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Drug registration

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Why Should I Use Auriga Accounting For Drug Registration ?

Auriga Accounting has a team of registration experts who can provide complete guidance to register your Drug Registration.

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Our team of experts will get in touch with you and collect all necessary documents and details

Resolve all your queries

We fill out and file your application for registration

Complete your registration

Your Drug Registration Is Done

Why Should I Use Auriga Accounting For Drug Registration ?

Auriga Accounting has a team of registration experts who can provide complete guidance to register your Drug Registration.

book appointment

Our team of experts will get in touch with you and collect all necessary documents and details

Resolve all your queries

We fill out and file your application for registration

Complete your registration

Your Drug Registration is Done

About Drug Registration

Ensuring equitable and fair access to drugs and medicines is a fundamental responsibility of any government. However, the authority to manufacture and sell these products must be granted with great care. To this end, the government enforces stringent regulations for issuing licenses for the manufacturing and sale of drugs and medicines. In India, the Drugs and Cosmetics Act, 1940 (“the Act”) governs the entire process, from production to distribution, ensuring compliance with safety and quality standards..

What is Drug Registration ?

Drug registration is the formal procedure through which pharmaceutical companies seek approval to market their products. It involves submitting detailed documentation to regulatory agencies, demonstrating that the drug is safe for use, effective in treating the intended conditions, and manufactured to the highest quality standards.

Then, you also need a good guide to perform all types of work. Auriga Accounting Company Registration do you best services, with full guidance and told Advantages about  Drug Registration. 

Types of Drug Licenses in India

In India, the type of drug license required depends on the nature of the drug-related business. The primary categories are as follows:

  1. Manufacturing License – Issued to businesses involved in the manufacturing of drugs, including allopathic and homeopathic medicines.
  2. Sale License
    • Required for businesses engaged in the sale of drugs. This is further divided into:
      • Wholesale Drug License: Needed for wholesalers who sell drugs to other retailers or businesses for resale.
      • Retail Drug License: Required for retailers who sell drugs or cosmetics directly to end consumers, including dispensaries, hospitals, educational institutions, medical or research centers, and standalone pharmacies.
  3. Loan License – Granted to businesses that do not own manufacturing units but utilize the facilities of another licensed manufacturer to produce drugs.
  4. Import License – Required for entities importing products for drug manufacturing or engaged in the business of importing drugs into India.
  5. Multi-Drug License – Issued to businesses operating pharmacies under the same name in multiple states.

List of Application Forms

Sr. No

Form No

Purpose

1

Form 8

Application for license to import drugs apart from those specified in Schedule X of the Drugs and Cosmetics Rules, 1945 (‘Rules’)

2

Form 8A

Application for licence to import drugs specified in Schedule X of the Rules

3

Form 9

Undertaking accompanying an application for an import license

4

Form 12

Application for licence to import drugs for the purpose of examination, test, or analysis 

5

Form 12A

Application for the issue of a permit to import small quantities of drugs for personal use 

6

Form 12AA

Application for licence to import small quantities of new drugs by a government hospital or
autonomous medical institution for the treatment of patients

7

Form 14A

Application from a purchaser for test or analysis of a drug

8

Form 19

Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs apart from those specified in Schedule X

9

Form 19A

Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs by retail via dealers who don’t engage the services of a registered pharmacist

10

Form 19AA

Application for grant or renewal of a licence to sell, stock or exhibit or offer for sale by wholesale or distribute drugs from a motor vehicle

11

Form 19B

Application for license to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines

12

Form 19C

Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs specified in Schedule X of the Rules

13

Form 24

Application for the grant of or renewal of a licence to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C (1) and X of the Rules

14

Form 24A

Application for grant of a loan license or renewal of a loan license to manufacture for sale or distribution of drugs other than those specified in Schedule C, C (1) and X of the Rules

15

Form 24B

Application for grant or renewal of a license to repack for sale or distribution of drugs, being drugs other than those specified in Schedule C and C (1) excluding those specified in Schedule X of the Rules

16

Form 24C

Application for the grant or renewal of a license to manufacture for sale or for distribution of Homoeopathic medicines or a license to manufacture potentised preparations from back potencies by licensees holding a license in Form 20 C

17

Form 24D

Application for the grant or renewal of a licence to manufacture for sale of Ayurvedic, Siddha or Unani drugs

18

Form 24E

Application for grant or renewal of a loan licence to manufacture for sale of Ayurvedic (including Siddha) or Unani Drugs

19

Form 24F

Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedule C and C (1) of the Rules

20

Form 27

Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule C and C (1) excluding those specified in part XB and Schedule X of the Rules

21

Form 27A

Application for grant or renewal of a loan licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in part XB and Schedule X of the Rules

