India market balm for Gujarat pharma units

Times of India | 5 days ago | 06-08-2022 | 09:52 am

India market balm for Gujarat pharma units

AHMEDABAD: New pharma plants in Gujarat which have been built to cater to European markets have been waiting to get European Union Good Manufacturing Practice (EUGMP) licences for a long time. Industry sources said the European regulator has a huge backlog and the new plants will get licences only next year. Indian Drug Manufacturers’ Association president Viranchi Shah said: “Gujarat pharmaceuticals industry got a level playing field after the implementation of GST in 2017 and estimates suggest that about 240 new plants came up since then.” Shah added: “Of these, 40% of the plants have been built with the focus on European markets. However, since the Covid outbreak, the EU Drug Regulatory Authority has not conducted any inspection and so these plants have not received EUGMP licences.” Shah went on to say: “These units have invested about Rs 5,000 crore and are not recording the desired profitability because of the delay in the process.” However, he said that the Gujarat-based companies have found options and are supplying medicines to domestic and African markets. “Many units have started producing generic medicines and have been taking up contract manufacturing as well,” Shah said. “We hope these units will get the EUGMP licences soon. Then our exports to the EU will increase from the current 18%.” Ahmedabad-based Corona Remedies Pvt Ltd established a new plant near Bavla with an investment of about Rs 100 crore and started production last year. Corona Remedies director Nirav Mehta said: “We applied for the EUGMP licence in September 2021. Generally, a regulatory authority team visits the plant within six months of the application, but an inspection has not been carried out so far.” Mehta added: “We hope to get the EUGMP licence by the end of this year or the beginning of 2023. We have continued to supply to the domestic market and when we get the EUGMP licence, we will start exporting to Europe.” According to sources, the EU Drug Regulatory Authority will prioritize renewals of licences once it starts inspections and after that the process to issue new licences will begin. Kadi-based Pashupati Group has ventured into the pharma business with Uniza Healthcare and has set up a plant with an investment of Rs 35 crore. The plant is of EU standards, the group said. “Currently, we export our medicines to 12 countries in Africa, Latin America, and Southeast Asia. As the visits of the EU Drug Regulatory Authority teams are not happening, we have not applied for the EUGMP licence as of now,” said Saurin Parikh, the MD of Uniza Group. “We have decided to apply for the EU licence only after the teams start inspections in India.”

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