(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.
Friday, August 7, 2009
Human trials of H1N1 vaccine by Dec: Serum
PUNE: The preventive vaccine against the H1N1 flu will be ready for clinical trials in humans by December, senior director of city-based Serum
Institute of India Limited (SIIL) Rajeev Dhere told on Thursday. "The development of the vaccine is in full swing. We obtained the H1N1 virus strain from UK-based National Institute for Biological Standards and Control (NIBSC) a month ago. If everything goes as per the scheduled plan and strategy, the vaccine will be out for human clinical trials in December," said Dhere. Elaborating on the scheduled plan of vaccine development, Dhere said, "First, a trial batch comprising a few thousand doses will be out and animal trials will be done by the third week of August to assess the immunogenicity of the vaccine," said Dhere. The company has zeroed in on two laboratories in India in Bangalore and Pune where animal trials will be carried out, Dhere added. "A month after the animal trials, a detailed report of toxicity as well as the immunogenicity of the vaccine will be submitted by the end of October to the Drugs Controller General of India (DCGI) for carrying out human clinical trials," said Dhere. "After obtaining the necessary permission from the DCGI, human clinical trials will begin in December," said Dhere. "The vaccine has to go through a regular testing process, but the DCGI had promised us they will do their best to fast-track the process following guidelines of the World Health Organisation (WHO) and European Medicines Agency," Dhere said. "If these human trials are successful, we have the technology to produce a vaccine which can be pressed into service for commercial production depending upon the scale of requirement after regulatory clearances," he added. The SIIL was part of a teleconference spread over 30 countries with the director-general of the WHO, Dr Margaret Chan, to develop a preventive vaccine against H1N1 flu hours after the disease was declared globally pandemic.
ANTI- H1N1 VACCINE DEVELOPMENT PLAN
1) SII obtains virus strain from UK-based NIBSC in July
2) Animal trials or pre-clinical trials will begin in August
3) A report of the toxicity and immunogenicity of the vaccine will be submitted to the DCGI in October
4) Safety trials in humans or clinical trials will begin by December
Institute of India Limited (SIIL) Rajeev Dhere told on Thursday. "The development of the vaccine is in full swing. We obtained the H1N1 virus strain from UK-based National Institute for Biological Standards and Control (NIBSC) a month ago. If everything goes as per the scheduled plan and strategy, the vaccine will be out for human clinical trials in December," said Dhere. Elaborating on the scheduled plan of vaccine development, Dhere said, "First, a trial batch comprising a few thousand doses will be out and animal trials will be done by the third week of August to assess the immunogenicity of the vaccine," said Dhere. The company has zeroed in on two laboratories in India in Bangalore and Pune where animal trials will be carried out, Dhere added. "A month after the animal trials, a detailed report of toxicity as well as the immunogenicity of the vaccine will be submitted by the end of October to the Drugs Controller General of India (DCGI) for carrying out human clinical trials," said Dhere. "After obtaining the necessary permission from the DCGI, human clinical trials will begin in December," said Dhere. "The vaccine has to go through a regular testing process, but the DCGI had promised us they will do their best to fast-track the process following guidelines of the World Health Organisation (WHO) and European Medicines Agency," Dhere said. "If these human trials are successful, we have the technology to produce a vaccine which can be pressed into service for commercial production depending upon the scale of requirement after regulatory clearances," he added. The SIIL was part of a teleconference spread over 30 countries with the director-general of the WHO, Dr Margaret Chan, to develop a preventive vaccine against H1N1 flu hours after the disease was declared globally pandemic.
