Drug License grants permission under the Drugs and Cosmetic Act to carry out a drug/medicine (Pharmaceutical) or cosmetic business. As per the Drugs and Cosmetics Act, 1940, the Central or State Drug Standard Control Organization grants such License.

Normally, there are three types of Drug Licenses, one is Retail Drug License which is issued to a firm to run a chemist/medical shop, second one is a Wholesale Drug License which is issued to a firm who wants to sell drugs on a wholesale level, and third one is Drug Manufacturing License which is issued to manufacture of drugs.

State Vs Central (SDSCO~CDSCO):

Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Approval for Blood Banks, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

Central Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

All manufacturers/retailers/traders that are directly or indirectly related in sale/purchase/manufacturing of medicines or involved in pharmacy business in India are required to obtain a drug license from the Drugs Controller General (India) or Central Drugs Standard Control Organization (CDSCO).

• A

  Retail License

  1. Statutory form – 19 for licenses in form (20,21).
  2. Declaration by the proprietor / Partner / Director / Competent Persons / Regd. Pharmacist with proof of residential address (Present and Permanent) for proof of residential address – Aadhar Card, Pass Port, Driving License, Voter ID.
  3. Partnership deed in case of partnership firm/ List of Directors downloaded from MCA website signed by Company Secretary / Managing Director (In case of company).
  4. In case of company an Affidavit under Section 34 of Drugs and Cosmetics Act, 1940 on Rs.20/- stamp paper signed by one of the Directors of the company.
  5. Special declaration by Registered Pharmacist on Rs.20/- Non-Judicial stamp paper.
  6. Self-attested copy of Registered Pharmacist certificate (renewal up to date) affixed with latest original photograph and signature of the candidate / original to be produced to the Drugs Inspector at the time of inspection for endorsement.
  7. Plan of the premises indicating the carpet area (specifying length and breadth in meters and area in Sq.m) with the signature of Building owner and the applicant (Prop/ partners / Authorized signatory / Managing Director, etc,.) in a legal size.
  8. Declaration of building owner (Photograph of the building owner with self-attestation). Self-attested photocopy of the document showing the proof of ownership of the building owner for the premises to be licensed (E.C / any other legal document showing the present ownership.
• B

  Wholesale License

  1. Statutory form – 19 for licenses in form (20B,21B).
  2. Declaration by the proprietor / Partner / Director / Competent Persons / Regd. Pharmacist with proof of residential address (Present and Permanent) for proof of residential address – Aadhar Card, Pass Port, Voter ID.
  3. Partnership deed in case of partnership firm / List of Directors downloaded from MCA website signed by Company Secretary / Managing Director (In case of company).
  4. In case of company an Affidavit under Section 34 of Drugs and Cosmetics Act, 1940 on Rs.20/- stamp paper signed by one of the Directors of the company.
  5. Special declaration by Registered Pharmacist on Rs.20/- Non-Judicial stamp paper (in case of Registered Pharmacist is appointed as C.P).
  6. Self-attested copy of Registered Pharmacist certificate (renewal up to date) affixed with latest original photograph and signature of the candidate (in case Registered Pharmacist is appointed as C.P) / SSC / degree certificate (in case of candidate other than R.P).
  7. Plan of the premises indicating the carpet area (specifying length and breadth in meters and area in Sq.m) with the signature of Building owner and the applicant (Prop/ partners / Authorized signatory / Managing Director, etc,.) in a legal size.
  8. Declaration of building owner (Photograph of the building owner with self attestation). Self attested photocopy of the document showing the proof of ownership of the building owner for the premises to be licensed (E.C / any other legal document showing the present ownership.
  9. Experience certificate of Competent person.
• C

