In India, the entity which works for the health care sector such as medicines, drugs or cosmetics shall obtain the Drug License Brochure from the relevant authority. According to the Drugs and Cosmetics Act, License is issued by the State or Central Drug Standard Control Organization.
So any infringement in the medically defined terms and restrictions should have a relentless effect on the health of person consuming the drug and to protect the customers having various medications. Government is adapting medicines manufacturing by imposing severe and rigorous rules and policies that are required to be followed by distributor and producer of drugs and medicines in India.
Types of Drug License Brochure Issued in India
Following are the various types of Drugs licenses issued depending upon the type of business for which the permit is acquired:-
Manufacturing drug License
All the producers of cosmetics, allopathic, ayurvedic products or any other medicine or drugs as defined under the Drugs and Cosmetics Act 1940. Manufacturing drug License is a state license that is issued by the state government of the particular State where the manufacturing unit is located.
The manufacturer of drugs who doesn’t possess land on his own somewhat willing to manufacture using his brand name on the area to which license is already issued.
Any trader importing the products for the production of drugs or who is involved in the business of importing drugs in India should obtain Import license.
Multi-license for drugs is acquired by the entity operating in more than one state having multiple units of the production house.
Sale license is obtained by the individual who is engaged in wholesale or retail business for distribution & allocation of drugs in India.
Wholesale Drug License
Wholesalers who are doing the business of pharmaceuticals in India should obtain a wholesale drug license from the central drugs standard control organization. The wholesale drug license specifies the particular minimum requirement on the person applying for this license, such as:
- Degree and diploma in pharmacy
- Minimum 1-year experience in drug dealing
Retail Drug License
Retail Drug License is acquired by the retailers involved in the business of pharmaceuticals or stand-alone pharmacists by applying to the State Pharmacy Council & obtains this type of license.
Key-Requirement to Acquire Drug License Brochure in India
Following are the necessary key-factors to be kept in mind before applying for Drug License Brochure in India:-
The minimum area of 10 square Meters is necessary for setting up a medical shop or a retail pharmacy in India. Though, if they are working with the wholesale business along with retail business, the minimum area required has to be 15 square meters.
The proper storage facility shall be in-housed by the execution providing facility for cold storage, refrigerators or related places for the storage of medications and vaccines as they are required to be restored in cold places.
Technical & Expert Staff
The retail pharmacies are required to have a competent and professional staff with thorough knowledge of the medicines and drugs in India. Businesses that are dealing with medicines & drugs are required to have various types of licenses based on their production.
The permit has to be region-specific and is required to be acquired by a single drug trader having multiple production units in more than a state. Other than a migrant seller the drug license has to be applied for every state where drugs are stored and sold in India.
The Drug license holders have to make sure that comply with the terms and conditions provided the relevant authority. The license issued after overlooking these terms and conditions can get suspended or cancelled. Authorities have to be notified about any change or modification if taken place in business.
Process to obtain Drug License Brochure in India
Following is the necessary procedure to get Drug License in India:
- Based on the type of business and type of Drug license needed, the applicant is required to apply online for registration of Drug License;
- Once the application form is filed and registration is accomplished, the system will auto-generate a Unique Registration Number that will be used for future indication.
- Within 15 days of registration for drug license, all the necessary documents should be submitted to the officials of the Drug Licensing Authority of a concerned state in hard copy.
Essential Documents to obtain Drug License Brochure
Following is the list of documents required for applying for drug license Brochure in India:
- Application Form duly signed that has been filed already;
- Copy of Challan as an evidence for depositing the required fee;
- Identity Proof such as PAN, Driving license, Voter Id, Passport, etc. in case the applicant is the owner;
- If the applicant is a partnership firm then ID Proof of every co-worker along with the copy of partnership deed;
- Copy of Memorandum of Association, Articles of Association, and Certificate of Incorporation in case of private company, public company or one person company;
- CTC of Board Resolution for approving the company for acquiring the drug license;
- Appointment letter of the individual who is being sanctioned by the company itself;
- Proof of availability of storage space such as refrigerator or cold storage for storing medicines and drugs.
Additional Documents if the applicant is a Registered Pharmacist
- Diploma in pharmacy
- Certificate of Registration issued by the Pharmacy Council
- Letter of Appointment
- Affidavit of being a pharmacist
- Education qualification certificates such as high school, graduation certificate, and post-graduation degree are required to be submitted.
- Minimum of one year of experience is obligatory for sales of drugs and marketing of any pharmaceutical company in India
- Layout plan of the premises for which the license is being applied
- There should be an area of a least of 10 square meters if the permit is used for the wholesale or retail drugs sale.
- There should be an area of a minimum of 15 square meters if the license is applied for both wholesale as well as retail sales of drugs.
- Essential Electricity should be available and related installation in the premise for storage of electricity.
Drugs used in the creation of medicines should be mainly done in a defined ratio. Medications are used in drugs that cure disease and are used as per the needs to ensure the well-being of human beings. Therefore the preparation and use of such medications in medicines is restraining, and the principles are set for using the accurate amount of drugs that will not harm the body by its overdose. In case of any query related to Drug License Brochure, contact CorpBiz.
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