Drug License in : Types, Eligibility, process, documents & benefits

Introduction

A Drug license in India is a compulsory legal requirement for the business who engaged in manufacturing, selling and distributing the drugs in India. Basically, this license is issued by the CDSCO (Central Drug Standard Control Organizations) or state-level authority. This license is not only a license to run a business but essential to ensure quality and safety of pharmaceutical goods. In addition to protecting consumers from harmful or substandard products, the license ensures that drugs sold or manufactured meet legal safety and quality standards. A business can’t legally operate pharmaceutical space without having a valid drug license in India. In this article we will uncover all about the Drug License in including its different types, eligibility, process, documentation, fees and time taken.

What is a Drug License?

Drug License is a legal document granted by the regulatory authority such as CDSCO (Central Drugs Standard Control Organization or state-level authority. Any individual or business wants to manufacture, sell, distribute or import drugs or any pharmaceutical goods mandatory to obtain a drug license in . This license determines that the businesses who involve in the pharma industry comply with laws, intend to safeguard public health by assuring that drugs are manufactured, stored and sold as per the specific quality and safety standards.

Types of Drug License

There are three types of Drug License, as follow:

1. Drug Manufacturing License: This drug license is required for production of pharmaceutical drugs and medicine.
2. Wholesale Drug License: For wholesale distribution of pharmaceutical products, wholesale drug license is required.
3. Retail Drug License: If someone wants to open or run a chemist shop, they have to obtain a retail drug license.

Eligibility for obtaining drug license in

For obtaining Drug License in , there are some general criteria which is as follow:

Premises Requirements:

• Area - Minimum 10 square meters to start a medical shop or pharmacy. For pharmacy businesses who retails and wholesale both require a minimum 15 Square meter.
• Storage Facilities - should have refrigerator, air condition and other requirements if necessary.

Educational Requirements:

• For Retail Drug License - It should be a registered pharmacist or an individual with pharmacy degree must be employed.
• For Wholesale Drug License - The applicant should be registered pharmacist or have a competent person with the necessary qualifications and experience.

Legal Age:

Documents required for drug license in

The complete list of documents required for drug license in is as follow:

1. Application Form (should be prescribed form)
2. Covering letter with intent of application signed
3. Challan Receipt
4. Declaration form
5. Ownership Proof
6. Incorporation Certificate
7. Partnership Deed
8. Affidavits
9. Site plan (blueprint) for the premises
10. Other premises documents (such as - electricity bill, refrigerator bill, rent agreement, etc.)

Process for Drug License in

Here is the complete process for obtaining drug in license is as follow:

Step 1: Create an Account on Government Portal

At the initial stage, you have to create an account on the government portal as per your state, visit its state drug control website or the national portal.

Step 2: Submit Application

Gather all the relevant documents (complete list given above) and enter details such as business type, personal and business details and upload other relevant documents. These documents must be appropriate and accurate, if there are any discrepancies, it can lead to rejections.

Step 3: Pay Applicable Fees

Pay application fee online by the government payment gateway system.

Step 4: Premises Inspection

Once above mentioned stages have been cleared, an inspection will be held where the drug inspector will inspect and examine the premises to assure the compliances with safety and storage requirements are fulfilled or not.

Step 5: Licensing Decision

If you cleared all the criteria and there are no discrepancies in premises the drug licensing authority will grant the license within a stipulated time.

Fees for drug license

Drug licenses in require a fee of ₹3000, which must be paid online during the application process. Depending on the type of drug license in India and the region, additional fees may apply.

Note: Professional charges can vary, connect bizfoc for obtaining Drug license in under the professional guidance in minimum prices.

Time Taken for Obtaining Drug license in

The complete procedure for obtaining a drug license in takes around 30 working days that includes - 5 days for drug inspector’s verification, 15 days for the inspection report and 10 days for final approval.

Drug License Renewal in

A drug license in is typically valid for five years, after which it must be renewed. Renewal requires an updated submission of documents and payment of renewal fees, similar to the initial application process. Renewal should be applied for before the expiration date to avoid penalties.

Benefits of obtaining drug license

Obtaining Drug License have several benefits, some of them as follow:

• Legal Compliances: Ensure that your company complies with the legal requirements of drug regulation.
• Credibility: It helps in consumers trust building and expanding business reputation in the marketplace.
• Market Access: Drug License offers you to manufacture, sell and distribute drugs and open up several business opportunities.
• Avoid Penalties: Businesses may face hefty penalties for breaking drug licensing laws.

Why Bizfoc?

BizFoc is a dedicated Drug License consultant in who will simplify the Drug license registration procedure for your business under the professional guidance. Here’s how we assist you:

• We provide you with expert assistance and consultation for all your requirements that are required for your Drug Licensing.
• BizFoc also helps you to obtain a Drug License in India without any hurdles.
• Our team reviews each and every requirement accurately and fills out the Drug Licence Application form submission.
• We provide affordable and transparent professional charges.
• We liaise with Drug license officials to address queries and ensure smooth approval.

Conclusion

Getting a Drug License in is not only a legal formality, it is a crucial step to ensure the safety and quality of pharmaceutical products. The complete process mainly takes 30 days to complete if all the compliance and requirements are under the law otherwise it is the higher chance to be rejected during the inspection stage. With Bizfoc’s expertise, you may simplify the procedure where we are dedicated to growing your business while handling all the regulatory and complexities.

Frequently Asked Questions