Introduction
Under the Indian government, an authority gives the drug license as permission or allows enterprises to engage in businesses that relate to drugs and cosmetics. No person can operate a company without a drug license that deals in drugs or medicines. Drugs and Cosmetics Act of 1940 purviews of cosmetics or drugs in which including ayurvedic, allopathic, homeopathic, etc. the drug license rules help the government for monitoring and maintain the quality of drugs sold in India.
Drug License
In India, it is mandatory to obtain Drug License to start a business in Drugs and Cosmetics. The Provisions which is related to drug licenses are contained in the Drug and Cosmetic Act of 1940. This act was united with other laws related to drugs and cosmetics. The Drug control department is a regulatory authority that regulates the manufacture of medicine and cosmetics, storage, distribution, and sale of medicine. Later this act was amended in 1964 to include Ayurvedic & Unani Drugs.
Benefits of Obtaining the Drug License Certificate
In India, Businesses must file a drug license application because it is illegal to engage in the manufacturing or sale of drugs without it.
The drug license helps the government for monitoring and regulates the sale of medicines, making your business credible and trustworthy in India.
A drug license certificate proves to your consumers that you follow exacting quality measures while manufacturing the drugs.
Having such a Drug license Certificate proves to the customers that your medicines and drugs are safe and pose no health hazards.
Applicants can use the import drug license to grow their business and expand their products in foreign countries.
Types of Drug Licenses
There are many types of Drug License in India which are mentioned below: -
1. Manufacturing License: - This license is for manufacturing allopathic/ homeopathic medicine and cosmetics and also for repacking drugs and can be granted only to recognized Industrial areas.
2. Sale License: - It is for the sale of drugs and it is also classified into two categories:
Wholesale Drug License- He must obtain a license for wholesale. It means the sale of the drug to the retailer to further sell it.
Retail License- It is required for the retail sale of drugs. It means the sale of drugs or cosmetics for the consumption of the end consumer. The Retailer can sell the drugs to dispensaries, hospitals, educational or research institutes, etc. Retailers engaged in pharmaceuticals, cosmetics, stand-alone pharmacists, and many more pharmacists require this license.
3. Loan License: - This License is issued to a person who intends to help the manufacturing facilities owned by another license.
4. Import License: - it enables enterprises to import Drugs.
5. Multi-Drug License: - This license is for companies that operate the pharmacy business in multiple states under the same name.
If the pharmacy business is operating in more than two states then it is necessary to obtain a drug license in each state where the business is carried on. In case drugs are sold at more than one place then a separate license shall be issued.
The licensee must ensure that all the conditions of the license of the drugs must be fulfilled during the business after the license is granted to the business. In case of any changes or modifications in business activity then you must be informed of the authority and all the registers, records, and forms must be maintained within a specified manner.
Checklist for the application for Drug License
Following provide the checklist document for the application for a Drug License:
1. Application Forms (Form -19 under Drugs & Cosmetics Act)
Letter of Undertaking
Declaration Forms.
Appointment Letter for Registered Pharmacist
Full-time Engagement as Pharmacist
2. Key Plan.
3. Site Plan.
4. If the property is rented property then they give the proof of ownership (No Objection Certificate of Owner of the Property)
5. Certified copy of the Firm Registration by DC or SDM.
6. Certificate of non-conviction of Proprietor or Partners or Directors as per Drugs and Cosmetics Act, 1940.
7. Certified Copy of the Registration Certificate of the Pharmacist (according to the Sikkim Pharmacy Council).
8. Affidavit of Registered Pharmacist or any Competent Person about concerning full-time working with the firm duly Notary attested.
9. Certified Copy of Trade License
Application for a Drug License
The Drug License is issued by the Drug Controlling Authority or the regulatory authority. The applicant must apply to the drug controlling authority based on the license he/ she requires as each drug controlling authority is responsible to issue different licenses. The process for obtaining the drug license is given following: -
1. Visit the respective drug controlling authority website:
The applicant must visit the respective drug controlling authority (SDSCO, CDSCO, or Ayush) which depends upon the type of license he/she is applying for since each drug controlling authority issues different types of drug licenses.
2. Filing of application:
After that, the applicant must fill in all the details in the application form.
