Pharmacological Definition of Medication: a chemical substance used in the procedure, cure, avoidance, or analysis of disease or used to in any other case enhance physical or mental well-being.
i) All medications for internal or external use of human beings or animals and everything substances designed to be used for or in the analysis, treatment, mitigation or prevention of any disease or disorder in humans or pets, including arrangements applied on body for the intended purpose of repelling bugs like mosquitoes
(ii) Such substances (other than food) intended to affect the composition or any function of body or intended to be used for the damage of (vermin) or bugs which cause disease in human beings or pets, as may be given from time to time by the Central Authorities by notification in the Official Gazette
(iii) All substances intended for use as components of a medication including clear gelatin capsules
(iv) Such devices intended for internal or external use in the medical diagnosis, treatment, mitigation or reduction of disease or disorder in human beings or pets, as may be given every once in awhile by the Central Federal government by notification in the state Gazette, after assessment with the Plank.
The pharmaceuticals industry involves organizations that are generally involved with fabricating or control medicinal chemicals and pharmaceutical products. The industry also contains establishments that formulate pharmaceutical products. An establishment is a single physical location or a service where developing occurs.
Pharmaceutical Industry differs significantly from the rest of the chemicals industry in its commercial functions and regulatory requirements. For instance, in its professional techniques, the pharmaceuticals industry uses more batch operations than the chemicals industry as a whole. Since some of the bulk making operations entail extracting relatively small, highly focused quantities of substances from much larger volumes of uncooked material, the industry's creation produce for these functions is correspondingly low.
The pharmaceuticals industry also obtains comprehensive regulatory oversight by the National body like Food and Medication Administration (FDA). Whenever a pharmaceutical company discovers a element that may have medical probable, the company usually is applicable for a patent. Any medication created from the ingredient may be promoted only after authorization by the National Food and Medication Administration Systems. The medication development process, beginning with initial toxicology screening, followed by professional medical trials for safe practices and performance, and review of the application form by the FDA averages fifteen years. When the company's patent or period of exclusivity has expired, others may rely on the initial manufacturer's data on safe practices and effectiveness to obtain approval to advertise a general version of the medicine. Companies wanting to produce the same medicine once it is off-patent are required to obtain FDA marketing endorsement, based on information that the general version is "bioequivalent, " i. e. , differs in the rate and scope of medication absorption by no more than 25 percent nor less than the 20 percent from the original medication. While companies that focus on the development and marketing of brand-name, innovator drugs may have subsidiaries that make universal products, most common drug companies do not execute research designed to identify and develop innovator drugs
Marketing in Pharmaceutical Industry: Marketing Pharmaceutical products is different from other market sectors, as the ultimate consumers (Patients) aren't targeted instead, the trained doctors are targeted for marketing. The products can be promoted only after getting the Approvals from regulatory authorities of any Country.
Therapeutic moral pharmaceutical products fall into four extensive categories:
New chemical entities (NCEs)--new healing molecular compounds which have never before been used or tested in humans.
Drug delivery mechanisms--new approaches to delivering therapeutic brokers at the desired dose to the required site in the body.
Follow-on products-new combos, formulations, dosing varieties, or dosing advantages of existing compounds that must definitely be analyzed in humans before market launch.
Generic products--copies of drugs that are off patents or other exclusive marketing rights.
R&D is needed to bring all of these products to the marketplace. The penetration of the Drug depends on its security and efficacy. Innovative formulations having more efficiency can be produced by continuous affords in R&D activities.
Fig. 1. Growth of Global Pharmaceutical Sales
Finished generics provided from India account for 20% of the global generics market.
More Than 90% of WHO Prequalified API [ARVs, Anti-tubercular & Anti-malarials ] are sourced from India.
It is believed that 70% of the patients owned by 87 growing countries received medication procured from India by
The United Nations Children's Fund (UNICEF)
International Dispensary Relationship (IDA)
The Global Finance and
The Clinton Foundation.
