Drug License in India – Registration Process, Requirements & Compliance

Looking for the top drug license consultants in India? At PSR Compliance, we specialize in obtaining wholesale, retail, and manufacturing drug licenses with a streamlined and hassle-free process. A drug license is an official authorization granted to individuals or companies involved in the manufacturing, distribution, and sale of drugs in India. It ensures compliance with safety and quality standards set by regulatory authorities to protect public health. Our Achievements:

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Overview of Drug License

To conduct business in India, you must get a licence to sell drugs and cosmetics. The Drugs and Cosmetics Act of 1940 includes rules for this. It applies across of India.

This Act established the Drugs Control Department by combining all the laws pertaining to drugs and cosmetics. The Act included Ayurvedic and Unani medications in 1964 through an amendment.

A business must Apply for drug license in each state where it conducts business. If a business operates in two or more states, it will need a separate drug licence. If someone sells medicines at more than one place, they must submit a license application for each location. This rule does not apply to migrant sellers.

Our team of experienced drug license consultants is here to guide you through the entire process of obtaining your drug license.

What is a drug license?

A drug license is official government approval granted to an entity to handle and distribute drugs. Securing this approval is essential before launching a pharmaceutical business. The Drugs and Cosmetics Act of 1940 defines "drug" under section 3(b), outlining the scope of substances regulated under this law.

It consists of the following items:

  • The list includes all drugs and materials that treat, diagnose, prevent, or reduce any illness in humans or animals. This also covers preparations used on the skin to keep away insects like mosquitoes.
  • Every material that enters into making the medication.
  • Among them are empty gelatin capsules.
  • Medical Devices.

Meaning of Drugs

The Drugs and Cosmetics Act of 1940 defines a "drug" as any medication or device. You can find this definition in Section 3(b).

Humans or animals can use it for internal or external purposes. A drug is any substance that helps diagnose, treat, or prevent diseases in people or animals. This also includes substances applied to the body to ward off insects like mosquitoes. In 1964, authorities revised the term to include Unani and Ayurvedic drugs.

What is the importance of a Drugs License?

  • To prevent people from misusing medications and medical supplies, authorities must control access to them. Under the Drugs and Cosmetics Act of 1940, authorities require drug licenses. This applies to all pharmacists, wholesalers, retailers, producers, distributors, dealers, and importers of medicines. This includes cosmetics and Ayurveda, Siddha, and Unani medications.
  • The significance of a drug licence is to provide organizations or individuals with official approval to conduct operations related to medications and cosmetics. In India, businesses and individuals must obtain this authorization before dealing with medicines or cosmetics. Along with the Medication permit, they are required to register their shop or establishment and acquire a trade licence.
  • The government of India regulates the quality of medications sold in the country. The Medicines and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945 accomplish this.
  • From the time manufacturers make and sell medicines, the government controls them. The control lasts until a pharmacist sells the drugs. This can happen in a retail pharmacy, hospital, or dispensary.
  • The government can oversee issues related to importing and exporting medications. It also regulates the sale of drugs to minors.
  • Additionally, it monitors the use of drugs listed in Schedule H and X. These matters require careful planning and attention. In accordance with the Drugs and Cosmetics Act of 1940, the drug governing authority grants the pharmaceutical licence..

Types of Licensing for Drugs in India

Types of drug license

1. Retail Drug License

The term "retail sale" describes the distribution of medications to the final customer. Retailers can sell drugs to medical, educational, research, and dispensary facilities, among other entities. The Drugs and Cosmetic Act requires a drug retailer or chemist to obtain a shop license. Additionally, the State's Drug Controller Authority issues retail licenses.

If someone sells drugs without a license, they can face at least one year in prison. The sentence can be as long as three years. They may also have to pay a fine of up to Rs. 5,000.

2. Wholesale Drug License

A business, distributor, or agent approved to be an Indian agent for a manufacturer will get a wholesale license. Therefore, a manufacturer and an authorized Indian representative receive a wholesale license. The CDSCO grants Wholesale Drug Licenses to individuals engaged in the wholesale distribution of drugs.

