Vikram Punia, President of the Pharmasyntez Group of Companies, spoke at the Biotechmed discussion session “Pharmaceutical industry: providing national independence”. He began his presentation with data on the total volume of the pharmaceutical substances market and gave an example of creating the Metformin substance:

“Business today should invest in the full-cycle production of pharmaceutical substances: from profound stages of synthesis – starting from Key Starting Material (KSM) up to the final product. Pharmasyntez consumes more than 1 thousand tons of 15 thousand tons of substances consumed per year in Russia.

As an example, the Metformin substance can be considered. The full cycle of this substance manufacture starts from limestone and coking coal that are mixed in certain proportions, heated to over 1,000 degrees, and calcium carbide is obtained, which is the product more related to metallurgy than pharmaceutics. And this product is precisely one of the bases of KSM, from which the Metformin substance is subsequently derived.

Dozens of substances can be obtained from various KSM, KSM is the basis. And their production is available.

To ensure that Pharmasyntez and business in general are ready to invest in the production of pharmaceutical substances, the President of the Pharmasyntez Group of Companies presented a number of proposals to the regulators at the Forum: 

• Certificate of Origin (COO) for the drug product should be obtained by the substance manufacturer from the profound stages, i.e., from KSM. This condition should be included in the “Second Extra” rule.

• When importing KSM, the Federal Customs Service of Russia should confirm its authenticity. For this, the FCS must be provided with the necessary equipment. 

• Businesses should be given the time to switch to API production form KSM up to the end 2024 – early 2025. 

On the other hand, Vikram Punia noted that the development and manufacture of pharmaceutical substances from KSM is not always economically justified, since in many substances the Russian market volumes are minimal and, of course, in this case, state support is needed in the form of: 

• subsidies for the purchase of equipment for the manufacture of pharmaceutical substances

• accessible credits for pharmaceutical manufacturers of domestic substances