Which License is Required for Medicine Export Business?

Business

Which License is Required for Medicine Export Business?

Registrationwala

The medicine export business refers to the international trade of pharmaceutical products. In the pharma sector, India holds a prominent position, particularly in the field of generic medicines. In fact, by volume, it is the world’s largest supplier of generic medicines. In this blog post, we will discuss licenses, certificates and registrations required to start and operate a medicine export business in India.

Why Start a Medicine Export Business?

India is a leading medicine exporting country across the world. This is because it can produce or manufacture high quality medicines, especially the generic medicines, at costs that are much lower than other countries.

Due to large-scale manufacturing capabilities, a skilled workforce and a strong focus on meeting global quality and regulatory standards, the medicine export business is one of the most promising in India. It produces affordable, life saving medicines that help improve and save millions of lives across the world.

Licenses, Certificates and Registrations Required for Medical Export Business

Below, we have provided you with the list of some of the most important licenses, certificates and registrations for starting a medical export business in India.:

Business Registration

You need to choose the right business model for your medicine export business. If you prefer working independently without formally registering company, then you can opt for a sole proprietorship. Alternatively, if you plan to start the business with a partner without formal registration), then a partnership firm model would be suitable choice.

Keep in mind that in both sole proprietorship and partnership setups, the owners are personally liable for the debts and obligations of the business. Even the owners personal assets may be at risk if business incurs debt. If you want protection from personal liability, then it’s advisable to register your business under models such as a one person company, a private limited company or a limited liability partnership.

For these options, you must file a business registration application with the Registrar of Companies (ROC) through official MCA portal. Along with application, you’ll need to submit certain business incorporation documents depending on business structure you select.

Once the filing is completed, the ROC will review the application you filed. If everything in application meets the required legal and regulatory standards, the ROC will approve your registration and issue incorporation certificate in your business entity's name.

Drug Manufacturing License

To operate a business that produces medicines, it is mandatory to obtain drug manufacturing license. By obtaining this license, your business will ensure its compliance with Drugs and Cosmetics Act 1940 and can legally engage in manufacture of medicines.

For obtaining this license, you need to file an application with relevant state licensing authority, submit necessary documents like ID proofs, qualified personnel details, etc., and pass premise inspection conducted by central/state govt officials.

Import Export Code (IEC) Registration

In India, export and import businesses are required to secure import export code (IEC) registration. The IEC is a 10-digit no. that basically enables businesses to engage in import or export activities. The Directorate General of Foreign Trade (DGFT) issues this code.

To export vegetables from India, it is essential to obtain an Importer Exporter Code (IEC). To apply for an IEC, you need to submit an online application through the official DGFT portal. 

Once your application is carefully reviewed and receives approval, you will receive your IEC. This code is valid indefinitely and does not require renewal. However, it is important to update your IEC details on an annual basis.

GST Registration

The GST registration is mandatorily required for businesses when their annual turnover exceeds the threshold limits. For goods, the threshold limit is Rs. 40 lakhs and for services, it is Rs. 20 lakhs. However, GST registration is required regardless of annual turnover when a business is engaged in export business. 

To register under GST system, the process is completely digital and you need to visit the official GST portal to complete the process. Once you secure GST registration successfully, you will receive GSTIN. GSTIN stands for goods and services tax identification number. This number serves as proof of GST registration.

Quality Management Certificates

Maintaining high quality standards is one of the most important requirements for a medicine business. You cannot negotiate the quality of your medicines. Therefore, it is essential for you to obtain quality management certificates. These certificates ensure the company’s commitment when it comes to quality and builds trust among customers, partners and stakeholders.

ISO certification for your business would showcase adherence to global quality management standards. GMP certification would imply that your medicines are manufactured in compliance with safety, consistency and regulatory norms. 

SA8000 focuses on Social Accountability at the international level. So, by obtaining, your business would prove how committed it is when it comes to following ethical practices and ensuring employee welfare as well as social responsibility.

Conclusion

In this blog post, we discussed some of the most important licenses, certifications and registrations that you’ll need for a medicine export business. By obtaining them, you will be able to operate your business smoothly while complying with domestic as well as international standards. Also, there is a possibility that you may be required to obtain more approvals depending on target countries and their regulatory requirements and standards. For assistance in starting a medical export business, you can speak with the Registrationwala team. 

Related post

Subscribe to our newsletter