Medicine Sans Frontiers also buying 80% of its ARVs, for its assignments in over 30 countries, from India
Indian generic ARVs approved by the united states Food and Drug Administration (All of us FDA) also led to cost-savings of the over 90% of the ARVs for PEPFAR
Undoubtedly India has earned a place among the top
Unquestionable supremacy in research, chemistry skills, engineering, regulatory compliance, and IP Management
Fig. 11. Progress in quantity of USFDA approved systems in India
Research and development defined as future focused, long-term activity of research and technology. The R&D activity is clinical research that has aimed towards the desired end result with forecast of commercial yield.
However, the new product development is a risky, highly expensive and a time taking most of the companies providing an equal importance to R&D along with marketing. As per the recent studies, almost 16%-20% of the business's total investments are in R&D whereas for marketing it is up to 20% to 30%.
Marketing: - Marketing is the experience, set of institutions, and processes for creating, connecting, delivering, and exchanging offerings which have value for customers, clients, associates, and world (consumer).
Pharmaceutical marketing will involve various steps or levels as follows unawareness to understanding, awareness to interest, Interest to Evaluation, Analysis to trail, trail to consumption and utilization to repeated consumption.
The Fast Moving Consumer Goods (FMCG) marketing that work on 4Ps (Price, Product, promotion and Place) varies with pharma marketing entirely except in Promotion. The marketing promotions of pharmaceutical products are highly regulated and there must be clinical approvals for the words we mention in the sales aids.
The critical activity in New Product development is integrating R&D and Marketing. The potency of integrating R&D and Marketing increase successfulness of New Product Development and shorten the NPD processing time. This happens only because of exchange of knowledge and experience between R&D and Marketing. The integration between R&D and Marketing has improved business environment that are more energetic with organizations having a growing pressure to find acceptable control through quicker improvement series, lead time, new product development effectiveness and success
The proposed study is required to identify and gauge the extent of R&D investment and market strategies as a driver for business development of Generic Medicine Manufacturing companies
The proposed review is needed to demonstrate the R&D costs as the key the driver for various sections of Pharma Industry
The proposed analysis is needed for scientifically demonstrating the relationship between R&D expenditure and expansion of pharma industry to help the insurance policy makers (Govt. Regulators) for making strong and necessary insurance policies for sustainable growth of Indian Pharma Industry
(essential to identify the extent of relationship b/w growth in different segments of sale and R&D expenses)
To review the strategies followed by the Pharma companies in R&D ventures for their ecological growth
To study the effect of R&D ventures in traveling the growth in sales profits of pharma companies
To build/ research the correlation between the R&D expenditure and the sales performance.
To analysis the correlation between your R&D expenditure and the sales performance across
API concentrated companies
Formulation centered companies
Vertically integrated players
Collection of Data of deal earnings, regulatory approvals, key decisions in R&D investments, product profile of the sample pharma companies from various resources
Analysis of the data with statistical tools, evaluating and correlating the R&D expenses and market strategies with the success of the business which is measured in terms of regulatory approvals received by the company, sales income, sales of particular products or product category
Statistically proving the relation between R&D assets and the ongoing/sustained progress of the pharma companies
The following pharma companies are decided on for the suggested research from various sections of the pharma industry i. e
API centered companies
Formulation targeted companies
Vertically included players
M/s Aurobindo Pharma Ltd
M/s Dr. Reddy's Laboratories Ltd
M/s Natco Pharma Ltd
M/s Granules India Ltd
M/s Divis Laboratories Ltd
M/s vivimed Labs Ltd
M/s Gland Pharma Ltd
M/s MSN Laboratories Ltd.
M/s Matrix Laboratories Ltd
M/s Laurus Labs Pvt. Ltd
The pursuing tools will be utilized for analyzing the info of R&D assets, sales performance, results of R&D expenses in terms of regulatory approvals and individual product sales of the topic companies
R&D purchases as a share of total sales