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.
Showing posts with label ET. Show all posts
Showing posts with label ET. Show all posts
Wednesday, July 22, 2009
Saturday, June 27, 2009
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.
Tuesday, June 23, 2009
NEW DELHI: Elder Pharmaceuticals has signed an agreement with US-based MD Anderson Cancer Center to conduct human experiments for its
NEW DELHI: The domestic pharmaceutical industry has demanded exemption in income-tax and fiscal incentives in the forthcoming Budget for promoting
research and development (R&D) in the field of drug discovery in India. "We have sought exemption in income-tax under section 80, for promoting R&D in the pharmaceutical sector," Piramal Healthcare Executive Director Swati Piramal said. She said India is lagging behind countries such as Canada and Israel in R&D, which is very worrisome for the domestic pharma industry. "The provision for the exemption for R&D was there till 2007 and we simply want to revive it," Piramal added. Echoing similar sentiments, Indian Pharmaceutical Alliance Secretary General D G Shah said, "We are not making any special demand from the government but are only seeking that government must recognise the high risk associated with drug discovery and should provide adequate funding for that." The industry has also demanded a decision on the central drug authority bill, which is pending in Parliament for the last five years. Apex body of drug exporters Pharmaexcil, in its representation to the finance ministry and commerce ministry, has demanded a Rs 1,000-crore fund to support small and medium enterprises for Schedule M compliance (minimum standards set by government for producing drugs) and to meet global regulatory standards. Pharmaexcil Chairman Venkat Jasti said that for innovation led growth, the industry needs to build huge infrastructure to develop human resources, have a proper regulatory mechanism and for having a strong Intellectual Property Regime. "Besides, it needs funding for drug discovery activities. Long-term commitment with a special fund needs to be created," he added. However, another major chamber SPIC has demanded that the government should increase the limit of excise exemption for small scale industries to Rs five crore from the current Rs 1.5 crore.
research and development (R&D) in the field of drug discovery in India. "We have sought exemption in income-tax under section 80, for promoting R&D in the pharmaceutical sector," Piramal Healthcare Executive Director Swati Piramal said. She said India is lagging behind countries such as Canada and Israel in R&D, which is very worrisome for the domestic pharma industry. "The provision for the exemption for R&D was there till 2007 and we simply want to revive it," Piramal added. Echoing similar sentiments, Indian Pharmaceutical Alliance Secretary General D G Shah said, "We are not making any special demand from the government but are only seeking that government must recognise the high risk associated with drug discovery and should provide adequate funding for that." The industry has also demanded a decision on the central drug authority bill, which is pending in Parliament for the last five years. Apex body of drug exporters Pharmaexcil, in its representation to the finance ministry and commerce ministry, has demanded a Rs 1,000-crore fund to support small and medium enterprises for Schedule M compliance (minimum standards set by government for producing drugs) and to meet global regulatory standards. Pharmaexcil Chairman Venkat Jasti said that for innovation led growth, the industry needs to build huge infrastructure to develop human resources, have a proper regulatory mechanism and for having a strong Intellectual Property Regime. "Besides, it needs funding for drug discovery activities. Long-term commitment with a special fund needs to be created," he added. However, another major chamber SPIC has demanded that the government should increase the limit of excise exemption for small scale industries to Rs five crore from the current Rs 1.5 crore.
