Home
gibreel ferishta's Library tagged → View Popular
Financial Express : Anti-Indian generics policy stemmed from a global pharma report
A report prepared by the London-based International Policy Network (INP) could be greatly responsible for shaping the anti-Indian generics policy mindset that many of the African countries have either adopted in recent past or are in the process of adopting. This report, ‘Keeping it real: combating the spread of fake drugs in poor countries’, is learnt to be in wide circulation among the African countries and is being referred to. The governments of these countries conclude that India and China seem to be the largest producer of fake medicine.
It infers so on the basis of estimates derived from various secondary sources such as European Commission, The Associated Chambers of Commerce and media reports.
A 2004 survey of medicines on sale at a large bazaar in New Delhi found that only 7.5% were genuine. A report in a newspaper said that fakes are freely sold to exporters who sell them to unsuspecting health administrators in Sub-Saharan Africa, who receive some of the millions in aid money.
-
A report prepared by the London-based International Policy Network (INP) could be greatly responsible for shaping the anti-Indian generics policy mindset that many of the African countries have either adopted in recent past or are in the process of adopting. This report, ‘Keeping it real: combating the spread of fake drugs in poor countries’, is learnt to be in wide circulation among the African countries and is being referred to. The governments of these countries conclude that India and China seem to be the largest producer of fake medicine.
It infers so on the basis of estimates derived from various secondary sources such as European Commission, The Associated Chambers of Commerce and media reports.
A 2004 survey of medicines on sale at a large bazaar in New Delhi found that only 7.5% were genuine. A report in a newspaper said that fakes are freely sold to exporters who sell them to unsuspecting health administrators in Sub-Saharan Africa, who receive some of the millions in aid money.
Latha Jishnu: Setting aside Bayer's 'spurious' claims
Two weeks ago Justice S Ravindra Bhat of the Delhi High Court dismissed with costs the writ petition filed by the German pharmaceuticals giant Bayer Corporation against the Union of India, the Drug Controller General of India (DCGI) and Cipla. The importance of Justice Bhat’s judgment cannot be overestimated. It is a clear — and sharp — judgment that puts paid to attempts by foreign companies to modify India’s regulations to suit their commercial interest.
The judge characterised the litigation as “a speculative foray; an attempt to ‘tweak’ public policies through court mandated regimes” and, in a first of its kind, awarded costs of Rs 6.75 lakh. The amount, far from being punitive, is to be shared by the government and the third respondent Cipla, one of India’s top drug companies. However, the point that the judgment makes is strong: Companies with deep pockets may “achieve short term goals of keeping out competitors through interim orders” but the court will impose ‘realistic costs’.
Financial Express : ‘Stringent IP enforcement will limit access to generic drugs’
-
ivil society organisations, led by Centre for Trade and Development, have sent a strong missive to the Confederation of Indian Industry (CII), urging it to be careful about associating with multinational corporations and developed countries that are keen to push more stringent intellectual property (IP) enforcement laws in India . The letter is in response to an international conference recently hosted by CII to enhance IP standards and their enforcement.
Stressing that stricter IP enforcement laws will limit the access of life-saving generic drugs to people in developing countries, the letter asks CII to “not view IP as only a business tool” but also look at the larger scheme of things, given India’s social and economic realities.
The letter also pointed to the controversial seizure of generic drugs shipped from India to Africa by customs authorities in the European Union. Though the drugs were not patent-protected in India or the consignee countries, EU authorities seized them in transit, arguing that the rights of patent-holders in Europe were being infringed. Freedom of transit for legitimate trade is clearly laid down under GATT. The Trade-Related Aspects of Intellectual Property (TRIPS) Agreement also emphasises that measures to protect intellectual property shoul
Govt hospitals to be restructured in Andhra
Andhra Pradesh chief minister Y S Rajasekhara Reddy on Wednesday agreed for restructuring the government hospitals in the state in tune with the requirements of the Aarogyasri scheme, which provides cashless treatment to the poor.
