Introduction
Pharmaceuticals play a critical role in safeguarding public health across the nation. Unlike general commodities, drugs are subject to rigorous monitoring due to their direct impact on human and animal well-being. The regulatory framework for the production and commercial distribution of drugs is governed by the Drugs and Cosmetics Act, 1940, along with its accompanying Rules. Rigorous monitoring spans the entire lifecycle of the product, from procurement of raw materials, through manufacturing and distribution, to final dispensation by pharmacists in pharmacies, hospitals, and dispensaries.
What is Drug?
Section 3(b) of the Drugs and Cosmetics Act, 1940, defines the term “drug” to encompass all medicinal products and devices intended for internal or external use by humans or animals. It includes substances designated for diagnosis, treatment, mitigation, or prevention of diseases. Additionally, the definition covers preparations used on the human body to deter insects such as mosquitoes, substances intended for insect extermination, and essential drug components, including items like empty gelatin capsules. An amendment made in 1964 further extended the definition to include Ayurvedic and Unani medicines.
What is objective of Drug License?
The equitable and safe access to medication is a primary responsibility of the State. Consequently, the privilege to manufacture and market pharmaceuticals is granted with careful regulatory scrutiny. As per the Drugs and Cosmetics Act, 1940, all stakeholders including pharmacists, wholesalers, retailers, manufacturers, importers, and dealers of pharmaceuticals, cosmetics, and traditional medicines such as Ayurvedic, Siddha, and Unani must obtain a valid drug license before commencing operations. The licensure system ensures compliance with statutory provisions governing the entire spectrum from manufacturing to final sale.
Licensing authorities designated under the Act are as follows:
- State Drugs Standard Control Organisation (SDSCO) : Responsible for licensing related to manufacturing, distribution, and sales within state jurisdictions.
- Central Drugs Standard Control Organisation (CDSCO) : Manages the approval and licensing of newly developed drugs, supervises clinical trials, monitors the quality of imported drugs, and works in coordination with SDSCO.
Types of Licences issued for sale of Drugs and forms required:-
The Department issues various licenses for drug retail and wholesale activities, based on the type and scope of drugs being handled:
Licensing authorities designated under the Act are as follows:
| License Form | Purpose | Application Form |
|---|---|---|
| Form 20 | Retail sale of Allopathic drugs excluding those in Schedule C, C(1), X | Form 19 |
| Form 20-A | Retail sale of restricted Allopathic drugs excluding those in specified Schedules | Form 19A |
| Form 20-B | Wholesale of Allopathic drugs excluding Schedule C, C(1), X | Form 19 |
| Form 20-C | Retail sale of Homeopathic medicines | Form 19B |
| Form 20-D | Wholesale of Homeopathic medicines | Form 19B |
| Form 21 | Retail sale of Schedule C & C(1) Allopathic drugs | Form 19 |
| Form 21-B | Wholesale of Schedule C & C(1) Allopathic drugs | Form 19 |
| Form 21-A | Retail sale of restricted Schedule C(1) Allopathic drugs | Form 19A |
| Form 20-F | Retail sale of Schedule X drugs | Form 19C |
| Form 20-G | Wholesale of Schedule X drugs | Form 19C |
Checklist / Document required for Fresh Drug License of retail/whole sale license
Applicants seeking a new license must furnish the following documents:
- Receipt of online fee payment
- Appropriate application form(s)
- Site plan and key plan of the premises
- Firm’s constitutional documents (e.g., memorandum and articles of association with board resolution for companies; notarized partnership deed for firms; trust deed for societies/trusts)
- Valid government-issued photo identification of the proprietor, partner, or director
- Affidavit confirming non-conviction under the Drugs and Cosmetics Act
- Affidavit certifying compliance with Master Plan Delhi 2021, applicable to DDA residential properties
- Conversion charge receipt and supporting documentation as per MPD 2021 (e.g., notified commercial road/street verification)
- Affidavit from registered pharmacist or competent person (system-generated)
- Final or provisional degree certificate with mark sheet
- Registration certificate from Delhi Pharmacy Council
- Appointment letter and bio-data
- Academic qualifications (degree or provisional certificate with mark sheets)
- Experience certificate
- Appointment letter and bio-data
- Owned Property: Registered Sale Deed, GPA, or Conveyance Deed; alternatively, an unregistered sale deed/GPA supported by utility bills or property tax receipt
- Rented Property: Rent receipt and either registered rent agreement or unregistered agreement with supporting ownership documents of the landlord
- In rural settings, Khasra Khatauni records are accepted
Benefits of obtaining drug license
Securing a drug license under the Drugs and Cosmetics Act confers several legal and operational benefits:
- Authorized Operations : Empowers entities to legally manufacture, sell, or distribute pharmaceuticals
- Quality Assurance : Enforces compliance with prescribed quality standards to ensure efficacy and safety
- Market Legitimacy : Facilitates lawful marketing and expansion of product outreach
- Regulatory Alignment : Reduces legal risk by adhering to statutory obligations
- Consumer Confidence : Strengthens public trust and brand credibility
- Export Viability : Enables access to international markets with compatible regulatory protocols