Drug license is mandatory to operate any kind of pharmaceutical business in India that involves selling and dealing with different kinds of medicines, vaccines, cosmetics, allopathic drugs, homoeopathic drugs etc.
If you are planning to start a drug or cosmetic business in India, then this article will surely help you. In this article, we will discuss the main steps to obtain a drug license in India.
What is a drug license?
A drug license is basically permission granted by the government to start a drug and cosmetic business in India. Drug license is granted under the Drug and Cosmetic Act, 1940. A person cannot operate any kind of drug dealing or selling without having a drug license. Doing so is a cognizable offence under the law of drug and cosmetic license that covers all types of drugs and cosmetics business including homoeopathic, allopathic, Ayurveda or Unani drugs.
According to the law, the quantity of the drugs produced and used in the form of the dose is the mere responsibility of the people involved in the production of the drugs. And if any person is harmed or suffers due to that drug the persons will be answerable to the whole event and will be counted as the offence of grievance which will go under the trial under IPC. So, surveillance becomes important.
What are the steps involved in obtaining a drug license?
An applicant can file the application directly with the government. It is a long process and takes about 30-60 days. Another way you can choose out is to leave the whole process and work on Swarit advisors, who will make it more convenient and helpful for you.
Here are the steps you need to follow to obtain a drug license in India:
Step 1 :-
Obtain a user id and password by requesting a letter along with the details of the respective firm from the official website of FSDUAP.
Step 2 :-
Collect all the required document (the list is given below) and send it by scanning it in a 100ppi size in black and white print and upload it using the same id and password. All the information asked should be filled accurately for the respective application and re-send it. However, other authority may ask for some other documents too.
Step 3 :-
After following these steps you will require a follow up to obtain updates regarding the application with the government. If government is not satisfied or the provided information is incomplete, the application will get rejected and fees will be further fortified by the government.
Step 4 :-
The drug license department may take 30- 60 days in approving your submitted application.
Documents required for obtaining drug license
• Constitution of the firm in AOA and MOA.
• Photo id of the applicant
• Owned property papers
• Copy of rent agreement (in case of rented property)
• Site plan and key plan of the premises
• Details and invoice of the refrigerator used to store drugs
• An affidavit under the compliance with MPD 2021
• Some additional documents for registered pharmacist.
• Qualification proof (degrees and certificates)
• Appointment letter with bio-data
• Experience certificate
• Other wholesale documents to obtain wholesale drug license
Conclusion
Obtaining a drug license is a tedious process. You have to collect all the required documents, submit it in prescribed format and keep follow-ups with the government to get the information about the ongoing process an in case you have provided insufficient information it may get rejected too. Swarit Advisors are here to make it simple and convenient for you. You just have to sit relax and provide them with all the required documents, and they will submit the application on behalf of you. To get your drug license now or to know more about it, drop a mail to Swarit Advisors at info@swaritadvisors.com or make a call at +91-9821399320.