India is home to numerous pharmaceutical companies. They mainly manufacture and supply OTC medicines, vaccines, generics, and APIs. While many of them operate within the country, a good number of them have established a name in the global market. A huge quantity of medicines is exported from India to various parts of the world each year. The country is known to be one of the biggest exporters of generic drugs worldwide. Reports suggest that Indian medicines constitute 20% of the global generic drug exports and 60% of the global vaccines. The demand for Indian medicines is high worldwide because of their reasonable price and good quality.
To export medicines from India, it is important to follow stringent guidelines. Individuals sending medicines from India to their acquaintances in other countries also require following certain rules and regulations. Seeking assistance from a reputed international medicine courier service in Indiaenables smooth shipping and timely deliveries.
In this article, you will learn all about shipping medicines from India to other parts of the world. This includes the laws to be adhered to, the documentation process, best practices, and more. Read on to find out!
India – The Pharmacy Of The World
Before we understand how to export pharmaceutical products from India, let us take a closer look at how India ranks in the pharmacy industry. India most commonly supplies vaccines like DPT, BCG, and MMR (for measles) to foreign countries. Most USFDA-approved plants outside the USA are also situated in the country.
India is also referred to as the “Pharmacy of the World” due to Indian pharmaceutical industry’s low cost and good quality primary USPs.
In 2019–20, the Indian pharmaceutical industry’s total yearly revenue was $36.7 billion, with the availability of inexpensive HIV medications among the greatest successes. In 2021, it reached $42 billion. A further rise is expected in the coming years with the anticipation that the annual revenue of the Indian pharmaceutical industry will reach $120 billion in 2030. Furthermore, India is one of the biggest exporters of affordable vaccines. Most medicines exported from India today are drug formulations and biologicals, which make up around 75% of all exports.
Why is India’s Contribution Important To The World Pharmaceutical Landscape?
India is the biggest contributor to the pharmaceutical industry. Here’s how.
India’s export medicines are targeted to the Middle East, Asia, CIS, Latin America, and the Caribbean (LAC), North America, Africa, the EU, ASEAN, and other European regions.
Africa, Europe, and NAFTA receive almost two-thirds of India’s export of medicines. In 2021–22, the USA, the UK, South Africa, Russia, and Nigeria were five of India’s top export markets for pharmaceutical products.
Do you know which countries import medicines from India? The United States is the largest importer of Indian medicines. United Kingdom, Brazil, South Africa, Venezula and Russia are among the top importers from India. Around 200 countries across the globe import medicines from India.
In FY21–22, India exported medicines to nations like the USA ($7,101,6 million), the UK ($704,5 million), South Africa ($612,3 million), Russia ($597,8 million), and Nigeria ($588.6 million).
Over the past three years, the value of India’s pharmaceutical exports to the USA increased at a CAGR of 6.9%. Additionally, over the same period, it increased at a CAGR of 3.8% for the UK and 7.2% for Russia, respectively.
These statistics show why India is a key player in the global pharmaceutical industry.
Registration For International Shipping Of Pharmaceuticals
The process for registering for international shipping is as follows:
Applicants must go to the official DGFT website, select the “Online Application” button, and select the “IEC” option from the drop-down menu. To continue, select the “Online IEC Application” option.
Use your PAN to log in to the system. Then select “Next.”
Select the “File” tab and press the “New IEC Application Details” button.
A new window with an application form will open.
Users must click the “Upload Documents” option to continue after submitting the form and verifying all the information they provided.
Users must click the “Branch” button to enter additional information about their branches after uploading all necessary supporting documents.
Users must use the “Director” tab to add information on the company’s directors.
Finally, users should click the “EFT” option to finish the online IEC application procedure by paying the necessary processing fee of INR 250.
Please note that applicants must also provide a hard copy of their application and the necessary supporting documentation to the DGFT’s office within 15 days of submitting the online application.
