMP (Good Manufacturing Practices) GLP (Good Laboratory Practice) GCP (Good Clinical Practice) GMP (Good Manufacturing Practices) for pharmaceuticals include assessment of quality, safety & efficacy: a. Crude plant material - pharmacognosy b. Plant preparation - analytical c. Finished product - formulation and development d. Stability - stability studies are conducted on all our products as per ICH (International Conference for Harmonization) guidelines to ensure quality of the product throughout its shelf-life Safety Assessment

a.

Toxicological studies - acute, subchronic, chronic, and teratogenicity

Efficacy assessment

a.
b.

Activity - pharmacological Clinical studies - phases I, II, & III

Formulation of products

1.
2. 3. 4. 5. 6.

Identification (Literature surveys of ancient classical texts and scientific literature) Pharmacognosy - microspical identification, macroscopical identification, maceration and cultivation Preclinical pharmacology Standardization - Certificate of analysis, quality assessment, purity Formulation and Development - development of dosage forms, stability studies Clinical studies - Phases I, II & III, and Phase I V (post-marketing surveillance)

The Quality Management System at Himalaya 1. QA holds prime responsibility for generating systems and procedures, handling product complaints, audit, process stabilization and validation 2. Regulatory Affairs prepares QA-related documents for product registration, GMP documentation and answering technical queries 3. QA regulates sourcing, site approval, GMP maintenance, transfer of technical documents, training support, product technology transfer, daily reviews and audits 4. For GMP - documentation of critical steps in the manufacturing process and any significant changes made to the process are

validated Good Laboratory Practices (GLP) 1. Organizational process; includes the conditions under which laboratory studies are planned, performed, monitored, recorded and reported 2. Purpose - to promote development of quality test data - comparable for mutual acceptance in different countries - to avoid technical barriers to trade - to develop standards for herbal formulations - to protect human health and environment 3. GLP principles - Standard Operating Procedures, test facilities, personnel and test systems Good Clinical Practices (GCP) 1. An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human subjects 2. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with principles in the declaration of Helsinki, and that the clinical trial data are credible 3. Objective - to provide a unified standard Good Agricultural Practices (GAP) A benchmark of acceptable crop production methods A prerequisite to manufacturing pharmaceutical-grade products A code of conduct that lays down how crops must be grown right so quality of product is not compromised Stipulates that use of pesticides and herbicides, if any, be documented, synthetic fertilizer be minimized and banning human sewage sludge in fields Introduced by European Herb Growers Association GAP considers parts of plant used, water availability, temperature during growing season, time of harvest, and storage and transport of the raw material as all impact the therapeutic properties of herbal medicine Good Agricultural Practices are helped by Good Harvesting Practices

Good Harvesting Practices (GHP) Covers wild crafting of medicinal plants Designed to ensure that wild material is harvested in a sustainable and environmentally acceptable way

Research Activities Pharmacognosy Establish bona fides of herbal materials through morphological and microscopic studies Maintain herbarium of phyto-medical materials. Formulation and Development Pre-formulation studies to check the biochemical action of ingredients. Trials to assess safety and efficacy of formulations. Accelerated stability trials to check physical, chemical, microbiological and biological aspects of formulations. Standardize processes for uniform quality. Transfer of technology to the production department. Immuno-pharmacology Study the mechanism of drug action at a molecular level. Attempt to understand the endogenous mediators involved in the activity. Develop immuno-protective agents to counter opportunistic infections in AIDS, carcinogenic malignancy, septic shock, organ transplantation and chronic infections. Substitute work with in vitro (in the laboratory) cell line models for in vivo (in the body) experiments. Veterinary Pharmacology Study the safety and efficacy of veterinary formulations in experimental and clinical trials on different animal species. Study the mechanism of action in the formulations.