US law moots stiff penalty for spurious drug makers

A new Bill has been introduced in the US Congress, proposing stiff punishment for manufacturers and traders of counterfeit pharmaceutical products and to prevent their entry into the US from countries such as India and China. The Bill is a part of the recent US initiatives to give greater protection to intellectual property rights of its domestic companies.

According to the new Bill, introduced by US Attorney General Alberto Gonzales in the US Congress this week, any counterfeiting offence that causes serious bodily injury would result in 10 to 20 years of imprisonment, and in the event of death, the culprit could face life imprisonment.

Further, the Bill says "the government will forfeit any property used or intended to be used in any manner or part to commit or facilitate the commission of a Federal copyright infringement offence".

Though a criminal offence, the current US laws on counterfeiting were not stringent and the punishment provisions differed in various federal states, informed sources said.

Two weeks ago, the Office of the US Trade Representative had placed a dozen countries, including India, on its priority watch list for failing to protect the intellectual property and trademark rights of innovators in sectors such as pharmaceuticals.

Its Special 301 report, a review on the global scenario of intellectual property rights protection and enforcement, had mentioned that the United States was concerned with the proliferation of the manufacture of counterfeit pharmaceutical products in China, India and Russia and a significant contributing factor in this problem was the unauthorised use of bulk active pharmaceutical ingredients (APIs) to manufacture counterfeit drugs.

In another development, a drug import Bill to allow imports of cheap prescription drugs from abroad with less regulatory hurdles was dismissed by the US Senate in a 49-40 vote, mainly citing that the US pharmacies could face the risk of being flooded with counterfeit drugs.

Pharmaceutical industry experts said the US move had come as a boon for the Indian drug exporters as the law could clear the alleged doubts on the quality and the genuineness of Indian pharmaceutical and raw material products.

"Indian manufacturers do not export counterfeit drugs and the move will give more protection to our products in the US market. If counterfeits proliferate in the US, it is an internal issue of that government to regulate and punish the offenders. All Indian drug companies are exporting drugs according to the strict standards enforced by that country. There is no substantiative evidence to prove that India is a major source for counterfeit products," said D G Shah, secretary general of the Indian Pharmaceutical Alliance.

"Counterfeiting of pharmaceuticals is a serious global issue for many years. The new law will help clear the doubts on drugs originating from India. Often drugs which are found sub-standard are interpreted as spurious or counterfeits.

Sub-standard drugs could be the result of defects in manufacturing, storage or logistics. All companies, whether Indian or American, often face this problem for certain batches. It does not mean that the entire products of these companies are spurious or sub-standard.