 "Indian drug cos hopeful of Peru relaxing norms")
P V Appaji, director general of Pharmexcil informed that a delegation led by Sudhanshu Pandey, joint secretary, department of commerce, ministry of commerce and industry, had been to Latin American countries recently, which included Peru and Argentina among others like Brazil. “Peru had put all applications from Indian pharma companies using the loan-licensing system. They had some doubts related to this process and we have explained to them even regulated markets like the US and the European Union (EU) allow such contract manufacturing and that the Indian government permits it,” Appaji said.
He added further that, post this interaction, Peru has decided to send senior officials from its drug regulator to study the loan licensing system in India and gather details about it. Loan-licensing system of manufacturing basically refers to the process when a pharma company uses someone else’s licensed manufacturing facility to manufacture drugs designated for a particular market, Appaji explained. It is a form of contract manufacturing, which is often used by small and medium pharma companies, and hence, the move could benefit the SMEs significantly.
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Alok Dalal, pharmaceutical analyst with Motilal Oswal said that, “Peru is a smaller market compared to other major Latin American markets, however, for smaller companies, this might be a good opportunity. Big pharma might not be very interested.”
As for Argentina, Dalal feels that meaningful results would start flowing in only after two to three years, as product approvals would take time. “Argentina is second largest in terms of population after Brazil in the Latin American region, and hence the opportunity is big,” he said.
Appaji elaborated that Argentina has been a market that India has not been able to crack since now. While it allowed exports of bulk drugs (active pharmaceutical ingredients), it did not allow formulation imports from India. There were about 25 countries from where import of formulations were allowed, and India did not feature in the list. “During our visit, we explained that more than 55 per cent of our total exports are going to regulated markets. Soon after our visit, Argentina issued a notification allowing imports from India effective August 8 this year,” he claimed.
The delegation has held meetings with public sector pharma companies in Argentina as well as leading importers. The Argentina drug market is expected to be around $6 billion at the moment, expected to grow to $ 15 billion by 2020. Of India’s net pharma exports of $15.04 billion, nearly 8 per cent goes to Latin American countries now, Appaji informed.