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Argentina to allow Indian drug imports after inspecting five plants

By Gareth MacDonald+

25-Aug-2014
Last updated on 25-Aug-2014 at 17:00 GMT

Do try to supply Argentina Indian drugmakers told by Gov
Do try to supply Argentina Indian drugmakers told by Gov

Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.

The Argentinian Government named India as the 27th country from which it will accept drug imports this month, explaining in a statement [here in Spanish ] that the move will improve its citizens' access to medicines. 

Prior to the decision, Indian finished dosage drugmakers were not allowed to supply the Argentinian market under directive 150/1992 of the country's constitution  (Spanish).

The Argentinian change of heart was welcomed by Hyderabad-based industry group Pharmexcil , which was quick to try and claim some credit by suggesting the decision followed years of lobbying.

Director general P V Appaji said: "As members are aware, export of Drugs and Pharmaceuticals to Argentina hitherto was restricted due to domestic policies of Argentina Government. While import of APIs was allowed, Pharmaceutical formulations from India was not permitted.

"In fact, import of Pharmaceutical formulations into Argentina was permitted only from a few countries. Pharmexcil and Government of India have been trying to get India also included in the list of permitted countries for the last several years." 

He added that: “This incredible policy change by Argentina, including India in the list of countries allowed to import pharmaceuticals, has become possible only due to constant persuasion by H.E. Ambassador of Indian Embassy in Argentina and senior officials of Department of Commerce, Govt. of India, at various levels.

Inspections

What impact these lobbying efforts actually had is hard to gauge, but what is clear is that Argentina took the decision after inspecting only a very small fraction of the plants in India that are deemed to meet World Health Organisation (WHO) manufacturing standards.

In its statement the Argentinian National Administration for Medicines, Food and Medical Technology said: “It is informed of the inspection of five production plants…located in the Republic of India, which are certified for their fulfilment of good manufacturing practices.

According to the Agency there are 793 WHO GMP approved finished drug manufacturing facilities in India, meaning that it decided to add the country to its import list last after visiting 0.6% of plants that could make pharmaceuticals for the Argentinian market. 

Market potential

The Argentinian decision was also trumpeted in the media with the Economic Times suggesting that it will allow Indian finished dose drug firms to access a market with as much as $6bn (€4.5bn) a year.

Whether this forecast hold true following the likely reduction in public healthcare spending following Argentina’s debt default last month remains to be seen.

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