 "US FDA chief Hamburg in India next week")
When US Food and Drug Administration (US FDA) Commissioner Margaret Hamburg visits India next week, she will have her hands full. Hamburg will meet several Cabinet ministers, drug regulatory authorities and industry captains.
Formally announcing Hamburg's first official trip to India, a US FDA statement said the commissioner would travel to Delhi, Kochi and Mumbai between February 10 and 18, with an aim "to further strengthen cooperation between the FDA and its Indian regulatory counterparts".
The US regulator has confirmed Hamburg will meet authorities involved in the regulation of medical and food products exported to that country. "Indian regulators are important strategic partners to the FDA and regular engagement is essential," the statement said. Currently, India is the second largest provider of finished drug products and the eighth-largest exporter of food products to the US. In India, Hamburg will also meet industry leaders and discuss the importance of maintaining high standards in producing goods to ensure consumers have access to safe products, FDA said.
At a time when India and the US are struggling to keep diplomatic, as well as trade relations intact, the coming week may be significant not just for the governments of the two countries, but also for other stakeholders such as the pharmaceuticals sector and patients.
Hamburg's visit comes amid an increasing number of FDA enforcements faced by generic drug-manufacturing facilities in India. While Ranbaxy's active pharmaceutical ingredient-manufacturing factory in Toansa (Punjab) is the latest to come under the US FDA scanner, other major drug makers such as Wockhardt, RPG Life Sciences and Agila Specialities have faced enforcements from the US regulator in the past year.
Sources said Hamburg was scheduled hold separate meetings with Health Minister Ghulam Nabi Azad, Commerce & Industry Minister Anand Sharma and Drugs Controller General of India (DCGI) GN Singh on February 10. The meeting with Singh is likely to be attended by state drug regulators and industry representatives. DCGI Singh will discuss issues related to manufacturing practices, the conduct of clinical trials and product safety with the US FDA commissioner. A senior official said the Indian drug regulator was planning raise the issue of lapses by multinationals while conducting clinical trials in India.
Hamburg would be accompanied by two other representatives from US FDA’s America office, as well as US FDA’s India head Altaf Ahmed Lal, sources said.
“The FDA’s ongoing engagement with our regulatory counterparts in India is critical to our ability to effectively promote the health and safety of American and Indian consumers,” Hamburg said in the statement. “I look forward to enhancing our existing relationship and identifying additional opportunities for collaboration.”
In the past few years, the US FDA has enhanced its activities in India, the second-largest generic drug supplier to the US. India also has the largest number of US FDA-approved plants outside the US. However, of late, many violations and deviations from US FDA norms have raised concern against Indian drug-manufacturing facilities.
Formally announcing Hamburg's first official trip to India, a US FDA statement said the commissioner would travel to Delhi, Kochi and Mumbai between February 10 and 18, with an aim "to further strengthen cooperation between the FDA and its Indian regulatory counterparts".
The US regulator has confirmed Hamburg will meet authorities involved in the regulation of medical and food products exported to that country. "Indian regulators are important strategic partners to the FDA and regular engagement is essential," the statement said. Currently, India is the second largest provider of finished drug products and the eighth-largest exporter of food products to the US. In India, Hamburg will also meet industry leaders and discuss the importance of maintaining high standards in producing goods to ensure consumers have access to safe products, FDA said.
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At a time when India and the US are struggling to keep diplomatic, as well as trade relations intact, the coming week may be significant not just for the governments of the two countries, but also for other stakeholders such as the pharmaceuticals sector and patients.
Hamburg's visit comes amid an increasing number of FDA enforcements faced by generic drug-manufacturing facilities in India. While Ranbaxy's active pharmaceutical ingredient-manufacturing factory in Toansa (Punjab) is the latest to come under the US FDA scanner, other major drug makers such as Wockhardt, RPG Life Sciences and Agila Specialities have faced enforcements from the US regulator in the past year.
Sources said Hamburg was scheduled hold separate meetings with Health Minister Ghulam Nabi Azad, Commerce & Industry Minister Anand Sharma and Drugs Controller General of India (DCGI) GN Singh on February 10. The meeting with Singh is likely to be attended by state drug regulators and industry representatives. DCGI Singh will discuss issues related to manufacturing practices, the conduct of clinical trials and product safety with the US FDA commissioner. A senior official said the Indian drug regulator was planning raise the issue of lapses by multinationals while conducting clinical trials in India.
Hamburg would be accompanied by two other representatives from US FDA’s America office, as well as US FDA’s India head Altaf Ahmed Lal, sources said.
“The FDA’s ongoing engagement with our regulatory counterparts in India is critical to our ability to effectively promote the health and safety of American and Indian consumers,” Hamburg said in the statement. “I look forward to enhancing our existing relationship and identifying additional opportunities for collaboration.”
In the past few years, the US FDA has enhanced its activities in India, the second-largest generic drug supplier to the US. India also has the largest number of US FDA-approved plants outside the US. However, of late, many violations and deviations from US FDA norms have raised concern against Indian drug-manufacturing facilities.