Know How to Export Pharmaceutical Products from India

The Indian pharmaceutical industry is perhaps one of the biggest sectors in the country, both in terms of value and volume, anticipated to escalate by 12% CAGR by FY2030. The pharmaceutical sector provides impetus to the country’s economy. Globally, the country has secured the third position regarding pharmaceutical production by volume and ranked thirteenth in terms of sheer value.

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Furthermore, the country is a global manufacturing and research pivot, holding a share of 5.92% of pharmaceuticals and drugs. In 2021-22, India exported US$ 24.62 billion of pharma products. The robust growth trajectory has made pharmaceutical sectors in India offer lucrative business opportunities.

Top Ways to Export Medicine and Pharmaceutical Products from India

Business owners must adhere to the following parameters before exporting pharmaceutical products.

• Approvals from Pharma Regulatory Authorities

Business owners must seek approval from the supreme pharma regulatory authorities like USFDA, CDSCO, etc., to ensure the safety and security of the masses. The CDSCO (Central Drugs Standard Control Organization) regulates all the particularities of drug export, import, sales, and clinical research. The FDA also promotes public health awareness and develops rules that all medicines must be clinically tested before marketing, preventing the ingression of violated medical products.

• Know the Step-By-Step Procedure to Export Pharmaceuticals

Here are the steps to Export pharmaceuticals from India:

Step 1: The first and foremost thing that every manufacturer must do is register themselves with Director- General of Foreign Trade and collect the Import Export Code.

Step 2: On applying for IEC (Import Export Code), companies or business owners must communicate with the interested vendor of the importing countries.

Step 3: Now look through the terms and conditions, rules, and laws of importing country and other particulars, helping them register products in the importing country without facing any further complications.

Step 4: Register the product from DCGI (Drug Controller General of India) upon receiving approval.

Step 5: Research and decide on the shipping method and payment mode.

Step 6: Now business owner will have to wait to get approval for the purchase order. Alongside preparing a proforma invoice containing vital information like packing type, product rate, freight details, etc.

Step 7: Based on how the business owner plans to finance an order, draft a frame of a commercial invoice against the purchase order sent by the buyer.

Step 8: Proceed to sign a contract with a freight forwarding agency to export the pharma product to the respective importing country.

Step 9: In this stage, business owners must complete the entire documentation process and head to custom clearance.

Step 10: Pharmaceutical products will be shipped to the designated importing country after receiving customs clearance.

It is imperative to note that customs clearance is also required in importing countries.

• Apply and Obtain IEC (Import Export Code) to Export Pharma Products from India

It is mandatory for an exporter to apply for an IEC number to initiate the process of exporting pharma products from India. Here are the steps that will guide business owners or any forms to do so:

Step 1: First, visit the official website of DGFT (Directorate General of Foreign Trade) and select the ‘Online application tab’.

Step 2: Now select ‘IEC’ from the drop-down menu and choose the ‘Online IEC application’ tab.

Step 3: To access the account, enter PAN and click on the Next button.

Step 4: Navigate to the ‘File’ tab and select ‘New IEC Application Details’.

Step 5: On selecting the tab, get redirected to the online form. Now fill it out with necessary information and attach relevant documents.

Step 6: Select the’ branch’ button if business owners would like to add inputs about their branches and head to the ‘Directors’ tab to provide information about the directors.

Step 7: Select ‘EFT’ to initiate an online payment, mention the amount details and pay the processing charge to complete the transaction and IEC application procedure.

Step 8: Applicants or business owners must get the hard copy and submit it to DGFT’s office.

• Keep Regulatory Compliances in Check

There are several regulatory compliances that the Ministry of Health and Family welfare has laid out, which applicants must adhere to before exporting a pharma product from India. One of the daunting tasks in exporting medicinal products is to receive approval from the Drug Controller General of India. Hence, applicants must keep all necessary documents in order and abide by the laws.

• Things to Consider before Exporting Pharma Products from India

It is absolutely important for exporters to factor in the following pointers before exporting pharmaceutical products from India:

1. Applicants must be well versed in registering a product in any importing country.
2. It is also vital for an applicant to know regulatory compliances and additional certificates requirement of the importing country.
3. Furthermore, applicants should also know the customs clearance procedure and how to search for vendors or potential buyers.

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Role of Consulting Firms in Exporting Pharmaceutical Products from India

Consulting firms like Tecnova provide crucial assistance to businesses looking to export pharmaceutical products from India. These firms bring years of expertise to help global companies establish a presence in India and guide Indian businesses in expanding their export capabilities. They offer tailored solutions, ensuring that pharmaceutical companies navigate regulatory challenges and comply with international standards. By securing necessary approvals from India's drug authorities, optimizing manufacturing processes, and identifying potential buyers, consulting firms help Indian pharmaceutical companies effectively grow their businesses globally.

Key Roles of Consulting Firms in Pharmaceutical Exports:

1. Regulatory Compliance Assistance: Help businesses navigate the regulatory landscape of both India and importing countries.
2. Approval Facilitation: Ensure pharmaceutical products meet the standards set by India’s drug authorities for export eligibility.
3. Market Strategy Support: Assist in formulating strategies to penetrate international markets and identify potential buyers.
4. Manufacturing Process Optimization: Help optimize production processes while adhering to government regulations.
5. Legal Guidance: Advise on legal implications and help companies ensure they meet international shipping requirements.
6. Export Facilitation: Streamline the export process by handling logistics and ensuring compliance with both local and international laws.
7. Global Market Access: Assist pharmaceutical companies in expanding their reach and gaining access to global markets.

‍References

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