Medicine has been vital to the survival of humanity throughout history and the treatment of serious diseases. Medicine is the only mechanism we have to combat disease. However, a pill used for specific/original purpose illness does not classify as a consumable good like chocolate, Used grown for consumption. Furthermore, medication should only be taken with the care of an experienced physician providing direction on when medication to treat a condition should be administered. Otherwise, the usage of such medication could also have an adverse side effect on the body.
However, the Government of India enacted in the year 1940 in order to consolidate and amend existing laws of drugs and cosmetics and was named the Drugs and Cosmetics Act. Predominantly, all of the provisions related to the manufacture, import, export, purchase, sale and distributions of the drugs and cosmetics are decided under this Act. This act mostly regulates all of the rules concerning Ayurvedic, Siddha as well as unani medicines.
What are Drugs?
- A chemical molecule, usually having particularly a known structure, is known as a drug in pharmacology when it contains a biological effect on a living being.
- Consequently, there are certain limitations on how such drugs are usually prepared as well as used in medications, and certain guidelines are in place to make sure that the right dosage of such drugs is particularly used so as not to overdo it and as well as cause any harm to the body.
Drug License: Purpose
- The drug license's primary purpose is to give organizations or individuals authorization to conduct medication and cosmetics-related operations.
- In India, it is however unlawful and illegal for any company or any individual to deal with pharmaceuticals, medications, or any kind of cosmetics without in the first place acquiring a license of a drug.
- In addition to obtaining a license of a drug, they also need to register their business as well as obtain a trade license.
Drug License: Who Can Apply?
Let's say you want to distribute pharmaceuticals or open a medical store and need a drug license.If so, you must fulfil the Drugs and Cosmetics Act's educational requirements (1940).
- Competent people as well as pharmacists must hold a pharmacy degree.
- The competent individual needs to have prior drug distribution experience.
- At the same time, the pharmacist needs to keep up their registration with the Pharmacist Council.
- They should have the documentation because it will be included with the drug license application.
Drug License: Essential Requirements for Registration
- In connection to the wholesale license of drugs, the applicant has to possess a minimum of 15 square meters space available, and in connection to the obtain a retail license, the minimum must be 10 square meters space that is required.
- It is also required that a layout plan must be submitted by the applicant and the regulations of the National Building Code of India must also be complied with.
- A registered pharmacist in a wholesale or any type of retail setting needs to be particularly well-versed in all of its operations.
- The pharmacist usually needs to get registered with the Pharmacist Council of India and as well as hold a legal and valid license.
- A building constructed on property allocated by the DDA is not eligible for a drug license.
- There should be adequate storage facilities. There must be refrigeration facilities available if the medications must be kept at a low temperature.
Obtaining Drug License in India: Required Documents
The following is a list of documents required in India to obtain a drug license:
- Application form;
- Cover letter containing the applicant's name and position;
- A copy of the challan obtained by paying the required payments to get a drug license;
- Declaration made in the required format;
- The site plan as well as the kite plan for the premises;
- The reason for owning a property;
- Evidence of ownership in the case of rented property;
- Documents pertaining to the establishment of the business, such as partnership deeds, MOAs, AOAs, and certificates of incorporation;
- Affidavit concerning the owner, partner, or director's innocence;
- Testimony of a licensed pharmacist or other qualified individual, along with their employment letter in the case of an employed individual.
Obtaining Drug License in India: Procedure Followed
The license for a drug has to be issued by its regulatory body, also known as the drug controlling authority.
- Visiting the Drug Authority Official Website:Depending on what kind of license one is looking for; the applicant particularly needs to visit the official website of the drug controlling authority as there are mostly different drug controlling authorities who are particularly in charge of issuing different kinds of drug licenses.
- Application Filing:The application for a obtaining a license for drug needs to be submitted online on its official website of the relevant drug control body. This application form has to be filled out entirely by the applicant.
- Uploading of Documents:Then next step comes up with the uploading of the important documents and as well as submitting the application form with all of the necessary funds after entirely completing all the required fields carefully. The applicant needs to however maintain all of the current copies of all the important documents prior to submitting the drug license application.
- Drug Inspector Visit:Following the receipt of the application, the drug inspector will however pay a personal visit to the location of the business, retail location, or to the pharmacy to confirm all the necessary details and accuracy of the information that is provided or mentioned in the application and also to verify all of the necessary documents.
- Grant of Drug License:The drug controller will then grant the license for the drug following the drug inspector's examination as well as proper verification.
Conclusion
Obtaining a license for a drug is of utmost importance before opening any drugstore. A drug license is however required if you are a manufacturer, distributor, or retailer of pharmaceuticals as well as any cosmetics in India or outside India.
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