Elder signs deal with US co for human trials of anti-cancer drug
NEW DELHI: Elder Pharmaceuticals has signed an agreement with US-based MD Anderson Cancer Center to conduct human experiments for its
newly-discovered anti-cancer drug. As per the agreement, the cancer centre will invest into human trials in the US, while Elder Pharmaceuticals would retain exclusive manufacturing rights for the drug. “The deal is unique, as the ownership rights of the drug will lie with MD Anderson and the manufacturing rights will be with Elder. MD Anderson has the option of selling the rights to any major pharma company in the world, but that company will have to manufacture the same only through Elder,” said Elder Pharmaceuticals director (international) Alok Saxena. The anti-cancer drug, developed by Elder Pharmaceuticals, is an alternative to chemotherapy, and hence, has no known major side-effects, said a company official. The drug can be delivered both through intravenous as well as oral methods. The company expects the commercial launch of the drug by 2012. The market size for such cancer therapies is estimated to be at around $3 billion across the globe. The US, Europe and Japan together contribute 78% to this market. Elder estimates this drug to have a potential to capture a global market share of 3-4%. According to a company official, the cancer centre is likely to invest around $200 million on human trials. Elder Pharmaceuticals has a presence in niche therapeutic segments, such as female healthcare, osteoporosis, dermatology, pain management, cardiology, diabetology, nutraceuticals and vitamin supplements. The company also have a major presence in calcium supplements, wound healing and injectable B12 vitamin. The company shares dipped 3.83% to Rs 27.60 at the Bombay Stock Exchange on Thursday. The company follows the non-infringing business model of either in-licensing products of innovator companies or manufacturing off-patented drugs. It has entered into marketing and manufacturing alliances with 30 international companies to launch their research-based products in India, said the official.
newly-discovered anti-cancer drug. As per the agreement, the cancer centre will invest into human trials in the US, while Elder Pharmaceuticals would retain exclusive manufacturing rights for the drug. “The deal is unique, as the ownership rights of the drug will lie with MD Anderson and the manufacturing rights will be with Elder. MD Anderson has the option of selling the rights to any major pharma company in the world, but that company will have to manufacture the same only through Elder,” said Elder Pharmaceuticals director (international) Alok Saxena. The anti-cancer drug, developed by Elder Pharmaceuticals, is an alternative to chemotherapy, and hence, has no known major side-effects, said a company official. The drug can be delivered both through intravenous as well as oral methods. The company expects the commercial launch of the drug by 2012. The market size for such cancer therapies is estimated to be at around $3 billion across the globe. The US, Europe and Japan together contribute 78% to this market. Elder estimates this drug to have a potential to capture a global market share of 3-4%. According to a company official, the cancer centre is likely to invest around $200 million on human trials. Elder Pharmaceuticals has a presence in niche therapeutic segments, such as female healthcare, osteoporosis, dermatology, pain management, cardiology, diabetology, nutraceuticals and vitamin supplements. The company also have a major presence in calcium supplements, wound healing and injectable B12 vitamin. The company shares dipped 3.83% to Rs 27.60 at the Bombay Stock Exchange on Thursday. The company follows the non-infringing business model of either in-licensing products of innovator companies or manufacturing off-patented drugs. It has entered into marketing and manufacturing alliances with 30 international companies to launch their research-based products in India, said the official.
Wednesday, June 17, 2009
New price formula for 184 drugs; 77 to get cheaper
NEW DELHI: The country’s top drug price regulator has reworked the prices of 184 bulk drugs, thus making 77 medicines more affordable, and brought
in another 71 under its purview. The National Pharmaceutical Pricing Authority (NPPA), which fixes the prices of bulk drugs that go into the making of essential medicines to ensure that they stay within the reach of the common man, also hiked the prices of 36 medicines. “While some of the prices are reduced suo moto based on the reduction in their bulk drug prices, prices of some were revised based on the applications received from drug companies asking for a price revision,” an NPPA official said. Among the medicines that have become cheaper include those used in the treatment of arthritis, eye ailments, diabetes and infections, and some antibiotics, primarily marketed by companies such as Pfizer and Novartis. The price reduction is in the range of 0.41-34.38%. For instance, the price of a 2-ml vial of Pfizer’s Medrol 80-mg, a steroid used for treatment of arthritis, will now cost Rs 75.76 instead of Rs 88. 79. A 30-ml bottle of Novartis’ Vitalux TR tablets will now cost Rs 262.53 instead of Rs 304.76. Vitalux TR is a specially tailored combination of vitamins and minerals to maintain healthy eyes. NPPA fixes the prices of 74 bulk drugs, used to manufacture essential medicines, and revise their prices periodically based on a cost study. Prices of all medicines containing one or more of these bulk drugs are also directly controlled by the pricing authority. However, companies manufacturing any other medicines can increase the price of their drug by 10% annually. The latest price revision by NPPA also includes medicines that were being sold in the market without a price approval, the official said. The regulator has caught such price violations, calculated their cost of production and fixed the prices at which they should be sold henceforth. After this, selling these 71 medicines above the government fixed price would make the producers liable for punishment.
