Changing Regulatory Environment

Changing Regulatory Environment

 

Warnings and awareness are already being disseminated around the world with the persistent campaign of Food and Drug Administration (FDA). However, the battle is still being relentlessly fought. Global contributions have indeed lifted some issues but with the increasing profit, this illegal act is now considered as one of the most lucrative businesses.

 

It is absolutely imperative that people understand the degree of risk involved in this illegal process. It is also important that the government implement the right regulations to prevent the total widespread of counterfeiting.

 

Current regulations include implementing new technologies in pharmaceutical companies. Some firms prefer barcodes as the automated identification method for item level packaging because they are familiar with the technology, and because barcodes are inexpensive to print and apply. Others use far more advanced and sophisticated technologies including RFIDs and holograms which include a more complicated process.

 

However, many medicines are now nearing expiration dates of patents. A number of expensive and on-demand drugs have already been pulled out of the shelves in many pharmacies in both developed and developing cities. Because of this, regulations now include the growing competition of cheaper generic drugs. Pharmaceutical manufacturers are likely to see “minimal growth of branded products up to 2016” on the most successful drugs and medicines.

 

According to a review of The Peterson Group, one of the leading sources of information on the latest news about medicine counterfeiting, the global generic drug market is worth US$225 billion and will continue to grow at 10% Compound Annual Growth Rate (CAGR) to US$358 billion in the next five years.

 

It was not long since the surge of strong growth in the generic drugs market. The industry has not totally embraced the peak of success when it is already challenged and threatened potentially from counterfeit medicines.

 

New regulations are once again being drafted for the fast growth of fraudulent medicines. From national policies, different non-profit organizations gathered to integrate rules which can be used internationally. Globalization has made the pharmaceutical industry procurement and supply chain more complex than ever before. Today, raw materials are often sourced in one country, processed in another, with the finished product being sold in a third. This complicated supply chain has only increased the importance of track and trace technology on pharmaceutical processing lines to enable manufacturers to demonstrate compliance with relevant safety regulations throughout its operations.

 

From illegal business trades in Jakarta, Indonesia to the surge of growth of manufacturing of fake medicines in Beijing, China and drug smuggling in Central America, the environmental regulations continue to change and we will expect more changes in the near future.