Compliance with Local and International Laws
You can ship various kinds of medications such as generic drugs, injections, prescription drugs, ointments, lozenges, Ayurvedic herbs, and Homeopathic medicines to international locations. It is important to learn the local as well as international laws for sending medicines to different countries. Not every country follows the same set of rules when it comes to receiving medicines. The laws about shipping may also differ depending on the type of medicine you are sending. Some medicines are prohibited in certain countries or may require special permission. Likewise, there is a limit to the quantity of medicines you can send to different countries. They also have different packaging requirements. Thus, it is necessary to check the regulations of the country you intend to send the medicines. Knowing the customs clearance procedures and other laws related to shipping medicines overseas helps move the consignment swiftly through the clearing process.
Documentation and permits needed for transporting medications
Medicines need to be accompanied by relevant documents when shipping overseas. Each shipment containing medicines is closely examined. Essential documents for transporting them must be sent along with your packages to ensure they pass through customs smoothly. Seeking assistance from a reputed international medicine courier service from Indiacan prove to be beneficial. The personnel at trusted companies that specialise in shipping pharmaceutical products know the necessary documents, certificates, and permits required to ship these products.
The following documents are required for exporting medicines from India:
Company PAN number
Incorporation Certificate
Bank account statements and other financial documents
Indian Trade Classification (HS) of the product
Bankers Certificate and other customs documents
IEC Number
Cancelled cheque
Proof of ownership of business premises or rental agreement
WHO: GMP certification
The documents outlined above should mandatorily include the following details:
Product details
Approved generic names
Strength per dosage
Dosage form
Details regarding the packaging
List of all active pharmaceutical ingredients with their properties
Visual description
List of countries where the product has been approved, rejected, and withdrawn
Sites of manufacture and method of synthesis
Stability testing
Efficacy and safety
How To Export Pharmaceutical Products From India?
If you are planning to venture into the export medicines segment, you must fulfill various certification and documentation requirements. This includes acquiring certain licenses, GST identity number, and registration. Let’s look at these essential requirements and the procedure for export of pharmaceutical products from India.
IEC Registration: The first major requirement is the IEC (Import/Export Code) Number. All Indian importers and exporters are given this number. You must apply to the Director General of Foreign Trade at the location where your company’s office is located. No transportation of goods into or out of the nation is permitted without an IEC code.
According to our foreign trade policy, only licensed pharmaceutical businesses are permitted to export pharmaceuticals from India; thus, the company must apply for an Import Export Code and register with the Director-General of Foreign Trade.
Regulatory Compliance: To avoid issues later, you must review the rules of the country you are exporting your pharmaceutical products to and officially register their product there. While exporting medicines from India, you must understand the guidelines shared by the Central Drugs Standard Control Organisation and the Pharmaceutical Export Promotion Council of India. Having a clear understanding about these guidelines will help with the export process.
Licenses and Permissions: It is essential to obtain certain licenses for medicine export from India. This includes wholesale drug license, loan license, or manufacturing license based on your business type. These licenses prove that your products comply with the global pharma standards set by the World Health Organisation and other regulatory bodies.
Furthermore, it is essential to get permission from the importing nation and India’s drug controller general. This is essential as pharmaceuticals and medicines are significant goods that may hurt customers’ general well-being and health.
Market Research And Export Strategy: Once the required paperwork is complete, you must contact people in importing nations to locate a vendor or buyer who is interested. As an exporter, you should conduct thorough market research and choose a suitable shipping strategy.
Accurate Documentation: Here, the buyer will submit a proforma invoice along with the order confirmation that includes specifics on the product, the amount of packing needed, and shipping information. Depending on how you intend to finance the order, you must subsequently create a commercial invoice to be submitted in response to this purchase order or Letter of Credit.
Effortless And Reliable Shipping: To ensure effective order fulfillment, business owners must draw a contract with the shipping or freight forwarding company. Exporters should only use reputable organisations to deliver their goods to avoid needless delays and issues. The final customs clearance phase occurs after the documentation procedure is complete. You can do this efficiently by engaging an agent. The same applies to shipping goods to the country of importation, where they may then be dispersed as needed after receiving customs clearance. For businesses dealing in healthcare, offering same-day medicine delivery can be a game-changer in ensuring timely service and customer satisfaction. This not only enhances convenience but also builds trust, especially for critical medical needs.
