News The Aftermath of USFDA Action against Indian Pharmaceuticals   Email this page
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BANGALORE: A section of U.S. doctors has raised concern over prescribing India manufactured generic drugs to patients, reports Reuters. The Indian doctors are, however, ambiguous to the development with some sections imposing faith and the rest doubting the credibility of Indian pharmaceuticals.
In a most recent development, the USFDA has banned import of drugs from Sun Pharmaceuticals’ Karkhadi plant in Gujarat citing non-adherence to prescribed manufacturing standard as the reason. In a similar case, Dr. Reddy’s lab has voluntarily withdrawn 58,000 bottles of heartburn disease lansoprazole due to microbial contamination. Drugs by Ranbaxy Laboratories, Wockhardt have been already banned by the USFDA.

Dr. Harry Lever, a cardiologist sums up the skepticism of the U.S. medicinal practitioners, “We are losing control over what people are swallowing. Now, when a patient comes in who is not doing well, the first thing I do is look at their drugs and find out who makes it. I'm tending to stay away from India.”

The honorary secretary general of Indian Medical Association, Narendra Saini defended the Indian drug makers and believed the officials at Central Drugs Standard Control Organization were doing their job sincerely, “Our drugs are being sold in many countries and being accepted, so we have no issues. We very much trust those medicines.”

In recent past, IMA has written to Drug Control General, G N Singh, seeking clarification on actions taken by DSCO to verify the facts in the light of the ban imposed by USFDA on an Indian drug maker. At that time Dr. Narendra Saini said, “The aim of this intervention by the IMA is to achieve good health through treatment with drugs that are safe and efficacious. Both the Drug Controller and the IMA have to work together to promote public health through the assured use of safe and quality drugs,” as reported by The Hindu.

In its reply, DSCO said, “making its own investigations in respect of compliance to the ‘Good Manufacturing Practices’ as applicable in India and the quality of the drugs marketed by the said company in the country.”

Following USFDA ban on Ranbaxy drugs, a section of doctors and patients in India had shown their reluctance to use Ranbaxy drugs. The Jashlok hospital in Mumbai has gone so far to ban the use of Ranbaxy drugs in its facility. Dr Tarang Gianchandani, CEO, Jaslok Hospital reasoned at that time, “We have decided not to include the drugs in our pharmacy till we are cent percent sure of their quality control mechanisms. Our board of trustees has decided against using Ranbaxy drugs in the hospital. It is not affecting patients in any way as alternative brands are available,” as reported by DNA.

Industry analysts predict the Indian pharmaceuticals will now be more careful in following standard manufacturing practices and they may consider investing in overseas facilities.

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