Tue May 6, 2014 11:14am EDT
<span id="articleText"/> * India invites buyers, regulators in charm offensive
<span id="midArticle_0"/> * Government plans to spend $500 million on education, training
<span id="midArticle_1"/> * Industry to collaborate with FDA, government to improve standards
<span id="midArticle_2"/> By Manoj Kumar
<span id="midArticle_3"/> NEW DELHI, May 6 (Reuters) - India is launching a campaign to repair its reputation as a global supplier of cheap high-quality drugs, responding to bans imposed by U.S. Food and Drug Administration (FDA) on several suppliers, two top officials said on Tuesday.
<span id="midArticle_4"/> As part of the charm offensive, New Delhi has invited global regulators - including the FDA - to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
<span id="midArticle_5"/> The move seeks to address U.S. quality concerns that have prompted the FDA to slap a slew of sanctions on Indian generics, choking off growth in drug exports.
<span id="midArticle_6"/> "Our quality standards are among the best in the world. If a neutral audit is done, it will find our true capabilities and strengths," Ashutosh Gupta, chairman of the Pharmaceuticals Export Promotion Council (Pharmexcil), which groups more than 3,700 exporters.
<span id="midArticle_7"/> "The U.S. is the biggest market for us. We are dealing with a lot of care. We want to fight these issues head on," said Gupta, also executive director at Medicamen, which supplies anti-malarials and other drugs to over 80 countries.
<span id="midArticle_8"/> Worries about quality control in India's $15 billion drug industry have come to the fore in the past year as plants run by Ranbaxy Laboratories Ltd and rival Wockhardt Ltd have been barred from sending drugs to the United States after falling short of the FDA's "good manufacturing practices".
<span id="midArticle_9"/> The FDA has also issued import alerts - allowing the FDA to automatically detain products - to more than 20 Indian facilities since January 2013 on quality concerns, including plants of Ranbaxy, India's top drugmaker, and Sun Pharmaceuticals Industries Ltd.
<span id="midArticle_10"/> That has hurt India's reputation as a supplier of safe, affordable drugs. Exports grew by just 2.6 percent in the 2013/14 fiscal year ending in March to $15.04 billion. Two years ago, the growth rate was 23 percent.
<span id="midArticle_11"/> Gupta said the FDA has issued import alerts over issues of data documentation, testing facilities and procedures at Indian facilities. However, there was no issue with drug quality, he said.
<span id="midArticle_12"/> New Delhi plans to strengthen oversight following a U.S. threat to launch a special review of India's regulation of drug patents and rule on market access to U.S. companies.
<span id="midArticle_13"/> It is also inviting Washington to hold broader trade talks once a new government is formed after a general election. Opinion polls show that opposition nationalist Narendra Modi's Bharatiya Janata Party (BJP) is likely to win the vote that ends on May 12. Results are due on May 16.
<span id="midArticle_14"/> India is second only to Canada as a drug exporter to the United States, where it supplies about 40 percent of generic and over-the-counter drugs.
<span id="midArticle_15"/><span id="midArticle_0"/> BRAND PHARMA
<span id="midArticle_1"/> The industry, which supplies drugs to nearly 200 countries, is concerned that curbs by the FDA have encouraged even regulators from Kenya and Ghana to seek plant audits.
<span id="midArticle_2"/> "It is a challenge for us," P.V. Appaji, director general of Pharmexcil, told reporters. "But in future it can be a positive for us because it will help us improve the dark areas."
<span id="midArticle_3"/> The industry, in collaboration with the Ministry of Commerce, is organising the 'iPHEX' international summit in Mumbai from May 21-23 to address buyers' concerns.
<span id="midArticle_4"/> Over 500 importers and 25 regulators from U.S., Europe, Africa and Latin America are likely to attend the meet, some of whom would visit plants and meet Indian regulators.
<span id="midArticle_5"/> The exporters' body has also invited FDA and India regulators to meet suppliers in Hyderabad, Goa, Chandigarh and Ahmedabad to create awareness about required standards.
<span id="midArticle_6"/> "We are upgrading standard operating procedures in plants such as testing, documenting and packaging," Gupta told a news conference.
<span id="midArticle_7"/> Trade Ministry officials said the government planned to spend up to 30 billion rupees ($500 million) over five years to strengthen pharmaceutical education and research and train manpower and state regulators.
<span id="midArticle_8"/> "There can be no compromise on the regulatory standards, quality parameters," said Sudhanshu Pandey, joint secretary in the Ministry of Commerce.
<span id="midArticle_9"/> Analysts said India would need more time and efforts to address the quality concerns of the U.S and other regulators.
<span id="midArticle_10"/> "It is not a panacea to solve the problems of the pharmaceutical sector," said Utkarsh Palnitkar, head of the life sciences practice at KPMG, who said he works closely with Pharmexcil.
