Ensuring equitable access to drugs and medicines is a fundamental responsibility of any government. However, the right to manufacture and sell pharmaceuticals must be approached with caution. To this end, the Indian government enforces strict regulations under the Drugs and Cosmetics Act, 1940 (the "Act"), which oversees the entire process from drug manufacture to sale.
What Defines a Drug?
According to Section 3(b) of the Drugs and Cosmetics Act, 1940, a "drug" encompasses all medicines and devices intended for human or animal use, whether administered internally or externally. This includes any substance utilized for diagnosing, treating, or preventing diseases, as well as preparations for repelling insects. The definition was expanded in 1964 to include Ayurvedic and Unani drugs, reflecting the diverse nature of medical practices in India.
Purpose of Drug Licenses
Drug licenses are crucial for regulating access to pharmaceuticals, preventing misuse and abuse. They are mandatory for all individuals and businesses involved in the sale, distribution, and manufacturing of drugs, including Ayurvedic, Siddha, and Unani products. This ensures that no entity can operate in the drug market without proper licensing, which also includes a trade license and registration for the establishment.
The Drugs and Cosmetics Act, 1940, along with the Drugs and Cosmetics Rules, 1945, enables the government to oversee drug quality at every stage—from raw material sourcing to retail distribution.
Types of Drug Licenses in India
In India, several types of drug licenses are issued based on the nature of the business:
- Manufacturing License: For businesses producing drugs, including allopathic and homeopathic medicines.
- Sale License: Divided into:
- Wholesale Drug License: For wholesalers who sell drugs to retailers.
- Retail Drug License: For retailers selling directly to consumers, including pharmacies and Ayurvedic shops.
- Loan License: For entities that do not own manufacturing facilities but utilize another licensee's resources.
- Import License: For dealers importing drugs for manufacturing or commercial purposes.
- Multi-Drug License: For businesses operating pharmacies in multiple states under the same name.
Regulatory Authorities for Drug Licensing
The regulatory framework includes various authorities responsible for issuing licenses:
- State Drugs Standard Control Organisation (SDSCO): Issues licenses for sales and distribution regulated by state authorities.
- Central Drugs Standard Control Organisation (CDSCO): Responsible for new drug approvals, clinical trials, and quality control of imports.
- State Drug Controlling Authority: Issues licenses for blood banks and their products.
- Department of AYUSH: Responsible for licensing Ayurvedic, Unani, Siddha, and homeopathic products.
Prerequisites for Obtaining a Drug License
To obtain a drug license, applicants must meet specific requirements:
- Qualified Pharmacist: A pharmacist must be present for retail businesses, while wholesalers need individuals with relevant educational and experience qualifications.
- Space Requirements: The pharmacy or manufacturing unit must meet specific area criteria, with a minimum space of 15 square meters for wholesale and 10 square meters for retail.
- Storage Facilities: Adequate storage must be provided, especially for drugs requiring refrigeration.
- Experienced Technical Staff: Staff must possess the necessary qualifications and experience.
List of Application Forms
Here is a comprehensive list of application forms used for various licensing purposes:
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Form No.
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Purpose
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Form 8
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Application for importing drugs not specified in Schedule X of the Drugs and Cosmetics Rules, 1945.
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Form 8A
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Application for importing drugs listed in Schedule X.
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Form 9
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Undertaking accompanying an import license application.
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Form 12
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Application for importing drugs for examination, testing, or analysis.
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Form 12A
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Permit application for importing small quantities of drugs for personal use.
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Form 12AA
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Application for importing small quantities of new drugs by government hospitals for patient treatment.
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Form 14A
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Application from a purchaser for drug testing or analysis.
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Form 19
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Application for granting or renewing a license to sell, stock, or distribute drugs, excluding those in Schedule X.
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Form 19A
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Application for retail licenses from dealers not using registered pharmacists.
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Form 19AA
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Application for wholesale licenses for distribution from motor vehicles.
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Form 19B
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License application for selling or distributing Homeopathic medicines.
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Form 19C
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Application for licensing to sell or distribute drugs specified in Schedule X.
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Form 24
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Application for manufacturing licenses for drugs not specified in Schedules C, C (1), and X.
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Form 24A
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Application for loan licenses to manufacture drugs not specified in Schedules C, C (1), and X.
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Form 24B
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Application for repacking licenses for drugs other than those specified in Schedule C and C (1).
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Form 24C
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Application for manufacturing licenses for Homeopathic medicines.
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Form 24D
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License application for manufacturing Ayurvedic, Siddha, or Unani drugs.
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Form 24E
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Application for loan licenses for Ayurvedic (including Siddha) or Unani drugs.
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Form 24F
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License application for manufacturing drugs specified in Schedule X but not in Schedules C or C (1).
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Form 27
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Application for manufacturing licenses for drugs specified in Schedules C and C (1).
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Form 27A
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Application for loan licenses for drugs in Schedules C and C (1).
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Form 27B
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Application for manufacturing licenses for drugs in Schedules C, C (1), and X.
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Documents for Obtaining a License
To acquire a sale license for pharmaceuticals in India, applicants must provide the following documents:
- Entity Constitution Documents: This includes the Memorandum of Association (MOA) and Articles of Association (AOA) for companies, or a partnership deed/LLP agreement for partnerships and Limited Liability Partnerships (LLPs).
- ID Proof: Identification documents for partners, directors, or proprietors.
- Premises Documentation:
- Copy of ownership documents or rental agreements.
- No Objection Certificate (NOC) from the property owner if renting.
- Site Plans: Detailed site and key plans of the premises.
- Board Resolution: A resolution from the board permitting the application for the license.
- Storage Facility Proof: Evidence of adequate storage options, such as cold storage or refrigeration.
- Payment Receipt: Copy of the challan as proof of fee payment.
- Affidavit of Non-Conviction: An affidavit confirming that the proprietor, partner, director, and the firm have not been convicted of any offenses.
- Pharmacist Affidavit: An affidavit from a registered pharmacist or competent individual.
- Cover Letter: A cover letter that includes the applicant's name and designation.
- Declaration Form: A completed declaration form in the prescribed format.
- Qualification Certificates: Relevant qualification certificates for the applicant.
- For Retail Pharmacists:
- Proof of qualifications.
- Registration with the local pharmacy council.
- Appointment letter.
- For Wholesale Pharmacists:
- Proof of qualifications.
- Experience certificate.
- Appointment letter.
Application Process for a Drug License
- Visit the Regulatory Authority’s Website: Determine the relevant authority based on the license type.
- File Application Online: Complete the application form on the respective authority's website.
- Upload Required Documents: Submit necessary documentation along with the application fee.
- Inspection by Drug Inspector: A drug inspector will verify the premises and documents.
- Issuance of License: Upon successful inspection, the drug license will be granted.
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