Also Read
Related Stories
News Now
- India losing 2,000 patents every year: Jairam Ramesh
- YSR Reddy writes to McCarthy over attacks in Australia
- AP to set up Slum Rehab Authority
- Sabita Reddy is AP's first woman home minister
- YSR sworn in for second term
- YSR to resign as Andhra CM tomorrow
Also Read
Related Stories
News Now
- Sensex volatile; ACC down 4%
- NEWSALERT: Inflation in red, at -1.61%
- SpiceJet hikes fuel surcharge by Rs 400
- Most active stocks on the BSE
- Mahindra firm in volatile market; MHRIL IPO to open on June 23
- Asian markets in red; Hang Seng sheds 356pts
More
The health department prepared a blueprint for revamping the policies, support services, infrastructure and restructuring the staff of government hospitals.
The government proposed to increase the participation of government hospitals in the Aarogyasri programme from the present 9 per cent to 30 per cent in a year by creating better infrastructure and staff.
Antibiotics, pain killers,insulin get 3% cheaper
Medicines sold at government-set prices have become cheaper by nearly 3% after the country’s drug price regulator ordered a price cut
in the wake of the recent cut in excise duties.
The government last weekend announced a 4% cut in excise duties as part of a fiscal stimulus package to boost the economy. Various industries, most notably the automobile industry, have announced price cuts as companies look to pass on the benefits of the duty cut to consumers to boost demand.
The drug price regulator — the National Pharmaceutical Pricing Authority (NPPA) — notified the 2.84% price cut on Thursday and its decision is effective immediately. The price cut will cover about 17% of the Rs 45,000-crore domestic pharmaceutical market. The market segment affected by the price cuts has revenues of Rs 7,800 crore, industry officials say.
Lupin sends notice to Oscient over cholesterol generic
Indian pharma major Lupin has sent a legal notice to US-based Oscient Pharmaceuticals to inform them that they are seeking regulatory appr
oval for a generic version of Oscient’s cholesterol drug, Antara. Oscient received a notice to this effect on Wednesday, its official website said.
The notice stated that Lupin had filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (USFDA) to launch a generic version of Antara in the market. The notice alleges that US Patent No. 7,101,574, owned by Ethypharm, exclusively licensed to Oscient and listed in the FDA Orange Book for Antara, is invalid and will not be infringed by Lupin's manufacture, use or sale of the product. US Patent No 7,101,574 will be expired in 2020, the website stated.
New definition of fake drugs could save the day for local companies
The risk of India’s generic drugs being labelled counterfeit under the new definition proposed by WHO has receded, a government represe
ntative concerned with the issue said. This would ensure that India’s manufacturers continue to sell their drugs in foreign markets.
The WHO-funded International Medical Products Anti-Counterfeiting Taskforce (IMPACT) had proposed a new definition of counterfeit drugs as medical products with a “false representation about their identity, history or source”.
Flawed moves for a National Biotechnology Regulatory Authority
The proposal to create a National Biotechnology Regulatory Authority (NBRA), for which a draft bill is now in circulation, is being moved in an unprofessional manner by the Government of India.
The bill is driven by the Department of Biotechnology. The DBT ought to know that biotechnology covers some 30 areas, of which many need to be regulated. These areas include stem cells, nanobiotechnology, biological warfare, vaccines, bioinformatics, organ transplantation, new drug delivery systems, new materials such as spider silk and bacterial ropes, plant-based traditional drug formulations, and assisted reproductive technologies. But the proposed bill is confined to Genetically Manipulated Organisms (GMOs) and their products. Should it not, therefore, have been called a National GMO Regulatory Authority instead of an NBRA? Biotechnology cannot be equated with genetic engineering. If the DBT really thinks so, it ought to change its own name to “Department of Genetic Engineering.”
The bill has a range of other problems as well.
The objective of any proposed bill should be to fill a defined void. There is already a regulatory procedure in place for GMOs and their products, involving the Review Committee on Genetic Manipulation (RCGM) of the DBT and the Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment and Forests. Therefore, it should first be determined if anything is wrong with the present system. Then an attempt should be made to correct the existing system. Only if this is not possible should a new bill be considered. The authorities concerned should state what part of the existing procedures is undesirable and how the proposed bill will correct it. For example, the present system does not prescribe any penalty for contamination of a non-GMO farm by GMOs in an adjoining farm. The proposed bill is silent on such problems.
