Drug License – An Overview
Drug License is crucial for every business that is dealing with drugs and pharmaceuticals. This license would provide the basic requirements for a pharmaceutical business to carry out its operations daily. The government has made specific rules related to manufacturing and selling of drugs and pharmaceuticals. Any pharmaceutical dealing with the distribution of pharmaceuticals has to comply with the provisions of the Drugs and Cosmetics Act, 1940.
There are different forms of drugs and pharmaceuticals governed under the provisions of the above act. These types of drugs include homeopathy drugs, allopathic drugs, ayurveda and Unani Drugs. Any pharmaceutical selling drugs without proper license would be liable under the provisions of the Drugs and Cosmetics Act, 1940. Plus this offence would attract some stringent penalties under the Indian Penal Code, 1860.
Statutory Meaning of Drug License
Drug License is also known as a pharmaceutical license. This license is required for all form of businesses that engage in distribution of medicines and pharmaceutical supplements.
According to section 3(b) the meaning of drug has different interpretations:
As per this section a drug is a medicine which is used for internal and external use of human beings. It will also include any form of substances used for diagnosis or mitigation or treatment of any form of diseases. Such substances are for human beings and animals.
Any substance which is used for the destruction of insects or vermin that cause problems to the human system. Humans and animals can utilise such substances.
Any form of component which is utilised to store drugs which will also include empty gelatine capsules.
Any such devices which are used for internal or external treatment of human beings to reduce or prevent or mitigate any form of disease.
The above definition has been amended by the Ayurvedic and Unani Drugs Act, 1964.
Forms of Drugs License
There are different forms of drug license which can be provided based on the requirement of the applicant. The following are the forms of drug license provided:
Import Drug License-
Such license is usually used for import of drugs from other countries.
Multi Drug License-
Usually this form of license is issued to pharmaceutical businesses that have their pharmacies in different states and cities. A classic example of this form of license is the company Medplus.
This license is usually issued to large industries for manufacture of drugs. In this form of license manufacturing of any form of drugs can occur. Even allopathic and ayurvedic drugs can be manufactured using this form of license.
This license is usually issued for the sale of drugs in pharmaceuticals and other form of stores. Such license is provided to stores for the sale of pharmaceuticals, restricted pharmaceuticals and other stores.
Benefits of Drug License
By securing a drug license the following benefits can be enjoyed by the pharmacy:
Compliance with Law-
All pharmacies that have the drug license would be compliant with the provisions of the Drugs and Cosmetics Act, 1940. Apart from this, pharmacies would not need to pay penalties for any issues related to non-compliance.
Pharmacies with drug license would have more reputation in the eyes of the public.
Eligibility Criteria for Drug License (Online Drug License)
The applicant has to satisfy the below criteria for the drug license:
Area of Set up-
First and foremost, the applicant must have proper premises to distribute and sell pharmaceutical products. There has to be an independent shop available for the applicant to apply for the drug license. Such an application must be made as a retail or whole sale drug license. If the license made, is under Form 20 or Form 21, then the premises must be not less than 10 Square Meters. If the license applied for is in Form 20-B or Form 21-B then the premises must be not less than 15 Square Meters. Apart from the above pre-requisites the height of the premises must be in accordance to the National Building Code of India. These premises must satisfy the above criteria to be applicable for a drug license in India. An applicant has to apply to the respective state council for securing the drug license in the state. The requirement of the premises and their respective square foot must be adhered by the applicant.
All pharmacies and drug stores must have adequate storage facilities to operate. Such requirements are mandatory as certain drugs and substances are stored at low temperatures. Hence the applicant has to ensure that proper storage facilities are available in the premises.
All individuals working in the pharmacy must have special educational and technical requirements. For example all individuals must have the bachelors of pharmacy certification (B.Pharm). Apart from this, any pharmacy must have an individual with at least one to four years experience. Such requirements are different when it comes to owning a retail business and a wholesale business.
Procedure for Securing Drug License in India
The following steps have to be carried out for this form of license in India:
Fill in the application online for the respective state drug license-
The applicant has to first fill the application online for the respective state drug license. The requirements for drug license would be different from one state to another state. Hence, the applicant has to ensure that the requirements for the drug license confirm with the state requirements.
Provide Updated Documents and Upload the Same-
In the second step, the applicant has to provide updated documents and upload the same online. Such documents should be as per the requirements of the authority.
Pay the Fees-
In the next step, the applicant has to pay the fees for the drug license. This has to be carried out online.
After applying for the license, verification will occur. The authority will verify the application. An inspector would be assigned to view the premises of the retail or wholesale shop. If all the requirements confirm with the requirements, then the inspector would approve the premises.
Issue of Drug License-
In the last step, the license would be issued by the authority.
Application Forms required for Drug License
There are specific application forms required to be filled by the applicant for the drug license. The following are the application forms which have to be submitted by the applicant:
- Form 19- This form is for the sale, distribution and storage of medicines for distribution. Some drugs which are present in Schedule X are supposed to be displayed or sold as per the requirements of the Drugs and Cosmetics Act, 1940.
- Form 19A- Such form is the application for grant of license of renewal for a restricted license to sell medicines and drugs. Retailers who do not engage the services of a qualified individual would come under the purview of this form of license.
- Form 19B- If an applicant wants to sell, stock, distribute any form of Homeopathy medicines then such application must be utilised.
- Form 19C- This form of application is used for license to grant certifate or renewal for selling, stocking or distributing medicines which are mentioned under Schedule X of the Act.
- Form 20B- Application for Sale or Distribution of Drugs at Wholesale.
- Form 21C-Application for Wholesale license for the sale or distribution of drugs for specific renewal.
- Form 24- Application for granting of license or renewal of license for specific medicines or to manufacture for sale or distribution of drugs other than the drugs which are mentioned under Schedule X , Schedule C and Schedule C1.
- Form 24A- Application for the form of Loan License would be present under this form. Such license is for the grant of the loan license or the renewal of loan license for medicines and pharmaceutical products.
- Form 24B-Application form for repacking of medicines and other forms of drugs but not the drugs which are mentioned under Schedule X, Schedule C or Schedule C1 of the Drugs and Cosmetics Act, 1940.
- Form 24C- Application form for grant of the renewal of license to manufacture and distribution of homeopathy medications.
- Form 24F- Application from for renewal of license for sale and manufacturing of drugs which are mentioned under Schedule X but not the manufacture and sale of drugs mentioned under Schedule C and C1.
Documents for Drug License
- Incorporation Documents and Constitution Documents- If the applicant is a company, then certificate of incorporation must be provided along with other documents such as the memorandum of association and articles of association. In case the entity is a partnership then respective partnership documents must be provided. This will include the partnership deed.
- Identification Proof of the Director or Shareholder or the Applicant.
- Premises Documentation- Such as utility bills, electricity bills, water bills and property documents.
- Site Plan and the Architecture Plan Of the Pharmaceutical Outlet.
- Copy of the Board Resolution related to the License.
- Proof of Challan and Copy of the Deposit Fee for the Pharmacy.
- Evidence showing proof of availability of storage place and cold storage facilities.
- Evidence showing no form of conviction is against the partner or the director of the company.
- Educational Qualifications and Experience of the Pharmacist.