How to Start Pharmaceutical Business

According to Drug and Cosmetic Act & Rules , Drug Includes: (i) All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; (ii) Such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette; (iii) All substances intended for use as components of a drug including empty gelatin capsules; and (iv) Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or

Medicines are classified into branded drugs and generic drugs based upon the development or research for discovery new molecule. When a pharmaceutical company develop a new molecule, a exclusive rights is provided to company by government for certain period of time to cover expenses and investment involve during research for development of that molecule. The pharmaceutical company market this researched molecule by fixing a brand name which is different from its International Non proprietary Name (INN) or common name (generic name). This product is known as branded drug. After expiry of exclusive rights time period, other pharmaceutical companies have allowed to manufacture this molecule and sell into market. These products are known as generic drugs which are bio equivalent of branded medicines which means rate and extent of availability after administration in the same dosage form, same route of administration are similar to such a degree that their effects, with respect to b

A pharmaceutical product is marketed and sells through many ways like prescription sale ( branded medicines , generic medicine ), franchise medicine supply , OTC drugs marketing and supply to hospitals, pharmacy chains , online pharmacies etc. In prescription, generic, franchise, OTC etc, pharmaceutical companies have to build a distribution channel for selling medicines. But big institutions and integrated delivery networks (IDNs) likes corporate hospitals, big hospitals, medical colleges, government hospitals, pharmacy chain’s governing bodies, online pharmacies hub etc purchase medicines at bulk quantity. They don’t want to indulge into distribution channel to share profit of margin among other members of distribution channel. They procure medicines and other pharmaceutical products through offering tenders, tie-up directly with pharmaceutical companies, big distributors etc. This helps them to procure medicines and other pharmaceutical products at lowest price as possible and

Quick Preview: If we talk about OTC medicine, OTC word used for the over the counter medicines. These are the medicines that you can purchase directly from pharmacy without prescription of medical practitioner.   Detailed Article: Drugs are termed as Branded Drugs , Generic Drugs , Pseudo generics, OTC drugs; prescription drugs etc depend at their marketing type, distribution type, original type, availability for sale type etc. When a medicine is available for sale at medical stores and pharmacies without prescription of registered medical practitioner is known as Over the Counter (OTC) Drugs. These are considered as safe and effective for use of common person without consultation of healthcare profession. Over the counter drugs are generally use for small illness and conditions like minor aches and pains, fever, diarrhoea, cold symptoms, sore throat, and allergies etc. In India, there are requirement of retail drug license under drug and cosmetic act & rules for selling

Pharmacy retail business is one of the most profitable businesses in healthcare industry . The total Indian retail pharmacy market is growing at an average of 18% per year over the last few years, and is anticipated to grow by even higher numbers in the future. What is a Pharmacy Store? A pharmacy store is retail counter which deals in dispensing and compounding of drugs and medicines.  Pharmacy business in India is regulated through Drug and Cosmetic Act & Rules and there is requirement of  retail drug license  for operating pharmacy and drug store in India. Requirement of pharmacist is necessary for taking retail drug license in India. Pharmacist is a person who is responsible for carry out or supervise all activity of pharmacy or drug store.  Check out:  How to open medical store? What is Chain Pharmacy? When a pharmacy store organization consists of four or more pharmacy stores, it is known as  Pharmacy Chain Stores. In simple word, when an organization or individual set-up/op

Generic Drugs are the drugs which are sold with only international non proprietary name (INN) or common name. When a pharmaceutical company develop a new molecule, pharmaceutical company is granted by exclusive right of that molecule for certain period of time known as patent. After expiry of that patent, other pharmaceutical manufacturers are also allowed to manufacture that molecule. Products other than innovator’s brand are known as Generic Drugs. Marketing of generic medicines vary market to market. In USA, only one brand name product is allowed for any molecule, other products of that molecule can only be sold with its international non proprietary name (INN) or common name or generic name. But in India, a molecule could have number of brand names and every manufacturer can sell their products by fixing a brand name. These generic medicines with brand name are also known as Branded Generics . Marketing and promotion of generally same in all regulated markets but vary in unregula

