How to start a generic pharmaceutical company in India?
Generic pharmaceutical company is the company who deals in manufacturing and/or marketing of generic drugs. Licenses and registration procedure of all types of pharmaceutical companies are same, only difference in marketing and distribution type.
Generic drugs:
Generic drugs are the drugs (other than patent brand) which are out of patent and all manufacturers are allowed to manufacture and market it. A pharmaceutical company innovates a new molecule which has efficacy and safety desired to treat any ailments for human or animals, a patent is granted for specific period to innovative pharmaceutical company for recovering its expenditure spent at research and development of that molecule. After expiration of patent, all pharmaceutical companies are allowed to manufacture and market it. All these products whether launched with generic name or brand name other than patent brand are known as generic drugs. Read in detail about generic drugs here.
Generic medicines which are sold by affixing a name is known as Branded Generics and in India, branded generics hold more than 70% market share in pharmaceutical industry.
Generic drugs:
Generic drugs are the drugs (other than patent brand) which are out of patent and all manufacturers are allowed to manufacture and market it. A pharmaceutical company innovates a new molecule which has efficacy and safety desired to treat any ailments for human or animals, a patent is granted for specific period to innovative pharmaceutical company for recovering its expenditure spent at research and development of that molecule. After expiration of patent, all pharmaceutical companies are allowed to manufacture and market it. All these products whether launched with generic name or brand name other than patent brand are known as generic drugs. Read in detail about generic drugs here.
Generic medicines which are sold by affixing a name is known as Branded Generics and in India, branded generics hold more than 70% market share in pharmaceutical industry.
Requirements, procedure, licenses and registration:
Requirements, procedure, licenses and registration are same for starting generic pharmaceutical company as in case of mainline pharmaceutical company. Product approval phenomena could vary product to product. In case of generic medicines, an already existing molecule manufacturing would be started, so, there is no requirement of clinical trial report, safety profile of molecule etc during applying for product approval. Only BE and stability study may be required.
Check out procedure and documents to start pharmaceutical distribution company here
check out procedure and documents to start pharmaceutical manufacturing company here
Distribution of generic drugs:
Generic drugs includes all types of drugs like prescription drugs and OTC drugs etc. All generic medicines are available in Indian market in form of Branded Generics. Only doctor’s prescription differentiates between branded drug brand and generic drug brand in India. If a doctor is prescribing brand name of any drug, it is considered as branded and if it is sold as a substitute or without brand name prescription by doctors is considered as generics.
Check out: Difference between Generic drugs and Branded drugs
Marketing and distribution of generic drugs are done according to drugs type. Chemist and institutions are major market consumers of generic drugs. Aim of distribution channel of generic drugs in pharmaceutical industry is to maximize reach of their generic drugs to chemists/pharmacies and institutions/hospitals.
Generic market is rate based market. How much best rates you can provide, there is chances of getting better sale.
Check out: How to develop distribution channel for generic drugs?
Hope above information is helpful to you...
Requirements, procedure, licenses and registration are same for starting generic pharmaceutical company as in case of mainline pharmaceutical company. Product approval phenomena could vary product to product. In case of generic medicines, an already existing molecule manufacturing would be started, so, there is no requirement of clinical trial report, safety profile of molecule etc during applying for product approval. Only BE and stability study may be required.
Check out procedure and documents to start pharmaceutical distribution company here
check out procedure and documents to start pharmaceutical manufacturing company here
Distribution of generic drugs:
Generic drugs includes all types of drugs like prescription drugs and OTC drugs etc. All generic medicines are available in Indian market in form of Branded Generics. Only doctor’s prescription differentiates between branded drug brand and generic drug brand in India. If a doctor is prescribing brand name of any drug, it is considered as branded and if it is sold as a substitute or without brand name prescription by doctors is considered as generics.
Check out: Difference between Generic drugs and Branded drugs
Marketing and distribution of generic drugs are done according to drugs type. Chemist and institutions are major market consumers of generic drugs. Aim of distribution channel of generic drugs in pharmaceutical industry is to maximize reach of their generic drugs to chemists/pharmacies and institutions/hospitals.
Generic market is rate based market. How much best rates you can provide, there is chances of getting better sale.
Check out: How to develop distribution channel for generic drugs?
Hope above information is helpful to you...
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