Working meeting with representatives of the Indian Pharmaceutical Manufacturers Association

On the 7^th of April, a working meeting was held as part of a joint initiative between representatives of the Indian Pharmaceutical Manufacturers Association (IPMA) and the State Service of Ukraine on Medicines and Drugs Control.

The following representatives of the pharmaceutical companies participated in the meeting: Hetero Labs Limited Ukraine, Konark Intelmed Ltd., Euro Lifecare Ltd, Dr. Reddy’s Laboratories LLC, Sun Pharma, Macleods Pharmaceuticals Limited and M. Biotech Limited.

Volodymyr Korolenko, Acting Head of the State Service of Ukraine on Medicines and Drugs Control, wished those present fruitful cooperation and noted that such meeting is primarily driven by the importance of fostering direct, constructive dialogue between representatives of the pharmaceutical industry and the state regulatory authority, which provides real opportunities to resolve the most crucial issues facing the pharmaceutical sector. This is particularly important now, with less than a year remaining before the new Law of Ukraine “On Medicines” comes into force.

IPMA Executive Director Dr. Menon Raman Unni Parambat also emphasized the importance of cooperation, in which parties can express their views, discuss crucial issues, and reach timely and constructive decisions. 

During the meeting, the participants discussed the following points:

– optimizing and shortening of the duration of procedures for confirming compliance (certification) of production with GMP requirements;

– organizing quality control of medicines, including the submission of medicines samples for laboratory testing and the conducting of such testing;

–  the procedure for determining reference medicines, in accordance with the Law of Ukraine “On Medicines” dated 28 July 2022, No. 2469-IX;

–  the ability to exchange data electronically between the State Expert Center and the State Service of Ukraine on Medicines and Drugs Control, etc.;

– criteria for classifying products as “medicines,” “medical devices,” or “dietary supplements.”

The representatives of the State Service of Ukraine on Medicines and Drugs Control provided clarification on a number of crucial issues. It was subsequently decided to address specific situations on a case-by-case basis.

Summarizing the results of the meeting, Volodymyr Korolenko thanked the participants, emphasized on the SMDC’s openness to communicate with representatives of the pharmaceutical industry, and expressed its willingness to engage in discussions on important issues for the pharmaceutical market.