Telangana Drug License
Telangana Drug License
Telangana drug license is a document of permission for carrying out businesses related to pharmaceutical industries that deal with drugs, medicines and cosmetics. Government issues drug license to regulate the manufacture, storage, distribution, sales of drugs and cosmetics. The government of Telangana issues drug license under the Drug and Cosmetics Act, 1940 to citizens. As per this act, it is essential to obtain a drug license before the commencement of the drug business. In this article, look at the procedure for obtaining Telangana drug license in detail. Know more about How to Start a Pharmacy Business
Drug and Cosmetics Act, 1940
Telangana drug license is mandatory under the provisions of Drugs & Cosmetics Act; 1940. This act regulates the import, manufacture, distribution and sale of drugs and cosmetics which includes allopathic drugs, homoeopathic drugs and even the Ayurvedic, Siddha or Unani drugs.
Importance of Telangana Drug license
Some of the significance of Telangana drug license is explained in detail below:
- The Telangana drug license gives the permit to sale, resale, market, manufacture, trade, etc. of drug and cosmetics.
- Without a drug license, no person can do pharmacy business or even start to associate with any dealings in the state.
- For ensuring good health our nation through adequately accessing the drugs and medicines, the Drugs & Cosmetics Act of 1940 made it mandatory for obtaining drug license
- Drug license also ensure that the drug and goods are not misused or abused by any individuals
- Dealing with drugs and cosmetics without a drug license is a cognizable offence. Every business person in the pharma industry needs to have their drug incense to carry out their day-to-day business work.
- Drug license contains the rules and regulation for the person who is dealing with drugs and details of the business premise.
Note: To maintain the quality of drugs/medicine and cosmetics is the responsibility of all persons dealing with the process line. If any person consuming a drug or cosmetic suffers any harm from the negligence on the part of the manufacturer or seller, the same is an offence, which is triable as an offence of grievous hurt under IPC. Hence holding drug license is essential.
Know more about the Medicine and Drugs Allowed for Import Without a Licence
Who needs Drug Licence?
Drug license is mandatory for dealing with the following type of business in Telangana. Any individual, partnership, limited liability company, corporation or business firm located In Telangana and is physically distributing the drugs & cosmetics in the state is required to hold a Telangana drug license.
- Business with any cosmetics intended to be rubbed, poured, sprinkled, or introduced into the human body or for cleansing, beautifying, promoting attractiveness, or altering the appearance of a Human, must obtain Telangana Drug license.
- It is mandatory to obtain Drug license to deal with medicines which are used for external or internal use of human beings or animals
- Manufacturing and distribution drugs/cosmetics applied to the human body to repel insects like mosquitoes need Telangana drug license.
- Business with substances used for the destruction or insects which cause disease in human beings needs drug license.
- Telangana drug license is essential for dealing with empty gelatine capsule
- Manufacturing, storage and distribution of medicines used for diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals
Basic Requirement for Obtaining Telangana Drug License
As per the provision of drug and Cosmetics Act, 1940 to get a Telangana Drug license the following requirements to be met by the applicant
The minimum area of ten square meters is needed to set up a medical shop or pharmacy, In case store business combination with the retail and wholesale than the minimum area of 15 square meters is required.
It is crucial to have refrigerator and air conditioner on the premises because some drugs such as vaccines, insulin injections are wanted to be stored in the fridge.
Sale of drugs can be only carried in the presence of a registered Pharmacist approved by the department who is required throughout the working hours in the retail shop.
The wholesale of medicines & drugs can be made either by a registered pharmacist or another competent authority who must be a graduate with one year experience in drugs or in the presence of anyone who has passed SSLC having experience of four years in drugs, specially approved by state drug control department.
Classification of Telangana Drug License
Based on the requirement of the pharmaceutical/drug business, Telangana Drug License can be classified in the following categories:
- Sale License
- Manufacturing License
- Blood Bank License
- NDPS License
Sale license will be issued to sell medicines in Telangana. The sale license can be further classified into two types.
- Retail License: It is granted to run and sell drugs or drug products in India.
- Wholesales License: It is issued to persons or agencies engaged in wholesale of drugs and medicine.
A manufacturing license is required to manufacture drugs/medicines and cosmetics. Issued to persons or agencies involved in the manufacturing of drugs and medicines. Government also issued Manufacturing loan license.
A manufacturing loan license loan will be issued to licensee or person using the premises, equipment and staff of another drug licensee having a manufacturing license.
Blood Bank License
It is a licence to operate a Blood Bank for collection, storage and processing of whole human blood and/ preparation of blood components for sale or distribution.
Issued to persons or agencies engaged in manufacturing of Narcotic Drugs and Psychotropic Substances.
The fee structure for Telangana drug license will be varied according to the type of drug license. The applicant can go through the document attached here for applying for drug license.Fees Table
Application Processing Time
Timeline for grant and renewal of retail sales, wholesale and Drug Manufacturing license is 14 days from the date of application.
