Retail or Wholesale Drug business in Hyderabad
If you are planning to start or continue a retail or wholesale drug business in Hyderabad, obtaining a Drug Sales License is a mandatory requirement under the Drugs and Cosmetics Act, 1940. The license is required for carrying on the business of sale of medicines, whether through retail or wholesale mode. Here’s everything you will need to know.
A Drug Sales License in Hyderabad is granted under the Drugs and Cosmetics Act, 1940 and the rules made thereunder. Depending on the nature of business, the license may be obtained in Form 20 and 21 for retail sale, or Form 20B and 21B for wholesale sale of drugs. The application is required to be made in the prescribed statutory forms along with supporting documents as specified under the rules.
The process involves submission of application, verification of documents, and inspection of the premises by the Drug Inspector before grant of license. The applicant is required to ensure that all prescribed conditions relating to premises, pharmacist or competent person, and documentation are complied with before applying.
What is Retail and Wholesale Drug License?
A Drug Sales License is an approval required for carrying on the business of sale of drugs in Hyderabad. It applies to both retail and wholesale sale of medicines.
Retail Drug License is applicable where drugs are sold directly to consumers. Wholesale Drug License is applicable where drugs are sold to retailers, hospitals or other dealers.
The license is granted only after verification of documents and inspection of premises by the concerned authority.
Types of Drug Sales License
| Particulars | Details |
| Retail License | Form 20 and Form 21 |
| Wholesale License | Form 20B and Form 21B |
| Household Remedies License | Form 20A and Form 21A |
Which authority issues Retail and Wholesale Drug License in Hyderabad?
Basic details relating to application for Retail and Wholesale Drug License in Hyderabad are as follows:
| Particulars |
Details |
| Department |
Department of Health & Family Welfare, Government of Telangana |
| Directorate |
Directorate of Drugs Control |
| Competent Authority |
Assistant Director of Drug Control of the respective district |
| Processing Time |
90 days after receipt of complete application |
| Fees |
As per applicable Act and Rules |
| Payment |
To be made through GRIPS before application |
Basic Application Details
| Particulars | Details |
| License Type | Retail Drug License / Wholesale Drug License / Household Remedies License |
| Applicable Location | Hyderabad |
| Governing Law | Drugs and Cosmetics Act, 1940 |
| Retail License Forms | Form 20 and Form 21 |
| Wholesale License Forms | Form 20B and Form 21B |
| Household Remedies License Forms | Form 20A and Form 21A |
| Statutory Application Form for Retail / Wholesale | Form 19 |
| Statutory Application Form for Household Remedies | Form 19A |
| Key Person Required for Retail License | Registered Pharmacist |
| Key Person Required for Wholesale License | Competent Person / Registered Pharmacist, as applicable |
| Premises Requirement | Plan of premises showing carpet area, length, breadth and area in Sq.m |
| Company Requirement | List of Directors from MCA and affidavit under Section 34, if applicant is a company |
| Inspection Requirement | Original pharmacist certificate is required to be produced before the Drugs Inspector at the time of inspection for endorsement, in case of retail license |
Procedure for New Retail or Wholesale Drug License

Role of the Drugs Control Directorate
The Drugs Control Directorate works as a public health measure through enforcement of the applicable drug laws.
The Directorate is entrusted with grant or retention of manufacturing and selling licences relating to allopathic drugs, homoeopathic medicines, cosmetics manufacturing licences, Blood Bank, surgical and medical device units.
It also carries out inspection of manufacturing process of sera or vaccines units, monitors and issues GMP and GLP certificates, including MSC, NVC, COPP and Free Sales Certificate, and approves quality control laboratory of medicines and cosmetics.
Outcome of the Application
After submission, the application is processed by the department.
The form and submitted documents are verified. Inspection is conducted by the Senior Inspector or Inspector of Drug Control. The inspection report is submitted to the Assistant Director of Drug Control.
After completion of the departmental process, the competent authority communicates the decision to the applicant. If approved, the applicant can download or take print out of the license or approval.
Applicable Laws and Regulations
The following laws and regulations are applicable:
| Sl. No. | Regulation |
| 1 | Drugs and Cosmetics Act, 1940 and rules formed thereunder |
| 2 | Drug Price Control Order, 2013 |
| 3 | Narcotic Drugs and Psychotropic Substances Act, 1985 |
| 4 | Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 |