(Aug 31, 2009) Indian pharmaceutical company Aurobindo Pharma has received the FDA's final approval for clindamycin hydrochloride capsules USP 150mg and 300mg. Clindamycin hydrochloride capsules USP 150mg and 300mg are generic equivalent to Cleocin Hydrochloride Capsules 150mg and 300mg of Pharmacia & Upjohn Company.
According to Aurobindo Pharma, clindamycin hydrochloride is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria and falls under the anti-infective therapeutic segment. The product will be launched shortly.
Wednesday, September 2, 2009
Human trial of swine flu vaccine to begin in India
New Delhi: Search for a H1N1 Influenza A (swine flu) has intensified in India even as at least 100 people have already succumbed to the virus across the country.
With the death toll due to swine flu rising, the Health Ministry has decided to give a go ahead to clinical trials of influenza vaccine on humans
The vaccine being purchased by international pharma companies will be tried by Indian scientists to see its affect on Indians.
Centre has written to all the four international pharma giants - Glaxo Smithkline, Baxter, Novartis and Sanofi.
Glaxo is the first one to have come on board and has agreed to conduct clinical trials in the country after Central Government clears the number of units it needs.
But Health Ministry is of the view that trial should be conducted by Indian scientists to get an unbiased result.
"We want India to be a part of the global trial because the vaccine might react differently to Indians. In India the law is that even international companies have to conduct batch tests before they can be approved," says ICMR Director General Dr VM Katoch.
But before the clinical trials start the Health Ministry is debating on the sample size or minimum number of people on whom the vaccine needs to be tested before it can be cleared for use, and the number can go into thousands.
"In the past vaccines have had very unfortunate results. We have to gauge the expected and unexpected side effects before allowing them for common use," says Dr Katoch.
The clinical trials are likely to take about two months so the H1N1 vaccine will only be available around November.
The vaccines will be used for high risk groups including the medical fraternity and patients suffering from diabetes, chronic heart diseases and lung ailments. Also on the priority list are persons of the Armed Forces.
The four Indian companies who're also in the race to produce the vaccine indigenously are expected to be ready for clinical trials by November.
Sources in the Ministry say that till now Serum Institute is leading the vaccine race in the country. Once the Indian version of the vaccine is ready, it will be available to all.
With the death toll due to swine flu rising, the Health Ministry has decided to give a go ahead to clinical trials of influenza vaccine on humans
The vaccine being purchased by international pharma companies will be tried by Indian scientists to see its affect on Indians.
Centre has written to all the four international pharma giants - Glaxo Smithkline, Baxter, Novartis and Sanofi.
Glaxo is the first one to have come on board and has agreed to conduct clinical trials in the country after Central Government clears the number of units it needs.
But Health Ministry is of the view that trial should be conducted by Indian scientists to get an unbiased result.
"We want India to be a part of the global trial because the vaccine might react differently to Indians. In India the law is that even international companies have to conduct batch tests before they can be approved," says ICMR Director General Dr VM Katoch.
But before the clinical trials start the Health Ministry is debating on the sample size or minimum number of people on whom the vaccine needs to be tested before it can be cleared for use, and the number can go into thousands.
"In the past vaccines have had very unfortunate results. We have to gauge the expected and unexpected side effects before allowing them for common use," says Dr Katoch.
The clinical trials are likely to take about two months so the H1N1 vaccine will only be available around November.
The vaccines will be used for high risk groups including the medical fraternity and patients suffering from diabetes, chronic heart diseases and lung ailments. Also on the priority list are persons of the Armed Forces.
The four Indian companies who're also in the race to produce the vaccine indigenously are expected to be ready for clinical trials by November.
Sources in the Ministry say that till now Serum Institute is leading the vaccine race in the country. Once the Indian version of the vaccine is ready, it will be available to all.
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