Pharmaceutical industry is different from other sectors in term of marketing and sale type. In pharmaceutical industry, pharmaceutical companies can’t sell drugs directly to customers. Drugs require a prescription of a registered medical practitioner to be sold to patient or its care taker. Without prescription, sale of prescription drugs like Schedule H , Schedule H1 , and Schedule C and C1 , Schedule G , and Schedule X etc drugs are prohibited. No pharmacy or chemist shop allows selling prescription drug to patient or its care taker. OTC and herbal medicines are allowed to sell without prescription of medical practitioner. Selling drugs through generating prescription from registered medical practitioner is known as prescription drug marketing. Pharmaceutical companies have to market and promote their products to the registered medical practitioners. It is also known as detailing marketing. Pharmaceutical company sales representative also known as medical rep, medical represent

Medicines are generally available in two forms; one is Branded Medicines and second is Generic Medicines . Branded medicines are the medicines which are sold with a brand name by innovator pharmaceutical company who have exclusive rights for certain period of time i.e. Patent whereas generic medicines are the medicines which are manufactured by pharmaceutical companies who are not innovators of molecule and are allowed to manufacture a particular molecule after expiration of its patent. When a generic pharmaceutical manufacturer manufactures a generic medicine by affixing a brand name to it, is known as Branded Generics. Branded generics are marketed with affixing a brand name in same way as of original brand. The generic versions of a particular medicine must have bio equivalent and properties similar to the innovator’s brand and are interchangeable. Same in case of Branded generics, branded Generics must have equivalent properties and action similar to the innovator’s brand and

Generic medicine is the medicine which contains same active pharmaceutical ingredient that is present in original branded medicine protected by patent. Generic medicines are allowed to sale after the expiry of patent of original branded medicine. Generic medicines have same dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. A generic version of branded medicine has same active pharmaceutical ingredient but may have slightly indifferent inactive ingredients which may change look (shape or colour) of generic medicine from its branded medicine but does not change the effectiveness and safety of medicine. Read: Difference between branded medicine and generic medicines In order to enter a Generic medicine into pharmaceutical market , it must be bioequivalent to the branded medicine. Generic medicine should have similar bioavailability as of branded medicine. Bioavailability is the rate and extent of absorption of active ingredi

Branded medicines are the medicines which has given a name for advertising purpose by a company. When a pharmaceutical company develops/researches a medicine  molecule which is safe and effective for human use, pharmaceutical company is granted by exclusive rights so no other manufacturer can produce it for certain period of time which is known as patent. Innovator Pharma Company gives a brand name for advertising purpose to this researched molecule which is different from its International Nonproprietary Name (INN) or generic name. Branded medicine is referred to the medicines which are sold by its innovator by giving it a brand name. Example of certain branded medicines: Augmentin (co-amoxiclav) , Glucophage (Metformin), lopressor (metoprolol), Prilosec (Omeprazole) etc. In case of Augmentin (Co-amoxiclav), Augmentin is a brand name whereas Co-amoxiclav is its INN or generic name. Likewise for other examples quoted above. After expiry of patent, other companies can also apply for a

Registered Medical Practitioner Registered Medical Practitioner is a person who is registered under state medical register of state medical council after finishing the undergraduate medical course in a college recognized by state government and approved by medical council of India. A doctor/medical professional is authorized to conduct practice only after registering name in state medical register. Without registration he/she is not eligible to conduct any practice related to his/her profession i.e. do job in any hospitals including government and private hospitals, conduct own practice etc. Registered Medical Practitioner e ligibility and qualification: (i) Holding a qualification granted by an authority specified or notified under section 3 of the Indian Medical Degrees Act, 1916 (7 of 1916), or specified in the Schedules to the Indian Medical Council Act, 1956 (102 of 1956); or (ii) Registered or eligible for registration in a medical register of a State meant for the registr

Branded Medicines: When a pharmaceutical company develop a new medicine which is effective in curing the condition it claims to treat and safe for human being. Pharmaceutical company fix a brand for its innovative medicine. These medicines are known as Branded Medicines. Pharmaceutical company has to invest considerable amount of money to develop a new medicine, so they are given patent for a period of time. Generic Medicines: A generic medicine is a copy of the original branded product. Once a patent of medicine is expired, other pharmaceutical companies have become eligible to manufacture and distribute their own version of the medicine. These versions are known as Generic Medicines. Generic medicines may be with brand name or without brand names. Difference Between Generic Medicines and Branded Medicines: In term of manufacturing of pharmaceutical products , there is no difference between branded and generic medicines. Branded and generic medicines are manufactured in sa