<span id="midArticle_11"/> "You can't do it only by promotion, but focused promotion clearly will help put out the right message." ($1 = 60.1800 Indian Rupees) (Additional reporting by Zeba Siddiqui; Editing by Douglas Busvine and Susan Thomas)
<span id="midArticle_12"/>
<span id="articleText"/> * India invites buyers, regulators in charm offensive
<span id="midArticle_0"/> * Government plans to spend $500 million on education, training
<span id="midArticle_1"/> * Industry to collaborate with FDA, government to improve standards
<span id="midArticle_2"/> By Manoj Kumar
<span id="midArticle_3"/> NEW DELHI, May 6 (Reuters) - India is launching a campaign to repair its reputation as a global supplier of cheap high-quality drugs, responding to bans imposed by U.S. Food and Drug Administration (FDA) on several suppliers, two top officials said on Tuesday.
<span id="midArticle_4"/> As part of the charm offensive, New Delhi has invited global regulators - including the FDA - to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
<span id="midArticle_5"/> The move seeks to address U.S. quality concerns that have prompted the FDA to slap a slew of sanctions on Indian generics, choking off growth in drug exports.
<span id="midArticle_6"/> "Our quality standards are among the best in the world. If a neutral audit is done, it will find our true capabilities and strengths," Ashutosh Gupta, chairman of the Pharmaceuticals Export Promotion Council (Pharmexcil), which groups more than 3,700 exporters.
<span id="midArticle_7"/> "The U.S. is the biggest market for us. We are dealing with a lot of care. We want to fight these issues head on," said Gupta, also executive director at Medicamen, which supplies anti-malarials and other drugs to over 80 countries.
<span id="midArticle_8"/> Worries about quality control in India's $15 billion drug industry have come to the fore in the past year as plants run by Ranbaxy Laboratories Ltd and rival Wockhardt Ltd have been barred from sending drugs to the United States after falling short of the FDA's "good manufacturing practices".
<span id="midArticle_9"/> The FDA has also issued import alerts - allowing the FDA to automatically detain products - to more than 20 Indian facilities since January 2013 on quality concerns, including plants of Ranbaxy, India's top drugmaker, and Sun Pharmaceuticals Industries Ltd.
<span id="midArticle_10"/> That has hurt India's reputation as a supplier of safe, affordable drugs. Exports grew by just 2.6 percent in the 2013/14 fiscal year ending in March to $15.04 billion. Two years ago, the growth rate was 23 percent.
<span id="midArticle_11"/> Gupta said the FDA has issued import alerts over issues of data documentation, testing facilities and procedures at Indian facilities. However, there was no issue with drug quality, he said.
<span id="midArticle_12"/> New Delhi plans to strengthen oversight following a U.S. threat to launch a special review of India's regulation of drug patents and rule on market access to U.S. companies.
<span id="midArticle_13"/> It is also inviting Washington to hold broader trade talks once a new government is formed after a general election. Opinion polls show that opposition nationalist Narendra Modi's Bharatiya Janata Party (BJP) is likely to win the vote that ends on May 12. Results are due on May 16.
<span id="midArticle_14"/> India is second only to Canada as a drug exporter to the United States, where it supplies about 40 percent of generic and over-the-counter drugs.
<span id="midArticle_15"/><span id="midArticle_0"/> BRAND PHARMA
<span id="midArticle_1"/> The industry, which supplies drugs to nearly 200 countries, is concerned that curbs by the FDA have encouraged even regulators from Kenya and Ghana to seek plant audits.
<span id="midArticle_2"/> "It is a challenge for us," P.V. Appaji, director general of Pharmexcil, told reporters. "But in future it can be a positive for us because it will help us improve the dark areas."
<span id="midArticle_3"/> The industry, in collaboration with the Ministry of Commerce, is organising the 'iPHEX' international summit in Mumbai from May 21-23 to address buyers' concerns.
<span id="midArticle_4"/> Over 500 importers and 25 regulators from U.S., Europe, Africa and Latin America are likely to attend the meet, some of whom would visit plants and meet Indian regulators.
<span id="midArticle_5"/> The exporters' body has also invited FDA and India regulators to meet suppliers in Hyderabad, Goa, Chandigarh and Ahmedabad to create awareness about required standards.
<span id="midArticle_6"/> "We are upgrading standard operating procedures in plants such as testing, documenting and packaging," Gupta told a news conference.
<span id="midArticle_7"/> Trade Ministry officials said the government planned to spend up to 30 billion rupees ($500 million) over five years to strengthen pharmaceutical education and research and train manpower and state regulators.
<span id="midArticle_8"/> "There can be no compromise on the regulatory standards, quality parameters," said Sudhanshu Pandey, joint secretary in the Ministry of Commerce.
<span id="midArticle_9"/> Analysts said India would need more time and efforts to address the quality concerns of the U.S and other regulators.
<span id="midArticle_10"/> "It is not a panacea to solve the problems of the pharmaceutical sector," said Utkarsh Palnitkar, head of the life sciences practice at KPMG, who said he works closely with Pharmexcil.
<span id="midArticle_11"/> "You can't do it only by promotion, but focused promotion clearly will help put out the right message." ($1 = 60.1800 Indian Rupees) (Additional reporting by Zeba Siddiqui; Editing by Douglas Busvine and Susan Thomas)
<span id="midArticle_12"/>
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