Drug License in India: Full Guide

Drug license guide

The business organizations dealing in drugs or medicines would need Drug License based on the organization's activities. The license is region-specific and must be obtained by an individual drug dealer having multiple units in more one state.


Overview of Drug License in India:

Business organizations working in the health care sector, such as medicines, cosmetics, or drugs, must acquire drug license from the concerned authority. According to the provisions of the Drugs and Cosmetics Act of 1940, the license is issued by the State Drug Standards Control Organization or Central Drug Standards Control Organization. Drugs are used to form medicines in a medically prescribed ratio that helps in curing diseases and making sure that a person remains healthy. The preparation of medicines is done by using a different kind of in a prescribed ratio, and it is considered a very delicate process that is why the standards are very stringent for using the correct amount and combination of drugs so that the medicines do not have any harm or side effect on the human body.

Therefore, any violation or breach of a medically prescribed limit will have a harmful effect on a person's health. In order to save the health of a consumer from the dangerous side effects of medication, the Indian Government regulates the process of manufacturing medicines by imposing stringent and strict rules and regulations that must be followed by every distributor and manufacturer of drugs and medicines in India.


What are the different types of Drug Licenses in India?

The license is granted based on the type of business. Below-mentioned is the different types of the license granted in India:

  • Manufacturing Drug License:

The manufacturers of ayurvedic, allopathic, cosmetics, or any other form of approved medications or drugs, as prescribed in the Drugs and Cosmetics Act,1940. A manufacturing license is a state license granted by the state government where the business organization is manufacturing.

  • Loan Drug License

The manufacturers of drugs or medicines who don't own land in their name, but are rather keen on manufacturing medicines using a brand name on the land, who already holds a license.

  • Import Drug License:

An individual importing products or materials used in the manufacturing medicines or is indulged in the business of importing drugs in India should obtain this license.

  • Multi-Drug License:

The business entities having multiple operating units in one or more states must obtain this license.

  • Sale Drug License:

Sale license is acquired by the business organizations involved in the wholesale or retail activities for selling drugs in India.

  • Wholesale Drug License:

Wholesalers indulged in pharmaceuticals' business should obtain a wholesale license issued by the Central Drugs Control Organization. Wholesale license stipulates the minimum requirement for an individual applying for a wholesale license, such as:

  1. Degree or Diploma in Pharmacy

  2. A minimum work experience of one year in dealing with medicines or drugs

  • Retail Drug License:

A retail license is obtained by the retailer indulged in pharmaceuticals, stand-alone pharmacists, etc. by submitting an application to State Pharmacy Council.


What are the key requirements for obtaining a Drug license in India?

The following are the key requirements for obtaining a drug license in India:

  • Premise Area:

The premise area's minimum requirement is ten sq. meters for setting up a retail pharmacy or medical store. Though, if an individual is operating wholesale business along with a retail shop, the minimum premise area required is 15 sq. meters.

  • Storage:

The appropriate storage facility must be in-housed by setting up refrigerators, cold storage, or any other similar equipment for storing vaccines and medicines as they must be stored in cold places.

  • Technical Staff and Experts:

A retail pharmacy must have technical and qualified staff with experience and knowledge of the same.

Business organizations dealing in drugs or medicines require different types of drug licenses based on business activities. The license is region-specific and must be obtained by an individual drug dealer having multiple units in more one state. Except for a migrant vendor, a drug license must be applied for each place where drugs are sold and stocked.

License holding organizations have to ensure that it complies with the rules, regulations, terms, and conditions. The license issued ignoring these rules, regulations, terms, and conditions can get suspended or canceled. The license issuing authorities must be notified about any modification or change that occurred in business.


How to Obtain Drug License in India?

Following is the basic process to obtain a license:

  • The business entity has to identify the type of license required based on the business activity and apply for online registration for a particular license.

  • After the online application is submitted, a unique registration number will be auto-generated by the system. The applicant entity can use this unique registration number for future reference.

  • After registration is completed, the required documents must be submitted within 15 days to the authorities responsible for issuing the concerned district's license in a hard copy.

Documentation:

Below-mentioned is the necessary documents required for obtaining a drug license in India:

  • Duly signed the application form, which has been already filed

  • A certified copy of challan as proof of depositing fee

  • Identity proof such as voter ID card, Driving License, PAN card, Passport, etc. If the applicant is a proprietor.

  • Identity proof of all the partners, along with a certified copy of the partnership deed. Suppose the applicant is a partnership firm.

  • A certified copy of the Memorandum (MoA) of Association and Articles of Association (AoA). Suppose the applicant is a Private Company, Public company, or one-person company.

  • CTC of Board Resolution for authorizing the business organization for acquiring the license.

  • Appointment letter of the individual who is authorized by the business organization.

  • Proof of availability of storage equipment such as refrigerator, cold storage, etc.

Conclusion

Business organizations working in the health care sector, such as medicines, cosmetics, or drugs, must acquire drug license from the concerned authority. According to the provisions of the Drugs and Cosmetics Act of 1940, the license is issued by the State Drug Standards Control Organization or Central Drug Standards Control Organization. Drugs are used to form medicines in a medically prescribed ratio that helps in curing diseases and making sure that a person remains healthy.

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