To conduct business in India, you must get a license to sell drugs and cosmetics. The Drugs & Cosmetics Act, of 1940 has provided provisions for this, and it is applicable throughout the territory of India. This Act established the Drugs Control Department by combining all the laws pertaining to drugs and cosmetics. Ayurvedic and Unani medications were included in the Act in 1964 through an amendment.
A business must get a drug license in each state where it conducts business. In case a business exists in two or more states, then a separate drug license will be required. In the unlikely event that pharmaceuticals are provided or offered for purchase at more than one location, a license application must be submitted and granted for each location, with the exception of migrant sellers.
What is a Drug License?
A drug license is the official government authorization given to an entity to deal with drugs. Obtaining a drug license is a requirement before starting a drug company. The Drugs and Cosmetics Act of 1940 defines "drug" under section 3(b).
It consists of the following items:
According to the definition of "drug" in Section 3(b) of the Drugs and Cosmetics Act of 1940, a "drug" is defined as any medication or device intended for internal or external use by humans or animals, as well as any substance intended for use in the diagnosis, mitigation, treatment, or prevention of any disorder or disease in humans or animals. This also includes substances applied to the body to ward off insects like mosquitoes. In 1964, the term was revised to include Unani and Ayurvedic drugs.
To make sure that people don't abuse or misuse medications and other medical supplies, access to them needs to be controlled. Therefore, under the Drugs and Cosmetics Act of 1940, drug licenses are required for all pharmacists, wholesalers, retailers, producers, distributors, dealers, and importers of medicines, cosmetics, Ayurveda, Siddha, and Unani medications.
The significance of a drug license is to give organizations or individuals authorization to conduct medication and cosmetics-related operations. In India, it is illegal for any company or individual to trade in pharmaceuticals, medications, or cosmetics without first acquiring a drug license. They need to register their shop and establishment and secure a trade license in addition to a drug license.
The government of India is assisted in regulating and overseeing the quality of medications sold in the country by the Medicines and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945. From the time medicines are manufactured, sold, and distributed to the point at which a pharmacist sells them to a patient or consumer in a retail pharmacy, hospital, or dispensary, the government maintains control over the drugs.
The government also has the authority to look over the matters pertaining to the import and export of medications, the sale of pharmaceuticals to minors, the use of drugs listed in Schedule H and X, and other matters that call for careful planning and monitoring. In accordance with the Drugs and Cosmetics Act, of 1940, the drug governing authority grants the drug license.
The types of Drug licenses are mentioned below:
The term "retail sale" describes the distribution of medications to the final customer. Drugs can be sold by retailers to medical, educational, research, and dispensary facilities, among other entities. A drug retailer's or chemist's shop's license is required under the Drugs and Cosmetic Act. Additionally, the State's Drug Controller Authority issues retail licenses.
If someone sells drugs without a license, they can be punished with a minimum one-year sentence, which can go up to three years, or a fine of up to Rs. 5,000.
If a business, distributor, or independent agent is approved to function as an Indian agent for a domestic or international manufacturer, they will be granted a wholesale license. Therefore, a manufacturer and an authorized Indian representative are granted a wholesale license. The CDSCO grants WholeSale Drug Licenses to individuals engaged in the wholesale distribution of drugs.
This is a license to manufacture drugs. The term "manufacture in drugs" refers to any procedure, or portion of a process, used to create, modify, finish, package, label, fragment, or handle any substance in any way for selling or distributing it.
This is permission to manufacture drugs on the premises of any other manufacturer. A valid drug license and manufacturing capacity are requirements for the manufacturer who supplies the drug's production facility.
In India, importing drugs is mandatory. Licenses for the import of medications are issued by the Central Drug Standard Control Organization or CDSCO.
The documents required to obtain a drug license in Delhi:
The following are the main prerequisites for getting a drug license in Delhi, India:
A minimum of 10 square meters must be available for anybody wishing to open a retail pharmacy or medical store. It is crucial to note, that a retail or wholesale drug business must have a minimum of 15 square meters.
To keep medications, one must make sure that the space is outfitted with the appropriate storage facilities, such as a refrigerator or cold storage area.
Technical staff having knowledgeable and skilled staff with extensive expertise in the field is essential for a retail pharmacy store. In addition, the pharmacist must meet the requirements in order to be eligible for a drug license.
