For setting up a pharmaceutical manufacturing company, government formalities have to be completed unlike other types of businesses. Many types of permissions are also required for this. Some of the major licenses required for the company are as follows:-
Choose a good and attractive name for the company
- Get the company registered with the Registrar of Companies under the Shop and Establishment Act
- Decide the format of the company, whether to form OPC, Partnership, LLP or Private Company
- Get the necessary certificates to comply with the rules of the Central, State Governments as well as the local administration
- Drug manufacturing license
- Drug distribution license
- Testing laboratory license
- GST
If required, no objection certificates from the concerned departments, such as fire, pollution etc.
Process of manufacturing license and necessary documents
The license required for the manufacture of pharmaceutical products or medicines, also known as drug license, has to be obtained through the Drug Controller General of India (DCGI). Apart from this, State Drug Controllers are also appointed in the state capitals, this license has to be obtained from them. For more info about companies get in touch with top pharma companies with the list of pharmaceutical companies in India. This State Drug Controller is appointed by the state government as per the guidelines of DCGI. You should apply for a drug license at the State Drug Controller.
Along with applying online or offline, some necessary documents also have to be submitted. When this application is received by the State Drug Controller along with the documents, a team of officers from there comes to inspect your institute. This team inspects there closely and when it finds the means of construction and protection in the building as per the rules and the team is satisfied in its investigation, then it gives you the drug license. After that you can start your construction work.
If the team finds any violation of government rules or any deficiency in the construction of your institute etc., then it will ask you to remove that deficiency, after removing that deficiency, you have to submit it with proof to the State Drug Controller. After that action is taken again. After that you are provided with the drug license.
Machinery and Analytical Equipment
A pharmaceutical manufacturing company requires a variety of machines and analytical testing equipment to manufacture different types of medicines in different departments. Some of the main machines used in this work are as follows:-
For liquid/syrup/suspension section
- High speed mixer for 1000 liters
- Storage tank 1000 liters with wheels and lid
- Storage tank 200 liters with wheels and lid
- Liquid filling machine
- Packing cap sealing machine
- Liquid filtering machine
- Machine
For making capsules/tablets/powder
- Air compressor
- Air conditioner
- Blister packing machine
- Capsule filling machine
- Capsule loader
- Tablet punching machine
- Coating pan
- Sifter
- Mixer 100 kg
- Dryer tray
- Double cone blender
- Powder filling and sealing machine
Apart from this, some other machines are also required, which are as follows:-
- Batch printing machine for medicines
- RO plant
- Lab equipment
- Air handling unit
How many technical staff are required in the company?
Different types of pharmaceutical manufacturing companies require different numbers of skilled workers. Experienced technical and unskilled workers are required. It is generally said that as per the rules of GMP standard, any pharmaceutical company requires at least two technical experienced staff. One of these technical staff should be deployed to oversee the drug manufacturing process in the company. He should get the drugs manufactured under his supervision. If any kind of problem arises, it should also be resolved immediately.
The second technical staff should monitor the analytical process. He should do quality control. The name of the person working in the manufacturing process should be written as manufacturing chemist, production chemist, production officer, supervisor. The name of the person who is getting the analytical process completed should be written as quality control chemist, analytical chemist. So that the responsibilities of those people can be fixed and in case of any kind of problem, they can be identified and work can be done from them.
How much does it cost to set up a company
Setting up a pharmaceutical manufacturing company is a big job. A huge amount of capital is invested in it. This business idea is perfect for those businessmen who want to earn profits for a long time by investing a huge amount of capital at one go. However, there is no fixed cost to set up such a company because the price and rent of land or company building varies according to different cities. Apart from this, the price of many other essential goods also varies. Despite this, experts of this business believe that at least 15 to 20 lakh rupees are needed to set up an average company.
How much profit is earned
Pharmaceutical manufacturing and its business is done in two ways. If a company patents the salt of a business medicine in its name, then that company gets a monopoly on that salt. It can charge any price for its salt. Its example is the expensive medicines in the market these days. The reason for this is that the company spends a lot on online and offline marketing and offer-schemes etc. to make its salt a hit. It has to calculate its average from its salt.
Secondly, nowadays generic medicines are in vogue in India. In this type of business, any generic medicine manufacturer makes a product by taking the salt of any famous company, names it according to his wish, i.e. he does not copy its name. He does not do any big promotion of that salt, only gives information about his product to doctors and big hospitals. That is why he sells his product at a much lower rate than the rate of patented medicines.
By doing this business in these two ways, the businessman gets different types of profit. In the first way, i.e. the businessman who gets a patent, gets 50 to 60 percent profit on his salt. In the second way, i.e. the businessman who makes generic medicines can get an average profit of 25 to 30 percent.