In Mumbai (India), the Russia-India Forum on Interaction between Small and Medium Enterprises was launched. The Forum is a platform for several round-table discussions on the topical issues of bilateral cooperation between the two states. One of the topics is dedicated to the pharmaceutics and biopharma.
The share of Indian products in the Russian market of medicines consistently comprises 3%. In monetary terms, based on the results for 2017, the volume of the market was $22.34 bln, while the share of Indian drugs in it was $840 mln. In 2018, the total volume of the market was $21.43 bln. Out of this, $770 mln was the share of Indian drugs. It is obvious that the Russian market of medicines is of top interest for manufacturers from India. Consequently, India is second in the list of countries in terms of the total number of GMP inspections carried out by the Russian inspectorate: according to FSI “SID & GP”, from 2016, 212 inspections have been carried out; and 23 out of them were at the sites manufacturing biotech products.
“The majority of refusals to issue GMP certificates was witnessed in 2018 – 661 non-conformities with GMP or 50% of the total number of inspection carried-out,” emphasized the Director of FSI “SID & GP” Mr. Vladislav Shestakov talking about cooperation between Russia and India in inspections of the quality of pharmaceuticals. At the same time, the share of critical non-conformities did not exceed 8% and included such topics as
- no qualification protocol/report provided for the formulation and filling rooms of grade C with the local A zone in the production line;
- no proper functioning of the pharmaceutical quality systems sufficiently provided;
- no sufficient development and implementation of the complex of industrial hygiene measures;
- no qualification report provided for the filling room of grade B, etc.
Opening the Forum, the Minister of Industry and Trade of the Russian Federation Mr. Denis Manturov outlined a high demand for Indian drugs among Russia citizens and suggested switching to establishment of full-cycle drug manufacture within the Russian Federation territory. Taking this into account, the mainstream today is further development of cooperation both between Indian and Russian pharmaceutical companies and between inspectors. “Currently, unfortunately, we lack stable and robust cooperation,” had to admit Mr. Vladislav Shestakov. “Every time going to an inspection we notify the Indian regulator – CDSCO (The Central Drugs Standard Control Organization) – and invite them to take part in an inspection as observers. Every time finding a critical non-conformity during an inspection of Indian manufacturing sites we report to the Indian regulator, but we have not ever received any feedback.” To officially establish professional trust-based bilateral cooperation, on 28 January, 2019, via the Indian Embassy, FSI “SID & GP” initiated signing of the agreement on cooperation and understanding with CDSCO.
Let us remind that in the Russian market there are 129 drugs included into the List of Vital and Essential Medicines, 15 orphan drugs and 3 innovative drugs by Indian manufacturers.