In India, if any business or company works under the health care sector such as cosmetics, medicines, or drugs, shall obtain the Drug License, which is issued by State/Central Drug Standard Control Organization. Without a license, nobody can start any pharmacy business; doing so is a cognizable offence. Drugs are used in medicines that cure diseases. The preparation and use of drugs in medicines are restrictive, and rules are set for using the correct amount of drugs in medication so that they don't harm the body by its overdose. If the usage of drugs is high in medicine, it will have a severe effect on the person who consumes it. Scroll down to check the process to get Drug License in India.
What are the main features of a Drug License in India?
Check the features of Drug License in India are mentioned below:
License is mandatory for medicine, drugs, and cosmetics business.
Drugs and cosmetics businesses should follow all the rules and regulations proposed by authorities and laws.
The license should be displayed all the time in the place of business.
What are the different types of Drug License issued in India?
The different types of licenses issued are mentioned below; basically, it depends upon the types of business for which the license is issued:
Loan Drug License.
Import Drug License.
Multi-Drug License.
Sale Drug License.
What are the Benefits of Obtaining Drug License?
Following are the benefits of obtaining Drug License in India:
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.
Reputation
Pharmacies with drug license would have more reputation in the eyes of the public.
Different types of forms for Drug License for sale and wholesale of drugs
What are the requirements to obtain Drug License in India?
Following are the essential requirements to be kept in mind before applying for a drug license in India:
It requires a minimum area of 10 square meters for setting up a retail pharmacy or medical shop. If they are operating the wholesale business, the minimum space required shall be 15 square meters.
The implementation of refrigerators or cold storage for the storage of medicines and vaccines as they will be stored in cold places.
Medical shops or retail pharmacy should have a technical and qualified staff with thorough knowledge of the same.
What are the documents required for the registration of a Drug License in India?
Following are the lists of documents required for the registration of drug license in India:
Application form duly signed, which is already filled.
Copy of challan.
Identity proof such as Aadhar card, PAN card, Driving license, passport, Voter Id in case an applicant is a proprietor.
Obtain an id proof of every partner along with the partnership deed (in case of the applicant is a partnership firm).
Copy of Articles of Association (AoA) and (MoA) Memorandum of Association in case of Private Limited / Public Limited / One Person Company.
Appointment letter along with biodata.
Experience Certificate.
Obtain a copy of the rent agreement in case of a rented office.
Details and invoice of a refrigerator in use.
Certificate of registration with the Delhi pharmacy council.
Obtain degrees, certificates, or mark sheets as educational proof.
What are the additional documents required if the applicant is a registered pharmacist?
Diploma Pharmacy.
Registration certificate issued by the pharmacy council.
Appointment letter.
Affidavit of a pharmacist.
Certificates of high school, intermediary mark sheets, graduation and post-graduation for education qualification.
An experience letter is mandatory in drug sales and marketing of any pharmaceutical company.
Necessary availability of electricity and installation in the premise.
Plan the layout of the premise for which the license is applied.
What are the steps for getting a Drug License in India?
Usually, the process takes as long as 30-60 days; the following are the steps to get a Drug License in India:
Step 1: An Applicant must apply online for the license, for which he/she must have a valid contact number and email id.
Step 2: Keep all the necessary documents scanned in a 100ppi size and upload the documents and the application form along with the prescribed fees.
Step 3: After completing the online process, an inspector or authorized offer will come to the site and verify the validity of documents.
Step 4: After completing your application review and approve it, the authority will issue the drug license.
Conclusion
From above, we can say that the requirement of drug license in India is very important because it promotes public health; it regulates the distribution, sale, and import of drugs. It also makes sure a genuine organization will obtain the drug license. Without a drug license, nobody can start any pharmacy business; doing so is a cognizable offence. Drugs are used in medicines that cure diseases. The preparation and use of drugs in medicines are restrictive, and rules are set for using the correct amount of drugs in medication so that they don't harm the body by its overdose.