-
The proposal to create a National Biotechnology Regulatory Authority (NBRA), for which a draft bill is now in circulation, is being moved in an unprofessional manner by the Government of India.The bill is driven by the Department of Biotechnology. The DBT ought to know that biotechnology covers some 30 areas, of which many need to be regulated. These areas include stem cells, nanobiotechnology, biological warfare, vaccines, bioinformatics,
organ transplantation, new drug delivery systems, new materials such as spider silk and bacterial ropes, plant-based traditional drug formulations, and assisted reproductive technologies. But the proposed bill is confined to Genetically Manipulated Organisms (GMOs) and their products. Should it not, therefore, have been called a National GMO Regulatory Authority instead of an NBRA? Biotechnology cannot be equated with genetic engineering. If the DBT really thinks so, it ought to change its own name to “Department of Genetic Engineering.”The bill has a range of other problems as well.
The objective of any proposed bill should be to fill a defined void. There is already a regulatory procedure in place for GMOs and their products, involving the Review Committee on Genetic Manipulation (RCGM) of the DBT and the Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment and Forests. Therefore, it should first be determined if anything is wrong with the present system. Then an attempt should be made to correct the existing system. Only if this is not possible should a new bill be considered. The authorities concerned should state what part of the existing procedures is undesirable and how the proposed bill will correct it. For example, the present system does not prescribe any penalty for contamination of a non-GMO farm by GMOs in an adjoining farm. The proposed bill is silent on such problems.
How safe are our clinical trials?
The way the actual testing works is that the sponsor clears every project with the Drug Controller General of India (DCGI) and, as part of the process, has to have a Management Committee, an Ethics Committee and a Data Safety Management Board; there are then various monitoring committees and the DCGI is training people to ensure these guidelines are being followed. The structures are all there and the larger trials, by the Bill and Melinda Gates Foundation for instance, are being done under these rules. But much of this is self-regulatory and there will be lapses. The rules and their implementation are being strengthened and as the support eco-system gets better, the chances of regulatory failure also decline. In another five years, India will have a very strong clinical trials environment in place.
-
The way the actual testing works is that the sponsor clears every project with the Drug Controller General of India (DCGI) and, as part of the process, has to have a Management Committee, an Ethics Committee and a Data Safety Management Board; there are then various monitoring committees and the DCGI is training people to ensure these guidelines are being followed. The structures are all there and the larger trials, by the Bill and Melinda Gates Foundation for instance, are being done under these rules. But much of this is self-regulatory and there will be lapses. The rules and their implementation are being strengthened and as the support eco-system gets better, the chances of regulatory failure also decline. In another five years, India will have a very strong clinical trials environment in place
Peace on patents to boost Ranbaxy
Ranbaxy expects the settlement with Astrazeneca on Nexium, the world's second largest selling drug with annual global sales of around $5.5 billion, to fetch $1.5 billion in exclusive sale of its generic version and supply of raw materials. The out of court settlement with Pfizer on Lipitor is expected to generate even more revenues in the coming years.
By doing out of court settlements, Ranbaxy has opened multiple revenue streams from these products. Apart from generic clones, it can supply authorized generics as well as bulk drugs to some of these innovator companies.
Settlement of patent litigations, said the source, has brought certainty to the company's cash flows, besides saving it millions of dollars in legal fees. Ranbaxy still has 14 patent challenges going on at the moment. However, the source said, it may not settle all of these out of court.
-
Ranbaxy expects the settlement with Astrazeneca on Nexium, the world's second largest selling drug with annual global sales of around $5.5 billion, to fetch $1.5 billion in exclusive sale of its generic version and supply of raw materials. The out of court settlement with Pfizer on Lipitor is expected to generate even more revenues in the coming years.
By doing out of court settlements, Ranbaxy has opened multiple revenue streams from these products. Apart from generic clones, it can supply authorized generics as well as bulk drugs to some of these innovator companies.
