Every country has regulations for the pharmaceutical industry. The import, production, distribution, and sale of medications and cosmetics are all governed by the Drug and Cosmetic Act and Rules in India. To operate any kind of business in the pharmaceutical sector, we must first obtain a drug licence from the drug office.
We will also say that a pharmaceutical corporation obtain a drug licence. We will need a medication manufacturing licence from the state drug control authority to launch a pharmaceutical manufacturing business. We will need a Wholesale drug licence number for marketing, dealing, and distribution. We will demand a retail drug licence number for pharmacies and retail establishments.
This blog will provide you with a thorough understanding of how to launch a new pharmaceutical company in India. Here, we'll talk about everything, such as the prerequisites for participation, how to register, what documentation is needed, who needs to be qualified, how much money is needed, etc.
We advise having prior experience in the pharmaceutical sector or at least having a basic understanding of the pharmaceutical area before moving on with the establishment of a pharmaceutical company, whether manufacturing or marketing.
Which kind of pharmaceutical company you should establish depends on the experience you have. If you have experience in the pharmaceutical manufacturing industry, setting up a manufacturing facility will be your best option; however, if you have experience in the sales and marketing of pharmaceutical products, we advise starting with a marketing firm. If you have experience in drug creation and research, you may want to start a pharmaceutical business.
Each state in India follows essentially the same formalities. Minor requirements may differ from state to state. In order to establish whether you can create a pharmaceutical marketing company, you should first visit your district's drug inspector's office.
But before moving on, let's talk about a few issues that come up while launching a new pharmaceutical company.
Prior requirements to start a new pharmaceutical company
You or one of your partners should have experience in the pharmaceutical industry, particularly in sales and marketing, as well as knowledge of the fundamentals of business, among other things.
Summary, facts, target vs. actual accomplishments, analysis, next steps, risks, issues, resources, money, schedule, etc. are all included in the project report.
At the starting point, specialisation to focus on, items to introduce, investment needed, investment available, other resources, sales staff needed, licences and NOC needed, region to cover, and much more.
You should be well-versed in the area where you plan to open your firm. The number of doctors now working there, your target market's potential clients, distributors, merchants, hospitals, pharmacies, etc.
A business takes time and work to establish. You need enough money to establish, run, and maintain it until it starts to generate enough revenue to cover your costs as well as your own. A loan, personal savings, a mortgage, a source of side income, etc. are examples of financial resources.
Eligibility and qualifications for a competent person or EP
A competent person must possess one of the following qualities in order to be authorised to manage all aspects of a pharmaceutical marketing company:
- Pharmacist with the State Pharmacy Council registration or
- Following graduation, obtain proof of at least a year of experience with a wholesale drug-licensed company that is acceptable to the drug licencing body.
Necessary licences for a new pharmaceutical company in India
You must establish up your own pharmaceutical company on a marketing, selling, and distribution basis after obtaining registrations and licences.
The most significant permits and registrations are:
- Wholesale Drug Licence number (D.L. No.)
- Goods and Service Tax ( GST ) Registration
The following licences and registrations are optional but necessary:
- Firm or Company registration
- FSSAI registration
- Trademark registration
Investment required for starting a new pharmaceutical company
For a new pharmaceutical marketing company, three sources of investment are often necessary:
The premises/shop/office, furniture and accessories, computer and electronic equipment, fitting and furnishing, and other fixed investments for the pharmaceutical marketing company Costs associated with any additional requirements, such as licencing and registration, etc.
Rent and bills, employee salaries and everyday expenses, bank loan instalments, promotional and marketing costs, and other costs are all considered capital investments.
Investments in inventory include significant investments in the stock of goods.
Important steps to start a new pharmaceutical company
- Obtain pharmaceutical sales and marketing expertise, or hire qualified personnel.
- Write a project report or consult with pharma professionals
- Plan your business.
- Select a location for your business's setup. Find a store, building, or location for an office, licences, and stock. It may be rented or owned, but as per government regulations, there must be enough room.
- Money Source (Own Saving, Bank Loan, Investment etc.)
- Depending on the specialty (general, paediatric, cardiac, oncology, etc.) you want to enter, conduct research and prepare a list of all molecules and combinations.
- Finish naming the business and all of the product brands. Make sure these don't resemble any businesses or brands that are already active in the market. It is challenging to choose a distinctive name because there are thousands of brands and businesses, but you should try your best. Search for a Trade Name or Company Name that has already been registered or is currently being processed. Company name is in class 35 and trade name is in class 5.
- Work as a firm or register a company under the Company Act (as a private limited or limited liability partnership)
- Hiring of a registered pharmacist or competent individual in accordance with standards. (If neither you nor any of your partners is an EP or a pharmacist.) To obtain a drug licence, you must be an authorised person who is either competent or a pharmacist. We shall cover the requirements for competent people in the essay that follows.
- Get a drug licence number by applying. You must create a file and attach all necessary documentation before submitting it to the district drug control office (manually or online depend at your applying state policy). Applying for a drug licence under the same name as your business registration or firm registration is advised. If your business is registered as ABC Pvt Ltd, then you need obtain a licence with that name.
- Following receipt of a drug licence number, request a GST number.
- Look up contract manufacturers or third party manufacturers. Contact a pharmaceutical manufacturer and submit an application for a loan licence if you want to demonstrate manufacturing using your marketing company's address as well.
- Order from the manufacturer
- Make a contract or arrangement.
- Complete packaging and shipping, and create the material
- Complete all necessary paperwork and payments. (Usually 25% in advance and 75% against a performa invoice)
- Then, Manufacturer will complete all work.
- When the goods are prepared, the manufacturer will let you know and give you a Performa invoice (Time taken for new products is approximately 30 to 45 days)
- Manufacturer will ship the item to your billing address after the balance is paid.
- Launch your pharmaceutical products' marketing, promotion, and distribution campaigns.
Frequently Asked Questions
1. Can a doctor start a new pharmaceutical company?
Yes, using the same procedure, a doctor can launch a pharmaceutical company.
2. What is the pharma marketing company registration process in India?
You must first register your firm under the Company Act, or company registration, in order to register a new pharmaceutical marketing company. Once that is done, you must obtain a wholesale drug licence as well as a Goods & Service Tax identification number.
3. Where can I register a new pharmaceutical company?
For a manufacturing company, you will need four licences and registrations, as well as a company registration, a wholesale drug licence, a manufacturing licence for medicines, and a GST number. These licences and registrations serve as your pharmaceutical company's registration. You can launch your pharmaceutical company once you've finished this.
4. How can I start a new pharmaceutical company on my own?
By completing licences and paperwork, you can launch your own pharmaceutical company. Online Legal India can help you have a company registration, a wholesale drug licence, and a GST number in order to operate a marketing business. You must have a company registration, a licence to manufacture medicines, a licence to distribute drugs, and a GST number in order to operate a manufacturing business.
A marketing firm is also a preferable option if you wish to start a pharmaceutical company rather than a pharmaceutical manufacturing facility. Check out for Online Legal India, as they have the best experts to assist you form a new pharmaceutical marketing company very easily.