Vikram Punia, President of Pharmasyntez Group, spoke at the discussion session of Biotechmed called “Pharma: How to Ensure National Independence”. He began his speech with data on the total volume of the pharmaceutical substances market and gave an example of the creation of metformin substance:
“Today business must invest in the production of pharmaceutical substances on a full cycle: from the deep synthesis stages, starting from a Key Starting Material (KSM), to the final product. Of the 15,000 tons of substances consumed per year in Russia, Pharmasyntez accounts for over 1,000 tons.
As an example, we can consider metformin substance. The full production cycle of this substance begins with limestone and coking coal, which are mixed in certain proportions, heated to over 1000 degrees to produce calcium carbide, a product more related to metal industry and not to pharmaceuticals. And this product is just one of the foundations of the KSM which is then used to produce metformin.
We can get dozens of substances from various KSMs, they are the basis. And their production is possible.”
In order for the Pharmasyntez and business in general to be ready to invest in the production of pharmaceutical substances, the president of the Group outlined a number of proposals to regulators while speaking at the forum:
- A certificate of origin (CO) for a medicinal product should be granted to a company that produces substances from deep stages, i.e., from KSM. This condition should be included in the “second one out” rule.
- For a KSM to be imported, its authenticity has to be determined by the Federal Customs Service of Russia. In this connection, it is necessary to provide the FCS with the necessary equipment.
- The business should be given time to switch to the production of AFS from KSM by the end of 2024 – beginning of 2025.
On the other hand, Vikram Punia noted that the development and production of pharmaceutical substances from KSM is not always economically justified, since for many substances the volume of the Russian market is very low, and, of course, in this case, state support is needed in the form of
- subsidies for the purchase of equipment for the production of pharmaceutical substances;
- affordable loans for pharmaceutical manufacturers of domestic substances.
Pharmasyntez also presented a unique line of hormonal drugs at Biotechmed.