Starting manufacturing unit of Bulk drugs/active pharmaceutical ingredients requires almost same formalities as of pharmaceutical finished formulations manufacturing unit . Machinery and plant requirements vary in both cases. Bulk drug manufacturing unit is complex and requires more care as compare to finished pharmaceutical formulations manufacturing unit. Manufacturing of bulk drugs are also regulated through Drug and Cosmetic Act & Rules in India. India is known as Pharmacy of World but we lack at bulk drug manufacturing level. We import approx 75% of raw material/bulk drug from other countries. Plant specification is recommended under schedule M of Drug and Cosmetic act & rules. Schedule M Part 1 is dedicated to bulk drug manufacturing and provide detailed knowledge about premises, location and plant requirements and specifications. Download here: Drug and Cosmetic Act, 1940 and rules, 1945 as amended upto 31st December 2016 for referring Schedule M part 1. Bulk Drugs/A

For starting manufacturing unit of medical devices, manufacturing license will be issued by state drug control office. You have to complete all requirements as specified below and apply for grant of medical devices manufacturing license.  Read related: What are the medical devices? Medical Devices covered under this manufacturing licence: In-Vitro Diagnostics (Cardiac Stents, Drug Eluting Stents, Catheters, Intra Ocular Lenses, I.V. Cannulae, Bone Cements, Heart Valves, Scalp Vein Set, Orthopedic Implants, Internal Prosthetic Replacements etc), mechanical contraceptives (condoms, intrauterine devices, tubal rings), surgical dressings, surgical bandages, surgical staplers, surgical sutures and ligatures, blood and blood components collection bags with or without anticoagulants intended for human or animal use Requirements: Premises (As per WHO:GMP and/or Schedule M-III) Machinery and equipments Technical persons i.e. manufacturing chemist and analytical chemist Raw material s

Choosing a best main for any start-up is very crucial step. You have prepared mind set for starting own business . Now you will face to finalize a name that is unique, business related, not resemble to any existing brand, catchy and with specifications you would like to. In this article, we are going to cover aspects how you can choose or find out your start name. Whether you are going to launch a company (private limited/limited) , shop, firm, online business or need a creative business idea name for any other start-up, this article will help you to find a name for your business. Step 1: Know your business requirements: Every type of business has different needs. You should know about your business requirement while choosing company name or business name. What type of names is best suitable in your market? Whether your market accepts traditional name, modern name, similar name, unique name, short name or long names? You have to research about your market acceptance while searching

Read: Licenses and requirements for starting cosmetic manufacturing unit The following equipment, area and other requirements are recommended for the manufacture of: − Powders: Face powder, cake make-up, compacts, face packs, masks and rouges, etc. Powder mixer of suitable type provided with a dust collector. (b) Perfume and colour blender. Sifter with sieves of suitable mesh size. (d) Ball mill or suitable grinder. Trays and scoops (stainless steel). Filling and sealing equipment provided with dust extractor. For compacts: - (i) a separate mixer, (ii) compact pressing machine. Weighing and measuring devices Storage tanks. An area of 15 square meters is recommended. The section is to be provided with adequate exhaust fans. Cream and Ointments: Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade, brilliantine, shaving creams and hair-oils etc. Mixing and storage tanks of suitable materials. Heating kettle – steam, gas or electrically heated. Suitable ag

Cosmetic is any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleaning, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic or new cosmetic. Cosmetic in India is regulated under Drug and Cosmetic Act & Rule. For starting cosmetic manufacturing unit, you will require to take cosmetic manufacturing license. Cosmetic manufacturing license is granted by Drug Department as in case of medicine manufacturing license . Only difference in few requirements and specifications. Cosmetic products could be divided into two parts: Herbal Cosmetic Products Synthetic chemical cosmetic products In current time, herbal cosmetics are in trend but other cosmetic products has its own market. There are some ayurvedic medicine cosmetic products also available in market. These ayurvedic labelled cosmetics products

Fixed Dose Combinations refer to products containing one or more active ingredients used for a particular indication(s). FDCs can be divided into the following groups and data required for approval for marketing is described below: (a) The first group of FDCs includes those in which one or more of the active ingredients is a new drug. For such FDCs to be approved for marketing data to be submitted will be similar to data required for any new drug (including clinical trials) (b) The second group FDCs includes those in which active ingredients already approved/marketed individually are combined for the first time, for a particular claim and where the ingredients are likely to have significant interaction of a pharmacodynamic or pharmacokinetic nature. If clinical trials have been carried out with the FDC in other countries, reports of such trials should be submitted. If the FDC is marketed abroad, the regulatory status in other countries should be stated. For marketing permission, a