On November 7, 2024, Lidings held a round table discussion " Launch of Medicines and Pharmaceutical Substances in Russian and Indian Markets" as part of the business program of the Forum "Under One Sun: Russia-India. Business and Culture ", which took place in Delhi, November 6 - 8, 2024.
Over 40 delegates from India and Russia, representing major pharmaceutical companies of both countries such as Dr. Reddy's, Glenmark, Pharmstandard and others, took part in the business program of the Forum. In addition, the Forum was attended by medical device manufacturers, representatives of pharmaceutical companies providing contract manufacturing services, organizations conducting clinical trials, large network hospitals and leading Indian legal experts.
Alexander Rybas, Russian Trade Representative to India and Sri Lanka, made opening remarks at the Forum. In particular, he pointed out the timeliness of the Forum due to the high degree of interest of manufacturers of pharmaceuticals and medical devices in entering or expanding their business in the Russian market and emphasized the importance not to miss the opportunity to gain business advantages.
Boris Malakhov, Lidings’ Partner, Head of Intellectual Property practice, spoke about intellectual property protection, the current balance of power between original and reproduced drugs, as well as trends in protecting the exclusivity of drugs on the market and strategies for bringing generics to the market.
Natalya Thotahewage, Counsel at Lidings’ Life Sciences industrial practice, in her presentation focused on possible forms of entry of Indian companies into the Russian market, including not only distribution, but also partnerships with Russian contract manufacturers, as well as the purchase of assets in Russia, including the production of pharmaceuticals and substances of strategically important drugs. The latter allows us to achieve advantages in the segment of government procurement in Russia. Natalya also highlighted the peculiarities of registration of pharmaceuticals in the EAEU, inclusion of substances in the substance register, labeling and dispensing of pharmaceuticals, peculiarities of sales channels, marketing and promotion in the medical community.
Another serious question that was raised was about the recognition of GMP certificates for Indian manufacturing sites in Russia without inspections. The participants noted that this may require the development of bilateral recognition based on the principles of reciprocity.
