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Serum Institute may get USFDA approval

The Times of India
04 February 2009
By Umesh Isalkar
Pune, India

The city-based Serum Institute of India Ltd is likely to enter the exclusive league of USFDA (Food and Drug Administration) approved Indian pharma companies which manufacture generic versions of anti-cancer injectable drugs. This approval is likely to enable cancer patients in India to gain easy access to modern drugs.

The Intas Pharmaceuticals (Ahmadabad) and Cipla Pharmaceuticals (Goa) were the only Indian pharma companies which had the USFDA approval for producing generic anti-cancer drugs. The USFDA conducted an inspection of the Serum Institute's facility between January 18 to 28 and their response has been positive, the Serum Institute officials said.

"The US companies are usually reluctant to bring their latest anti-cancer medicines to India because of patent problems and lack of good manufacturing facilities. With the USFDA's likely approval, these Western companies will come forward with the license to manufacture and sell modern medicines in India," R R Vidwans, the director of Serum Institute, told TOI.

An average patient faces many hurdles while importing modern medicines from the West, which can be avoided by the approval and licensing arrangement, he added.

"There are quite a few effective cancer medicines in Western countries. The companies producing such drugs give manufacturing and sales license to only those companies which have the USFDA's approval," said Vidwans.

"The perspective of Western innovative multi-nationals, who produce new drugs, will change favourably towards the Indian pharmaceutical industry and market and many anti-cancer drugs, which are not available in our country now, will arrive due to this approval," said Vidwans.

About 25 commonly available anti-cancer drugs for all types of cancers are available in the global market. "Of which, Serum is targeting at least 12 drugs for the US and global market. At present, we have submitted five generic versions for the USFDA's approval. The rest seven generic versions will also be submitted for their nod, once we formally receive the approval from the USFDA," said Vidwans.

Elaborating on stringent norms of the USFDA, Vidwans said, "These drugs are cytotoxic and handling and processing them require a lot of sophisticated containment procedures in which Serum has heavily invested." For common injectable drugs, such sophisticated containment procedures, safety precautions and waste disposal are not required, said Vidwans, adding "And this is what the USFDA looks for in addition to good manufacturing practice."

Adar C Poonawalla, the Serum Institute's executive director (operations), told TOI: "Now, we are awaiting a formal approval from the USFDA." Serum is among the few Indian companies whose anti-cancer products will now be available in the US market, he said.

"The market size for all the 25 generic versions of anti-cancer drugs is $15 billion. We hope to achieve a turnover of Rs 200 crore in the first year," said Poonawalla. The Serum has invested over Rs 100 crore for manufacturing these anti-cancer drugs to match the stringent norms of the USFDA, he said.

The formal approval from the USFDA is expected to come by July, 2009. All the five generic versions will be launched immediately after that in the US market, said Vidwans. The cost of these drugs will range between Rs 200 to 2,000 per vial, he added.

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