Risk Management Strategies – Safeguarding Medications during Transit
Medicines need to be handled with caution during shipping to ensure they reach their destination in the right condition. Since the time taken to transport these products is higher during international shipping, special measures should be taken to keep them safe all along. Here are a few strategies to safeguard medicines on the way:
Prepare Well for the Transit: It is important to invest in pre-shipment preparations to ensure your medicines remain safe during transit. This should include inspecting your medicines to verify they are in the right condition and are labelled properly.
Ensure Temperature Control: You need to store certain medicines in temperature-controlled environments to keep them from deteriorating. To keep them in perfect condition during transportation, you must make use of insulated containers and maintain appropriate heating and cooling. Do not forget to use temperature monitoring devices to keep a check.
Use the Right Packaging Material: Proper packaging and sealing of medicines ensure they remain safe during transit. Make use of the right packaging material to guard your medicines from tampering or damage. Don’t forget to ensure proper sealing of syrup bottles to avoid spilling and contamination. It is advised to add proper cushioning to absorb vibration and prevent the risk of leakage.
Handle with Caution: To ensure the safe transition of your medicines, it is important to handle the packages carefully. Specifying necessary handling instructions on the package can help carriers handle them accordingly. This reduces the risk of physical damage and facilitates a secure transition.
Monitor and Track the Shipment: Real-time tracking of the shipment must be done. This can be done using advanced tracking systems. This way you can take prompt action in case the shipment gets stuck somewhere.
Ensuring Quality: Protocols for Maintaining Medication Integrity
Maintaining the integrity of medication is of utmost importance. Here are a few tips to ensure the quality of medicines and maintain their integrity:
Appropriate Storage Conditions: It is suggested to establish standardised storage conditions based on medication requirements including temperature and humidity. Using dedicated storage facilities equipped with temperature-controlled environments and monitoring systems can be helpful in this regard. You must regularly monitor and record storage conditions to ensure compliance with specified parameters.
Inventory Management: An efficient inventory management system for tracking the medicine quantities and expiration dates must be employed to start with. It is important to conduct regular inventory audits to minimise excess inventory and identify expired or damaged medications for disposal. It is suggested to use first-in-first-out (FIFO) or first-expired-first-out (FEFO) protocols to ensure proper rotation and usage of medications.
Packaging and Labelling: The use of tamper-evident packaging materials and secure seals helps protect medications from contamination or tampering. It is important to label your medicines clearly and accurately. It should include the product name, strength, dosage, and expiration date among other essential details.
Train Your Staff: You must train your staff members to handle the medicines properly to minimise the risk of damage. Besides, you must hire trustworthy staff to ensure your medicines are not tampered with.
Quality Assurance Testing: It is imperative to conduct routine quality assurance testing to maintain the integrity of medicines. This helps assess the potency and purity of medicines and determines whether or not they are fit for consumption.
Regulatory Compliance: It is important to ensure your medicines comply with the standards and specifications set by the relevant authorities. They must pass the regulatory inspections and audits to prove they adhere to the required quality standards.
Risk Assessment for Maintaining Integrity: You should identify potential risks to medicines’ integrity throughout the supply chain. This can be done by conducting risk assessments to evaluate the likelihood and impact of various threats. Some of these threats may include temperature excursions, supply chain disruptions, or counterfeit medications. It is a good practice to develop contingency plans to address unforeseen events that may compromise medication integrity.
Conclusion
India exports a large number of medicines, especially generic drugs, to various countries each year. It is the world leader in exporting DPT, Measles, and BCG vaccines. Reportedly, the country ranks third globally in terms of the volume of generic medicine exports and fourteenth in terms of value. Shipping medicines from India involves taking care of several things. Seeking reliable international medicine courier service from India can help ship your medicines safely and timely to other parts of the world. Reputed courier service providers have a thorough understanding of the customs clearance policy, documentation, permits, regulations, and more. They handle your medicines carefully, pack them properly, and ship them safely to ensure they reach their destination timely and in the right condition.
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