ANTI- H1N1 VACCINE DEVELOPMENT PLAN
1) SII obtains virus strain from UK-based NIBSC in July
2) Animal trials or pre-clinical trials will begin in August
3) A report of the toxicity and immunogenicity of the vaccine will be submitted to the DCGI in October
4) Safety trials in humans or clinical trials will begin by December
Friday, July 31, 2009
Indian Pharma mkt valued at Rs 55,000 cr in FY09
The total size of Indian pharmaceutical industry, excluding exports and government purchases, stood at Rs 55,454 crore in the last fiscal, the Lok Sabha was informed today."As per the information available with the department through ORG-IMS, April (2009)MAT, value of Indian pharmaceutical market is Rs 55,454 crore," Minister of State for Chemical and Fertiliser Srikant Jena said while replying to a written query.The total value includes retail pharmaceutical market at Maximum Retail Price (MRP), generic and companies not tracked by ORG, hospitals and institutional sales excluding government procurement, direct doctor purchases, over the counter (OTC) products and diagnostics, Jena said."In addition to this, Indian pharma industry's export was worth Rs 38,433 crore in 2008-09," the minister added.The total size of the domestic industry in 2006-07 fiscal was at Rs 43,904 crore and in 2007-08 it was Rs 50,410 crore.
Wednesday, July 22, 2009
Healthcare industry to double in value by 2012: KPMG
Propelled by rising income levels as well as changing demographics and illness profiles, particularly with a shift from chronic to
lifestyle diseases, the Indian healthcare industry is estimated to double in value by 2012 at $14.2 billion and more than quadruple by 2017, says the latest Indian Healthcare edition of KPMG’s Global Infrastructure – Trend Monitor. According to the report, this is likely to result in considerable infrastructure challenges and opportunities. Of the 32 Indian states that the report considers, the six states of Maharashtra, Rajasthan, West Bengal, Uttar Pradesh, Tamil Nadu and Andhra Pradesh are estimated to represent approximately 50 per cent of the expenditure for the 2009-2013 period. Speaking on the release of this report, Pradip Kanakia, head of markets and healthcare services, KPMG, said, “While the Indian healthcare system has grown manifold over the past few years, it has yet not been able to keep pace with the rapid rise in the population. One example of that is the availability of hospital beds in our country – against a world average of 4 beds per 1000 population, India lags behind at just over 0.7 presently.” Thus, there is a dire need to introduce some radical reforms in the healthcare infrastructure development process. For instance, use of PPP models on a larger scale and foreign investments are some which could be considered. The report suggests that there is a growing need to deal with the issues of urban healthcare infrastructure as rural to urban migration has significantly increased the demand for these services. The report also looks into the fact that the Indian healthcare system is controlled by respective state authorities, presenting an opportunity to improve responsiveness to healthcare needs at a more local level. Ameeta Chatterjee, director - corporate finance, KPMG, said, “There has been an increasing awareness of private sector involvement in meeting the requirement of the country’s health services requirement. The Indian solutions that will evolve need to be focused on developing affordable, low cost basic healthcare services with scalability and sustainability as key drivers.” The report suggests that there is opportunity to improve responsiveness to the country’s healthcare needs at a more local level due to uneven focus on healthcare infrastructure in India This can be attributed to the healthcare system in the country which is controlled by respective state authorities. The variety of organizational structures and processes in healthcare delivery may result in greater inequalities between geographical areas. There is a growing agenda to deal with the issues of urban healthcare infrastructure as rural to urban migration has significantly increased demand for these services.
lifestyle diseases, the Indian healthcare industry is estimated to double in value by 2012 at $14.2 billion and more than quadruple by 2017, says the latest Indian Healthcare edition of KPMG’s Global Infrastructure – Trend Monitor. According to the report, this is likely to result in considerable infrastructure challenges and opportunities. Of the 32 Indian states that the report considers, the six states of Maharashtra, Rajasthan, West Bengal, Uttar Pradesh, Tamil Nadu and Andhra Pradesh are estimated to represent approximately 50 per cent of the expenditure for the 2009-2013 period. Speaking on the release of this report, Pradip Kanakia, head of markets and healthcare services, KPMG, said, “While the Indian healthcare system has grown manifold over the past few years, it has yet not been able to keep pace with the rapid rise in the population. One example of that is the availability of hospital beds in our country – against a world average of 4 beds per 1000 population, India lags behind at just over 0.7 presently.” Thus, there is a dire need to introduce some radical reforms in the healthcare infrastructure development process. For instance, use of PPP models on a larger scale and foreign investments are some which could be considered. The report suggests that there is a growing need to deal with the issues of urban healthcare infrastructure as rural to urban migration has significantly increased the demand for these services. The report also looks into the fact that the Indian healthcare system is controlled by respective state authorities, presenting an opportunity to improve responsiveness to healthcare needs at a more local level. Ameeta Chatterjee, director - corporate finance, KPMG, said, “There has been an increasing awareness of private sector involvement in meeting the requirement of the country’s health services requirement. The Indian solutions that will evolve need to be focused on developing affordable, low cost basic healthcare services with scalability and sustainability as key drivers.” The report suggests that there is opportunity to improve responsiveness to the country’s healthcare needs at a more local level due to uneven focus on healthcare infrastructure in India This can be attributed to the healthcare system in the country which is controlled by respective state authorities. The variety of organizational structures and processes in healthcare delivery may result in greater inequalities between geographical areas. There is a growing agenda to deal with the issues of urban healthcare infrastructure as rural to urban migration has significantly increased demand for these services.
