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New Delhi: The United States has warned India of its growing problem of counterfeit or spurious drugs.

In its annual ‘Special 301 Report’ on intellectual property protection and review of ‘notorious markets’ for piracy and counterfeiting released Thursday, the office of the United States Trade Representative (USTR) blamed India for its growing problem of counterfeit medicines.

The USTR report said almost 20 per cent of all pharmaceutical goods sold in the Indian market are counterfeit — a damning claim considering the growing pharmaceutical market of India and its decades-old reputation of being the “pharmacy to the world”.

“In particular, China and India are reportedly leading sources of counterfeit medicines distributed globally. While it may not be possible to determine an exact figure, studies have suggested that up to 20 percent of drugs sold in the Indian market are counterfeit and could represent a serious threat to patient health and safety,” the report said.

While the report blamed India for jeopardising the health and safety of its own population, it also ranked India among top producers for exporting counterfeit medicines to Africa, Canada, the Caribbean, the EU, South America, and the United States.

India is the world’s third-largest drug producer by volume and its pharma market is expected to grow to $55 billion by 2020.

A senior official at the Ministry of Health and Family Welfare, however, rejected the findings.

“The figures are exaggerated. While there is a problem of counterfeit medicines in India, it amounts to be lesser than 10 per cent of total medicines sold in India,” the official said.

“To counter the problem, we are looking at the end-to-end implementation of the blockchain technology and implementation of QR is also ready to be rolled out,” said the official who didn’t wish to be named.

Also read: US drug authority warns Indian homoeopathy firm after it finds insects & rodents at factory

India, China top producers of counterfeit drugs

In its special report, the office of the United States Trade Representative said, “The United States notes its particular concern with the proliferation of counterfeit pharmaceuticals that are manufactured, sold, and distributed in numerous trading partners, including China, India, Indonesia, and Thailand.”

Over 7 lakh people die every year across the world due to consumption of fake or spurious drugs, suggest estimates of Washington-based International Policy Network.

“In 2018, the majority of the value of all counterfeit pharmaceuticals seized at the U.S. border were shipped from or transshipped through China, Hong Kong, India, and Vietnam,” said the USTR report.

It further identified that counterfeit drugs are becoming a greater issue through illegitimate online sales, particularly in countries such as China and India.

“The manufacture and distribution of pharmaceutical and biopharmaceutical (pharmaceutical) products and active pharmaceutical ingredients bearing counterfeit trademarks is a growing problem that has important consequences for consumer health and safety, and is exacerbated by the rapid growth of illegitimate online sales,” it said.

India on ‘priority watch list’ once again

According to the report, India continues to remain on the US ‘Priority Watch List’ for alleged violations of intellectual property rights (IPR).

While the USTR applauded India for its efforts to address IP challenges, it called India “one of the most challenging major economies for enforcement of IP laws”.

“Over the past year, India took steps to address intellectual property (IP) challenges and promote IP protection and enforcement. However, many of the actions have not yet translated into concrete benefits for innovators and creators, and long-standing deficiencies persist,” said the report.

It added that the US will continue to monitor developments with its trading partners, including India.

The USTR has identified 11 countries on its ‘Priority Watch List’ including India, China, Russia and Venezuela, among others. It has also listed 25 countries, including Pakistan, on the ‘Watch List’.

“India’s commitment to bilateral dialogue remains strong, and the United States intends to continue to engage with India on IP matters, including through the U.S.-India Trade Policy Forum,” the report said.

Also read: How India’s culture of ‘jugaad’ is challenging the US drug agency


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