3. Drug Manufacturing License

This is a license to make drugs. "Making drugs" means any process used to create, change, package, label, or handle materials for sale or distribution.

4. Loan License

This is permission to manufacture drugs on the premises of any other manufacturer. A valid drug license and manufacturing capacity are requirements for the manufacturer who supplies the drug's production facility.

5. Drug Import License

In India, importing drugs is mandatory. The Central Drug Standard Control Organization (CDSCO) issues licenses for the import of medications

What are the documents required to obtain a Drug Licence in Delhi?

The documents required to obtain a pharmaceutical licence in Delhi:

  • The company's rules include the partnership deed, articles of association (AOA), memorandum of association (MOA), and LLP agreement.
  • Identification of the director, partner, or proprietor.
  • Records about the property include several important documents. These are a copy of the ownership papers and the rental agreement. If necessary, there is also the NOC (No Objection Certificate) from the property owner.
  • The premises' site plan and key plan.
  • A copy of the board resolution authorizing licence acquisition.
  • Evidence of the availability of cold storage, refrigerators, and other storage spaces.
  • Challan copy as evidence of paid deposit.
  • Affidavit of non-conviction of the firm, its proprietor, partner, or director.
  • A cover letter from a qualified individual or certified pharmacist.
  • Cover letter with applicant's name and title Declaration form in the manner required by law.
  • The education certificate of the applicant
  • Proof of Education, local Pharmacy Council registration, and letter of appointment of the wholesaler or retailer.

What are the requirements for getting a Pharmaceutical certification?

The following are the main prerequisites for getting a Pharmaceutical certification in Delhi, India:

1. Area of Premises

At least 10 square meters of space is required. This is necessary for anyone who wants to open a retail pharmacy or medical store. Crucial to note is that a retail or wholesale drug business must have a minimum of 15 square meters.

2. Storage Space

To store medications, you need to have the right storage options. This includes a refrigerator or a cold storage area.

3. Staff

Having knowledgeable and skilled staff is essential for a retail pharmacy. Their proficiency in the field is crucial. Moreover, the pharmacist must fulfill the necessary criteria to qualify for a medicines license.

To get a wholesale Pharmaceutical certification, the employee must meet certain requirements. They need to be an undergraduate with four years of experience. Confirmation, they can be a graduate with one year of experience.

4. Property Examination

A Drug Inspector can visit the site to inspect it before issuing a Pharmaceutical certification. He will also measure the property, check the information given, and talk with the qualified person.

What is the Process of Pharmaceutical licence Registration?

The process of Pharmaceutical licence in Delhi registration is given below:

Step 1: Register on the Drug Licensing Portal

Start by registering on your state's Pharmaceutical Licensing Portal. Each state has a Drug Regulatory Authority.

This authority manages an online Pharmaceutical Licensing Portal. Users utilize the portal to register for drug-related licenses. You can apply for the Pharmaceutical License Certificate by logging into the portal if you have the right credentials.

Step 2: Submission of an Application

You must input the pharmacist's and competent individuals' details after registering on the website. Next, enter the name and parties related to the Pharmacist Council Registration. After that, you can submit your application using the form that matches your application type.

You can use Forms 19, 19A, 19B, or 19C to apply for a certificate of Medication permit in Delhi registration according to your needs. After you enter the necessary information, check it one last time. You cannot change it later. Then, submit the online Medication permit Application Form.

Step 3: Procedure for Inspection

The Drug Licensing Authority (DLA) will inspect your property after they get your completed Medication permit Application Form. They will set a time for the inspection. To register for a Medication permit in Delhi, a drug inspector comes to the location on the prescribed date.

The Drug Inspector (DI) checks the conditions needed to issue a Medication permit. The DI also verifies the applicant's original documents. After this, the DI sends the report to the Drug Licensing Authority.

