With environmental pollution, skin diseases are also increasing. Especially in hot weather of undeveloped and developing countries, the situation is more serious. Personal hygiene and sanitation is one of the important reasons of infecting skin diseases.
Fungal skin disease is one of the most common skin disease. Ciclopirox Olamine, with its excellent antifungal treatment of the dermatological infections tinea pedis, tinea cruris, tinea corporis, candidiasis(moniliasis) and tinea(pityriasis) vesicolor, the demand is increasing gradually.
CPhI Japan 2012
21-23 March, 2012 at Big Sight Exhibition Centre, Tokyo, Japan
CPhI China 2012
26-28 June, 2012 at SNIEC, Shanghai, China
CPhI South America 2012
21-23 August, 2012 at Sao Paulo, Brazil
CPhI Worldwide 2012
9-11 October, 2012 at Feria de Madrid, Spain
CPhI India 2012
21-23 November, 2012 at Bombay Exibition Centre, Mumbai, India
Turkey has a population of 72.6 million people. Turkey is the world's 12th largest pharmaceutical market. Turkish pharmaceutical market growth has been keeping more than 10% each year.
There’re more than 300 pharmaceutical companies, 95% of them are foreign capital companies. And the top 6 pharmaceutical companies covers 90% of the market share.
60% of Turkey drugs relies on imports. All the imported drugs must be registered first. Turkey don’t have its own GMP standard but adopts European GMP standard. For the 40% of local production drugs, 95% of it is produced by the joint venture pharmaceutical production. Due to expensive cost of drugs, Turkey government encourage to use generic drugs.
Turkey is also a re-export country. Their main exports countries is European Union, Russia and CIS countries.
Columbia Laboratories has transferred the new drug application (NDA) for progesterone vaginal gel 8% to Watson Pharmaceuticals.
The product is developed for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy.
Watson has gained full rights and regulatory responsibility for all activities and sponsor obligations relating to the application.
Watson will continue to work with FDA in support of the review of the NDA.
Columbia Laboratories president and CEO Frank Condella said they believe this is the appropriate time to transfer the NDA.
Singapore and EU bilateral free trade agreement negotiations successfully came to an end on the 16th Dec.2012. Under the agreement, within 5 years, the EU will eliminate all tariffs on goods imported from Singapore. In the beginning of the entry into force of the Agreement, the EU will cancel the 80% of the tariffs for the goods imported from Singapore, especially electronics, pharmaceuticals, chemical products and processed foods.
APIs produced in third countries in Asia (like China and India) can only be imported into the EU if the regulatory authority of the exporting country issues a written confirmation that those APIs have been manufactured in GMP-compliant conditions which comply with the European regulations. Moreover, the statement must also comply with the European regulations and ensure that information about non-Compliance shall be immediately reported by the authority of the third country to the EU.
It seems that neither authorities operating in the Indian provinces nor those operating in China have recognised the requirement of the EU and taken adequate measures. Although the API industry in India is concerned by the new requirement, no measure has been taken. As a consequence, some APIs might not be available in 2013. This scenario has already been raised by different industry organisations. Now the British Authority (MHRA) has also expressed their concern.
How to solve this issue? Currently many APIs are manufactured outside the EU in manufacturing sites without the necessary GMP supervision. The heparin scandal has recently shown the dramatic consequences of insufficient GMP monitoring of APIs. People died in the USA after heparin batches from different workshops have been processed to APIs without any control and falsified with the cheapest oversulfated chondroitin sulphate made of partly synthetic cartilage.
If manufacturing sites within the EU have to meet the latest GMP requirements (EU GMP Part 2 equivalent to ICH Q7) why should the EU authorities allow the import of APIs which may not meet the same standards? There is clearly a challenge to assure the availability of APIs on one hand but on the other hand also to guarantee that manufacturing sites outside the EU have no cost advantages due to the fact that GMP has not been implemented and supervised.
Also in terms of quality of medicinal products, the manufacture of APIs without GMP compliance can’t be acceptable. If no "written confirmation" is provided, the pressure remains in the hands of the European authorities which should perform inspections in the third countries. The significance of the QP Declaration as well as the underlying audits of pharmaceutical manufacturers keep on increasing.
One possible solution to the problem is that EU authorities provide regulators in India and China with much more information about new regulations than they have so far. Both ministries and administrative bodies have been extensively exchanging information with these two countries for years already. Another option would be to postpone the implementation deadline for some months.
