FDA Begins Training Hundreds of Indian Regulators
Posted 24 February 2016 | By
The push to get India’s pharmaceutical and medical device regulators up to speed with international norms and the US Food and Drug Administration’s (FDA) regulations is progressing with new cooperative training sessions.
Recently, in Ahmedabad and Bengaluru, India, FDA officials conducted training sessions for about 200 Indian regulators, the majority of which were new inspectors, representing the Central Drugs Standards Control Organization (CDSCO) and some state drug control agencies. The training was part of efforts by both agencies to increase knowledge and skills.
FDA in recent years has been particularly focused on API and generic drug manufacturing in India as the country continues to be one of the main suppliers to the US. FDA’s presence in the country is important for ensuring the products are safe and effective, and last February, FDA announced plans to double the number of its inspectors in India – from about nine to 19.
But even if FDA quadrupled its inspectorate in India, the agency would still have problems trying to physically inspect the more than 550 manufacturing sites the Indian government says are registered with FDA. Data integrity and contamination issues have been a growing concern for Indian manufacturers.
Most recently, CDSCO has focused on clinical research regulations, medical devices and new investments in state drug regulators.
But this latest collaboration resulted in representatives from both agencies learning more about the regulatory perspectives of the other – and doing so first-hand.
“It was clear from the interactions that the Indian inspectors had extensive knowledge of FDA and of the international techniques for conducting inspections,” Mathew Thomas, Director of FDA’s India Office in New Delhi, India and Dean Rugnetta, Deputy Director in FDA’s India Office, wrote in a blog post on Wednesday.
FDA representatives at the sessions also said they benefited from input regarding the differences between FDA and Indian legislation and regulations.
The training sessions follow collaborative work from November 2015, when representatives from FDA’s India Office, Center for Drug Evaluation and Research, Office of Regulatory Affairs and Office of International Programs, partnered with CDSCO officials to share inspection techniques and guidance for conducting current good manufacturing practices of pharmaceutical facilities.
CDSCO in October also signed a memorandum of understanding with the UK’s Medicines and Healthcare products Regulatory Agency to increase collaborations.
FDA first established an office in India in 2008, in part to promote government-to-government interactions and to keep pace with rapid developments and innovations in the pharmaceutical sector.