Thursday , November 30 2023
License for a New Medicine

How Can You Get the License for a New Medicine- know the Process Completely

Before a medicine is brought into the market it is fully tested, licensed and then given a clinical trial. This is the procedure done in every country. Once a medicine gets its license then only it is approved in the market for selling.

Because of this Coronavirus Pandemic (Covid – 19 ), every person on this earth existing is looking forward to a medicine that can be eaten or is drinkable to make sure that the corona runs away as soon as possible. 

This will only happen in the future but for now do you know how medicines are brought in India? ( how new medicines are launched in India) how can you get a license for a new medicine? ( A new drug license)  what are the rules behind the launch of a new medicine? 

How can you get a license for a new medicine?

There are many medicines that are sold all around the globe. Medicines are all directly related to health. If someone unknowingly takes the wrong medicine then he might have to wash his life away. 

Every medicine that is brought in the market is tested first and then given a license after it is conducted for clinical trials. This happens in every country. Once the medicine gets a license then only it starts selling in the market.

How long does it take for a medicine to get its license?

Under the normal conditions, it takes about three years to build a drug and perform its clinical trial. In emergency cases, it takes less time and the license is also provided a little sooner. It nearly takes about ten months to give a new medicine a license in emergency situations. 

What is the new drug license process?

The license is taken according to the act of drugs and cosmetics 1940  and rules 1945 to bring the new medicines to India. Under this, the Central Drugs Standard Control Organization (CDSCO) is responsible for approving the drugs, conduct the tests and also prepare the standards of the medicines.

To get a new license for any medicine in India, an application needs to be submitted to the headquarters of the Central Drugs Standard Control Organization. The application is called the Investigational New Drug Application. After this, it gets tested by the New Drug Division. Later the IND committee performs an in-depth study and also review. 

After this, the medicine is sent to Drug Control General of India to get its approval. It is then sent for the clinical trial. Once the clinical trial is done, another application is made for New drug registration with the CDSCO. 

DCGI then reviews it after registering with the new drug. If the medicine results to meet all the standards then it is given a license by the DCGI. If it does not meet all the requirements then it gets cancelled by the DCGI. If any institute or any person wants to achieve the license for a new medicine then it needs to meet all the requirements and standards of the Pharmaceutical cosmetic act of 1940 and rule 1945.

The new medicines can be done in two ways

  • It should have a new formula and a new compound
  • The compound is old and some new changes have been made 

How can you get a license for ayurvedic medicines?

There are no big issues behind getting a license for an ayurvedic medicine besides that, it should only be prepared according to the reputed book of Ayurveda. 

If medicine is prepared according to the book, then the medicine gets its license quickly. If someone is manipulating the quantity and presenting it in another form then he needs to give the reference. Moreover, he’ll require the approval of the license which may take a little longer in this case.

The state government new drug license?

Besides taking the license from the DCGI, any institution making the drug also has to take a license from the state drug controller of the state where the medicine is being made. After taking the medicine license if any organization violates the standards of the drug then the license can get cancelled.

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