Three Indian biotech cos get nod to develop swine flu vaccine
NEW DELHI: India’s drug regulator has given approval to three domestic biotech firms to start tests and analyses to develop a vaccine for swine flu,
or the H1N1 virus, which killed hundreds across the globe this year, subsequently classified by the World Health Organisation as a “pandemic”. Bharat Biotech, Panacea Biotech and Serum Institute will now be able to procure seed strains from labs in the US and UK, but will have to follow the strict bio-safety standards mandated by the Drugs Controller General of India (DGCI). Novartis AG had claimed last month that it has successfully produced the first batch of vaccines for the virus, but the global markets are yet to see a product. The WHO had recently said that a fully licensed swine flu vaccine might not be available until the end of the year. In India, however, producing the vaccines may take more time. “We have given approvals to three Indian companies to get seed strains from the US-based Center for Disease Control and the UK-based National Institute for Biological Standards and Control (NIBSC) to start preliminary research,” DCGI Dr Surinder Singh told ET. According to Dr Singh, the domestic companies are expected to take at least six months before they apply for an approval for the next stage of trials. Once the companies submit their preliminary test and analysis data, they will have to apply for potency test, pre-clinical trials and finally clinical trials before launching the medicine in the market. The WHO has said countries could use emergency provisions to get the vaccines out quicker if required. In India, the Drugs and Cosmetics Act (DCA) has a provision through which the government can allow relaxations in launching of a drug or a vaccine in the country if there is an emergency. However, such provisions are used only after weighing the risk and benefit ratio. At present, the government has no plans to evoke any such provision as there is no community-wide spreading of the virus reported in India, Dr Singh said. He added that by September, global companies might be able to roll out a vaccine in the country.
or the H1N1 virus, which killed hundreds across the globe this year, subsequently classified by the World Health Organisation as a “pandemic”. Bharat Biotech, Panacea Biotech and Serum Institute will now be able to procure seed strains from labs in the US and UK, but will have to follow the strict bio-safety standards mandated by the Drugs Controller General of India (DGCI). Novartis AG had claimed last month that it has successfully produced the first batch of vaccines for the virus, but the global markets are yet to see a product. The WHO had recently said that a fully licensed swine flu vaccine might not be available until the end of the year. In India, however, producing the vaccines may take more time. “We have given approvals to three Indian companies to get seed strains from the US-based Center for Disease Control and the UK-based National Institute for Biological Standards and Control (NIBSC) to start preliminary research,” DCGI Dr Surinder Singh told ET. According to Dr Singh, the domestic companies are expected to take at least six months before they apply for an approval for the next stage of trials. Once the companies submit their preliminary test and analysis data, they will have to apply for potency test, pre-clinical trials and finally clinical trials before launching the medicine in the market. The WHO has said countries could use emergency provisions to get the vaccines out quicker if required. In India, the Drugs and Cosmetics Act (DCA) has a provision through which the government can allow relaxations in launching of a drug or a vaccine in the country if there is an emergency. However, such provisions are used only after weighing the risk and benefit ratio. At present, the government has no plans to evoke any such provision as there is no community-wide spreading of the virus reported in India, Dr Singh said. He added that by September, global companies might be able to roll out a vaccine in the country.