in another 71 under its purview. The National Pharmaceutical Pricing Authority (NPPA), which fixes the prices of bulk drugs that go into the making of essential medicines to ensure that they stay within the reach of the common man, also hiked the prices of 36 medicines. “While some of the prices are reduced suo moto based on the reduction in their bulk drug prices, prices of some were revised based on the applications received from drug companies asking for a price revision,” an NPPA official said. Among the medicines that have become cheaper include those used in the treatment of arthritis, eye ailments, diabetes and infections, and some antibiotics, primarily marketed by companies such as Pfizer and Novartis. The price reduction is in the range of 0.41-34.38%. For instance, the price of a 2-ml vial of Pfizer’s Medrol 80-mg, a steroid used for treatment of arthritis, will now cost Rs 75.76 instead of Rs 88. 79. A 30-ml bottle of Novartis’ Vitalux TR tablets will now cost Rs 262.53 instead of Rs 304.76. Vitalux TR is a specially tailored combination of vitamins and minerals to maintain healthy eyes. NPPA fixes the prices of 74 bulk drugs, used to manufacture essential medicines, and revise their prices periodically based on a cost study. Prices of all medicines containing one or more of these bulk drugs are also directly controlled by the pricing authority. However, companies manufacturing any other medicines can increase the price of their drug by 10% annually. The latest price revision by NPPA also includes medicines that were being sold in the market without a price approval, the official said. The regulator has caught such price violations, calculated their cost of production and fixed the prices at which they should be sold henceforth. After this, selling these 71 medicines above the government fixed price would make the producers liable for punishment.
Monday, June 15, 2009
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BASEL: Swiss pharmaceuticals company Novartis AG said on Friday it has successfully produced a first batch of swine flu vaccine weeks ahead of
expectations. The vaccine was made in cells, rather than grown in eggs as is usually the case with vaccines, the company said. The announcement comes a day after the World Health Organization declared swine flu, also known as A(H1N1), a pandemic. The move indicates that a global outbreak is under way. WHO says drugmakers will likely have vaccines approved and ready for sale after September. Novartis said it would use the first batch of vaccine for pre-clinical evaluation and testing. It is also being considered for clinical trials, the company said. The vaccine was produced at a Novartis plant in Marburg, Germany. Novartis said the facility could potentially produce millions of doses of vaccine a week. A second plant is being built in Holly Springs, North Carolina, the company said. Novartis said more than 30 governments have requested vaccine supplies, including the US Department of Health and Human Service, which placed a $289 million order in May.
expectations. The vaccine was made in cells, rather than grown in eggs as is usually the case with vaccines, the company said. The announcement comes a day after the World Health Organization declared swine flu, also known as A(H1N1), a pandemic. The move indicates that a global outbreak is under way. WHO says drugmakers will likely have vaccines approved and ready for sale after September. Novartis said it would use the first batch of vaccine for pre-clinical evaluation and testing. It is also being considered for clinical trials, the company said. The vaccine was produced at a Novartis plant in Marburg, Germany. Novartis said the facility could potentially produce millions of doses of vaccine a week. A second plant is being built in Holly Springs, North Carolina, the company said. Novartis said more than 30 governments have requested vaccine supplies, including the US Department of Health and Human Service, which placed a $289 million order in May.
