CDSCO and USFDA sign Letter of Intent (LoI)

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In a strategic move towards consolidating the regulatory apparatus further, the CDSCO and the US FDA have entered into a collaborative understanding by signing the letter of intent. Through this initiative, the regulatory bodies plan to work closely on regulatory issues, exchange programmes, specialty training and data sharing activities that will help in ensuring better healthcare and efficient patient services to all.

The agreement was signed between drug controller general of India, Dr G N Singh and US FDA commissioner Margaret Hamburg in Delhi on February 10. It is understood that the think tanks agreed upon strengthening the existing inter regulatory collaborative initiatives while identifying additional opportunities for collaboration. One of the notable aspects of this meeting was that both the regulatory heads agreed upon sharing the data of their pharmacovigilance programme so as to get a better idea on the possible adverse drug reactions (ADRs).

“This will not only help us in generating a wider data pool on ADRs from both the countries but also will help us in beefing up our existing PvPI programme further, which is a major thrust area for us. Apart from that, the crux of the meeting was on initiating strategies that will help in strengthening the regulatory mechanism for the benefit of the health and safety of the patients,” informed Dr H G Koshia, commissioner, Gujarat FDCA. He was one of the representatives present in the meeting along with other five state licensing authorities (SLAs) from Goa, Maharashtra, Andhra Pradesh, Himachal Pradesh and Odisha.

Interestingly, the regulatory heads from both the countries also discussed the burning issue of clinical trials and compensation, evaluating the strengths, weaknesses, opportunities, and threats (SWOT) affecting the clinical trial industry in the country. India is exporting pharma products to around 200 plus countries, making it a major contributor of good quality affordable medicines globally, Dr Koshia said and further added that the US FDA commissioner’s maiden visit to the country shows the growing importance of the Indian pharmaceutical products worldwide.

Source: PharmaBiz


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