STEP BY STEP GUIDE FOR LAUNCHING A GENERIC PHARMACEUTICAL UNIT
Once you decide to launch a pharmaceutical company, now it is time to prepare for it. You must remember that manufacturing generic medicine is a specialized process.
You should find out experienced people who have a rich experience in the niche. It makes the things quite simple.
First, make a detailed business plan. You should arrange the place (rented or lease). Don’t miss the norms laid by the authorities about the premises.
After this, spend some time in deciding the detailed requirements. Thankfully, the government has made the process quite simple. Still, you shouldknow the process well.
Here is a step-by-step guide for launching a generic pharmaceutical unit.
Do it first
- You should start with the brand name, company name, and logo. Make sure it is unique.
- You need to register the company first. Once it is done, then apply for the trademark and FSSAI registration.
Many people find it more comfortable hiring a consultant instead of doing it own. It depends on your choice.
APPLICATION FOR THE ALLOTMENT OF DRUG LICENSE NUMBER
For this, you should check who is the local drug inspector. Also, you must know who the approving authority is?
Once you meet them, you have a fair idea about what all documents are needed and what is the procedure for application.
The inspector will tell you about the specific guidelines to be followed. For example, one of the partners must be a registered pharmacist.
Alternatively, you can hire an experienced person who is registered in the same registration office. The person will be authorized to manage on behalf of the company.
Get the list of documents you are supposed to submit along with the application. It is quite an extensive list and takes some time to collect everything.
Typically, the blueprint of the premises, ownership details or rent agreement, partnership deed, power connection details, pollution control certificate, and several affidavits.
Check the documents twice to ensure nothing is missed. Keep a copy of every document with you before submitting.
GST REGISTRATION
In the new GST regime, you must have GST registration number.
The process is quite simple, but it is online. Hence, you should meet a consultant if you aren’t comfortable with it.
The registration number is unique, and it will be mentioned everywhere.
It is a brief description of the process involved in launching a generic drug manufacturing process. For further details, you can refer the official websites.
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