Jubilant Organosys ties up with US-based Endo Pharmaceuticals
NEW DELHI: Jubilant Organosys through its Bangalore-based subsidiary Jubilant Biosys has entered into a three-year drug discovery & development
collaboration with US-based Endo Pharmaceuticals to come out with a portfolio of oncology molecules. The focus of the tie-up is to develop pre-clinical candidates for joint clinical development, a Jubilant Organosys release said. Endo will own the compounds developed under the partnership and will also be responsible for its worldwide commercialisation. Delhi-based Jubilant Organosys will receive research funding and success-based milestone payments from the American firm, besides royalties on successful commercialisation, the company statement added. Jubilant Organosys CMD Shyam Bhartia and Co-CMD Hari Bhartia in a joint statement said: “We anticipate significant rewards on successful development of compounds and its subsequent commercialisation.” While funding for research is expected to kick in from this quarter onwards, milestone linked payments for such research projects usually takes 6-9 months, subject to meeting the targets.
collaboration with US-based Endo Pharmaceuticals to come out with a portfolio of oncology molecules. The focus of the tie-up is to develop pre-clinical candidates for joint clinical development, a Jubilant Organosys release said. Endo will own the compounds developed under the partnership and will also be responsible for its worldwide commercialisation. Delhi-based Jubilant Organosys will receive research funding and success-based milestone payments from the American firm, besides royalties on successful commercialisation, the company statement added. Jubilant Organosys CMD Shyam Bhartia and Co-CMD Hari Bhartia in a joint statement said: “We anticipate significant rewards on successful development of compounds and its subsequent commercialisation.” While funding for research is expected to kick in from this quarter onwards, milestone linked payments for such research projects usually takes 6-9 months, subject to meeting the targets.
Dr Reddy's Labs gets USFDA nod for Omeprazole Mg OTC
MUMBAI: Drug manufacturer Dr Reddy’s Laboratories on Wednesday said it has received US regulatory approval for anti-heartburn capsules.
The company has received US Food and Drug Administration approval for its Abbreviated New Drug Application for Omeprazole Mg OTC, Dr Reddy’s Laboratories said in a filing to the Bombay Stock Exchange. Omeprazole Mg OTC is indicated for the treatment of heartburn. Dr Reddy’s formulation contains 20.6 mg Omeprazole Mg and the dosage form is a capsule, the filing added.
The company has received US Food and Drug Administration approval for its Abbreviated New Drug Application for Omeprazole Mg OTC, Dr Reddy’s Laboratories said in a filing to the Bombay Stock Exchange. Omeprazole Mg OTC is indicated for the treatment of heartburn. Dr Reddy’s formulation contains 20.6 mg Omeprazole Mg and the dosage form is a capsule, the filing added.
India can become a global pharma innovation hub, experts say
WASHINGTON: India has the potential to emerge as a global innovation hub and the US's collabortion with Indian pharma and health companies will not
only help the two countries, but also entire world, eminent experts and industry leaders said. Speaking in favour of the US forging collaborations with Indian firms and academic institutes in the field of biopharma and healthcare sector, Pfizer President (Global R&D) Martin Mackay said not only there is a great willingness to collaborate in India, there is a great ability of Indian companies to adapt to western needs. India can be a major centre for innovation globally said Joe Smith, Vice-President at Johnson & Johnson. J&J doesn't view India as an emerging market and felt infectious innovation can come from India, he added. William Chin, Vice-President, Discovery Research & Clinical Investigation, Eli Lilly, felt the pharma industry is under siege with flood of patent expiries, higher safety hurdles and pricing pressure. As the sector is facing the problem of managing the huge data at its disposal, Chin said India with its IT strengths can play a vital role. Lilly has moved beyond level 1 partnerships, based on cost arbitrage, to level II based on partnerships of shared rewards and risks in India. Lilly would eventually like to move towards level III partnerships based on equity stake in Indian companies to share success, he said.
only help the two countries, but also entire world, eminent experts and industry leaders said. Speaking in favour of the US forging collaborations with Indian firms and academic institutes in the field of biopharma and healthcare sector, Pfizer President (Global R&D) Martin Mackay said not only there is a great willingness to collaborate in India, there is a great ability of Indian companies to adapt to western needs. India can be a major centre for innovation globally said Joe Smith, Vice-President at Johnson & Johnson. J&J doesn't view India as an emerging market and felt infectious innovation can come from India, he added. William Chin, Vice-President, Discovery Research & Clinical Investigation, Eli Lilly, felt the pharma industry is under siege with flood of patent expiries, higher safety hurdles and pricing pressure. As the sector is facing the problem of managing the huge data at its disposal, Chin said India with its IT strengths can play a vital role. Lilly has moved beyond level 1 partnerships, based on cost arbitrage, to level II based on partnerships of shared rewards and risks in India. Lilly would eventually like to move towards level III partnerships based on equity stake in Indian companies to share success, he said.