Settlement of patent litigations, said the source, has brought certainty to the company's cash flows, besides saving it millions of dollars in legal fees. Ranbaxy still has 14 patent challenges going on at the moment. However, the source said, it may not settle all of these out of court.
Babies'death in AIIMS trials open Pandora's box
Bangalore:The death of 49 babies in clinical trials at the All India Institute of Medical Sciences (AIIMS) in New Delhi may have opened a Pandora's box as two of the trial drugs have never been tried on patients below 18 years, an expert said.
How many of the children died because of the trial drugs will be known only when an enquiry committee submits its report this month, but doctors have already raised questions of ethics.
In reply to a Right to Information (RTI) query, the AIIMS said that 49 babies had died during clinical trials over the past two-and-a-half years.
The AIIMS paediatrics department conducted 42 sets of trials on 4,142 babies - 2,728 of them below the age of one - since Jan 1, 2006.
Two of the trial drugs - olmesartan and valsartan, meant for reducing blood pressure - have never been tried on patients below the age of 18 years, said Chandra M. Gulhati, editor of the Monthly Index of Medical Specialties and a keen obserger of the clinical trials in India.
Ranbaxy buyout awaits CCEA nod
Japan's Daiichi Sankyo's proposal to acquire Ranbaxy will go to the Cabinet Committee on Economic Affairs (CCEA) for approval. Any foreign deal exceeding Rs 600 crore has to be approved by the CCEA under the existing policy.
Industry secretary Ajay Shanker told reporters that he does not see any problems related to the Tokyo-based Daiichi Sankyo's controlling bid on Ranbaxy Laboratories. The takeover is valued at $ 4.6 billion (Rs 19,780 crore).
The open offer by Daiichi to acquire upto 20 per cent of Ranbaxy's shares will close on September 4
Financial Express : Chemists in new deal to beat big retail
he fierce battle in the retail pharma space is set to reach new dimensions, as drug retailers have started entering into exclusive tie-ups with drug manufacturing companies. The All Indian Origin Chemists & Distributors Limited (AIOCDL), the newly formed company with 5 lakh chemists across the country as members, is set to sign an exclusive tie-up with a Mumbai-based drug manufacturer. The deal is seen by many as AIOCDL’s strategic move to thwart the growth of retail pharmacy chains belonging to corporate giants in the country.
According to the deal, the manufacturer, Maneesh Pharma, will supply its drugs exclusively to AIOCDL, and not to other organised pharmaceutical retailers. Vinay Sapte, managing director, Maneesh Pharma, told FE, “We are considering an alliance with AIOCDL. In a couple of days, the model will be finalised.” In a few markets, the drugs will be supplied exclusively to AIOCDL, he added, without refusing to disclose further.
Ranbaxy buy may hit generic drugs supply
Ranbaxy has been aggressive in supplying generics, like anti-AIDS drugs, to developing countries, the company has participated in pre-grant oppositions in India (where a patent application is opposed before the Patent Office takes a decision) and it has been able to make similar versions of drugs like Tamiflu, used in the case of bird-flu, even as the patent situation was not clear.
This generic orientation could get influenced under the new owner and that would affect the supply of low-cost medicines to patients in India and other developing countries, the Centad representative said.
Corporate mergers and acquisitions in the pharma segment should not be viewed with the same lens as a regular corporate deal, as it could affect access to medicines, he added.
India bats for generics, seeks clarity on counterfeits
In the global battle against counterfeit medicines, India has sought clarity on the proposed expanded definition of counterfeits, staving off attempts to equate counterfeits with generic medicines.
Counterfeiting is a trademark-related issue that affects branded, patented and generic medicines, the Indian delegation said at the recent World Health Assembly (WHA) in Geneva.
At present, the World Health Organisation defines counterfeits as medicines that are deliberately and fraudulently mis-labelled, regarding identity or source. Also, counterfeits could contain varying levels to no level of the active ingredient of the original medicine. The expanded definition refers to the “history” of the drug, bringing in several implications, a Union Health Ministry source familiar with the development told Business Line.
