Drug license

Drug License

Why register for a drug license?

The authority that grants the drug license is under the drugs and cosmetics act, 1940. No person is allowed to carry the business related to medicines and drugs without obtaining a license from the concerned authority. To assure the quality of medicines and cosmetics the license is required.

If a person dealing with medicines and drugs provides medicines to the consumers and if such medicines cause harm to such consumers then the same will be treated as an offence. The seller and manufacturer may be liable under the IPC. Therefore it is essential to comply with the conditions imposed on the license.

Benefits of availing of the drug license

Following are the advantages and perks of obtaining a drug license:

  • Drug license helps in offering: The legal ground for carrying drug-related activities. The entities which are unregistered are not allowed to carry drug-related activities in the country. The entities that are registered to ensure the code of conduct is in line with the existing regulations. The entities having drug licenses can enjoy seamless supply chain management of drugs. The drug license empowers the relatives and wholesalers to continue their business proceedings without any legal complications.
  • Presents transparency and boost the credibility of the business: The wholesalers that ensure compliance with drugs and cosmetics act for a longer period helps them to achieve greater credibility in the market.
  • It ensures better management and effectiveness: Those who comply with CDSOs has a positive impact on the company’s effectiveness but the owner should be willing to stay in line with the given act.
  • Create a stronger relationship with the retailers: Those who are retailers of drugs remain extremely cautious while purchasing drugs from the wholesalers. They are very much concerned about the quality, storage, and pricing of drugs before making the actual purchase. But those having a wholesale drug license in place, need not worry about the above characteristics. The license itself is proof that the entity is following all the measures as outlined by the authorities to ensure greater transparency in their code of conduct.
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  • It helps in increasing market reach: The wholesale drug license not only helps the entities to meet their business goals but also helps in increasing the market exposure with time. The wholesale drug license leaves a long impact on the business as far as growth is concerned.
  • Helps in preventing adulteration: Adulteration is a very common practice that has been obstructing drug authenticity for ages. When the drug and cosmetics act, 1940 came into force, the government has a limited scope of adulteration by importing heavy practices on the defaulters. Those who are holding the drug license needs to maintain a strategic distance from the sort of practices to prevent penalties.
  • Ensure fair pricing on drugs: The act that governs the medicines and drugs would not allow the manufacturer, wholesaler, and retailer to charge unfair prices on the trading of drugs.

About the drug license

A drug license is required to be obtained by all those persons who are engaging in the business of medicines and drugs. The classification of drug licenses will defend categories of drugs and businesses involved with them.

There are many types of drug licenses:

  1. Manufacturing drug license
  2. Loan drug license in India
  3. Import drug license
  4. Multi-license for drugs
  5. Sale drug license in India
  6. Wholesale drug license in India
  7. Retail drug license
  8. Restricted license for a general store in India

Registration requirements for a drug license

A drug license is required to be obtained by all those persons who are engaging in the business of medicines and drugs. The classification of drug licenses will defend categories of drugs and businesses involved with them.

 

There are many types of drug licenses:

  1. Manufacturing drug license
  2. Loan drug license in India
  3. Import drug license
  4. Multi-license for drugs
  5. Sale drug license in India
  6. Wholesale drug license in India
  7. Retail drug license
  8. Restricted license for a general store in India

 

Registration requirements for a drug license

Following are the said requirements for registering for a drug license:

  1. In the case of a pharmacist, he/she must be qualified. In the case of a retail business, wholesale business, the individual must be a graduate with 1 year experience or undergraduate within 4 years of experience.
  2. The other vital requirement is the requirement of space. In both the cases, both wholesaler or retailer, 15 square meters and for all the remaining cases, 10 square meter space is needed. The clear height of the sales premises shall be as per the guidelines laid by the national code of India, 2005.
  3. The other important requirement is the storage of facilities since some drugs require to be stored in low temperatures. Hence, refrigerators and air-conditioners are a must.

Procedure to obtain a drug license

The following are the steps to be taken to obtain a drug license:

    1. The applicant is required to apply online for the license as per the line of business for which he/she must have a valid email address and contact number.
    2. The next step is to keep all the documents updated.
    3. Next is to upload the documents and the form along with the applicable fees.
    4. Upon completion of online process an inspector will list the site and verify the validity of documents.
    5. If are the above steps have been duly complied with the authority will issue the drug license.

Documents required to obtain a drug license

Following are the documents required:

  1. Constitution of the entity – MOA, AOA for a company, partnership deed, LLP agreement in case of partnership and LLP
  2. ID Proof of partners/directors/proprietor
  3. Document related to premises – Copy of ownership documents of property or rental agreement  as the case may be.
  4. Site plan and key plan of the premises
  5. Copy of board resolution permitting obtaining a license
  6. Proof of availability of storage space as cold storage, refrigerator, etc.
  7. Copy of challan as a proof of depositing fee
  8. Affidavit regarding non-conviction of proprietor/partner/director and the firm
  9. The affidavit from the registered pharmacist
  10. For a pharmacist at retail sale proof of qualification
  11. For pharmacist at wholesale, proof of qualification experience certificate appointment letter.

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