DCGI, India to set up own labs to test new drugs
NEW DELHI: India’s top drug regulator Drug Controller General of India (DCGI) has identified six labs to test new drugs before launching them in the
market. It is now looking at public-private-partnership (PPP) models to build infrastructure and better testing facilities in order to keep a vigil on the quality of drugs. Currently, the drug regulator gives marketing approval to new drugs based on the evaluation of the clinical trial data submitted by them. Testing of new drugs by a government agency will give more quality assurance to the consumer. “We have identified six government labs that can be used for testing new drugs. Now, we are in talks with some private labs for tie-ups to develop the infrastructure of these labs, so that they can be used for testing new drugs,” a health ministry official said. DCGI is also planning to test spurious drug samples, collected from the market, in the labs. “Drug inspectors have collected around 24,600 samples of spurious drugs from across the country. However, only 30-40% of the collected samples could be tested due to lack of manpower and facility. A PPP model would allow private laboratories to bring in more manpower and upgradation of facilities in these labs,” the official said. The government is looking at a revenue-sharing model with private labs to upgrade the labs. While the government will fund the projects, the private companies will bring in manpower and expertise, he added. According to official estimate, there is a substantial increase in the number of new drug applications received by the drug regulator annually. While DCGI received only around 1,200 application for new drugs in 2005, it received 1,600 applications in 2007 and 1,750 in 2008. In 2009, the drug regulator has received 920 applications for new drugs within the first six months. “While the number of applications has gone up, monitoring the quality of drugs in the market is a challenge that we have to face,” the official said.
market. It is now looking at public-private-partnership (PPP) models to build infrastructure and better testing facilities in order to keep a vigil on the quality of drugs. Currently, the drug regulator gives marketing approval to new drugs based on the evaluation of the clinical trial data submitted by them. Testing of new drugs by a government agency will give more quality assurance to the consumer. “We have identified six government labs that can be used for testing new drugs. Now, we are in talks with some private labs for tie-ups to develop the infrastructure of these labs, so that they can be used for testing new drugs,” a health ministry official said. DCGI is also planning to test spurious drug samples, collected from the market, in the labs. “Drug inspectors have collected around 24,600 samples of spurious drugs from across the country. However, only 30-40% of the collected samples could be tested due to lack of manpower and facility. A PPP model would allow private laboratories to bring in more manpower and upgradation of facilities in these labs,” the official said. The government is looking at a revenue-sharing model with private labs to upgrade the labs. While the government will fund the projects, the private companies will bring in manpower and expertise, he added. According to official estimate, there is a substantial increase in the number of new drug applications received by the drug regulator annually. While DCGI received only around 1,200 application for new drugs in 2005, it received 1,600 applications in 2007 and 1,750 in 2008. In 2009, the drug regulator has received 920 applications for new drugs within the first six months. “While the number of applications has gone up, monitoring the quality of drugs in the market is a challenge that we have to face,” the official said.
Saturday, June 27, 2009
Sandoz receives approval for Japanese biosimilar
Sandoz has received marketing authorization for the first-ever Japanese biosimilar, recombinant human growth hormone somatropin. The precedent-setting decision further reinforces Sandoz's global leadership position in the rapidly-emerging market for biosimilars, or follow-on versions of existing state-of-the-art biopharmaceuticals.Sandoz CEO Jeff George said, "We are pleased that Sandoz, the pioneer in biosimilars and a company with a global reputation for offering high quality medicines at affordable prices, is paving the way in Japan as well. Together with our parent company Novartis, we are fully committed to broadening access to innovative and affordable biopharmaceuticals over the years and decades to come, both in Japan and worldwide."The Ministry of Health, Labour and Wealth (MHLW) announced the approval on June 22, barely three months after the Japanese authorities published guidelines that paved the way for a national biosimilar regulatory pathway, based on similar scientific principles to the approval pathway already in place in the European Union.The Sandoz product will be marketed in Japan as Somatropin BS S.C. injection 5mg / 10mg [Sandoz]. It is approved for the treatment of growth hormone deficiency in children and growth disturbance associated with Turner's syndrome or chronic renal insufficiency. This is the same range of indications covered by the reference product, Genotropin, as approved in Japan. It is approved on the basis that it offers patients comparable quality, safety and efficacy to the reference product.Sandoz pioneered the field of biosimilars / follow-on biologics with the approval and subsequent launch of Omnitrope in the US and Europe. Omnitrope was the first such product to be made available to patients in both regions and the first ever medicine to be approved in the EU as a biosimilar, the European regulatory term for such products. Sandoz is the only company with three biosimilar medicines marketed in Europe.Biosimilars are an integral part of the Sandoz strategy to focus on difficult-to-make products that provide added patient benefits. Due to the rising costs of health care and the growing need for more complex treatments, they will play an increasingly important role in ensuring and broadening global access to medicines. Sandoz is building a strong global biosimilar pipeline, with numerous projects at all stages of development.
