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Drug License
Registration

In India, licensing is required for doing business in the drug and cosmetics industries. The Drugs and Cosmetics Act of 1940, which applies throughout India, includes regulations for this. The Drugs Control Department was founded by an Act that consolidated all drug and cosmetic legislation. In 1964, the Act was revised to include Ayurveda and Unani medications. However, based on their industry, a certain company entity may require different forms of drug

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What is a Drug License?

 A drug licence is an approval provided by the authority under the Drugs and Cosmetics Act to operate a drug or medicine or cosmetics business. The Drug Licence is issued by either the State Drugs Standard Control Organisation or the Central Drug Standard Control Organisation. Drugs are employed in medicines in a medically established ratio to treat human diseases. 

However, these drugs are produced with a very limited and proper amount of medications, and they do not affect the body. However, any disregard of the medically prescribed limitations might have a negative impact on the health of the individual using it. So, the government must regulate the process of manufacturing and distributing medicines in India by enforcing strict laws and regulations. If you have a Drug Licence from the government, you can deal with drugs; otherwise, you cannot. 

 

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Drugs License for Pharmaceuticals

The demand for pharmaceuticals is never-ending, making pharmacy business the most perfect business. It’s not impacted by financial cycles. In the past few years, there has been a high degree of development in hospitals, which has led to an increase in demand for pharmacies. Pharmacies are found in hospitals, shopping malls, residential complexes, and housing developments; pharmacies in residential buildings are a built-in form of the firm. E-commerce and e-health companies are the primary participants due to their market reach, ease of access to pharmaceuticals, and cost-effectiveness through same-day delivery.  

List of Required Documents for Getting a Drug License

List of Required Documents for Getting a Drug License

  • Memorandum of Association (MOA), Articles of Association (AOA) for a company, partnership deed and LLP agreement (if applicable).
  • Proof of identity for partner/director/proprietor.
  • Copy of property ownership document or rental agreement, and a No Objection Certificate (NOC) from the owner of the rented premises.
  • A copy of the Board resolution approving the licence application.
  • Proof of available storage space, such as cold storage and refrigerators.
  • Provide a copy of the challan as proof of fee deposit.
  • Affidavit of non-conviction for proprietor/partner/director and the firm.
  • Affidavit from registered chemist or competent person.
  • Provide a cover letter with the applicant’s name and designation.
  • Complete a declaration form in the approved format.
  • The applicant’s qualification certificate.

For chemists during retail sales

Provide proof of qualification, registration with the local pharmacy council, and appointment letter.

For chemists at wholesale sales

Required documents: proof of qualification, experience certificate, and appointment letter.

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Drug Licence Application Procedures

The process for procuring a drug licence is as follows:

Visit the respective drug control authority website

The applicant must attend the right drug controlling authority (SDSCO, CDSCO, or Ayush) based on the type of license he or she is applying for, as each drug controlling authority is responsible for issuing various types of drug licenses.

Filing of application

The applicant must attend the right drug controlling authority (SDSCO, CDSCO, or Ayush) based on the type of license he or she is applying for, as each drug controlling authority is responsible for issuing various types of drug licenses.

Upload documents

After completing the application form, the next step is to upload the papers and submit the form with the appropriate costs. Prior to filing the application, the applicant must keep all documents up to current.

A visit by a drug inspector

After receiving the application form, the drug inspector will physically visit the corporate premises, shop, or drugstore to verify the papers and the accuracy of the information contained in the application.

Grant of the drug licence

The drug controller will grant the drug licence after an examination and verification by the drug inspector. You must get the necessary approval and acknowledgement at each stage to establish your drug business.

A visit by a drug inspector

After receiving the application form, the drug inspector will physically visit the corporate premises, shop, or drugstore to verify the papers and the accuracy of the information contained in the application. 

Grant of the drug licence

The drug controller will grant the drug licence after an examination and verification by the drug inspector. You must get the necessary approval and acknowledgement at each stage to establish your drug business.

If you want any of the above services, please contact our ECS India. We offer the best drug license consultancy services.  We provide complete drug licensing services for importers, producers, sellers, and wholesalers. We draft the Drug License application, review your business, and handle all follow-up with the Drug License department. Also, we give frequent updates on amendments to the Drugs and Cosmetics Act via registered mail.

You can be confident in our drug license consulting services because we are a well-known name. Our services are inexpensive, allowing businesses of all sizes to benefit from them.

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Our Services

ECS India specializes in providing Drug License services across India. Our expert team ensures a seamless registration process, helping you establish your business efficiently. Contact us for more details and take the first step towards securing the benefits of a Limited Liability Partnership.

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Drug License Registration Now!

Get A Free Consultancy For Your Drug License Registration Now!

Our expert team of professionals is ready to guide you through the entire process, ensuring a hassle-free and smooth registration. Our goal is to make it as easy and stress-free as possible.

FAQ

What is a Drug License, and why is it required?

An LLP is a business structure that combines the benefits of a partnership and a company. It offers limited liability to its partners, meaning their personal assets are protected from business debts and liabilities.

Who issues a Drug License in India?

Drug Licenses are issued by the State Drugs Standard Control Organisation (SDSCO) or the Central Drug Standard Control Organisation (CDSCO), depending on the type of license required. These authorities regulate the production and sale of drugs and cosmetics to ensure compliance with national standards.

What are the types of businesses that need a Drug License?

Businesses such as pharmacies, drug wholesalers, manufacturers, and e-commerce platforms dealing in drugs, cosmetics, or Ayurvedic medicines need a Drug License. Additionally, companies operating in more than one state require separate licenses for each location.

How can ECS India assist with obtaining a Drug License?

ECS India provides end-to-end consultancy services for Drug License procurement, including drafting applications, document review, follow-ups with licensing authorities, and staying updated on amendments to the Drugs and Cosmetics Act. This ensures a smooth and hassle-free licensing process

Why is a Drug License crucial for pharmaceutical businesses?

A Drug License is vital for ensuring legal compliance, maintaining quality and safety standards, and building credibility with customers and stakeholders. It also protects businesses from legal complications and enhances their ability to compete in the pharmaceutical market.

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