India and China may together move the World Trade Organisation (WTO) against the European Union (EU) regulation on bulk drugs which may affect the current exports of Active Pharmaceutical Ingredients (APIs) from both the countries to Europe.
EU has changed the rules for importing active substances into EU for medicinal products for human use and the amended regulation would come into effect fully by July 2013. It would make mandatory the current good manufacturing practices (cGMP) certificate from the local authority for all bulk drugs exports.
Sources said the Commerce Ministry had already taken up the matter with the EU authorities as the directive is expected to pose serious challenge to the API exports and is meant to secure the EU pharma supply chain.
Under the technical barrier to trade (TBT) provisions, India can raise the issue at the WTO forum and it is learnt that India would all possibly make a joint statement with China at the next meeting of the WTO. China Chamber of Commerce had already written to Pharmaceutical Export Promotion Council of India (Pharmexcil) on the possibility of making joint representation, it is learnt.
China’s share in EU’s API imports is 12 per cent while India commands only two percent share in the API imports into the EU. Hence, China is going to be affected more than India.
The Commerce Ministry has also sought the opinion of the Bulk Drug Manufacturers Association over the issue.
Meanwhile, the industry representatives are also trying to take up the issue with Drugs Controller General of India (DCGI). Industry had pointed out that the DCGI was not authorized or conversant enough with EU GMP standards to issue certification. The companies will have to produce such certificates even after their manufacturing facilities and products (meant for exports) get all regulatory clearances directly from the EU drug regulatory authorities in that case.
Reported by Joseph Alexander, New Delhi
According to figures released by the Department of Pharmaceuticals (DoP) of India, China retains its position as a major exporter of Active Pharmaceutical Ingredients (APIs) and other intermediaries to India. There was a slight decline in the quantum of supply last year from China as it went down from $1881 million in 2010-11 to $1646 million till February during the financial year of 2011-12.
In totality, total import of API by India went up from $2998 million in 2010-11 to $ 3069 million in 2011-12. Figures suggest that with this, the share of China came down to 54% in the total imports. union Minister of State for Chemicals and Fertilisers Srikant Kumar Jena said, “Ministry of Commerce & Industries has clarified that Indian pharmaceutical Industry has been importing APIs and Intermediates from various countries, including China to meet the increasing demand.”
While the DoP did not form an Inter Ministerial Committee, which was recommended by the 45th Report of Parliamentary Standing Committee on Health, a High Powered Inter-Ministerial Coordination Committee was formed under the Chairmanship of Secretary (Pharmaceuticals). The attempt of this committee was to look at implementation of the government commitment for quality medicines at affordable prices.
A global pill price survey has revealed that the price of a commonly used antibiotic ‘ciprofloxacin’ is beyond the reach of many people in Africa because of its high cost.
With richness in heparin materials and the quality of heparin API getting accredited by the international community, China has become one of the largest heparin API producers and exporters in the world. In 2010, there were 24 heparin API manufacturers with the heparin sodium API production license granted by SFDA in China, with the export volume of heparin API reaching 15.9 trillion units, a 52.1% market share globally.
Europe and America are the major export destinations of heparin API made in China. From January to July of 2011, heparin and heparinate made in China were exported to 44 countries. In terms of export volume, the top 5 export destinations were France, Germany, America, Austria and Italy, with the combined export volume standing at 83.7%.
It is required to obtain CEP certification of EU or FDA authentication of the US for companies to access into the European and American markets. Due to the stringent authentication criterion, many unqualified enterprises are forced to withdraw from the market. As of August, 2011, China had 6 CEP certified heparin API producers and 2 FDA certified ones.
The Active Pharmaceutical Ingredient (API) forms the most vital part of every formulated end product, and is an important part of the whole pharmaceutical industry. The overall API market was valued at $101.08 billion in 2010, and is expected to grow at a CAGR of 7.9% from 2011 to 2016.
Africa has become the largest export market for medicine made by China and one of the fastest-growing markets for Chinese medical products, a senior medical official said at an ongoing import-export fair in South China's Guangdong province.
Statistics released by the China Chamber of Commerce for Import & Export of Medicine & Health Products (CCCMHPIE) showed the value of medical products exported from China to Africa from 2012 January to September totaled $1.47 billion, an increase of 13.48 percent year on year.