India has its own norms and punishments on counterfeit medicines and is not opposed to being part of global initiatives to tackle them, the source said. But, a clear global definition on counterfeits was necessary, as countries often rely on WHO’s norms and definitions when framing their laws, and an ill-thought-through definition could cast a shadow on generic medicines, the source said.
-
In the global battle against counterfeit medicines, India has sought clarity on the proposed expanded definition of counterfeits, staving off attempts to equate counterfeits with generic medicines.
Counterfeiting is a trademark-related issue that affects branded, patented and generic medicines, the Indian delegation said at the recent World Health Assembly (WHA) in Geneva.
At present, the World Health Organisation defines counterfeits as medicines that are deliberately and fraudulently mis-labelled, regarding identity or source. Also, counterfeits could contain varying levels to no level of the active ingredient of the original medicine. The expanded definition refers to the “history” of the drug, bringing in several implications, a Union Health Ministry source familiar with the development told Business Line.
India has its own norms and punishments on counterfeit medicines and is not opposed to being part of global initiatives to tackle them, the source said. But, a clear global definition on counterfeits was necessary, as countries often rely on WHO’s norms and definitions when framing their laws, and an ill-thought-through definition could cast a shadow on generic medicines, the source said.
Indian drug companies are largely producers of generic drugs or medicines that are chemically similar and are as efficacious as an innovative medicine. And India’s stance at the WHA brought cheer to the local industry, as they feared that the expanded counterfeit definition could be used as a non-tariff barrier against medicine exports from India.
Ranbaxy gets mixed verdict on Pfizer’s Lipitor in Australia
In a partial victory for Ranbaxy Laboratories in its patent litigation against Pfizer, an Australian court has ruled in favour of the Indian company in a case relating to Atorvastatin, the world’s largest selling cholesterol-lowering drug (marketed by Pfizer as Lipitor).
The court at the same time also ruled that a proposed Ranbaxy generic product under a different patent infringed Pfizer’s basic Lipitor patent.
The Federal court had ruled that one of Pfizer’s patents was invalid for inutility, false suggestion and misrepresentation in obtaining the grant of Australian patent.
Mr Jay Deshmukh, Ranbaxy’s Senior Vice President-Global Intellectual Property, noted, “We are pleased with this decision as it stands, as it advances the entry of Ranbaxy’s generic atorvastatin in Australia to May 18, 2012.”
The ruling, the culmination of a lawsuit filed in 2005 by Ranbaxy, preserves Lipitor’s patent coverage in Australia through May 2012. Ranbaxy can appeal the decision.
Separate department for pharma sector on anvil
In view of the robust growth of the pharmaceutical sector, the Government has decided in-principle to create a separate department dedicated to the sector, Union Minister of Chemicals and Fertilisers Ram Vilas Paswan said on Tuesday.
Addressing the media, the Minister said the proposed department for the pharma sector would be carved out from the existing chemical and fertilizer department, which is now also taking care of the sector.
Responding to a question on the demand of the Indian Drug Manufacturers Association (IDMA) for revising the ceiling prices of 33 bulk drugs in the wake of the appreciating dollar against the rupee, the Minister said, “In a situation where the profit margins are as high as 200 per cent, there is no possibility of any company closing its manufacturing business due to the price control mechanism of the government.
-
In view of the robust growth of the pharmaceutical sector, the Government has decided in-principle to create a separate department dedicated to the sector, Union Minister of Chemicals and Fertilisers Ram Vilas Paswan said on Tuesday.
Addressing the media, the Minister said the proposed department for the pharma sector would be carved out from the existing chemical and fertilizer department, which is now also taking care of the sector.
Responding to a question on the demand of the Indian Drug Manufacturers Association (IDMA) for revising the ceiling prices of 33 bulk drugs in the wake of the appreciating dollar against the rupee, the Minister said, “In a situation where the profit margins are as high as 200 per cent, there is no possibility of any company closing its manufacturing business due to the price control mechanism of the government.
Financial Express : New DGCI system to make life easier for the pharma industry
In an effort to facilitate the fast growing Indian pharma industry to position itself globally, Drugs Controller General of India (DGCI) has initiated a centralised uniform system for various processes of the industry.
