India says its drugs 'safe' after US generics fraud

India, known as the "pharmacy to the world", defended Monday its lucrative generic drug industry as safe and tightly regulated, after the nation's biggest drug firm pleaded guilty last month to US charges of making adulterated medicines.

The government also charged that "isolated reports" of spurious drugs found in global markets allegedly from India represented "desperate attempts" by other countries to hurt the strength of the fast-growing Indian pharmaceutical industry.

India's "pharmaceutical sector is a highly regulated one and exports are heavily guided by various regulatory regimes of the importing countries", the government said in a statement.

India's drug exports totalled $14.6 billion in the financial year to March 31, marking growth of nearly 11 percent from the previous year.

The statement came after New Delhi-based Ranbaxy Laboratories, India's largest drug company by sales, pleaded guilty to US criminal charges of making adulterated medicines and agreed to a $500 million settlement.

The fraud, investigated over eight years by US authorities, was exposed by a whistle-blowing ex-employee who said Ranbaxy created "a complicated trail of falsified records and dangerous manufacturing practices".

India has built a reputation as the "pharmacy to the world" for its production of life-saving generic versions of medicines for poor nations that cost a fraction of brand names.

But analysts have warned that Indian drugmakers may find it tough winning new contracts in their main US market, with the case involving Ranbaxy raising questions about the safety and quality of Indian-made drugs.

The government's statement came as one of India's leading generics makers, Dr Reddy's Laboratories, and Japan-based Fujifilm Corp said they had called off "by mutual agreement" plans for a joint venture to make generic drugs.

They gave no reason for the decision to abandon the plan for the Japanese market formulated two years ago.

But their anouncement said Fujifilm, a unit of Fujifilm Holdings, was realigning its long-term pharmaceutical growth strategy. It said the two companies would continue to explore pharmaceutical partnership possibilities.

Generic drug firms in India have been a major supplier of copycat medicines to treat diseases such as cancer, TB and AIDS for those who cannot afford costlier branded drugs.

The country "has proven international quality standard capabilities", the Indian government said.

India enjoys "a unique position of low-cost manufacturing and the highest quality medicine, the best of both the worlds", the statement added.

It invited global importers to visit Indian factories to "satisfy themselves of the quality of production of drugs". India said its drug regulator regularly meets his global counterparts to ensure the nation meets international manufacturing standards.

Japanese drug company Daiichi Sankyo, which bought Ranbaxy in 2008, has alleged the firm's former owners hid vital information about the US regulatory inquiries at the time of the $4.6 billion purchase.

The charges have been denied by the billionaire Singh family that used to control Ranbaxy as "baseless".

India has long alleged complaints about the quality of its generic medicines originate with brand-name rivals unhappy about growing use of cheaper knock-off drugs, as developed nations fight soaring health care costs.

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