How to Start Pharmaceutical Business

Pharmaceutical industry is an evergreen industry. Even in most worst economical conditions, medicines don’t lose their craze. At all circumstances, there is need of healthcare facilities. If you want to start your business into pharmaceutical industry, we are providing here top business Ideas in pharmaceutical industry and how you can start business in pharmaceutical industry .   Video language is Hindi The Indian pharmaceuticals market is the third largest in terms of volume and thirteenth largest in terms of value. The pharmaceutical industry in India was valued at US$ 33 billion in 2017 and expected to grow to US$100 billion by 2025. India’s pharmaceutical exports stood at US$ 16.8 billion in 2016-17 and are expected to grow by 30 per cent to reach US$ 20 billion by 2020. Have look at start-up ideas in pharmaceutical industry: Active Pharmaceutical Ingredients (API) manufacturing Unit Medicine manufacturing unit Medicine Marketing Company Medicine import/export business

In this article, we will discuss about how you can apply for wholesale drug license and retail drug license. In last we will also discuss, how you can renew/retain tour drug license to continue your medicine profession. Documents, area and procedure are almost same for retail drug license and wholesale drug license , only difference in competent technical staff. For wholesale drug license, competent staff qualification and experience is either registered pharmacist or graduate in any stream with one year experience in selling of drugs at wholesale drug firm where as for retail drug license, competent person shall only be a registered pharmacist. Check: How to be registered as pharmacist in India? Checklist of documents required for drug license: Documents to be uploaded or submitted along with the application form: Scanned documents are to be uploaded and hard copies of documents are to be handed over to Inspecting Officer/Drug Control Officer during the Inspection: 1.

Pharmaceutical distributors include chemists, pharmacy store, medical store, drug store etc. Pharmaceutical distributors are the retail drug stores having retail drug license and deals in dispensing of medicines against prescription of a registered medical practitioner. They are in directly contact with patient or its caretaker. That makes them eligible for gaining maximum profit margin in pharmaceutical distribution channel. Chemists and Pharmacies are the bottom part of pharmaceutical distribution channel . Whether a pharmaceutical company sell through branded drug marketing , generic drug marketing , pharma franchise marketing or OTC drugs marketing , pharmaceutical retailers is important part of their distribution channel. Every part of distribution channel gets a certain amount of profit margin as we have discussed in our article: Profit margin in pharmaceutical industry . Pharmaceutical retailers are having a certain amount of profit margin which vary little bit as marke

In India, Drugs are regulated through Drug and Cosmetic Act, 1940 & Rules 1945. Drugs are classified through Schedules. Schedules are the set of provisions for classifications of drugs, forms, fees, standards, requirements, regulations related to drugs. Unlike other countries Like UK, Australia, USA where specific category mention prescription drug, prescription drugs in India are not included in any single schedule but divided according to their severity of side effects and use. Generally Schedule H, Schedule H1 and Schedule X drugs are considered to be prescription drugs in India. Drugs listed in these schedules are considered as prescription drugs. Definition of Prescription Drugs: Prescription drugs are the drugs which require a valid prescription from registered medical practitioner to be sold by retail. Drugs which are included as prescription drugs are the drugs which may cause severe side effects and complications if taken without under proper guidance and monitoring of

Medicines are regulated under drug and cosmetic act 1940 & rules 1945. Manufacturing, import, export, sale, purchase, supply, distribution and dispensing of medicines etc are regulated through this act and a licence is required to conduct any type of business related to medicines . Different types of medicine business will require different types of licences. Types of Businesses in medicine industry: Import of Medicines (Raw material and Finished products) Manufacturing of Active Pharmaceutical Ingredients (API)/Bulk Drugs Manufacturing of medicines (Finished products) Wholesale and Distribution of medicines and API/Bulk Drugs Retailing and dispensing of medicines Export of medicines Medicine marketing company Import of Medicines: For importing medicines in India, import licence is required. Along with import licence, Registration certificate of every medicine is required that is to be imported into India along with registration of premises where manufacturing of med

