The PharmaceuticalIndustry develops, manufacture, and markets drugs licensed for use as medicines.For this they have a well-equipped Research and Development department.Pharmaceutical companies are allowed to deal in generic and/or brand medicinesand medical devices.
They are deal with variety of laws and regulations of thegovernment regarding the patenting, testing, pricing and ensuring safety and adequacyand marketing of drugs. The Indian Pharmaceutical industry is thesecond-largest in the world by volume and is ahead to manufacturing sector ofIndia. The first pharmaceutical company of india was Bengal Chemicals andPharmaceutical Works, which still exists today as one of 5 government-owneddrug manufacturers, in Calcutta in the year 1930. For the next 60 years, mostof the drugs in India were imported by multinationals either in fullyformulated or bulk form. The government started to encourage the growth of drugmanufacturing by Indian companies in the early 1960s, and due to the PatentsAct in 1970, the industry got an opportunity to grow. This patent act removedcomposition patents from food and drugs, and though it kept process patents,these were shortened to a period of five to seven years. The lack of patentprotection made the Indian market undesirable to the multinational companieswho had dominated the market, and while they streamed out, Indian companiesstarted to take their places. The multinationals were market leaders at thattime because of their superior technology.
As a result of this, they had gainedexpertise in reverse-engineering new processes for manufacturing drugs at lowcosts. Although some of the larger companies have taken small steps towardsdrug innovation, the industry as a whole has been following this business modeluntil the present. Introduction to Pharma Industry 28 Research and DevelopmentDrug discovery is the process by which the required drugs are discovered ordesigned. In the past most drugs have been discovered either by isolating theactive ingredient from traditional remedies or by serendipitous discovery. Agreat deal of early-stage drug discovery has traditionally been carried out byuniversities and research institutions. All this requires constant innovationand research by either the traditional or modern methods, or a combination ofboth. Drug development refers to activities undertaken after a compound isidentified as a potential drug in order to establish its suitability as amedication.
Objectives of drug development are to determine appropriateFormulation and Dosing, as well as to establish safety. Research in these areasgenerally includes a combination of in vitro studies, in vivo studies, andclinical trials. The amount of capital required for late stage development hasmade it a historical strength of the larger pharmaceutical companies.
Often,large multinational corporations contribute in a broad range of drug discoveryand development, manufacturing and quality control, marketing, sales, anddistribution. On the other hand, smaller organizations lay emphasis on aspecific aspect such as discovering drug candidates or developing formulations.Often, collaborative agreements between research organizations and largepharmaceutical companies are formed to discover any probability of new drug.