Monday, June 8, 2009
Row over generic drugs intensifies after seizure in Germany
NEW DELHI: German authorities last month seized a large consignment of antibiotic Amoxicillin made by Chennai-based Medopharm during transit at
Frankfurt over alleged trademark infringement, in the latest incident of European Union nations interfering in legitimate trade of generic medicine. Amoxicillin is used to treat a wide range of bacterial infections. Medopharm was exporting its drugs to Republic of Vanuatu in the Pacific. The development has intensified global healthcare groups’ and Indian drugmakers’ opposition to the EU Border Measures Regulation that allows seizure of drugs during transit for alleged patent, trademark violation and counterfeit charges. “There is no valid reason for detaining these medicines especially since the name Amoxicillin is an international non-proprietary name (INN),” said a joint statement issued by five social organisations, Health Action International (HAI), Oxfam International, BUKO-pharma, Medico International and Third World Network. The consignment worth e28,000, seized on May 5, was released on May 20 after British company GlaxoSmithKline, the former patent holder for Amoxil brand of Amoxicillin, said that there was no trademark infringement. “This seizure is the latest in the list of cases that demonstrate that EU regulations are actively hampering timely access to medicines to developing countries,” it added. Last year, 17 consignments of Indian medicines were halted at the Netherlands. This year again, the Dutch authorities seized several Indian consignments, including those of Dr Reddy’s, Aurobindo and Cipla. The Frankfurt seizure was the first in Germany. The group of NGOs has asked the European Commission to take immediate steps to ensure that its regulations and laws do not deny developing countries timely access to essential medicines.
Frankfurt over alleged trademark infringement, in the latest incident of European Union nations interfering in legitimate trade of generic medicine. Amoxicillin is used to treat a wide range of bacterial infections. Medopharm was exporting its drugs to Republic of Vanuatu in the Pacific. The development has intensified global healthcare groups’ and Indian drugmakers’ opposition to the EU Border Measures Regulation that allows seizure of drugs during transit for alleged patent, trademark violation and counterfeit charges. “There is no valid reason for detaining these medicines especially since the name Amoxicillin is an international non-proprietary name (INN),” said a joint statement issued by five social organisations, Health Action International (HAI), Oxfam International, BUKO-pharma, Medico International and Third World Network. The consignment worth e28,000, seized on May 5, was released on May 20 after British company GlaxoSmithKline, the former patent holder for Amoxil brand of Amoxicillin, said that there was no trademark infringement. “This seizure is the latest in the list of cases that demonstrate that EU regulations are actively hampering timely access to medicines to developing countries,” it added. Last year, 17 consignments of Indian medicines were halted at the Netherlands. This year again, the Dutch authorities seized several Indian consignments, including those of Dr Reddy’s, Aurobindo and Cipla. The Frankfurt seizure was the first in Germany. The group of NGOs has asked the European Commission to take immediate steps to ensure that its regulations and laws do not deny developing countries timely access to essential medicines.