22

Form 27B

Application for grant or renewal of a licence to manufacture for sale or for distribution of drugs specified in Schedules C, C(I) and X of the Rules

23

Form 27C

Application for grant or renewal of licence for the operation of a Blood Bank for processing of whole blood and/or preparation of blood components

24

Form 27D

Application for grant or renewal of a licence to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding those specified in Schedule X of the Rules

25

Form 27DA

Application for grant or renewal of a loan licence to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding those specified in Schedule X of the Rules

26

Form 27E

Application for grant or renewal of licence to manufacture blood products for sale or distribution

27

Form 27F

Application for grant or renewal of license for collection, processing, testing, storage, banking, and release of umbilical cord blood stem cells

28

Form 30

Application for license to manufacture drugs for purposes of examination, test or analysis

29

Form 40

Application for issue of registration certificate for import of drugs into India

30

Form 44

Application for grant of permission to import or manufacture a new drug or to undertake clinical trial

essential Documents for Obtaining a Sale License

The following documents are required to apply for a sale license:

  1. Constitution Documents
    1. Company: Memorandum of Association (MOA) and Articles of Association (AOA).
    2. Partnership/LLP: Partnership deed or LLP agreement.
  2. Identification Proof
    1. ID proof of the partner, director, or proprietor.
  3. Premises Documents
    1. Ownership documents of the property or a rental agreement.
    2. No Objection Certificate (NOC) from the property owner for rented premises.
  4. Site and Layout Plans
    1. Site plan and key plan of the premises.
  5. Board Resolution
    1. A copy of the board resolution authorizing the application for a license (if applicable).
  6. Storage Space Proof
    1. Proof of availability of appropriate storage facilities, such as cold storage or a refrigerator.
  7. Fee Payment Proof
    1. Copy of the challan as evidence of the fee deposit.
  8. Affidavits
    1. Affidavit confirming the non-conviction of the proprietor, partner, director, or firm.
    2. Affidavit from the registered pharmacist or competent individual.
  9. Cover Letter
    1. A formal cover letter with the name and designation of the applicant.
  10. Declaration Form
  1. A declaration form in the prescribed format.
  1. Qualification Certificates
  1. Qualification certificates of the applicant.
  1. Additional Documents for Pharmacists:
  1. For Retail Sale:
    • Proof of qualification.
    • Registration with the local pharmacy council.
    • Appointment letter.
  2. For Wholesale Sale:
    • Proof of qualification.
    • Experience certificate.
    • Appointment letter.

Process for Drug Registration

Although the process may vary slightly between countries, it generally involves the following steps

  1. Preclinical Studies: Extensive laboratory and animal testing to assess the drug’s basic safety and biological activity.
  2. Clinical Trials: Human trials are conducted in phases to evaluate safety, dosage, efficacy, and side effects.
  3. Regulatory Submission: Submission of a detailed dossier to the relevant authority, including clinical trial data, manufacturing details, and labeling information.
  4. Regulatory Review: A thorough evaluation by experts to ensure compliance with safety and efficacy standards.
  5. Approval and Monitoring: Upon approval, the drug is registered for use. Post-marketing surveillance ensures ongoing safety and effectiveness.

Prerequisites for Obtaining a Drug License

  1. Pharmacist/Competent Individual
    • For a retail business, the pharmacist must be a qualified professional.
    • For a wholesale business, the responsible individual must either:
      • Be a graduate with at least one year of experience, or
      • Be an undergraduate with a minimum of four years of experience.
  2. Space Requirements
    • The pharmacy or unit must meet the following area requirements:
      • Wholesale and Retail License: A minimum area of 15 square meters.
      • Retail and Medical Shop License: A minimum area of 10 square meters.
    • The height of the sales premises should comply with the guidelines specified in the National Building Code of India, 2005.
  3. Storage Facility – Adequate storage facilities are essential, especially for drugs requiring controlled temperatures. Refrigerators and air conditioning systems must be in place to ensure proper storage.
  4. Technical Staff
    • Retail pharmacy staff must be knowledgeable and experienced.
    • Wholesale pharmacy staff must meet the following criteria:
      • Be a graduate with at least one year of experience, or
      • Be an undergraduate with a minimum of four years of experience.

Validity

The validity of the certificate is for 5 years

How Auriga Accounting Helps You for Drug Registration – Why Auriga?

The best thing about us is that our clients also tell us, that we give equal time to everyone, we are very happy that our work is liked by our clients, who are sitting in different states. They cannot come to us, We Cannot go to them, but we are just connected through phones or E-mail. If the client gets satisfied with our work, then it is known that Auriga Accounting did a good job today.

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2023-06-10
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2023-06-10
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2023-06-10
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2023-04-07
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