Assistant director of Drugs Control Administration Government of Telangana issues drug license as per the provisions of drugs.
Following documents need to be submitted for Obtaining Telangana Drug license.
Documents required for Retail Licence
- Statutory Application form – 19 for licenses in form (20,21)
- Residential address proof of proprietor / Partner / Director / Competent Persons / Registered Pharmacist
- Partnership deed in case of partnership firm or List of Directors downloaded from MCA website signed by Company Secretary / Managing Director
- In case of the company an Affidavit on Rs.20 stamp paper signed by one of the Directors of the company. I
- Special declaration by a registered pharmacist on Rs.20 Non-Judicial stamp paper.
- Self-attested copy of Registered Pharmacist certificate (renewal up to date) affixed with latest photograph and signature of the candidate
- Plan of the premises is indicating the carpet area (specifying length and breadth in meters and area in square meter) with the signature of building owner and the applicant (Prop/ partners / Authorized signatory / Managing Director) in legal size.
- Photograph of the building owner with self-attestation
- Self-attested copy of the document showing the proof of ownership of the building owner for the premises to be licensed such as Encumbrance Certificate or any other legal document showing the present ownership.
Note: Original to be produced to the Drugs Inspector at the time of inspection for endorsement.
Documents required for Wholesale Licence
In addition to the above text an experience certificate of a competent person, need to be produced to get Telangana drug license. The application form for wholesale drug license is form – 19 for licenses in form (20B, 21B).
Documents required for Blood Bank License
- Wholesale Licence
- Application in Form 27-C
- Partnership deed in case of partnership firm or Ministry Of Corporate Affairs Extract of List of Directors in case of Companies/ documents of registration and list of members in case of a voluntary or charitable organisation
- List of machinery and equipment
- List of technical staff appointed with their qualifications, experience, consent and appointment letters
- Ownership tenancy agreement for the premises
- Affidavit U/s. 34 of Drugs and Cosmetics Act 1940
- Plan and Layout of Blood bank
- Service certificate issued by the agency which handles disposal of bio-medical waste
- SBTC approval
Documents required for NDPS LICENCE
- Application form – 1
- Covering Letter (Introduction of the applicant with the address of the Plant and administration office and his requirement), along with required possession capacity (i.e. the requirement for one year)
- Application form in prescribed proforma (duly signed/ countersigned by the director of a firm)
- An Affidavit in prescribed format on Rs. 20/- stamp paper
Documents required for a manufacturing license
Documents required for applying manufacturing license can be found from below attached file.Mfg_Licences_New
To get more details regarding Telangana drug license checklist, visit the Drugs Control Administration webpage.
Telangana Drug license Application Procedure
The procedure to obtain drug license in Telangana is explained in step by step procedure here:
Access DCA portal
Step 1: Applicant needs to visit the official website of Drug Control Administration and select the tab “Online Drug Licensing System’ option.
Note: If drugs are sold or stocked for sale at more than one place, the application has to be made separately.
Step 2: Select apply online option, first-time applicants need to register under “New Users” by filling in the details including the license information and obtain a User ID and password for login.
Step 3: Confirmation to new portal users or applicants will be sent to the registered mail-ID or through SMS on the registered mobile number.
Login to Portal
Step 4: Once registered in the portal, the applicant can now Log-in to proceed with the online application.
Step 5: Select the service category and type of license from the drop-down list and then select the type, i.e. Grant, Renewal or Amendment.
Step 6: Applicant needs to fill in the – firm details, constitution details, RP/CP details and other required information.
Note: Application can be saved, and pages can be revisited to make any changes before submission.
Step 7: Upload all the documents as per the type of Telangana drug license.
Note: Checklist as per the license selected will also be provided during the application process.
Step 8: Applicant needs to pay an application fee for processing the Telangana drug license application to further.
Acknowledgement of fee payment and application submission confirmation will be sent to the applicant’s registered maid ID and through SMS.
Step 9: The Submitted online application will be processed by the concerned area drug inspector (DI).
Verification by Drug Inspector
Step 10: Drug Inspector (DI) Schedules & Conducts Site Inspection The inspector will verify the following aspects at the time of inspection of the outlet for grant/ renewal of sales licences:
- Area of the business outlet to verify the compliance with the statutory limit
- Capabilities to provide proper storage conditions for the drugs/medicines stocked in the premises such as racks, refrigerator (for cold storage drugs)
Step 11: Drug Inspector (DI) will submit the Inspection Report to the Assistant Director (AD). Assistant Director (AD) will review the Inspection Report and verifies the documents and Information.
Get Telangana Drug License
The applicant can download the approved Telangana drug license from the Drugs Control Administration website.
Note: Once the licence is granted to the business, all such drug license must ensure that all the condition in the drug licence is compiled at all the time during the business. The Telangana drug license needs to be displayed at the prominent place of premises.