Pharmaceutical Export Business – Pharma Export Business Plan
The Indian Pharmaceutical Industry ranks very high in the global market, in terms of expertise, know-how, technology, quality, and the vast range of medicines that are manufactured here. It currently tops the chart in India with its wide-ranging capacity and potential in the complex field of drug manufacture and technology. The pharmaceutical industry in India is only growing, as India exports to major countries in the world like the U.S and Western Europe.
Major Indian Pharma Companies maintain high standards. Along with Brazil & PR China, India has left its footprints on the map of top business players in the Pharma industry. India has a leadership position in the global presence and is a major generic pharma player. The export market in India is growing at a very rapid rate.
What is a Pharmaceutical Product?
A pharmaceutical product or medicine is defined as a substance or mixture of substance manufactured, sold, or supplied for use in the treatment, mitigation of any abnormal physical or physiological state or its symptom; or altering, modifying, correcting, or restoring any organic function, in human beings or in animals, that is subject to control by pharmaceutical legislation. Public health concerns demand that the pharmaceutical product exported/imported must conform to international safety standards.
Two factors determine whether or not a product falls under the Pharmaceutical category:
- The usage claims made in relation to the product. This is the description of what the product is used for. It usually appears at the back of the products or as a pamphlet inside the packaging of the product. If the usage is intended for medical purposes, then it falls into the Pharmaceutical category.
- The composition of the product. If a product includes a drug substance, then it is classified as a pharmaceutical product. A drug substance is one, which is again used for the treatment or prevention of a disease/disorder.
India currently exports various pharmaceutical/medical products like drug intermediates, Dosage Formulations (FDFs), Bio-Pharmaceuticals, etc. to various parts of the world. The country now ranks 3rd in terms of volume of pharmaceutical products’ production (10% of global share) and 14th largest by value. Looking at this, the world is now considering India as a profitable venue for both markets and manufacture its pharma products. Pharma export market in India is very potential for the buyers to spread the world over for procuring their required pharmaceutical formulations in all the available dosage forms.
The application for an export permit for a Pharmaceutical product usually entails the following:
- A generic name or International Non-proprietary Name (INN)
- Strength/dosage form
- Name and strength of each ingredient
- Trade name or proprietary name; if any
- Pharmacopoeia* specification of the medicine, wherever applicable
- Total quantity to be exported
- Name and address of the exporter
- Name and address of the manufacturer
- Name and address of the consignee
- Country of consignee
* Pharmacopoeia in its modern technical sense is a book containing directions for the identification of compound medicines and published by the authority of a government or a medical or pharmaceutical society. (source: wiki)
Before applying for an export permit, make sure you have applied for an export license as well. Make sure that you follow international drug regulations of the importing country as well. If they are not up to the standards of the importing country, your products could be refused entry and seized by customs officials. It might be even considered illegal importation.
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