The growth rate of exports to Africa was higher than that for European and North American markets in the same period.
"Africa now has a population of about 900 million, accounting for 12 percent of the whole world, so it has large demand for medical products," told by director of CCCMHPIE at the China Import and Export Fair in Guangzhou.
Chinese medical producers exporting medical products to Africa have played a great role in the African market in recent years, and China is changing the historical lack of medicine there.
In fact, the volume of medicine that China imports to Africa is growing at a faster rate than the volume it is exporting to Southeast Asia, Mexico and Russia, according to the official.
Purchasers from Africa attending the fair said that the low prices and good quality of China's medical products were the major reason they chose to import.
Chinese API makers will have to tell the SFDA if they have a European GMP certificate as part of a wider industry investigation prompted by new EU import laws.
Regulators in Non-EU countries can use results of previous inspections of API plants by EU or equivalent authorities in written confirmations, according to the European Commission.
Scientists at Aston University and Russells Hall Hospital have discovered that an extract from a common plant in Pakistan may help cure breast cancer.
The plant, Fagonia cretica, and known as Virgon's Mantlem, is commonly used in herbal tea. It has been traditionally used to treat women in rural Pakistan who have breastcancer, but up until now this treatment has been regarded as something of a folklore remedy. However, patients in Pakistan who have taken the plant extract have reported that it does not appear to generate any of the serious common side effects associated with other cancer treatments, such as loss of hair, drop in blood count or diarrhoea.
Now, scientists at Aston University in Birmingham and Russells Hall Hospital in Dudley have undertaken tests of the plant extract and proved that it kills cancer cells without damage to normal breast cells in laboratory conditions.
Professor Helen Griffith and Professor Amutul R Carmichael who lead the study are now aiming to identify which element or elements of the plant are responsible for killing the cancer cells with a view to eventually begin trails with human cancer patients.
Professor Helen Griffith of Aston University said; "More research is needed to establish the role of the extract in cancer management and It now needs to be demonstrated that this extract is as effective in killing cancer cells inside the body as it is within laboratory. The next steps are to identify which element of the plant is responsible for killing the cancer cells with a view to eventually begin trails with human cancer patients."
Dr Caitlin Palframan, policy manager at Breakthrough Breast Cancer said; "Some of the most important cancer-fighting drugs are originally derived from plants. As this research is at the very earliest stage we won't know for quite some time whether drugs derived from this plant will be effective in treating breast cancer but we look forward to seeing any progress."
The Chinese Authorities have recently released a few newslets, one concerning the “Written Confirmation for active substances exported to the EU”, an omnipresent topic.
The China Food and Drug Administration (CFDA) (former SFDA) recently issued a document on relevant issues on written confirmation for active substances exported to EU, which specifies the issuer, the issuance method, and the format of the written confirmation for active substances exported to EU. The notice also specifies the scope of active substances which can apply the written confirmation, and the application and issuance procedures for the written confirmation.
Furthermore the CFDA has announced the implementation of an electronic supervision for drugs in the National Essential Medicine List and has published two drug quality announcements of illegal drugs, medical devices and health food advertisements.
Even though the announcements are kept to a minimum they show, that changes are underway.
Edinburgh University scientists hope the quercetin extract will pave the way for new treatments to ease the symptoms of incurable spinal muscular atrophy.
The disease, known as floppy baby syndrome, leaves children with little or no control of their movements.
One in 6,000 babies are affected by the condition, and about half with the most severe form will die by the age of two.
Edinburgh University experts found evidence that quercetin, found in some fruits, vegetables, herbs and grains, could help prevent damage to nerves associated with spinal muscular atrophy (SMA).
The chemical targets the build-up of a specific molecule inside cells, called beta-catenin, that is responsible for some of the symptoms of the condition.
Tests of a purified form of the extract on zebrafish, flies and mice led to a significant improvement in the health of nerve and muscle cells.
Prof Tom Gillingwater, of Edinburgh University, said: "This is an important step that could one day improve quality of life for the babies affected by this condition and their families.
"There is currently no cure for this kind of neuromuscular disorder so new treatments that can tackle the progression of disease are urgently needed."
It is hoped better versions of quercetin can be created that are more effective than the naturally-occurring chemical.