  Manufacturing License

  1. Application (statutory) in Form-24/ 27/ 31/ 27D/ 24B duly signed by the Proprietor / Managing Partner / Managing Director/ Person declared as responsible under Sec.34 / Person Authorized by the Board of Directors accompanied by Company Board Resolution.
  2. Declaration of the Proprietor / Partners / Directors etc. in Affidavit (as per format) & List of Directors downloaded from MCA website signed by Company Secretary / Managing Director (In case of company).
  3. Partnership deed in case of Partnership firms.
  4. Self-attested Copy of Aadhar card/Passport/Electoral card as proof of residential address of the responsible person as mentioned in the Affidavit at Sl.No. 2.
  5. Rent / Lease deed in case of Rental premises.
  6. Declaration of the ownership of the premises if premises owned by the applicant firm or company, with the documentary evidence of ownership like Registered sale deed and/or proof of allotment of the site along with the latest property tax receipt.
  7. Plan and layout of the premises showing the installation of Machinery and Equipment. preferably a Blue Print duly signed by the applicant who signed in the statutory form.
  8. Detailed list of Manufacturing and Analytical Equipment.
  9. Application for approval of Technical Staff in the prescribed format with enclosures of consent letter, copies of qualification certificates, experience certificates of proposed technical staff along with earlier approvals, if any, appointment order of the Technical staff.
  10. Permission obtained from the Municipal Authorities/ Panchayat authorities/ Industrial Local Authority, Certificate in conformity with Factories Act for construction and starting the Unit & Permission from the State Pollution Control Board clearance of the area for setting up the manufacturing facility.
  11. Form CT-22 (for APIs) / Form CT-23 (for Formulations) in case of ‘New Drugs’ as defined as per New Drugs & Clinical Trial Rules, 2019 (for New Drugs for Human Use) (or) Form 46/ Form 46-A in case of ‘New Drugs’ under Rule 122E of Drugs and Cosmetics Act and Rules made thereunder (for New Drugs for Veterinary Use) (or) NOC for specific quantity export of New Drugs.
  12. Site Master File as per Para 29 of Part I of Schedule M of Drugs and Cosmetics Act, 1940 and rules made there under.
  13. Brief Manufacturing procedure of each product.
  14. Biopharmaceutical Classification System (BCS) class of the constituent API in case of Oral Dosage Forms and the results of bioequivalence study referred to in Schedule Y for Oral Dosage Forms containing drugs specified under category II and category IV of the Biopharmaceutical Classification System. (Results has to be submitted as per Annexure-I) (as per amendment to the Drugs and Cosmetics Rules, 1945.
  15. Evidence and data justifying that the applied drugs: (i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful; (ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulation and under the conditions in which the formulation for administration and use are recommended; (iii) are stable under the conditions of storage recommended; (adequate evidence and data regarding stability has to be submitted); (iv) contain such ingredients and in such quantities for which there is therapeutic justification. (as per amendment to the Drugs and Cosmetics Rules, 1945.
  16. Flow Chart with structural Formula of reactions (for bulk drugs) as per Master Formula record and specifications & analytical procedure of applied products with in-house specification claim.
  17. Copies of monographs for formulations with pharmacopoeial specifications other than IP.
  18. Form CT-22 (for APIs) / Form CT-23 (for Formulations) in case of ‘New Drugs’ as defined as per New Drugs & Clinical Trial Rules, 2019 (for New Drugs for Human Use) (or) Form 46/ Form 46-A in case of ‘New Drugs’ under Rule 122E of Drugs and Cosmetics Act and Rules made thereunder (for New Drugs for Veterinary Use) (or) NOC for specific quantity export of New Drugs.
  19. Declaration regarding the Brand Names of the Product. (in case of Formulations ONLY for Export).
  20. Undertaking in Form 51 of Drugs and Cosmetics Rules to the licensing authority regarding Brand Names.
  21. Contents of the Bioequivalence Report in Annexure.

You can get the Drug License in the following steps.

Retail Sale/Wholesale Sale Drug License Process:

• 1

  User ID Creation

  Through State Drug Controller Portal - 5 Min Job

  Visit Drug Control Administration website "www.dca.telangana.gov.in" And select the tab "Online Drug Licensing System". Select "Apply Online" - First Time Applicants need to Register Under "New Users" by filing in the details including the license information, and obtain a User ID and password for login. Confirmation to New Users/Applicants will be sent to their mail-id/ through SMS on the registered mobile number. Once registered, Applicant can now Log-in to proceed with the online application.

