Interaction between Russia and India in the field of quality control of pharmaceutical production. Priority areas of cooperation. Mumbai, February 21,

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Presentation transcript:

Interaction between Russia and India in the field of quality control of pharmaceutical production. Priority areas of cooperation. Mumbai, February 21, 2019

Inspections performed GMP certificates issued GMP inspections in India As for now, 10 production sites are to receive the decision 26 production sites are scheduled to be inspected 2016 2017 2018 2019 Total Biotech Inspections performed 31 (188*) 81 (521*) 97 (667*) 3 (61*) 212 (1437*) 23 (212**) GMP certificates issued 9 52 51 115 11(115**) Refusals 13 22 1 87 8 (87**) * Comparing with the total amount of inspections. India holds the second line in the list of the overall number of inspections performed. ** Comparing with the total numbers of inspections performed, GMP certificates issued and refusals in India.

Non-conformities revealed during GMP inspections in India 2018 Total number of non-conformities revealed in India – 661 Critical non-conformities – 50 Major non-conformities – 371 Minor non-conformities - 240

Indian Products maintain a stable medicines market share of 3 % Sales in Russian Federation Total market (2017) USD 22,34 bn Total market (2018) USD 21,43 bn Indian Products maintain a stable medicines market share of 3 % 2017 USD 0,84 bn 2018 USD 0,77 bn

Cooperation with CDSCO, we suggest the following activities: ■ Signing the MoU between CDSCO and SID & GP in order to officially establish professional reliable bilateral cooperation ■ Participation of CDSCO inspectors as observers in GMP inspections performed by SID & GP in India ■ Organizing training GMP inspections at production sites in India ■ Promoting joint publishing activity (joint articles in GMP news etc.) ■ Pro-active involvement of CDSCO in collaboration in the framework of BRICS ■ Participation of CDSCO in the IV All-Russia GMP Conference (September 23-25, 2019, Svetlogorsk, Russia) ■ Participation of Indian students in the III G*P Summit (dates and venue to be confirmed)* * Indian student received a special award upon the results of participation in the II G*P Summit

Thank you for your attention!