The U.S. Food and Drug Administration is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications. The agency recently issued letters warning 15 companies that the sale of their illegally marketed diabetes products violates federal law. The letters were sent to foreign and domestic companies whose products were sold online and in retail stores.
The FDA is advising consumers not to use these or similar products because they may contain harmful ingredients or may be otherwise unsafe, or may improperly be marketed as over-the-counter products when they should be marketed as prescription products. Using these products could cause consumers to delay seeking proper medical treatment for their diabetes. FDA-approved diabetes treatments, prescribed by a licensed health care professional and shown to be safe and effective, are readily available for people with diabetes.
"Diabetes is a serious chronic condition that should be properly managed using safe and effective FDA-approved treatments," said FDA Commissioner Margaret A. Hamburg, M.D. "Consumers who buy violative products that claim to be treatments are not only putting themselves at risk but also may not be seeking necessary medical attention, which could affect their diabetes management."
Nearly 26 million Americans have diabetes, a disease in which blood glucose or blood sugar levels are high, resulting from the body's inability to produce sufficient amounts of insulin or to effectively utilize its own insulin. There is a greater risk for serious health complications, such as heart disease, blindness, kidney failure, and lower-extremity amputations, if diabetes is not managed appropriately.
"The FDA is committed to protecting consumers from the dangers of these illegally sold products," said Howard Sklamberg, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "We will continue to take aggressive action against firms that sell illegal products claiming to treat diabetes."
Many of the illegally sold products that are the subject to this action include claims such as "prevents and treats diabetes," and "can replace medicine in the treatment of diabetes." In addition, some of the products may cause harm because the products contain undeclared active pharmaceutical ingredients or may not have been manufactured and handled according to FDA quality standards.
These illegally sold products include:
Products sold as "natural" treatments for diabetes, but containing undeclared active pharmaceutical ingredients in unknown quantities that could cause harm or complicate medical conditions;
Dietary supplements and ayurvedic products (medicine of the healing arts that originated in India) with claims to treat, cure, and/or prevent diabetes;
Unapproved drugs sold over-the-counter, including some homeopathic products, intended to treat complications associated with diabetes, which include relieving symptoms caused by nerve damage in the arms and legs (also called peripheral neuropathy); and
Prescription drugs for diabetes sold by online pharmacies without a prescription.
The FDA has requested a written response from these companies within 15 business days stating how the companies will correct the violations. Failure to promptly correct the violations may result in legal action, including product seizure, injunction, and/or criminal prosecution.
The increased cost of drug development has impelled pharmaceutical companies to seek better opportunities in emerging markets to successfully expand and sell their products. Most pharmaceutical companies consider emerging markets lucrative due to their economical infrastructure and manpower costs and a significant untapped market potential with a large population.
New analysis from Frost & Sullivan, Global Pharma-Biotech Alliance Analysis, finds that healthcare reform programmes in emerging markets have dramatically improved the level of healthcare coverage in these countries. The regions covered in this research service include the so-called BRIC countries, Brazil, Russia, India, and China. In fact, China is expected to be the third fastest growing pharmaceutical market in the world by 2011.
Global Pharma-Biotech Alliance Analysis is part of the Pharmaceuticals & Biotechnology Growth Partnership Services programme, which also includes research in the following markets: Global Active Pharmaceutical Ingredients (API) Market - An Outlook, Strategic Analysis of European DNA Microarrays Market, Life Sciences Funding, Overview of the Healthcare Industry in Central and Eastern European Countries, Global Skin Cancer Therapeutics Market, and European Lifestyle Disorders Therapeutics Market, among others.
"With companies focusing on emerging markets, they would need to address the varying medical requirements of each of these markets," says Frost & Sullivan Research Analyst Swetha Shantikumar. "Therefore, there will be an overall shift in the pharmaceutical industry from a very Western centric model to a global one."
When it comes to drugs, most of the attention goes to the active pharmaceutical ingredient. But typically the vast majority of what’s in a tablet, capsule, or liquid isn’t the active ingredient. A drug is formulated with many other compounds, called excipients, that play an essential role in delivering the active ingredient to the patient.
Lubricants, for example, make a bulk material easier to handle in a manufacturing facility. Fillers may be added to make small doses, such as 5 mg of an antihistamine, physically large enough for a person to handle easily. Fillers may double as binders to help hold a tablet together. Coatings protect a tablet from moisture or light or mask an unpleasant flavor. Disintegrants help a tablet fall apart in the digestive tract to release the active drug.