3. Upload documents:
After filling, the next step is to upload the documents and submit the form with the applicable fees. The applicant must check all the documents were updated before applying.
4. Visit by drug inspector:
The drug Inspector will personally visit the company premises, shop, or drugstore after receiving the application for the verification of documents and the correctness of facts stated in the application.
5. Grant of the drug license:
After the inspection and verification, the drug controller will issue the drug license.
Forms for the license of Drugs for Sale and wholesale of Drugs
Form 19 is for the application to grant or renew a license to sell, stock, exhibit or offer for sale, or distribute drugs apart from those mentioned in Schedule X.
Form 19 A is for the application to grant or renew a restricted license to sell, stock, exhibit or offer for sale, or distribute drugs by retail through dealers who don’t engage the registered pharmacist service.
Form 19 B is for the application for a license to sell stock or exhibit or offer for sale, or distribute Medicines of Homoeopathic.
Form 19 C is for the application to grant or renew a license to sell, stock, exhibit or offer for sale, or distribute drugs that are mentioned in Schedule X.
5) Form 20 is for the application for a license to sell, stock or exhibit or offer for sale, or distribute drugs by retail other than those mentioned in Schedules C, C(1), and X.
Form 20 A is for the application for a restricted license to sell, stock or exhibit or offer for sale, or distribute drugs by retail other than those mentioned for dealers who do not engage the services of a registered pharmacist.
Form 20 B is for the application for a license to sell, stock or exhibit, offer for sale, or distribute wholesale, drugs other than those mentioned in Schedules C, C(I), and X.
Form 20 C is for the application for a license to sell stock or exhibit or offer for sale, or distribute Homoeopathic medicines by retail.
Form 20 D is for the application for a license to sell, stock or exhibit or offer for sale, or wholesale distributes Homoeopathic medicines.
Form 20 E is for the application for a certificate of renewal of a license to sell stock or exhibit or offer for sale, or distribute Homoeopathic medicines.
Form 20 F is for the Application for a license to sell, stock, or exhibit for sale or distribute retail drugs specified in Schedule X.
Form 20 G is for the Application for a license to sell stock or exhibit or offer for sale, or distribute wholesale drugs specified in Schedule X.
Some are mentioned above but many more forms of Drug licenses for the Sale and wholesale of Drugs.
Essential Documents for Obtaining a License
The essential documents for obtaining a sale license are mentioned below:
MOA, AOA for a company,
In the case of partnership and LLP then the partnership deed and LLP agreement
Identity proof of partner or director or proprietor.
Documents related to premises – Copy of ownership documents of property or rental agreement and Site plan and key plan of the premises.
Copy of Board resolution
Proof of availability of storage space.
Challan copy as proof of depositing fee.
Affidavit regarding non-conviction of proprietor or partner or director and the firm.
Cover letter of the applicant
Declaration form in a prescribed format
Applicant’s qualification certificate
Documents for a pharmacist at a retail sale:
Proof of qualification
Registration of local pharmacy council
Appointment letter
Documents for a pharmacist at a wholesale sale:
Proof of qualification
Experience certificate
Appointment letter
The registration process for Drug License
The registration process for Drug License is given following:
1) Login credential: - The very first step for the registration of a Drug License is to obtain the applicant registered on the portal of a Drug License. When the applicant is registered on the website of Drug License then the login credentials are received over your mobile number and e-mail id.
2) Registration of pharmacist or competent person: - when the applicant gets the login credential then he or she requires updating all the necessary details of the registered pharmacist or qualified person.
3) Application filing: - after that, the applicant must submit all the necessary details and upload all the documents. Now the application is submitted and requisite fees are paid to the department.
4) Inspection: - After the submission of the application then the Drug Inspector visits the premises for inspection of the site and verification of the documents. Now, the Drug inspector submits the inspection report to DLA, and on this basis, the license is granted.
Conclusion
It concluded that the Drugs and Cosmetics Act of 1940 purview of all cosmetics or drugs in which including ayurvedic, allopathic, homeopathic, etc. the drug license rules helps the government for monitoring and maintain the quality of drugs sold in India. No person can operate a company without a drug license that deals in drugs or medicines.
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