About Retail and Wholesale Drugs Licence in Dadra & Nagar Haveli and Daman & Diu
If you are planning to start a medical store, pharmacy, wholesale medicine business or drug distribution activity in Dadra & Nagar Haveli and Daman & Diu, Retail or Wholesale Drug Licence is the approval you will need to obtain under the Drugs and Cosmetics law. Here’s everything you need to know.
Drug Licence is a statutory licence issued under the Drugs and Cosmetics Act, 1940 and the Rules thereunder, which contains details of the applicant, establishment, premises, category of licence, qualified person, competent person, storage arrangements, documents, inspection, fee payment and so on. It is required for selling, stocking, exhibiting, offering for sale or distributing drugs from the licensed premises.
The licence process is handled by the Drugs Licensing Authority. The applicant is required to submit Form 19 along with supporting documents and prescribed fee. After scrutiny of documents and inspection of premises, the Drugs Licensing Authority grants the licence with his / her signature.
What is Drug Licence?
Drug Licence is a statutory permission required to sell, stock, exhibit, offer for sale or distribute drugs under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.
It is one of the most essential licences required by pharmacies, medical stores, wholesale drug distributors and establishments dealing in medicines.
The licence ensures that drugs are sold or distributed only from approved premises and under the supervision of qualified / competent persons.
Which law governs Drug Licence?
Drug Licence is governed under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.
The licence is provided under Chapter VI of the Drugs and Cosmetics Rules, 1945. The grant of licence is issued under the provisions of Rule 61 of the said Rules and renewal / validity certificate is provided under Rule 63 of the said Rules.
| Particulars | Details |
| Name of law | Drugs and Cosmetics Act, 1940 |
| Relevant Rules | Drugs and Cosmetics Rules, 1945 |
| Chapter | Chapter VI |
| Application Form | Form 19 |
| Competent Authority | Drugs Licensing Authority |
| Purpose | Grant / Renewal of Retail or Wholesale Drugs Licence |
| Timeline | 30 days |
| Fee | ₹3,000 |
Types of Drug Licence covered
The uploaded documents cover the following types of licences:
| Sl. No. | Type of Licence | Purpose |
| 1 | Retail Drugs Licence (Pharmacy) | For retail sale of drugs through pharmacy / medical store |
| 2 | Wholesale Drugs Licence | For wholesale sale, stock, distribution or supply of drugs |
| 3 | Renewal of Retail Drugs Licence | For continuing retail pharmacy licence validity |
| 4 | Renewal of Wholesale Drugs Licence | For continuing wholesale drugs licence validity |
What is Retail Drugs Licence?
Retail Drugs Licence is a licence required for operating a retail pharmacy or medical store.
It allows the establishment to sell drugs to customers from the licensed premises, subject to the conditions of licence and supervision of qualified persons.
The licence is generally required before starting retail sale of medicines, pharmacy operations or dispensing activity.
What is Wholesale Drugs Licence?
Wholesale Drugs Licence is a licence required for wholesale sale, stocking, distribution or supply of drugs.
It is relevant for drug distributors, stockists, super stockists, C&F agents, pharma supply businesses and establishments dealing with supply of medicines to retailers, hospitals, institutions or other buyers.
The licence is required before starting wholesale drug sale or distribution activity.
Applicability of Retail and Wholesale Drugs Licence
Drug Licence is applicable where a person or establishment proposes to sell, stock, exhibit, offer for sale or distribute drugs.
| Particulars | Details |
| Retail pharmacy | Retail Drugs Licence is required |
| Medical store | Retail Drugs Licence is required |
| Wholesale drug distributor | Wholesale Drugs Licence is required |
| Stockist / Super stockist | Wholesale Drugs Licence is generally required |
| Drug distribution business | Wholesale Drugs Licence is required |
| Renewal of existing licence | Renewal / validity continuation is required |
| Premises dealing with drugs | Licence is required before operation |
Why Drug Licence is required?
Drug Licence is required to ensure that drugs are sold, stocked and distributed through regulated and approved premises.
It helps to achieve the main objective of the Drugs and Cosmetics Act, 1940, which is to prevent sub-standard drugs and maintain high standards of medical treatment.
It also ensures that the sale and dispensing of drugs is made under the personal supervision of qualified persons.