The pharmaceutical-standards-setting organization U.S. Pharmacopeia (USP) counts nearly 500 excipients in its National Formulary. The global excipients market was $5.9 billion in 2012 and is expected to reach $8.8 billion in 2018, according to market research firm BCC Research.
Despite the crucial role that excipients play in getting drugs successfully into patients, some regulatory analytical procedures for excipient quality control are decades old. These methods do not meet modern expectations for analytical rigor or actually test that a product is what’s said on its label. What’s more, excipients are not exempt from rising anxiety in recent years about the integrity of global pharmaceutical supply chains. In one instance, counterfeiters substituted less expensive and toxic diethylene glycol for glycerin in cold medicine sold in Panama in 2006, killing at least 100 people. In response to these concerns, USP, in collaboration with the U.S. Food & Drug Administration and similar organizations around the world, is working on updating analytical requirements for excipients.
It’s an effort that’s easier said than done. Many excipients are not cleanly synthesized small molecules. Instead, they may be analytically challenging materials that are polymeric, prepared from animal or plant material, or mined. Also, the markets for industrial or food uses for a particular product often far outweigh the pharmaceutical excipients market. Manufacturers may not see a strong need to continue to supply the pharmaceutical industry if they’re faced with buying expensive instrumentation that requires highly skilled operators. Raising analytical standards is consequently a balancing act between ensuring the safety of pharmaceuticals and preserving the excipient supplies to formulate them.
CPhI South East Asia-Jakarta 8 - 10 April 2015
CPhI Japan 22 - 24 April 2015
CPhI Russia 27 - 29 April 2015
CPhI Istanbul 3 - 5 June 2015
CPhI and P-MEC China 24 - 26 June 2015
CPhI South America 25 - 27 Aug. 2015
CPhI Korea 7 - 9 Sept. 2015
CPhI Worldwide Madrid 13 - 15 Oct. 2015
CPhI and P-MEC India 1 - 3 Dec. 2015
The U.S. Pharmacopeial Convention (USP), a global health organization that aims to improve lives through public standards for foods and medicines, hosted a seminar on pharmacopeial and regulatory compliance at CPhI China 2015 to help industry leaders and experts deepen their understanding of the latest quality standards and regulatory updates.
Former officials from U.S. FDA, experts from USP and the Chinese Pharmacopoeia Commission (ChP) as well as senior executives from pharmaceutical companies were invited to deliver keynote speeches. Over 120 industry leaders and executives from domestic pharmaceutical companies participated in the seminar.
“In recent years, we’ve seen an increasing number of Chinese pharmaceutical companies that are expanding internationally. It is necessary for these companies to be compliant to the latest pharmacopeial quality standards and regulations in order to run businesses in a stringent regulatory market.
“To address growing demands, USP is committed to helping these companies meet pharmacopeial standards, provide training and certification services to help them comply and also guide them to contribute towards shaping global standards,” said Dr. Feng Bingbing, chairman of the seminar and USP-China General Manager.
The USP seminar focused on key industry concerns related to global and local pharmacopeial standards and regulations. Industry’s concerns are closely aligned with recent efforts made by the Chinese government to step up the regulation of local quality and safety standards, strengthen compliance monitoring and enforce strict penalties and related accountability for food and medicines safety. Other key event highlights include:
- USP’s requirements for elemental impurities (which will replace USP’s existing standard for heavy metals) effective in 2018;
- US FDA’s new initiative, the Quality Metrics Program, and the use of big data to improve regulatory effectiveness;
- US Generics Market Overview: Opportunities and challenges for Chinese companies;
- ChP 2015 Overview, which is to be effective by December 1, 2015.
"China is a major exporter of raw materials for pharmaceuticals, and increasingly for drug products, throughout the world. USP places great importance on the Chinese market, and we are committed to supporting the growth of local industry. To this end, we have built R&D and training facilities with an area of 10,000 square meters in the Shanghai Pilot Free Trade Zone to better serve their needs. We will strengthen our collaboration with the Chinese Pharmacopoeia Commission and other partners to share knowledge on pharmacopeial standards, promote industry developments and improve public health,” said Dr. Feng Bingbing.