Drug license in India

In India, a health unit that works in the health care sector such as medicines, drugs or cosmetics will obtain a drug license from the appropriate authority. As per the Drugs and Cosmetics Act, a license is issued by the State / Central Drug Standards Control Organization.

Medications are used in the manufacture of medicines in medically defined proportions. Medications are used in medicines that treat disease and are used as needed to ensure the well being of humans. Therefore the preparation and use of such drugs in medicine is restrictive, and standards have been set to use the right amount of drugs that do not harm the body from its excess.

Therefore any violation in medically defined terms and limits will have a serious impact on the health of the person consuming it and for the safety of consumers consuming the drug, the government regulates the manufacture of drugs by enforcing strict and stringent laws and regulations Is being followed by the distributor and manufacturer of drugs and medicines in India.

Types of drug licenses

Different types of licenses are issued depending on the type of business for which the license is obtained:

• Manufacturing Drug License

  All manufacturers of allopathic, cosmetics, Ayurvedic products or any other drugs or medicines specified under the Drugs and Cosmetics Act 1940. It is the state license issued by the particular state government where the unit is located.

• Debt Drug License

  Manufacturers of drugs that do not own land are ready to use their brand name to build on land that has already been released.

• Import Drug License

  Any dealer importing products for the manufacture of drugs or engaged in the business of importing drugs into India will obtain this license. / />

• Multi Drug License

  Multi-drug licenses are acquired by an entity operating in more than one state, consisting of multiple units.

• Sales Drug License

  Cell drug license is acquired by an entity engaged in wholesale or retail business for distribution of drugs in India.

• Bulk Drug License

  Wholesalers doing the business of pharmaceuticals must obtain a wholesale drug license from the Central Drugs Standard Control Organization. Wholesale drug license specifies certain minimum requirements on the person applying for this license such as:

  1. Degree and Diploma in Pharmacy

  2. Minimum 1 year experience in drug dealing

Requirement

The following are the essential important factors before applying for a drug license:

• Campus A minimum area of ​​10 square meters is required to establish a medical shop or retail pharmacy. However, if they are dealing with wholesale business along with retail, the minimum area required will be 15 square meters.

• Storage The implementation of

  cold storage, refrigerators or similar locations for storage of medicines and vaccines should facilitate proper storage as they will be restored in cold places.

• Technical and Expert Staff Retail pharmacy will have a qualified and technical staff with full knowledge.

• Retail Drug License This license is obtained by applying to the State Pharmacy Council, retailers engaged in the business of pharmaceuticals, stand-alone pharmacists, etc.

Drugs or drug-related business entities will require different types of drug licenses depending on their business. Drug licenses need to be multiple units in more than one state by the same drug dealer to be region-specific. Apart from a migrant vendor, the drug license will be applied to every place where the drugs are stocked and sold.

Drug license holders have to ensure that they comply with the terms and conditions. Ignoring these terms and conditions, the license issued may be canceled or suspended. Officers will be informed about any changes or modifications in the business.

Registration Process

Following is the basic procedure to obtain a drug license in India:

• Depending on the type of business unit and license, the applicant will apply online for registration
• Once the application form is filled and registration is complete, the system will automatically generate unique registration numbers that can be used for future reference.
• Within 15 days of registration, the relevant documents will be submitted in hard copy to the officer of the Drug Licensing Authority of the concerned district.

Documentation

Following is the list of documents required to apply for a drug license in India:

• The application form is duly signed already filed
• Copy of the invoice as proof of depositing the required fee
• Identity proof like PAN, Voter ID, driving license, passport etc. in case of the applicant being the owner.
• If the applicant is a partnership firm, ID proof of each partner along with copy of partnership deed
• Copy of MOA, AOA and COI in case of Private / Public / OPC
• CTC of board resolution to authorize a company to obtain a license.
• Appointment letter of the person authorized by the company
Evidence of availability of storage space such as cold storage, refrigerators, etc.

Additional documents if the applicant is a registered pharmacist:

• Diploma Pharmacy
• Certificate of Registration issued by Pharmacy Council
• Appointment letter
• Pharmacist Affidavit
• Education qualification certificates such as high school & intermediary mark sheets, graduation certificate, post-graduation degree, etc.
• Minimum, one year experience, is mandatory in pharmaceutical sales and marketing of any pharmaceutical company.
• Plan the layout of the license for which the license is applicable
• In the event of license being applied for wholesale or retail sale of drugs, there will be a minimum area of ​​10 square meters.
• In the event of license being applicable for both wholesale and retail sale of drugs, there will be a minimum area of ​​15 square meters.
• Availability of Electricity required.