It is important to remember that in order to be granted a wholesale drug license, the employee must be either an undergraduate with four years of experience or a graduate with one year of experience.
A Drug Inspector with jurisdictional power may visit the premises for inspection prior to the issue of a drug license. In addition, he will be able to measure the property, confirm the information provided, and speak with the qualified individual.
The process of drug license in Delhi registration is given below:
The first step is to register on your state's Drug Licensing Portal. Each state has its own Drug Licensing Authority that oversees an online Drug Licensing Portal for the purpose of registering drug licenses. You can apply for the Drug License Certificate by logging into the portal directly if you already have the necessary credentials.
You must input the pharmacist's and competent individuals' details after registering on the website. Next, enter the name and parties related to the Pharmacist Council Registration. After that, you may submit the application by using the form that is relevant to the type of application you are submitting.
Forms 19, 19A, 19B, or 19C can be used to apply for a certificate of drug license in Delhi registration according to your needs. Once the necessary information has been entered, verify the information one last time as it cannot be changed later, and then submit the online Drug License Application Form.
Upon receipt of the completed Drug License Application Form, the Drug Licensing Authority (DLA) arranges for a time to inspect your property. To register for a drug license in Delhi, a drug inspector comes to the location on the prescribed date.
The conditions for premises for the issuance of a drug license are confirmed by the Drug Inspector (DI). Additionally, the applicant's original documents are verified by the Drug Inspector, and forward the report to the Drug Licensing Authority.
The Drug Licensing Authority reviews the report forwarded by the Drug inspector. The authority verifies if the application is in compliance with the Drug Rules. If the application is found accurate, the applicant is granted a drug license by the relevant authority based on the Drug Inspector's report.
When applying for a drug license online, pay the required fees at the Government Treasury or a State Bank of India branch in your district. Remember to include the original payment receipt with your application.
To renew your license, use the same application form as the one submitted for the initial license and include the required renewal fee. The renewal fee is the same as the initial grant fee.
If you renew your license late, the following additional fees apply for up to six months:
Late Fee for Drug License Renewal
Obtaining a drug license is necessary before manufacturing or selling drugs or starting a drug store. If you need any kind of drug license, you may get in touch with PSR Compliance directly, regardless of whether you are a manufacturer, distributor, or retailer of medicines and cosmetics in India or elsewhere. PSR Compliance guarantees that your license will be issued on time and this will enhance the credibility of your drugs or medicines. We provide a comprehensive solution to help medicine manufacturers in India secure licenses and testing facilities.
Once obtained, a drug license is valid for five years, until the Drug Department suspends or cancels it.
The applicant's store or premises must have a minimum of 10 square meters of space, and the person in charge (the Competent Person) must be a Registered Pharmacist, someone who has completed their high school education or its equivalent and must have four years of experience handling drugs, or hold a degree from an accredited university and have one year of experience handling drugs.
The Drugs & Cosmetics Act of 1940 and the rules enacted thereunder contain several sections pertaining to drug licensing. You can also contact the drug inspector of your area to obtain information about drug licenses. Moreover, in order to get any information, you can contact the expert of PSR Compliance and ask your questions.
Yes, selling drugs using motor vehicles does require a special license. Applicants must choose to take it at the time of making an application.
If the applicant's address changes, they must surrender the drug license that was issued for the previous location and apply for a new one.
You can check drug license status, visit the regulatory authority's website: https://www.statedrugs.gov.in/, enter the license number, and review the status. Ensure the site is official and secure to obtain accurate information.
To get a drug license in Uttar Pradesh, you will need these documents: a cover letter, an application form, a key plan and site plan of your location, proof of ownership or lease for the premises, an incorporation certificate, proof of the applicant's qualifications, an appointment letter for the registered pharmacist or qualified person, and an affidavit stating that The applicant has no criminal convictions.
The fee for a drug license in Uttar Pradesh depends on the type and scale of pharmaceutical operations. Costs differ for manufacturing, sales, and distribution licenses. For the most accurate and current fee information, it's best to consult the Food Safety and Drug Administration Department of Uttar Pradesh.
A Drug License generally remains valid for five years and must be renewed to maintain legal operations.
To verify your drug license online in India, go to the official website of the Central Drugs Standard Control Organization (CDSCO) or your local State Drug Control department. Find the Drug License section and input your application or license number to access the status and details of your license.