Step 4: Issuance of a Medication permit in Delhi, India

The Drug Licensing Authority reviews the report forwarded by the Drug inspector. The authority verifies if the application is in compliance with the Drug Rules. If the application is accurate, the relevant authority grants the applicant a Medication permit. The Drug Inspector's report forms the basis of this decision.

Medicine licenses Fees

To renew your licence, use the same application form you used for the first license. Also, include the required renewal fee.

You can easily renew your Medicine license online. Just follow the steps on the official website. The renewal fee is the same as the initial grant fee.

  • Wholesale Licence: 3000 rupees
  • Retail Licence: Rs. 3000 rupees

Medicine license Renewal Online Fee

To renew your licence, use the same application form you used for the first licence. Also, include the required renewal fee. The renewal fee is the same as the initial grant fee.

If you renew your licence late, the following additional fees apply for up to six months:

Late Fee for Medicine license Renewal Online

  • For Wholesale and Retail Licences: Rs. 1000 per month
  • For Restricted Licence: Rs. 500 per month

PSR Compliance Consultant for Obtaining a Pharmaceutical certification or Renewal Online

Whether you need a new wholesale drug license or require assistance with the renewal of your wholesale drug license, PSR Compliance provides expert guidance to ensure a hassle-free process.

This applies whether you are a manufacturer, distributor, or retailer of medicines and cosmetics in India or other places. PSR Compliance ensures that your license issues on time. This will improve the credibility of your drugs or medicines. We provide a comprehensive solution to help medicine manufacturers in India secure licenses and testing facilities.

Frequently Asked Questions

Once obtained, a drug license is valid for five years, until the Drug Department suspends or cancels it.

The applicant's store must have at least 10 square meters of space. The person in charge, called the Competent Person, must be a Registered Pharmacist.

This person should have completed high school or its equivalent. They must also have four years of experience handling drugs. Confirmation, they can hold a degree from an accredited university and have one year of experience handling drugs.

The Drugs & Cosmetics Act of 1940 and the rules enacted thereunder contain several sections pertaining to drug licensing. You can also contact the drug inspector of your area to obtain information about drug licenses. Moreover, to get any information, you can contact the expert of PSR Compliance and ask your questions.

Yes, selling drugs using motor vehicles does require a special license. Applicants must choose to take it at the time of making an application.

If the applicant's address changes, they must return the drug license for the old location. They will need to apply for a new one.

You can check drug license status, visit the regulatory authority's website: https://www.statedrugs.gov.in/, enter the license number, and review the status. Ensure the site is official and secure to obtain accurate information.

To get a drug license in Uttar Pradesh, you need several documents. First, you need a cover letter. Second, you must fill out an application form. You also need a key plan and site plan of your location.

Additionally, provide proof of ownership or lease for the premises. You also need an Registration certificate.

You must show proof of the applicant's Education. An appointment letter for the registered pharmacist or qualified person is necessary too. Finally, include an affidavit stating that the applicant has no criminal convictions.

The fee for a drug license in Uttar Pradesh depends on the type and scale of medicines operations. Costs differ for manufacturing, sales, and distribution licenses. For the latest fee information, check with the Food Safety and Drug Administration. This location exists in Uttar Pradesh.

A Drug License generally stays valid for five years, and you must renew it to maintain legal operations.

To check your drug license online in India, follow these steps. First, visit the official website of the Central Drugs Standard Control Organization (CDSCO).

Confirmation, you can go to your local State Drug Control department's website. Go to the Drug License section. Enter your application or license number to check the status and details of your license.

PSR Compliance is a leading consultancy firm offering expert assistance in drug license registration for wholesalers, retailers, and manufacturers across India.

To apply for a drug license in Gurugram, you need to submit the required documents and comply with government regulations. Our team at PSR Compliance provides expert drug license services in Gurugram to ensure a smooth and hassle-free approval process.

To start a new pharmacy, obtaining a drug license for a new pharmacy is mandatory as per regulatory requirements. The process involves submitting the necessary documents, meeting compliance standards, and applying to the appropriate drug authority. At PSR Compliance, we assist in every step to ensure a smooth and hassle-free approval.