St hammers Sun Pharma as USFDA seizes 33 drugs of arm
MUMBAI: US authorities seized drugs made by Sun Pharmaceuticals’ US subsidiary for violation of manufacturing standards, pushing down share prices
of India’s biggest drug company by market value by 12%. US Marshals on Thursday seized nearly 33 drug products, including generic versions of heart, pain and psychiatric medicines, manufactured at three units of Sun Pharma’s US subsidiary, Caraco Pharmaceuticals in Detroit, Farmington Hills and Wixom. The seizure, which was carried out at the request of the US Food and Drug Administration (USFDA), put immediate halt to the US firm distributing drugs until there is assurance that it complies with the FDA’s current good manufacturing practices (cGMP). “The action follows Caraco’s continued failure to meet the FDA’s cGMP requirements, which assure the quality of manufactured drugs,” the USFDA said in a media release. “The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our cGMP,” Janet Woodcock, director of the FDA’s Centre for Drug Evaluation and Research, said in the statement. Sun Pharma owns about three-fourth of Caraco. “Products manufactured at these facilities contribute around 15% to Sun Pharma’s topline and slightly more to the bottomline. So, in the short term, the impact will be around 15%. However, such issues do not get rectified quickly and I estimate that it will take around three quarters to resolve. It will be a stage by stage recovery,” said an analyst, who did not want to be named due to the sensitivity of the issue. The Sun management, he said, may consider shifting the production base to other sites and look at other acquisitions, which is a time consuming process. “Over all, Sun’s image has been damaged and it will take Sun Pharma some time to regain it. In the meanwhile, it will lose market share that won’t be easy to recover,” he said. The market reacted sharply. The stock lost 18%, its biggest intra-day drop, during the trading hours. However, it closed at Rs 1,140.45 on Friday, approximately 12% lower than Thursday’s close on the BSE. Caraco shares, on Thursday, plummeted 43% to an all-time low of $2.39 after the seizure. A Sun Pharma spokesperson declined to comment on the issue. However, it’s learnt that the company will host a conference call for investors on Saturday morning. “While we have not fully determined the impact of the FDA action on our financial condition, we believe that it may have a material adverse effect on our near-term operations. We anticipate working with the FDA to resolve these concerns as effectively and expeditiously as possible. We believe that corrective actions have been made and continual improvements are in process,” Caraco said in a media statement.
