Meeting between SID & GP and CDSCO in India
Deputy Head of the Russian GMP-Inspectorate Vladislav Shestakov and Head of Indian GMP-Inspectorate S. Eswara Reddy held a meeting in India. The both sides discussed the current situation, including a number of critical non-conformities regarding manufacturing sites and further cooperation perspectives between the regulators.
Within the Second Russia–India Strategic Economic Dialogue, which took place in New Delhi, the meeting took place between Director of SID & GP Vladislav Shestakov and Head of Central Drugs Standard Control Organization Dr. S. Eswara Reddy. Despite the fact that in 2018 Indian drugs held the 7th position on the Russian pharmaceutical market in its commercial segment and the 3rd place in the government procurement segment, from 2016 up to this day nearly half of the Indian pharmaceutical companies’ manufacturing sites got rejection of GMP certificate (111); this has been identified during the GMP inspections of SID & GP.
Consistently, more than 40% of all critical observations concerning the non-conformity with GMP standards account for India’s drug manufacturers. Even now in cases of the follow-up inspections, 30% of the companies show no reaction to critical non-conformities
and despite all that, they again submit applications for inspections without taking into account the inspectorate’s previous recommendations.
“As a result, as of this date, from the total rejections – all over the world – half of them account for the Indian companies”, – said Director of SID & GP Vladislav Shestakov during the meeting with his Indian counterpart. Among the reasons, a low level of cooperation between the Russian and Indian regulators was noted: “In spite of the regular inspection notification letters being sent to the Indian regulator regarding the planned visits of the Russian inspectors to all manufacturing sites in India, the CDSCO representatives were not present even once on those inspections. On the whole, the practice of participation of the country’s regulator with an observer status in the inspection of the localized manufacturing site is being regarded as a widespread and effective mechanism for improving the cooperation between Russia and countries with a high regulatory level. What is more, it leads to the harmonization of national and supranational standards,” – regretted Mr. Shestakov.
Among the measures of transforming and effectively developing cooperation between the regulators, Deputy Head of the Russian State GMP Inspectorate recalled his previous suggestion to organize a joint preparatory work with Indian colleagues on signing a Memorandum of Cooperation between the Ministry of Industry and Trade of the Russian Federation, the Ministry of Health of the Russian Federation, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and Indian regulator CDSCO; and also for Indian GMP inspectors to participate in inspections, conducted in India by SID & GP, as observers, and vice versa.
Moreover, several ways of cooperation were discussed such as the arrangement of the GMP training inspections at Indian manufacturing sites and the proactive involvement of CDSCO in the BRICS framework, where the SID & GP had initiated an establishment of the BRICS countries’ Inspectorate. For their part, the CDSCO representatives made a suggestion of establishing a National Academy for Pharmaceutical Regulators, to which Deputy Head of the Russian State GMP Inspectorate concurred and in return suggested a joint collaboration in this area, considering the SID & GP experience at the EAEU.
In concluding the conversation with Dr. S. Eswara Reddy, Vladislav Shestakov said that upon familiarizing himself with the colleagues’ experiences and subsequent consultations with Russian inspectors, he considers the introduction of “Best Inspector of the Year” and “Best GMP-Expert of the Year” nominations.
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- The rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements have been changed
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