Introduction: Drug License
A drug license in India is an essential requirement for any person or entity involved in the trade, sale, or manufacturing of drugs in India. The type of drug license applicable depends upon the type of activity the applicant is involved in and the type of drugs dealing with. The license is issued by their respective state food and drug authority when abided by their terms and conditions.
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A drug license from the state Food and Drug Authority is permission to the person or entity involved in the sale, trade, and import or manufacture of any pharmaceutical products in India.
The license ensures that the activities being carried out at the applicant are in compliance with the terms and conditions of the Drugs and cosmetic act in the supervision of a technical person example a registered pharmacist having a valid license number.
Also as per the Drugs and Cosmetic Act, all the medical devices in India will be regulated as drugs only. Hence any person or entity involved in business activities like sale, stock, or distribution of medical devices in India also needs to apply for drug sales and wholesale licenses to further apply for medical device import or manufacturing.
It is one of the mandatory requirements by the Central Drugs Standard Control Organization for medical device applications.
Depending upon the type of business activity, the drug license is categorized into 4 different types.
Steps Involved to apply for a drugs wholesale license application:
The licensing process is bifurcated into 10 steps as mentioned and described below.
- Check for pharmacist
- Mandatory document preparation
- Portal Registration
- Pharmacist registration on the portal
- Application filling
- Registered pharmacist mapping
- Application submission and fee payment
- Scrutiny of application
- Onsite inspection by Drug Inspector
- Grant of license
Step 1: The first step of the license application is to look for a pharmacist for their firm who will act as the technical person for the firm. The pharmacist is responsible for all the technical activities at the firm.
Step 2: All the mandatory documents must be arranged prior to filling out the application. The mandatory document set consists of the following documents as listed below,
- Layout plan of the premise
- Invoice of cold storage appliance if applicable
- Proof of establishment
- GST certificate
- Rent agreement or Purchase deed
- Photograph of applicant
- Address proof and ID proof of the applicant
- Qualification certificate of the applicant
Step 3: Once all the mandatory documents are in line, an online account must be created on the designated online website of that state's drug and food authority. In the process of account creation, some basic details are required from the applicant in order to generate login credentials for the firm.
Step 4: The first step that the applicant needs to follow once his entity is registered with the Food and Drug Authority is to register its pharmacist with the department and generate its unique reference number. The same number will be used at the time of application submission.
Step 5: The second step on the portal post registering the pharmacist is to fill out the online application for a drug wholesale license. All the mandatory details and documents are required to be submitted on the portal in their respective fields.
All the company details along with the applicant details must be filled in the application and all the documents must be uploaded in all the respective fields.
Step 6: The most crucial part of the application filling is to map the registered pharmacist in the application with the help of the unique reference ID. When the pharmacist is successfully mapped in the application the application can be processed for the final step.
Step 7: The final step of application filling is to submit it to the department and pay the corresponding fees across it as per the guidelines. Once the fees are paid and the application is submitted to the department, the applicant receives an acknowledgment or an online application that can be used for future references.
Step 8: Post submission of the application and government fees payment, the application is scrutinized by the department officials. In case any discrepancies or query is found, the department raises concern online and asks to reply online in a stipulated timeframe with a resolution of the concern.
Step 9: Once the online application is approved by the department and all the concerns are resolved with a satisfactory response.
An onsite inspection is conducted at the premise where the business activities are taking place by Drug Inspector. The drug inspector ensures all the firm details are exactly the same as provided online in the application. Also, he checks the competency of the pharmacist and checks if he has sufficient knowledge.
Once the officer is satisfied with the inspection and all the checkpoints are cleared by the applicant at the time of inspection. The DI forwards the application for a grant of license.
Step 10: Post satisfactory inspection the DLA (Drug licensing authority) finalizes the wholesale license in the name of the firm. Only once the final license is issued, the applicant can start with the business activities. In case of any breach of terms and conditions of the license, heavy penalties along with imprisonment.
To do business in pharma industry including Ayurvedic & Unani drugs, one must get a Drug license to operate legally. As per Drugs Act, 1940, License is mandatory throughout India. A particular license is required based on business requirement.
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This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.
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