Competent Authority and Timeline
| Particulars | Details |
| Competent Authority | Drugs Licensing Authority |
| Department | Drugs Control Department |
| Stage for Retail Licence | Pre-Operation |
| Stage for Wholesale Licence | Operation |
| Timeline | 30 days |
| Fee | ₹3,000 |
| Application Form | Form 19 |
The timeline for granting Retail Drugs Licence (Pharmacy) is 30 days. The timeline for Wholesale Drugs Licence is also 30 days.
Structure of Drug Licence Application
The application is made in Form 19 for grant or renewal of a licence to sell, stock, exhibit or offer for sale or distribute drugs other than those specified in Schedule X.
Part A - Applicant and Establishment Details
| Applicant Details | Establishment Details |
| Name of applicant | Name of establishment |
| Address of applicant | Address of premises |
| Age | Category of establishment |
| Qualification | Retailer / Wholesaler category |
| Owner / Partner / Secretary / Managing Director status | Premises details |
| Power of attorney, wherever applicable | Contact details |
This part records the applicant identity, establishment category and premises from which drug sale or distribution will be carried out.
Part B - Constitution and Responsible Person Details
| Constitution Details | Qualified / Competent Person Details |
| Proprietorship | Name of qualified person |
| Partnership | Address |
| Private Limited Company | Age |
| Public Limited Company | Qualification |
| Working partner details | Experience |
| Managing Director / Secretary details | Consent / appointment details |
In case of partnership, private limited company or public limited company, the details of working partner, managing director or secretary are required.
Part C - Premises, Storage and Business Details
| Premises Details | Business Details |
| Ownership / rent / lease details | Classes of drugs proposed to be stocked |
| Plan of premises | Categories of drugs to be sold |
| Layout of location | Special storage accommodation |
| Blue print with dimensions | Hours of business and working days |
| Building description | Other commodities, if any |
| Water, W.C., lighting and construction details | Financial resources |
This part ensures that the premises is suitable for drug sale, storage and distribution.
Additional information required in Form 19 / 19A
The application requires additional information to be supplied with Form 19 / 19A.
| Particulars | Details required |
| Establishment details | Name and address of establishment |
| Category | Retailer / Wholesaler |
| Applicant details | Name, address, age and qualification |
| Applicant status | Owner, Partner, Secretary or Managing Director |
| Constitution | Proprietorship, Partnership, Private Limited Company or Public Limited Company |
| Qualified person | Name, address, age, qualification and experience |
| Previous business | Business carried on by applicant during last three years |
| Drug business history | Whether applicant earlier dealt with drugs |
| Previous rejection / suspension | Whether application was rejected or licence was suspended, cancelled or surrendered |
| Existing licence | Whether applicant or firm is already licensed to sell drugs |
| Conviction details | Whether applicant or employee was convicted under relevant laws |
| Previous employment | Whether qualified person was employed during previous five years |
| Counter staff | Number of persons to be engaged for selling drugs |
| Manufacturer details | For wholesale application, manufacturer represented as distributor / agent / importer |
| Classes of drugs | Drugs proposed to be stocked |
| Storage | Separate cupboard with lock and key for narcotics or poisonous drugs |
| Other commodities | Milk powder, cosmetics or other commodities, wherever proposed |
| Business hours | Hours of business and working days |
| Financial resources | Details of resources to run the establishment |
| Premises details | Blue print, area, rooms, flooring, ceiling, water, W.C., lighting, windows and doors |
Compliance Required
Renewal / Validity of Drug Licence
Renewal of Retail Drugs Licence and Wholesale Drugs Licence is covered under the licence validity process.
The Licence Validity Certificate is provided under Chapter VI of the Drugs and Cosmetics Rules, 1945 and is issued under Rule 63 of the said Rules.
The licence remains valid subject to deposit of prescribed fees and compliance with the applicable process.
Premises and Storage Requirements
The application requires details of the premises from which the drug business will be carried out.
The applicant is required to provide plan of premises / layout of location and, wherever required, blue print of the premises with dimensions.
The applicant should also provide brief description of the building in respect of area, number of rooms, area of rooms, type of construction, type of flooring, ceiling, water connection, W.C., lighting arrangements, painting, number of windows, doors and other details.
In case of narcotics or poisonous drugs, the applicant is required to state whether separate cupboard with lock and key will be provided.
Qualified Person / Competent Person Requirement
The sale and dispensing of drugs is required to be made under the personal supervision of qualified persons.
The applicant is required to provide details and documents of the competent person / supervisor in charge.
The documents include offer of appointment, consent / acceptance letter, experience certificate, degree certificate, marks statement and affidavit of pharmacist.