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      Indian Pharma Inches Closer to US Markets

      Posted AtExpress PharmaPulse

      The recent spate of US FDA clearances for Indian anti-retroviral drugs opened up a host of new foreign markets to the manufacturers giving hope to the industry to eventually penetrate the US market

      Deepali Gupta - Mumbai

      Off late the US Food and Drug Adminstration (FDA) has approved a number to anti-retroviral drugs manufactured in India creating a stir in the Indian pharma industry. These numerous clearances are the result of a program called the PresidentÂ's Emergency Plan for AIDS Relief (PEPFAR). The objective of this program is to spread the medicines to the African sub-continent and other developing countries that immediately require drugs to contain the pandemic AIDS virus.

      Although authorised for the moment, the US FDA approvals are tentative and are not applicable to the US market. Yet the ease and speed at which the approvals are being granted has made Indian pharmaceuticals hopeful that they will soon be able to penetrate the enormous US generics market. In the mean time, companies are capitalising on an opportunity to expand their markets and improve their reputation around the world with the anti-retrovirals. Â"The profit margins on these products are low, but their reach is far and wide,Â" says the spokesperson of Ranbaxy.

      PEPFARÂ's raison dÂ'etre

      The increasing number of lives jeopardised by HIV (in 2004 alone HIV claimed close to 3.5 million lives) has brought substantial international attention to the issue. It was realised that the drive to eradicate AIDS should be conducted at a global scale to contain the disease. PEPFAR was an attempt initiated by the US to help suppress the disease in the developing countries where medication is scarce and expensive.

      As it appears this initiative has given a pep to the Indian Pharma industry. WHOÂ's questioning of the anti-retrovirals manufactured by Ranbaxy and Cipla also led to fingers being pointed at the US administrationÂ's responsibility towards patients in developing countries.

      As a result over the past few months as part of the PEPFAR program a number of anti-retrovirals have been cleared by the US FDA under the accelerated approval process.

      WhatÂ's in an approval

      The acceptance of the drug by the US FDA does not imply that the drug can be sold in the US. The US FDA inspects both the facility and process of the drug manufacturing and labels the drugs either as Â'approvableÂ' or as Â'not approvableÂ'. Â"These are tentative approvals. So in principle the drugs could be marketed if other issues such as patents are sorted out,Â" says the spokesperson of Ranbaxy. The mark of Â'approvableÂ' means the drug meets the quality parameters and can therefore be prescribed.

      Once cleared even if the drug cannot be marketed in the US because of patent issues, the approval still holds testimony to the legitimacy of the drug in other markets. As a result in developing countries and countries that do not have a patent policy these drugs are welcomed. In addition, the Indian manufacturers are known for the cost effectiveness of their products. Typically for the anti-retrovirals the target market is the African sub-continent.

      At present, Aurobindo Pharma is at the helm of getting such drugs approved. Four of its drugs have been cleared in the past few months. Ranbaxy too has two anti-retrovirals that have passed the US FDA testing and are now circulated in approximately 40 countries around the world. Â"At the moment we cannot market in the US but otherwise our market penetration is already quite high despite the fact that we launched only in the first week of March,Â" says Ramaprasad Reddy, Chairman, Aurobindo Pharma. Apart from the ones that have been certified and accepted, Aurobindo has already filed for FDA approvals for five more anti-retrovirals.

      Entering the US market?

      Most of the currently approved drugs including AurobindoÂ's Stavudine and RanbaxyÂ's Lamivudine cannot be sold in the US market because of existing patents with competitor products. However, the recent spate of FDA approvals has motivated the Indian manufacturers to explore the US market like never before. Aurobindo itself has filed for US FDA clearance for five generic products to be sold in the US. According to Reddy, the US market is the biggest one when it comes to generics. US alone holds the 50 percent of the market share.

      According to Reddy, it will be difficult to penetrate the US market, because drugs are sold primarily in retail chains. These chains only accept baskets of products, and most Indian companies still have just two or three products. Perhaps that is why Aurobindo is more interested in getting its manufacturing plants certified at the moment. Â"We are presently focussing on the plant approvals because our main interest in the international market is in the API business,Â" says Reddy.

      A healthy trend

      Both Reddy and the Ranbaxy spokesperson agree that the sudden attempt to get US FDA clearance for pharmaceutical products will lead to healthy competition. It will result in a quality conscience among Indian players that will help the industry step into the global scene. The start of the trend may have been due to the PEPFAR program, but the recent international acceptance of the Indian pharmaceuticals as manufacturers of cheap yet quality drugs surely has the promise of a massive boom for the industry.

      July 22, 2005


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