Ensuring that everyone has fair and equal access to medicines and drugs is the top priority of every government. However, the right to produce and sell treatments and medicines must be granted with care. The online drug licence renewal process can be easily done if you have the right assistance. This is why the government has strict regulations for granting licenses for producing and selling drugs and pharmaceuticals. The Act that regulates the complete procedure from the beginning of production until the sale of medicines in India is known as the Drugs and Cosmetics Act of 1940.
Meaning of Drugs
Section 3(b) of the Cosmetics and Drugs Act of 1939 provides definitions of “drug” to include all medications and devices that are intended for use by animals or humans both externally and internally.
The definition also covers all substances that may be used to kill insects and all the substances in a drug – such as empty capsules of gelatin. The report was modified in 1964, including Ayurvedic and Unani Drugs.
Purpose of Drug Licence
The availability of medications and drugs should be limited and controlled to ensure that the products aren’t misused or abused by people. Therefore, all pharmacists, wholesalers and sellers, manufacturers, retailers, dealers, and importers of cosmetics and drugs Ayurvedic, Siddha, and Unani drugs must obtain a drug license under the Drugs and Cosmetics Act, 1940.
The goal of a license is to provide permission for companies or individuals to conduct business activities related to drugs and cosmetics. A person or company can only run a business dealing with cosmetics, drugs, or other substances if they obtain a drug license in India. If you are looking for a drug license renewal process, then Legalpillers is one such company that can help you step by step.
The Drugs and Cosmetics Act of 1940 and The Drugs and Cosmetics Rules of 1945 assist the government in regulating and supervising the quality of drugs sold in India. The government controls drugs starting from the beginning of the raw material phase, through manufacture sales and distribution, until it is sold to consumers or patients through a pharmacist in a retail pharmacy, dispensary, or hospital. In case you are looking for a drug license renewal process, Legalpillers is one such company that can help you.
The government also exercises oversight in all aspects related to the export and import of drugs, the sale of the drug to minors, and the consumption of Schedule H and X drugs. This requires careful surveillance and careful execution. The license to use medicines is issued by the authority responsible for drug control following the Drugs and Cosmetics Act of 1940.
Types of Drug Licenses
When we look at the definition of “drug,” the pharmaceutical business in India requires the following kinds of licenses:
- Manufacturing License- License issued to a business that manufactures drugs inclusive of allopathic/homeopathy medicines.
- Sale License: It is a license that is issued to sell drugs. It is divided into two parts: Wholesale Drug License – Wholesale Drug License – Retail Drug License.
- Wholesale License: Drug wholesalers have to get a wholesale license. Wholesale is selling the drug to an individual or retailer to sell it further.
- Retail License: A retail license is required to sell prescription drugs. Retail sales are the sale of medicines or cosmetics for the buyer’s consumption. Retailers can offer it to a hospital, dispensary, educational, medical, or research center. Retailers who sell cosmetics, pharmaceuticals, standalone pharmacists, or ayurvedic stores require this license.
- Loan License – Licence issued to a company that doesn’t own the production facility, however, uses factories of a different licensee.
- Import License – A license is granted to any dealer importing products used to manufacture drugs or engaged in the import of narcotics into India.
- Multi-Drug License: It is given to businesses that own pharmacies in several states that share the same name.
Prerequisites For Obtaining a License
- The pharmacist or the competent person The pharmacist should be licensed in the event of a retail-based business. If it is a wholesale company, the person must be a graduate with a minimum of one year of work experience. Or an undergraduate with four-year experience. An online chartered accountant can assist in obtaining the license.
List of Essential Documents For Obtaining a License
The essential documents for obtaining authorization to sell and drug license renewal include the following:
- The constitution of the entity, Memorandum of Association (MOA), Articles of Association (AOA) for a corporation and partnership deeds, LLP agreement in case of a partnership, and LLP.
- ID proof of partner/director/proprietor.
- Documents about the premises: The copy of the ownership documents of the property or rental agreement and the NOC (No Objections Certificate) from the property owner, depending on the situation.
- Critical plan and Site design of the premises.
- Copy of Board resolution allowing the issuance of the license.
- The evidence of the storage space, such as refrigerator, cold storage, etc.
- A copy of the challan to prove the depositing fee is also required for drug license renewal.
- Affidavit regarding non-conviction of proprietor/partner/director and the firm.
Frequently Asked Questions
What are the kinds of businesses in the field of drugs which require a license for drug use?
All drugs or cosmetics businesses under the Drugs and Cosmetics Act 1940 must obtain a drug license before starting/establishing a drug or cosmetics business. This Drugs and Cosmetics Act covers all drug businesses, which includes homeopathic, allopathic, Siddha, or Unani drugs.
What are the prohibited substances in the Drugs and Cosmetics Act of 1940?
The substances that are covered under the Drugs and Cosmetics Act are as the following:
- All medications intended for internal or external use of human or animal beings and all substances that are designed to be used for treating, diagnosing, or preventing or cure of any illness or disorder that affects animals or human beings, such as products that are applied to the human body to repel insects such as mosquitoes.
Are the drug license and a business license for pharma identical?
Yes. The drug license is called a license for pharmaceuticals. A license to sell drugs is mandatory for all companies that distribute medications and supplements for medicines.
I have a license for a drug in Bangalore. Do I require another appointment to sell my drug in Chennai?
Yes. If a company dealing in drugs operates in more than one state and requires an individual drug license for each state where it works. The registration for a drug license is specific to the location. So, the drug is being sold or stored for distribution or sale in more than one location. In that case, it is recommended that the application be submitted to every state, and a permit will be issued for each site, excluding sellers who are migrants.
What is the legality of a prescription drug license?
A drug license is valid for five years unless it is removed and canceled by the department of drugs. It is possible to renew it before its expiration time by logging onto the drug control website by entering the drug license number, filling out the renewal application, and then submitting the form along with the required fee to be issued a license renewal. The drug control officer will then give the new permit to use drugs.
How will the drug license be when there is an alteration in the premises?
If there is an upgrade in premises, the license to operate a drug business at the previous premises must be surrendered. The owner of the drug business must apply for brand-new support for the new location.