How to Export Pharmaceutical Products?

 

Growing significantly over the years, it was between 1980 and 1990 that Indian pharmaceutical industry stepped into exports. Pharmaceutical exports stood at $ 17.27 billion for the year 2017 -2018 in comparison to $16.80 billion in the year 2016-2017. It shows a remarkable rise with a further expected growth of 30% to reach almost $20billion by the year 2020.

Why are Exports of Pharmaceutical Products from India a lucrative option?
➢ India is volume exporter in API (Active pharmaceutical ingredients) to treat acute or chronic diseases.
➢When it comes to production, India stands on the sixth position among the countries of the world and exports Indian vaccines to more than 150 countries.
➢ Several international NGOs like the UNCTAD, the Clinton Foundation, Bill & Melinda Gates Foundation, etc. look up to Indian pharmaceutical products to meet 70% of the medicine requirement of the developing countries.
➢ India has more than 3000 pharmacy companies and nearly 10,500 manufacturing units presently out of which WHO GMP has approved 1400 units.
➢ Manufacturing costs of pharmaceutical products in India are 35-40% less than the US.
➢ India is among the top countries to export generic formulations.
➢ 584 sites in India are approved by the USFDA (United States Food & Drug Administration).


Procedure for Export of Pharmaceutical Products from India

Export of pharmaceutical products is one of the most thriving options (over the edge concessions and facilities extended by the government) though it may be a bit difficult, as it involves stringent processes and documentation.
Pharmaceutical manufacturers who have an interest in exporting products from India must comply with all the norms as per ‘The Pharmaceutical Export Promotion Council (PHARMEXCIL)’. The introduction of PHARMEXCIL was by the Ministry of Commerce and the Government of India in 2004. The aim was to promote exports related to the pharmaceutical industry as a separate wing.


How to initiate the export process for pharmaceutical products?

To initiate exports of pharmaceutical products to another country, it is essential to carry out the following:

  • Register as an exporter and obtain an IEC number. Once an applicant submits all the important documents and completes all the necessary norms, he shall receive an IEC number. Once the application has approval, one is permissible to export pharmaceutical products from India.
  • Register an office in the importing country.
    • Register the pharmaceutical product in the importing country.
    • Complete the necessary details pertaining to shipping, payment, and delivery.
    • On receiving a purchase order, complete the domestic formalities and have the products sent for customs clearance. Customs clearance is a mandatory document without which products export from the country is not possible. (Applicable to all export products).
    • After customs clearance, ship the products and wait for the customs clearance in the importing country.


Mandatory Requirements for Exporting Pharmaceutical Products from India

It is vital that with each consignment to be exported, the exporter mentions the name of the drug, the dosage form, the composition, the date of manufacturing and expiry, and the quantity along with the name of the country the products are to be exported to. The authorized signatory should duly sign it.

The exporter must submit the purchase order with clear indications. Thus, it must show the name of the drug, the dosage form, the composition, the date of manufacturing and expiry. Also, it must include the quantity and name of the country (import). The authorized signatory must duly sign it. It should not be more than six months old than the application submitted by the exporter.

The exporter has to be precise in the labeling and packing of the pharmaceutical products. It will evade rejection both on the domestic front and the country importing it.

Each importing country has its norms and specifications related to the quality of imported pharmaceutical products. It is crucial that the exporter complies with the mandatory requirements laid down by the importing country.

If the targeted country of export is the USA, the exporter has to attain approval by the USFDA. Also, in the case of European countries, the exporter has to act in accordance with the specifications laid down under EMA requirements.