of India’s biggest drug company by market value by 12%. US Marshals on Thursday seized nearly 33 drug products, including generic versions of heart, pain and psychiatric medicines, manufactured at three units of Sun Pharma’s US subsidiary, Caraco Pharmaceuticals in Detroit, Farmington Hills and Wixom. The seizure, which was carried out at the request of the US Food and Drug Administration (USFDA), put immediate halt to the US firm distributing drugs until there is assurance that it complies with the FDA’s current good manufacturing practices (cGMP). “The action follows Caraco’s continued failure to meet the FDA’s cGMP requirements, which assure the quality of manufactured drugs,” the USFDA said in a media release. “The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our cGMP,” Janet Woodcock, director of the FDA’s Centre for Drug Evaluation and Research, said in the statement. Sun Pharma owns about three-fourth of Caraco. “Products manufactured at these facilities contribute around 15% to Sun Pharma’s topline and slightly more to the bottomline. So, in the short term, the impact will be around 15%. However, such issues do not get rectified quickly and I estimate that it will take around three quarters to resolve. It will be a stage by stage recovery,” said an analyst, who did not want to be named due to the sensitivity of the issue. The Sun management, he said, may consider shifting the production base to other sites and look at other acquisitions, which is a time consuming process. “Over all, Sun’s image has been damaged and it will take Sun Pharma some time to regain it. In the meanwhile, it will lose market share that won’t be easy to recover,” he said. The market reacted sharply. The stock lost 18%, its biggest intra-day drop, during the trading hours. However, it closed at Rs 1,140.45 on Friday, approximately 12% lower than Thursday’s close on the BSE. Caraco shares, on Thursday, plummeted 43% to an all-time low of $2.39 after the seizure. A Sun Pharma spokesperson declined to comment on the issue. However, it’s learnt that the company will host a conference call for investors on Saturday morning. “While we have not fully determined the impact of the FDA action on our financial condition, we believe that it may have a material adverse effect on our near-term operations. We anticipate working with the FDA to resolve these concerns as effectively and expeditiously as possible. We believe that corrective actions have been made and continual improvements are in process,” Caraco said in a media statement.
US drug officals raid Sun Pharma subsidiary in Michigan
MUMBAI: The US Food and Drug Administration (FDA) on Thursday seized 33 drugs manufactured by a subsidiary of Indian pharma major Sun
Pharmaceuticals at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom. As news of the raid broke, the Sun Pharma stock plunged 17.59 percent on the Bombay Stock Exchange Friday to Rs1,070 soon after opening bell. The company's subsidiary Caraco Pharmaceutical Laboratories, in which the Indian company holds about 75 percent, was raided owing to its "continued failure to meet the FDA's current Good Manufacturing Practice (cGMP) requirements," the US authorities said. "The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements," said Janet Woodcock, FDA's director of Center for Drug Evaluation and Research. "Compliance with these standards prevents harm to the public." This is not the first time the company has come under the regulator's scanner. Last October, the FDA had conducted inspection of its facilities and found "significant deviations from Current Good Manufacturing Practice (CGMP) regulations". Caraco's drugs were found to be contaminated, even after the company had conducted an internal investigation to determine the cause and taken corrective measures. Since January, Caraco had initiated voluntary recalls of products to protect the public from potentially defective medications. The recalls followed manufacturing defects, including oversized tablets and possible formulation error. But the FDA found these measures inadequate. "FDA's most recent inspection of Caraco, completed in May 2009, found unresolved violations of CGMP requirements," an FDA statement read. Sun Pharma is the second Indian company this year to have faced FDA's wrath. In February, the US drug watchdog had taken regulatory action against Ranbaxy's Paonta Sahib facility in Himachal Pradesh on the ground it had falsified test results.
Pharmaceuticals at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom. As news of the raid broke, the Sun Pharma stock plunged 17.59 percent on the Bombay Stock Exchange Friday to Rs1,070 soon after opening bell. The company's subsidiary Caraco Pharmaceutical Laboratories, in which the Indian company holds about 75 percent, was raided owing to its "continued failure to meet the FDA's current Good Manufacturing Practice (cGMP) requirements," the US authorities said. "The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements," said Janet Woodcock, FDA's director of Center for Drug Evaluation and Research. "Compliance with these standards prevents harm to the public." This is not the first time the company has come under the regulator's scanner. Last October, the FDA had conducted inspection of its facilities and found "significant deviations from Current Good Manufacturing Practice (CGMP) regulations". Caraco's drugs were found to be contaminated, even after the company had conducted an internal investigation to determine the cause and taken corrective measures. Since January, Caraco had initiated voluntary recalls of products to protect the public from potentially defective medications. The recalls followed manufacturing defects, including oversized tablets and possible formulation error. But the FDA found these measures inadequate. "FDA's most recent inspection of Caraco, completed in May 2009, found unresolved violations of CGMP requirements," an FDA statement read. Sun Pharma is the second Indian company this year to have faced FDA's wrath. In February, the US drug watchdog had taken regulatory action against Ranbaxy's Paonta Sahib facility in Himachal Pradesh on the ground it had falsified test results.
Subscribe to:
Posts (Atom)
