How do we get Drug Manufacturing License

How do we get Drug Manufacturing License


The drug manufacturing Industry of India also known as the pharmaceutical industry is one of the oldest and India is also called the pharmacy capital of the world. To start a business manufacturing drugs and cosmetics etc. it is compulsory to obtain a license under the Drugs and Cosmetics Act, 1940. This act also deals with other strict compliances and rules for which they do regular inspection of the manufacturing sites with a view to improve the quality and efficacy of drugs sold in India as well as to stop the misuse of drugs. Licenses such as to manufacture ayurvedic, cosmetics, allopathic drugs, and sales licenses are issued b the state licensing authority. Ayurvedic and Unani drugs were also included in the act of 1940, drugs and cosmetics in 1964.

How do you get a pharmaceutical manufacturing license?

The various stages through which one can obtain a pharmaceutical manufacturing license is explained as below-

First, the stage- State drugs controller -cum-state licensing authority is the designated place where one can apply online or offline by visiting his office with the requisite documents to be uploaded online or depositing to his office. One should apply for the application via the form with the required fees which have been provided by the issuing authority.

Information regarding fees and required form –

  • Form 24A for getting the loan license for non-biological drugs

  • Form 27A for getting the loan license for biological drugs.

  • Form 24 for getting a manufacturing license for non-biological drugs and fees is Rs 7500 for ten items and for more than ten items it is Rs 300 more per item

  • Form 27 for getting a manufacturing license for biological drugs with the same fees as mentioned above.

  • Form 24C for getting the license to manufacture homeopathic drugs

  • Form 24B for getting the repacked license with a fess of Rs 700 for 10 items.

The second stage- Once the application is submitted with requisite documents and fees to the state government drug controller and after the verification and analyses of each piece of information and analyses of all the required documents then the application is sent to the senior drug controller officer of that particular zone for further process of the inspection. The manufacturing site is inspected by the senior controller drugs officers and they prepare a report on the basis of inspection and also add their recommendation points and then they forward it to the state drugs controller.

The third stage- Generally this is the last step of acceptance or rejection of the application. If the conditions laid down in the act comply then the license is granted.

Types of Drug License in India

There are various types of drug licenses in India which are as follows –

1) Loan License- This type of license deals with the fact that the business which has been issued this type of license uses another licensee’s manufacturing facilities and it does not have its own manufacturing facility.

2) Sales license- It has two subparts -

a) Retail drug license

b) wholesale drug license

Both are used for the sale of medicines/drugs.

3) Import license- This type of license is issued for the purpose of importing drugs from other countries.

4) Manufacturing license- This type of license is issued to the manufacturing unit of drugs which also includes homeopathy drugs.

5) Multidrug license- This type of license is given to the drug stores or pharmacies that have their branches in different states with the same name.


National Institute of pharmaceutical education and research is a very important institute for pharma education as it can help India to achieve global standards in the field of the pharma market. These types of institutes create awareness and help in the creation of the due diligence required by any company to enter the pharma market in India. As there are different sets of rules and regulations for the Indian market, it is necessary that manufacturers are aware so that quality drugs can be manufactured in India.


Shefali Srivastav
Uttar Pradesh
L.LM from Amity University, Noida

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