Pharma outsourcing industry to cross $2.5 bn by 2012: India

[OhioChick]

New Delhi, Sept 25: Driven by the cost advantage and a better availability of talent pool, the total Indian pharmaceutical outsourcing industry in the country is expected to cross 2.5 billion-dollar mark by 2012.

"Indian pharmaceutical off shoring industry is set to become a 2.5 billion opportunity by 2012,"a study titled 'Indian Pharmaceutical off shoring industry' done by the management consulting firm Zinnov said.

One of the key factors driving the off shoring wave is increasing research and development (R&D) costs incurred in both development and manufacturing of new drugs, which in-turn is compelling global pharmaceutical organisations in the US and EU to look for new low cost R&D destinations such as India and China, it added.

Basic production cost of medicines in India is up to 50 percent lower than in the US. A US Food and Drug Authority (FDA) approved plant can be constructed in India at 30-50 per cent lower costs, compared with established markets, the study pointed out.

Out of the projected 2.5 billion-dollar market by 2012, contract manufacturing accounts for the maximum share as the total manufacturing outsourcing business in India will cross 900 million dollars by 2010 followed by clinical trials which are growing at the compound annual growth rate of 31 percent and are set to become 608 million-dollar industry by 2012.

India's rich talent pool, nearly 13.5 million science graduates growing at the rate of 36 percent, plays a major role in the growth of outsourcing development process, the study said.

http://www.zeenews.com/articles.asp?aid=472156&sid=BUS&ssid=50

[blue97keet]

1. import ban imposed by the USFDA

India may take up Ranbaxy ban issue with the US
22 Sep, 2008, 0350 hrs IST,Amiti Sen & Khomba Singh, ET Bureau

NEW DELHI: India may take up the issue of the import ban imposed by the USFDA on 30 drugs manufactured by Indian pharmaceutical company Ranbaxy in case the ban is not revoked following corrective actions taken by the company, according to senior officials in the commerce department.

Ranbaxy has told the commerce department that it has made procedural corrections at its manufacturing facilities in conformity with FDA rules and is in the process of informing the FDA.

“There is nothing wrong with the quality of the drugs banned by the US. There were small procedural violations pointed out by the USFDA. Ranbaxy has informed us that those violations have been corrected and it would now invite the FDA to come and inspect its facilities,” a commerce department official told ET.

The government would step in if the US FDA refused to revoke the ban despite the steps being taken by Ranbaxy. “We have no objections when genuine concerns are addressed. But if quality issues are unnecessarily raked up as non-tariff barriers, we will surely discuss the matter with the US,” the official added.

Expressing concern over USFDA’s actions against Ranbaxy, commerce & industry minister Kamal Nath had written to his US counterpart Michael O Leavitt last month, pressing for an early resolution of the issue.

“The company (Ranbaxy) has been fully co-operating with the concerned authorities and is willing to take appropriate steps to bring all concerns and issues to a closure. Since June 2008, requests for the company to meet the FDA and gain a better understanding of US’ concerns have been fully addressed,” the minister pointed out.

The chemicals minister Ram Vilas Paswan had also written to Mr Leavitt last month, supporting the pharma company’s case. The minister had sought the US health ministry's intervention to resolve the matter at the earliest. The external affairs ministry may also take up the issue with the US government, according to sources.

However, this could not be independently confirmed. Mr Paswan wrote to the external affairs minister Pranab Mukherjee, asking for Ranbaxy's case to be taken up through the Indian Embassy in the US.

The USFDA had banned 30 medicines manufactured by Ranbaxy at Dewas in Madhya Pradesh and Poanta Sahib in Himachal Pradesh. While drugs produced at the Dewas unit were banned on the ground of cross contamination, those manufactured in Poanta Sahib were banned due to improper maintenance of records. Sources said that these were not minor violations which could be corrected easily.

Some in the pharmaceutical industry believe that the ban could be a ploy by the US pharma lobby to discourage Indian drug manufacturers.

The Indian formulations used for treating serious diseases such as AIDS are several times cheaper than those manufactured by the US companies.

India may take up Ranbaxy ban issue with the US
22 Sep, 2008, 0350 hrs IST,Amiti Sen & Khomba Singh, ET Bureau

[blue97keet]

2. US won't source AIDS drugs from Ranbaxy

Now, US won't source AIDS drugs from Ranbaxy
26 Sep, 2008, 0140 hrs IST, ET Bureau

NEW DELHI: The US government will not source drugs under its global AIDS drug supply programme from one of the Ranbaxy Laboratories plants in India.

At present, the US government buys three AIDS drugs from Ranbaxy under the Presidents Emergency Plan for AIDS Relief (PEPFAR) programme for supply to patients globally, including several African countries. In 2007, Ranbaxy sold AIDS drugs worth $9 million under the PEPFAR.

“Funds cannot be used to support new orders, for the three Ranbaxy drugs, Zidovudine, Lamivudine and Nevirapine, manufactured at Poanta Sahib (Himachal Pradesh) plant in India, said a news agency report quoting an unnamed spokesperson of PEPFAR. Ranbaxy stocks closed at a 52-week low of Rs 296.20 at the BSE, down 4.7% from Wednesday’s close.

The US Food and Drug Administration on September 17 banned the import of over 30 drugs manufactured at Ranbaxy’s two plants in India citing violations of US manufacturing standards. However, FDA said that it has no evidence to prove that Ranbaxy’s drugs were harmful or have any adverse effects.

[OhioChick]

4. I read about that recently.

Thanks for posting!

[ihavenobias]

3. Kick n/t