• 2

  Online Submission

  Through State Drug Controller Portal - 2 Hours Job

  Select the service category and type of License from the drop down list. For e.g - Under Sales License - Retail or Wholesale, then the type i.e Grant / Renewal / Amendment. Checklist / Documents to be submitted for each services are available under "How to Apply" tab at home page. Checklist as per the License selected is also provided during the application process. Applicant need to prepare the soft copies of all the documents required for desired licences. Applicant need to fill in the - firm details, constitution details, RP/CP details and other required information, and upload documents as per the checklist. (Application can be saved and pages can be revisited to make any changes before submission). License Fee to be Paid and Application Submitted (Acknowledgement of Fee Payment & Application Submission Confirmation will be sent to the Applicant's registerd maid ID / through SMS.

• 3

  Allocation to Area Drug Inspector

  Through State Drug Controller Portal - 2 Days Job

  Submitted Online Application will be received by the Concerned Area Drug Inspector (DI). Pre-Scrutiny of the Application by Drug Inspector (DI). Application Complete & in Order?

• 4

  Inspection & Certificate of Registration

  Through State Drug Controller Portal - 2 Week Job

  Drug Inspector (DI) Schedules & Conducts Site Inspection. Drug Inspector (DI) submits the Inspection Report to the Assistant Director (AD). Assistant Director (AD) Reviews the Inspection Report and Verifies the Documents / Information. If no queries are raised, Assistant Director (AD) Issues the License.

Manufacturing Drug License Process:

• 1

  User ID Creation

  Through State Drug Controller Portal - 5 Min Job

  Visit Drug Control Administration website "www.dca.telangana.gov.in" And select the tab "Online Drug Licensing System". Select "Apply Online" - First Time Applicants need to Register Under "New Users" by filing in the details including the license information, and obtain a User ID and password for login. Confirmation to New Users/Applicants will be sent to their mail-id/ through SMS on the registered mobile number. Once registered, Applicant can now Log-in to proceed with the online application.

• 2

  Online Submission

  Through State Drug Controller Portal - 2 Hours Job

  Select the service category and type of License from the drop down list. For e.g - Under Manufacturing - Bulk drugs, formulations etc, then the type i.e Grant / Renewal / Amendment. Checklist / Documents to be submitted for each services are available under "How to Apply" tab at home page. Checklist as per the License selected is also provided during the application process. Applicant need to prepare the soft copies of all the documents required for desired licences. Applicant need to fill in the - firm details, constitution details, technical staff and other required information, and upload documents as per the checklist. (Application can be saved and pages can be revisited to make any changes before submission). License Fee to be Paid and Application Submitted (Acknowledgement of Fee Payment & Application Submission Confirmation will be sent to the Applicant's registerd maid ID / through SMS.

• 3

  Allocation to Area Drug Inspector

  Through State Drug Controller Portal - 2 Days Job

  Submitted Online Application will be received by the Concerned Area Drug Inspector (DI). Pre-Scrutiny of the Application by Drug Inspector (DI). Application Complete & in Order?

• 4

  Inspection & Certificate of Registration

  Through State Drug Controller Portal - 2 Week Job

  Drug Inspector (DI) Schedules & Conducts Site Inspection. Drug Inspector (DI) submits the Inspection Report to the Assistant Director (AD). Assistant Director (AD) Reviews the Inspection Report and Verifies the Documents / Information. If the application in order, Assistant Director Submits the Report to Concerned Deputy Director (DD). Deputy Director (DD) Reviews the Report and Verifies the Documents / Information. Deputy Director Submits the Report to the Concerned Joint Director (JD). Joint Director (JD) Reviews the Report and Verifies the Documents / Information. If the application in order, Joint Director (JD) Issues the License.

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