Pharma firms continue to face patent violation charges in Europe
NEW DELHI: Even after India raised concerns with EU, troubles of generic companies which export drugs to developing countries through Europe are far
from over as seizures by Dutch customs still continue. In yet another case, a shipment of popular antibiotic, Amoxicillin was seized in Frankfurt recently. The drugs manufactured by domestic company Medopharm were shipped to Republic of Vanuatu, an island nation in the Pacific Ocean, through Frankfurt. In this recent case, customs authorities seized a shipment of 3,047,000 pills (quantity equivalent to 76,000 courses of treatment) of Amoxicillin (250 mg) worth 25,000 euros, for almost a month before releasing it. Sources said that the consignment was detained on grounds of suspected trademark infringement. Experts pointed out that there was no valid reason for detaining these medicines especially since the name ‘Amoxicillin' is an international non-proprietary name. This seizure is the latest in a long list of cases that demonstrate that EU regulations are actively hampering access to medicines to developing countries. In 2008, there were 16 similar cases of seizures of medicines shipped from India in the Netherlands. (Other recent seizures include those of medicines from Dr Reddy's and Ind-Swift.) When this particular shipment came into Germany, customs noted that the medicines packed are of the same type as the drugs that GlaxoSmithKline in UK has copyrights for, according to an industry source. German customs authorities then informed the company, and gave them a sample of drugs for inspection. The consignment was later cleared and sent to the final destination. These seizures have been driven by an EU regulation on border measures that has empowered customs officials to interfere in legitimate trade of generic medicines, a statement from Health Action Network says. DG Shah, secretary general of Indian Pharmaceutical Alliance says "The EU member states continue to abuse Regulation 1383 of 2003 to create barriers and harass legitimate trade in generics. It is time that the government steps in and takes effective steps to protect India's exports of pharmaceuticals". Customs is incompetent to interpret IPRs and should not be entrusted to enforce the same, he added. The issue has been raised by India at the TRIPS (Trade-related aspects of Intellectual Property Rights) council meeting in February, and thereafter when the Dutch trade minister was on a visit here. Experts pointed out that earlier international public health and consumer groups have raised the issue with World Health Organization (WHO) and the World Trade Organization (WTO) voicing their concerns over seizures by Dutch customs authorities of Indian generic drugs shipped through the Netherlands en route to Brazil, Colombia and Peru. According to manufacturers, all products were ‘‘legitimate generics'' and did not violate any patent rights in the exporting or the importing countries.
from over as seizures by Dutch customs still continue. In yet another case, a shipment of popular antibiotic, Amoxicillin was seized in Frankfurt recently. The drugs manufactured by domestic company Medopharm were shipped to Republic of Vanuatu, an island nation in the Pacific Ocean, through Frankfurt. In this recent case, customs authorities seized a shipment of 3,047,000 pills (quantity equivalent to 76,000 courses of treatment) of Amoxicillin (250 mg) worth 25,000 euros, for almost a month before releasing it. Sources said that the consignment was detained on grounds of suspected trademark infringement. Experts pointed out that there was no valid reason for detaining these medicines especially since the name ‘Amoxicillin' is an international non-proprietary name. This seizure is the latest in a long list of cases that demonstrate that EU regulations are actively hampering access to medicines to developing countries. In 2008, there were 16 similar cases of seizures of medicines shipped from India in the Netherlands. (Other recent seizures include those of medicines from Dr Reddy's and Ind-Swift.) When this particular shipment came into Germany, customs noted that the medicines packed are of the same type as the drugs that GlaxoSmithKline in UK has copyrights for, according to an industry source. German customs authorities then informed the company, and gave them a sample of drugs for inspection. The consignment was later cleared and sent to the final destination. These seizures have been driven by an EU regulation on border measures that has empowered customs officials to interfere in legitimate trade of generic medicines, a statement from Health Action Network says. DG Shah, secretary general of Indian Pharmaceutical Alliance says "The EU member states continue to abuse Regulation 1383 of 2003 to create barriers and harass legitimate trade in generics. It is time that the government steps in and takes effective steps to protect India's exports of pharmaceuticals". Customs is incompetent to interpret IPRs and should not be entrusted to enforce the same, he added. The issue has been raised by India at the TRIPS (Trade-related aspects of Intellectual Property Rights) council meeting in February, and thereafter when the Dutch trade minister was on a visit here. Experts pointed out that earlier international public health and consumer groups have raised the issue with World Health Organization (WHO) and the World Trade Organization (WTO) voicing their concerns over seizures by Dutch customs authorities of Indian generic drugs shipped through the Netherlands en route to Brazil, Colombia and Peru. According to manufacturers, all products were ‘‘legitimate generics'' and did not violate any patent rights in the exporting or the importing countries.
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