“Online real time system for various approvals will be fully operational within two to three,” the new DGCI DrSurendra Singh said, while inaugurating a seminar on ‘How quality pays’, organised by the Indian Drug manufacturing Association.
Singh said 60% of the delays faced by the industry was in getting test licence, export NOC and to get approval for conducting clinical trials and all these delays will be addressed by setting up a system e-governance by digitalising offices (both head office and regional offices) and having interactive portals.
-
In an effort to facilitate the fast growing Indian pharma industry to position itself globally, Drugs Controller General of India (DGCI) has initiated a centralised uniform system for various processes of the industry.
“Online real time system for various approvals will be fully operational within two to three,” the new DGCI DrSurendra Singh said, while inaugurating a seminar on ‘How quality pays’, organised by the Indian Drug manufacturing Association.
Singh said 60% of the delays faced by the industry was in getting test licence, export NOC and to get approval for conducting clinical trials and all these delays will be addressed by setting up a system e-governance by digitalising offices (both head office and regional offices) and having interactive portals.
DGCI office is trying to fix time frame for all the procedures of not more than eight weeks, including issuing of test licenses, NOC for export and clinical trials, in cooperation with the pharma industry.
Ranbaxy begins operations in Yemen
Pharma-major Ranbaxy Laboratories Ltd on Wednesday said it has commenced its operations in Yemen, strengthening its presence in the West Asian region.
Ranbaxy has tied up with Pharma Ltd (Natco) as business partners for its Yemen operations. Ranbaxy will focus on therapy areas such as anti-infectives, gastro-intestinal, cholesterol lowering and anti-allergic categories in Yemen.
WHO Counterfeit definition worries Pharmas
The domestic drug industry is concerned over ongoing World Health Organisation (WHO) negotiations that aim to bring non-health issues, having no direct implications on the safety of a drug, within the ambit of the definition of "counterfeit medicine".
The industry feels that a proposal by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of the WHO to consider apparent "trademark violations" as "counterfeiting" cases would harm exports of generic drug makers.
If the changes do go through, they say, foreign drug firms could stall exports of low-cost versions of patent expired medicines to key markets.
Today, Indian firms have several brands that sound similar to those
-
The domestic drug industry is concerned over ongoing World Health Organisation (WHO) negotiations that aim to bring non-health issues, having no direct implications on the safety of a drug, within the ambit of the definition of "counterfeit medicine".
<script language="JavaScript">
google_ad_client = 'businessstandard';
//google_ad_client = 'ca-businessstandard_js';
google_ad_width = 200;
google_ad_height = 200;
google_ad_format = "200x200_as";
google_ad_type = "text";
google_ad_channel = "";
//google_color_border = "FFFFFF";
google_color_border = "F7F7F7";
//google_color_bg = "FFFFFF";
google_color_bg = "ffffff";
//google_color_link = "639ACE";
google_color_link = "0253B7";
google_color_text = "000000";
google_color_url = "D63431";
//google_skip = adsenseSkip;
</script>
<script src="http://pagead2.googlesyndication.com/pagead/show_ads.js" type="text/javascript">
</script>The industry feels that a proposal by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of the WHO to consider apparent "trademark violations" as "counterfeiting" cases would harm exports of generic drug makers.
If the changes do go through, they say, foreign drug firms could stall exports of low-cost versions of patent expired medicines to key markets.
-
Currently, this would at the most be treated as a trademark violation. However, according to the definition proposed by IMPACT, the Indian product could be rejected as counterfeit, the sources explained.
This attempt to widen the definition of counterfeit medicine is happening at a time when a deliberate attempt is being made to label India as a major source of counterfeit medicines.
Indian companies, increasingly dependant on exports of cheap off-patented medicines to developed markets to drive business growth, will find this a major problem, the sources said.
- 2 more annotations...
Selected Tags
Related Tags
Sponsored Links
Top Contributors
Groups interested in drugs
-
Venezuela-Russia-OtherCountries
Higlites from around the wo...
Items: 5 | Visits: 113
Created by: liveinfreedom .
Diigo is about better ways to research, share and collaborate on information. Learn more »
Join Diigo