Introduction

Indian pharmaceutical industry caters to businesses that involve manufacturing and supply of pharmaceutical ingredients and also involved in finished formulations. The industry is specifically confined to the export of generic drugs in bulk amounts. 

Currently, the pharmaceutical industry is under the hammer for collaborating, amalgamating and investing in foreign direct investment. Domestic markets are looking forward to the international arena where high margins can be reaped.

Manufacturing prospects exist in two areas for Indian pharmaceutical companies: formulations and bulk products. The formulations section can be further divided into two categories: consumption domestically and exports. The Indian pharmaceuticals industry is forecasted to be the third-largest by output and the thirteenth-largest by value, globally.

Exporting Medicines from India: The Whole Process

In accordance with the foreign trade policy, the pharmaceutical companies that are registered are only eligible to export medicines from India. Any pharmaceutical company must first get registered with the Director-General of Foreign Trade and thereafter make an application for import export code. After due consideration of fulfilling the requisite documentation, the step ahead lies in keeping in touch with the individuals from the importing countries and tapping on the interested buyers.

The very next step lies in getting familiar with the rules and regulations of the importing country and readily registering the product to avoid future stumbling blocks. After fetching approval from the importing country, the same is required to be obtained from the Drug Controller General of India since medicines constitute an essential commodity that casts a serious impact on a person’s life.

Further, a flexible shipping method must be finalized by the owners of the business that is most suitable. Make sure to have reliance on the reputed agencies for the purpose of delivering the product so that hindrances must be prevented. The business owner will have to wait for the customer to complete the purchase order after all of these pomp and circumstances are concluded. Once the order has been confirmed, together with it the buyer shall facilitate the business owner with the Performa invoice that shall be enclosed with the details with respect to the product and freight information.

Contingent on how they intend to finance the order, the company would then have to compose a commercial invoice against the purchase order. Following it, a contract must be signed with the shipping agency to ensure that the order is fulfilled efficiently. 

A very important step is to clear the customs, this can be achieved by appointing an agent. On a similar basis, the product shall reach the importing country and be distributed accordingly.

Exporting medicines: Steps to apply for IEC

• First and foremost, pay a visit to the official website of the Director-General of foreign trade. Proceed for the online application and select IEC from the option given in the drop-down list.
• Press on ‘Next' after logging in with your PAN.
• Additionally, go to the ‘File' tab and select the ‘New IEC Application Details' button.
• Additionally, this should generate a new window constituting an application form that users must complete correctly.
• Furthermore, users must press the ‘Upload Documents' button to continue after completing the form and double-checking all of the information given.
• The consumers must then upload all necessary supporting documentation and press the ‘Branch' button to add additional information about their branches.
• And users should go to the ‘Director' tab to make updates about the company's directors.
• Finally, users can click the ‘EFT' button to complete the IEC application process by paying the necessary processing fees of INR 250 online. Applicants should therefore provide a physical copy of their application, along with the requisite appropriate data, to the DGFT's office within 15 days of submission of an online application.

Read Our Blog: Import Export Code (IEC): Registration

Exporting Medicines: Required Documents

The requisite documents must be submitted to be able to export pharmaceutical products from India:

• PAN number of company
• Certificate of incorporation of the company
• Statement with respect to bank account and other documents of financial nature
• Documents related to customs
• Import-export code
• Product-related classification
• Proof related to ownership of the business
• A cheque that is cancelled
• Goods manufacturing practices: certification

A dossier must be submitted that must be encapsulated with the enumerated details:

• Details related to the product
• Form prescribing dosage
• Safety and efficacy
• Description entailing visual element
• A list specifying the names of the countries wherein the product has been rejected or approved.
• Manufacturing site details and method pertaining to synthesis.
• Generic names that are approved

Things to Adhere to Before Heading Towards Export of Medicines

Certain things must be taken into account prior to initializing the export of generic medicines from India, which are as follows:

• The procedure for registering a commodity in another country.
• Importing country's regulatory and enforcement standards.
• The importing country can need any substantial certifications.
• In order to locate distributors, sellers, and potential buyers in the importing country, efficient methods must be employed.
• In the importing nation, a good supply chain system must be developed.
• Procedures pertaining to customs clearance must be taken into account.
• Permission to export medicines from India must be acquired from the Drug Controller General of India.

Conclusion

It can be concluded that the Indian pharmaceutical industry is majorly dominated by exports and is currently witnessing a rise overall. The industry has achieved self-sufficiency in formulation manufacturing, producing nearly 70% of the country's bulk drug needs.