Pharma Trends

USFDA & CDSCO to hold workshops for Indian pharma companies

May 12, 2014: In a move that is expected to benefit the Indian pharmaceutical industry in the long run, the American drug regulator, United States Food and Drug Administration (USFDA) has joined hands with its Indian counterpart Central Drugs Standard Control Organization (CDSCO) in association with the Indian Pharmaceutical Alliance (IPA) for a series of workshops for the Indian drug industry.


The first workshop focused on the quality systems at drug firms and was first of four such workshops. The two regulators have collaborated to engage with the industry and to make them understand the requirements of a regulator when it comes to the quality of drugs.  


It is important to note here that this will be the first such workshop that the USFDA is conducting for drugs. The American regulator has had similar engagements in China and Latin America focusing on food. Considering that India is the second largest exporter of generic drugs to the US market and the numbers are only expected to go up moving forward, these workshops hold a lot of importance as far as the Indian pharma industry is concerned.  


It may be noted here that these workshops take forward the MoU signed by USFDA and the Government of India’s Ministry of Health during the recent visit of USFDA commissioner Margaret Hamburg.


The USFDA is already in the process of increasing its presence in countries like India and as the number of facilities are growing, the increase in the number of inspectors is but natural.


Moving forward, USFDA will be holding such workshops in Goa, Ahmedabad and Chandigarh involving close to 400 participants.


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