GENERIC DRUGS PRODUCT DEVELOPMENT Bashant kumar sah M.PHARM 157 SEMESTER DEPT.PHARMACEUTICS, Nargund college of pharmacyGENERIC DRUG a A drug product that is comparable to brand/innovator drug in dosage form , strength , route of administration , quality and performance characteristics , and intended use. It should contain the same active ingredients as the original formulationWHAT ARE GENERIC DRUGS ? _IThey are drugs which have the same chemical composition as branded drugs are and sold under their chemical name . For example paracetamol , a pain killer , is the generic name for branded drugs like Crocin and Calpol. _ The market situation is a little different in India than the USA or other developed nations . In USA, whena new drug is launched only the company that holds the FDA patent are legally allowed to set the drug , thus giving them market monopoly. _lIn India however there were no patent laws till 2005 which meant that anyone could replicate any drug in India without legal ramifications . This led to the trend of branded generic drugs which has 99.5% of the countrys generic drug shareWHEN GENERIC DRUG MARKETED IA patent and exclusivity after protection ends (JPatent owner waives its rights OIFDA requirements are met10. Labelling Pharma Chemistry Manufacturing Controls Microbiology Testing Animal studies Clinical studies Bioavailability 8. Labelling . Pharma Chemistry Manufacturing Control Microbiology Testing BioequivalenceWHERE ARE THEY AVAILABLE? _IGeneric drugs are sold everywhere including our local chemist. To buy them one simply has to ask for generic version of a branded drug though they don’t have them for all medicines JThe department of pharmaceuticals of the government is responsible for promoting generic drugs but they have not done a very good jobAfter the expiry of the patent or marketing rights of the patent drug , generic drugs are marketed. “IThey are comparable to brand drug in dosage form, strength , route of administration , quality and performance characteristics , and intended use. ()Generic drugs are available at affordable prices with maintaining quality.. These Generic formulations balance public interest as critical disease like cancer , AIDS etcPRODUCT DEVELOPMENT LIPRODUCT : A product is something sold by an enterprise to its customers. _JPRODUCT DEVELOPMENT : Product development is the set of activities beginning with the perception of a market opportunity and ending in the production , sale and delivery of a product.THE PRODUCT DEVELOPMENT PROCESS CJA process is a sequences of steps that transforms a set of inputs into a set of outputs CIA product development process is the sequence of steps or activities that an enterprise employs to conceive , design, and commercialize a product. “JSome organizations define and follow a precise and detailed product development process . While others may not even be able to describe their processesA GENERIC PRODUCT DEVELOPMENT PROCESS _]We will consider here a generic product development that can be used in a market pull- situation. _!The input of the process is a mission statement and the output of the process is the product launch _IMISSION STATEMENT : identifies the target market for the product , provides a basic functional description of the product , and specifies the business goals of the effort ; results from well executed product planning phase —JPRODUCT LAUNCH : Occures when the product becomes available for purchase in the market placeMISSION STATEMENT PRODUCT PLANNING CONCEPT: eat dee) the aa bape} ch SYSTEM : TESTING AND PRODUCTION RA\ tN aCONCEPT DEVELOPMENT _IThe needs of the target market are identified , alternative product concepts are generated and evaluated, anda single development is selected for further development CJA concept is the description of the form, function and features of a product and is usually accompanied by a set of specifications , an analysis of competitive products , and an economic justification of the projectSYSTEM - LEVEL DESIGN Includes the definition of the product architecture and the division of the product into subsystems and components The final assembly scheme for the production system is usually defined during this phase “The output of this phase is usually a geometric layout of the product , a functional specification of each of the products subsystems , and a preliminary process flow diagram for the final assembly processDETAIL DESIGN JIncludes the complete specification of the geometry , materials , and tolerance of all the unique parts in the product and the identification of all the standard parts to be purchased from suppliers. CJA process plan is established and tooling is designed for each part to be fabricated within the production system (The output of this phase is the control documentation for the product.TESTING AND REFINEMENT _IInvolves the construction and evaluation of multiple pre — production versions of the product. _lEarly prototypes are usually built with production intent parts [parts with the same geometry and material properties as intended for the production version of the product will work as designed and whether or not the product will work as designed and whether or not the product satisfies the key customer needs_lLater prototypes are usually built with parts supplied by the intended production process but may not be assembled using the intended final assembly process _\Later prototypes are extensively evaluated internally and are also typically tested by customers in their own use environment “|The goal of the beta prototypes is usually to answer questions about performance and reliability in order to identify necessary changes for the final product.PRODUCTION RAMP - UP JRamp up is a term used in economics and business to describe an increase in firm production ahead of anticipated increases in product demand. Alternatively, ramp up describes the period from completed initial product development to maximum capacity utilization, characterized by product and process experimentation and improvements. _JRamp up in the first sense often occurs when a company strikes a deal with a distributor, retailer, or producer, which will substantially increase product demand.THANK YOU