Introduction

If you are willing to start a medicine or pharmaceutical export business in India, this blog will guide you through the necessary procedures and compliances involved in medicine export from India. Trends show how attractive the pharmaceutical industry is for entrepreneurs. India being the global leader in the supply of DPT, BCG, and Measles vaccines holds opportunities for new businesses to manufacture drugs and other pharmaceutical products in India and export the same to other countries. India shares twenty per cent of the global generic medicine supply by volume and all these stats support the establishment of new drug manufacturing units to manufacture drugs for domestic use and export purposes. Let’s understand the regulations involved in the medical business establishment and licences needed for medicine exports and other pharmaceutical exports in India.

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Understand the Specific Market Demand and Potential

Before administering any business you need to understand the market demand of the specific drugs you are willing to manufacture and export and the potential hold by the same drug set. These drugs and their future trend needs to be understood for establishing a successful business. Another point that you may consider is to focus on fewer medicine types initially which you may increase later on as per convenience. This strategy is a part of risk assessment for the businesses to minimise and mitigate possible negative outcomes. Once the business idea is concentrated on the targeted pharmaceutical category, you may move next on to entity registration to establish a medicine export business in India.

Entity Registration

Entity Registration may include various types of business registration. Four types of businesses are majorly registered as an entity to undertake business activities under a separate title from the owners. These entities include company registration and partnership firm registration. Company registration further includes one-person company registration, private limited company registration and public limited company registration while on the other hand, the partnership can also be a limited liability partnership which is commonly referred to as LLP. Corpseed provides business entity registration of all types, you may get in touch and consult for the best choice according to your business needs.

Manufacturing and Outsourcing of Medicines and Pharmaceuticals

After the entity is registered, the next step is to start the medicine export business. A pharmaceutical export business can be undertaken in multiple ways including the manufacturing of drugs or outsourcing the medicine from existing manufacturing units and leading them to export. A Manufacturing unit is a plant to manufacture drugs as specified under the Drugs and Cosmetics Act. It has to perform all the responsibilities and duties as specified under the act such as getting necessary licences from the regulatory authorities and maintaining the specified standards while producing drugs. Drugs can be either utilised for domestic purposes or may be exported to other countries. When a business entity purchases these drugs and then utilises them for domestic or foreign use, it is called outsourcing.

Role of Regulatory Authorities

The medicine export businesses and pharmaceutical export businesses are regulated by the central licensing authority under the Drugs and Cosmetics Act of 1940. The legislation is age-old but the updated version is in progress with a more elaborated and efficient regulatory framework for drugs, cosmetics and medical devices. Central Drugs Standard Control Organisation regulates the drug manufacturing, sale and distribution. This regulatory authority is often abbreviated and referred to as CDSCO. Drugs Controller General of India (DGCI) chairs this organisation and monitors the medicine and pharmaceutical-related activities in the country. Apart from CDSCO, PHARMEXCIL and DGFT play a key role in regulating the medicine export and pharmaceutical export businesses in India.

Compliance for Manufacturing of Pharmaceuticals for Exports

A pharmaceutical manufacturing unit needs to fulfil some compliances for manufacturing drugs in a legally sound manner. Before undertaking any manufacturing activity, it needs to get a drug licence from the Central Drugs Standard Control Organisation. The Drug licence has various types for different kinds of manufacturing. You might manufacture sample drugs initially to test the quality and standards of the drug. For this, you need to get a test drug licence. Also if you wish to utilise the manufacturing setup of some other licensee to manufacture your drugs, you may get a loan drug licence. For some specific kinds of drugs, you may also need to get a specific licence. For example, if you are manufacturing medicines that are covered under Ayush Products then you need to get the licence for the same.

Compliances for Medicine Exports

To regulate exports of medicines and pharmaceuticals, you need to register on the online portal of DGFT. DGFT stands For the Directorate General of Foreign Trade. It provides RCMC registration to the exporters and IEC Code (Importer Exporter Code) to facilitate the export procedure of the medicines. To promote a specific category of exports, the government has constituted various export promotion council that registers the exporters and provide them with necessary assistance in their export procedure. For pharmaceutical products, PHARMEXCIL works as a promoter for Indian medicine exporters.

How to Obtain Documents Relevant to the Exports

The documents you need to get to undertake activities of medicine and pharmaceutical export are as follows-

• PHARMEXCIL Registration

The term ‘RCMC’ stands for Registration Cum Membership Certificate. It is a document that exporters in India obtain from export promotion councils or commodity boards. The RCMC is a mandatory registration for Indian exporters, and it is issued by the relevant export promotion council or commodity board associated with the product or industry of the exporter.

• IEC Code

IEC stands for Importer Exporter Code. It is a 10-digit code issued by the Directorate General of Foreign Trade (DGFT), Ministry of Commerce and Industry, Government of India. The IEC code is a unique identification number that is mandatory for individuals or businesses engaged in the import and export of goods and services to or from India.

• Drug Export NOC

To export pharmaceuticals, a No Objection Certificate (NOC) is required from the Drug Controller Office. Manufacturers with a valid drug manufacturing license can apply for NOC through regional CDSCO offices. This certificate ensures compliance with regulatory standards and permits the export of pharmaceutical products.

• Manufacturing Licence

A Drug Manufacturing License, also known as a pharmaceutical manufacturing license, is an official authorization granted by regulatory authorities to a pharmaceutical company or facility, allowing them to manufacture drugs or pharmaceutical products. This license is a legal requirement and is crucial for ensuring the quality, safety, and efficacy of pharmaceutical products produced for the market.

• Other Documents

Exportation documents such as proforma and commercial invoices, bills of landings, packing lists, certificates of origin, and letters of credit are crucial for international trade. Proforma invoices outline terms pre-shipment, commercial invoices detail the transaction, bills of landing act as shipment receipts, packing lists aid in customs, certificates of origin verify the source country, and letters of credit provide financial security. These documents collectively ensure transparency, compliance, and smooth global transactions.

Endnote

In conclusion, venturing into the pharmaceutical export business requires a meticulous understanding of market demands, focusing on specific drug categories, and assessing potential risks. The journey begins with entity registration, and choosing between company or partnership structures. Regulatory authorities, including CDSCO, DGCI, PHARMEXCIL, and DGFT, play crucial roles in overseeing and promoting pharmaceutical exports. Compliances, including obtaining a Drug Manufacturing License and necessary export-related registrations, are essential for legal operations. To navigate the complex landscape, exporters need documents like PHARMEXCIL Registration, IEC Code, Drug Export NOC, and Manufacturing License. These documents, coupled with exportation essentials such as invoices, bills of lading, and letters of credit, form the backbone of a transparent, compliant, and successful global pharmaceutical venture. As you embark on this journey, remember that staying informed, adhering to regulations, and embracing innovation will be your compass in navigating the exciting challenges of pharmaceutical exports.