Schedules are the set of provisions for classifications of drugs, forms, fees, standards, requirements and regulations related to pharmaceutical, Ayurvedic (including siddha), unani and tibb system of medicines, homeopathy, blood and realted products etc under Drug and Cosmetic Act, 1940 and Rules, 1945. The schedule to the drugs and cosmetics act are Schedule A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X, Y. Drug and cosmetic rules are divided into schedules alphabetically and named also alphabetically like Schedule A, Schedule B etc till Schedule Y. The schedules to the drugs and cosmetics act are important part. Every schedule contains specific information as discussed below. Schedule A:  Schedule A  describes application forms and licenses types. Download Schedule A Pdf Schedule B:  Schedule B  describes Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories. Download Schedule B Pdf Schedule B1: Schedule B1 describes

For manufacturing of drugs and pharmaceutical products, drug authority issued a license which is known as Drug manufacturing License. Manufacturing unit that want to indulge into manufacturing of drugs and other pharmaceutical products has to take a manufacturing license. Every Drug manufacturing License has a unique number which is known as drug manufacturing license number. Types of Drug Manufacturing Licenses: Form 24: Application for the grant of or renewal of a licence to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C (1) and X Form 24A: Application for grant or renewal of a loan license to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C (I) and X Form 24B: Application for grant or renewal of licence to repack for sale or distribution of drugs, being drugs other than those specified in Schedules C and C (1) excluding those specified in Schedule X Form 24C: Application

Who is a Pharmacist: Pharmacist is a person having educational qualification in pharmacy profession i.e. Diploma in Pharmacy or Bachelor in pharmacy or Pharma D etc. Who is a Registered Pharmacist: Registered Pharmacist is a person having educational qualification in pharmacy and his/her name is registered under state pharmacy council  of state in which person reside or want to conduct his/her profession or business . How to become a Registered Pharmacist? For becoming pharmacist in India, a person has to fulfill criteria as per Pharmacy Act. A person want to register himself/herself as a pharmacist should have at least minimum of Diploma in Pharmacy or Bachelor in Pharmacy or Pharma D. After completing above mentioned qualifications, you become eligible for registering as a pharmacist. If you have only Diploma in pharmacy, then 500 hours practical training spread over a period of not less than 3 months is also required to become eligible. download pdf After registering your name in s

Every drug manufacturing unit having a drug manufacturing license shall maintain a laboratory for carrying out tests on drugs or raw materials used in the manufacture for sale of drugs. Types of Drug testing laboratory applications and Licenses: Form 36: Application for grant or renewal of approval for carrying out tests on drugs/ cosmetics or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs /cosmetics Form 37: Approval for carrying out tests on drugs/ cosmetics and raw materials used in their manufacture on behalf of licensees for manufacture for sale of drugs/cosmetics Form 38: Certificate of renewal of approval for carrying out tests on drugs / cosmetics and raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs / cosmetics FORM 39: Report of test or analysis by approved institution Competent Technical Staff qualification: The head of the testing unit shall possess a degree

In One line we can differentiate Pharma Franchise and Pharma Distribution - A pharma distributor only redistributes products of a pharma company in an allocated area to retailers, Nursing homes, hospitals, Pharmacies whereas a Franchise apart from redistribution also promotes ethically or otherwise the said products to the medical fraternity for prescriptions or OTC promotion. Check out article link to know more about  How to contact with the medicine company for franchises? here In detail Pharma Distribution and Pharma Franchise Difference: In pharmaceutical distribution , Pharma company appoints own medical representatives and sell products through own sales team . Pharma company bill to distributor at price to stockist rate and pharmaceutical distributor has a particular margin like 8%, 10%, 12% etc, and distribute products to pharmaceutical retailers ( pharmacies and chemists ) by receiving orders from pharma company’s sales team. Pharmaceutical distributor must have

Retail drug license is the license issued by drug authority to sell, stock or exhibit or offer for sale, or distribute drugs by retail. Every retail drug license has a unique number assigned to it which is known as retail drug license number. Retail sale means a sale whether to a hospital, or dispensary, or a medical, educational or research institute or to any other person other than a sale by way of wholesale dealing . Types of Retail Drug Licenses: Form 19: Application for grant or renewal of a licence to sell, stock or exhibit or offer for sale, or distribute of drugs other than those specified in Schedule Form 19A: Application for the grant or renewal of a restricted licence to sell, stock or exhibit or offer for sale, or distribute drugs by retail by dealers who do not engage the services of a registered pharmacist Form 19B: Application for licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines Form 19C: Application for grant or rene