Indian pharma companies tie up with US FDA: Report

As part of the collaboration, the two organisations will be undertaking a two-day workshop next month to sensitize drug manufacturers within the country
Indian pharmaceutical companies have tied up with the US Food and Drug Administration (FDA), the drug and food regulator in the US. The Indian Drugs Manufacturing Association (IDMA) will work with the regulator to better understand regulatory policies practised by the FDA, while also promoting the adoption of advanced manufacturing technologies, reported Mint. The IDMA is the leading body of pharmaceutical manufacturers in India and represents over 3,500 members.
As part of the collaboration, the two organisations will be undertaking a two-day workshop next month. The jointly organised workshop will be focusing on trying to sensitise drug manufacturers within the country. The workshop will be held on 12 and 13 September.
Along with the numerous members of the IDMA, the Secretary, Department of pharmaceuticals and the Drugs Controller General of India are slated to attend the event. Other attendees include the Pharmaceuticals and Medical Devices Agency, the Therapeutic Goods Administration, and the Central Drugs Standard Control Organization.
Apart from sensitisation over regulations in the US, the workshop will also discuss topics like guidance and support for the adoption of advanced manufacturing technologies for Indian pharma companies.
India is one of the biggest exporters of drugs, medicine, and other biologics to the US, according to the FDA. As a result, the FDA has an on-site presence in New Delhi, India at the US Embassy. The India Office of the FDA is one of four global operations that the FDA has. The other three global offices are in China, Europe and South America. Part of the Indian Office’s (INO) responsibilities that it undertakes for the FDA is conducting commodity-specific inspections, building strong coalitions and partnerships, and helping the organisation better understand India’s regulatory environment.
Source: Firstpost