Drug Licence Registration

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For dealing in medicines and cosmetics

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Drug Licence Registration

Introduction of Drug Licence Registration

Drug License is a permission from the government to deal with drugs, medicines and cosmetics. Drug License is issued by State Department, the business operating in two or more states are required to apply for drug License for each state in which the business is being carried on. It is important to take drug license in order to manufacture or deal in trading of the same. The license assures that the drugs are used in prescribed ratio as to be used for human or animal consumption.

Drug License also includes Ayurvedic and Unani drugs. Once the license is granted by the department, all the conditions in respect of the same shall be carried out during the course of business. If there are any changes and modifications, it should be informed to the authorities. The License can be issued for manufacturing, retail and wholesale of medicines and cosmetics. Drug license is issued subject to certain conditions attached to premises and the competent person who shall be dealing with drugs.

Compliance Sagar will provide you all the necessary services relating Drug Licence Registration in Rajasthan and also guide for other related compliances. You may get in touch with our team on +91 63772 78327 or email compliancesagar@gmail.com for obtaining drug license.

Advantages of Drug Licence Registration

Drug license gives the permission to the dealer for sale, resale, market, manufacture, trade, etc. of drug and cosmetics.

Without drug license, one cannot do its pharmacy business or even start to associate with any dealings without having drug license.

Drug license also ensures that the drug and goods are not being misused or abused by any individuals

Dealing with drugs and cosmetics without a drug license is a cognizable offence. Every business person in the pharmacy industry needs to have drug incense to carry out their day-to-day business work.

Requirements for obtaining Drug Licence Registration

  • Proper storage facility: Medicines and vaccines require proper cold storage facility. Therefore, a person dealing with it requires full storage facilities like air conditioners, refrigerators for the pharmacy business to obtain a drug license.
  • Proper area for setting up a pharmacy business: for opening a retail pharmacy or medical shop you will require minimum 10 square meter area and if your business is of retail and wholesale both, you will require minimum 15 square meter of land to obtain the license as per the rules and regulations of the drugs and cosmetic act.
  • Technical staff recruitment: The drug must be supervised the registered pharmacist which is graduated with the experience of at least one year in drug dealing or individual who is SSLC passed with at least four years of experience in drugs dealing.
  • Documents Required for Drug Licence Registration

    MOA and AOA of company

    ID proof of proprietor/partner or director

    Business Premises Proof

    Site Plan and key plan of the premises

    Bio data along with an appointment letter.

    Refrigerator invoice and its details

    Experience certificate (if any).

    Additional wholesale documents for wholesale drug license.

    Affidavit with regard of compliance of MPD 2021 (if premises are located on DDA residential flat/ plot/ building)

    Sole proprietor, partners or directors Qualification proof in form of degrees, certificates or mark sheets.

    The certificate of registration with state council depending upon the region

    Receipts of refrigerator and air conditioner use for storage purpose.

    Note:- In case of NRI or Foreign National documents of Directors and Subscribers must be notarized or apostillled.

    Process of Obtaining Drug Licence Registration

    Complete the Application Form : You are requested to first fill the simple questionnaire provided by our expert team.
    Document Processing : At the second step we will be requiring the documents in accordance with the questionnaire filled by you so that we can arrange them as per the requirement and for processing.
    Filing of Application : We will apply for your application along with the documents required for drug license with the state government.
    Issuance of License : After the processing and verification of application and inspection by the Drug Inspector, Drug License will be generated and will be communicated to you via mail and call.

    Types of Drug Licence Registration

    Sale License :
    Sale license is issued to the persons or agencies engaged in the sales of drugs/medicines in any state. The sale license will be further classified into two types.

    • Retail License: It is granted to run and sell drugs or drug products in retail form.
    • Wholesales License: It is issued to persons or agencies engaged in wholesale of drugs and medicine.

    Manufacturing License: Manufacturing License is released to the persons or agencies involved in the manufacturing of drugs/medicines and cosmetics. Government also issue the manufacturing loan license. A manufacturing loan license will be issued to licensee or a person using the premises, equipment and staff of another drug licensee having a manufacturing license.

    Other Key Points

    • If the proposed Director is already having the DIN then you can also check whether DIR-3 KYC is completed. You can verify the same with the help of our experts. If the same is not done yet, it can be done with help of Compliance Sagar.
    • The producer company is required to manage all the compliances after incorporation of the company like appointment of statutory auditor, filing commencement of business, Income Tax Filing, Annual Returns with ROC and other compliances as required by the law. Compliance Sagar has a team of experts who keeps an eye on the due dates of your compliances and reminds you through mails.
    • The Share Capital of the Producer Company consist only of the Equity Shares
    • The voting rights shall be based on single vote for every member
    • The Producer Company can only carry the activities as mentioned under the Act.
    • Internal Audit is mandatory by an independent Chartered Accountant
    • Loans Under Producer Company : The Producer company may provide financial assistance by way of credit facility to any members for upto 6 months The Producer company can also provide financial assistance in the form of loans and advances against the security. The loan shall be repayable between 3 months to 7 years.