Saturday, November 21, 2009

Pharma export certificates to be issued by Centre, not states

Indian drug firms will soon have to approach the Centre rather than state authorities to get their facilities and export products certified, a move that industry players say could streamline the regulatory process for pharmaceutical sales overseas but add to delays.

The Certificate of Pharmaceutical Product (Copp) and good manufacturing practice (GMP), as laid down by the World Health Organization (WHO), will be issued by the national regulatory authority or the Drugs Controller General of India (DCGI) from 1 October, the government said in a notification last week.
Copp is mandatory in many countries that require WHO accreditation for products being imported. It will now be issued by the Central Drugs Standard Control Organisation (CDSCO).

The decision to take back the authority from the states was made during the 40th drug consultative committee (DCC) meeting in June, after several issues raised by WHO over the issuance of these certificates.“The WHO has time and again expressed concerns on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce,” the government said in the notification.

“The standard for giving Copp certificates by the states is lax and if tomorrow the WHO comes and audits the facilities, we can have problems,” said a senior official with the health ministry who did not want to be named.
Indian drug firms have had issues with foreign regulators in the past year over standards at their manufacturing plants.

A year ago, the US Food and Drug Administration (FDA) issued warning letters and import alerts on Ranbaxy Laboratories Ltd for deviations from good manufacturing practices after it audited the firm’s plants at Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh.The Indian pharmaceutical exports council, Pharmexcil, says the new system would help streamline exports. “This is a welcome step by the DCGI. It will help in the international market since it maintains uniformity and transparency,” said P.V. Appaji, executive director, Pharmexcil.
There were concerns, however, that possible delays at the Centre in issuing the certificates would lead to a delay in exports, he said. Till February, India’s pharmaceutical exports were worth Rs38,000 crore, a 30% growth over the previous fiscal year.

Small scale industries, too, are worried the move could hamper their exports.
“This decision of creating non-tariff barriers of centralizing issuance of Copp is just to please the MNCs (multinational companies), to kill the export competitiveness of the small sector against public interest,” said Lalit Kumar Jain, senior vice-chairman, SME Pharma Industries Confederation (Spic).

Indian pharma industry may grow around 13% in 2009

Indian pharma industry is likely to grow by 12-13% in 2009 against earlier projections of 15% due to the global economic meltdown, a research firm has said.“In 2009, the Indian pharma industry may see a growth of 12-13%, as against our earlier forecast of 14-15%, due to the macroeconomic condition that we are having,” ORG IMS Research managing director Sameer Savkur said at a conference here.
Mumbai-based ORG IMS Research Pvt Ltd is a joint venture of AC Nielsen ORG-Marg and IMS Health, the UK.

“Global pharma growth has been declining in the past five years. There is only a small impact on India. It will see double-digit topline growth,” IMS Health vice president (Europe) Graham Lewis said.

Lewis said there has been a significant amount of restructuring in the global pharmaceutical industry, with smaller companies running out of cash and bigger companies merging with each other.

The Indian pharma industry, which grew by over 10% last year, is likely to see a marginal 1-2% spurt in growth in the next four to five years, Savkur said.
The industry grew by 10.2% in 2008 due to some extraneous circumstances, he said.
He, however, termed the Indian pharmaceutical industry as “promising”, and estimated its size to touch $30 billion by 2020.

Chronic therapy will continue to be a key growth driver, Savkur said, adding that companies are focusing on extra-urban markets as these contribute about 40% to their turnover.

Sunday, October 25, 2009

Antibiotics rule pharma retail market

NEW DELHI: The first quarter (January-March) of this year has witnessed a change in the domestic pharma retail market with antibiotics and anti-bacterial drugs dominating the show in top 10 brands.

At least four major antibiotic and antibacterial drugs are figuring in the top pharma brands during the quarter for perhaps the first time. These include Augmentin (manufactured by GlaxoSmithKline), Mox (Ranbaxy), Zifi (FDC Ltd) and Taxim (Alkem).

Augmentin is ranked four with cumulative sales of Rs 27.4 crore, Mox is the fifth largest drug with cumulative sales of Rs 26.6 crore, followed by Zifi at number seven position (Rs 23.6 crore). Taxim — another antibiotic medicine, is the ninth largest, netting sales of Rs 22 crore in January-March quarter.

All these drugs have also shown a huge double-digit growth, with anti-bacterial medicine Zifi growing by nearly 40% during the quarter (37% in March alone) and Mox netting 30% growth. Even in March, the rankings are pretty similar to the quarter, with Augmentin the fourth largest drug, followed by Zifi, Mox and Taxim at number 9 slot.

Doctors attribute the growth in sales of these drugs to the fact that these antibiotics are used to treat a wide variety of infections, and do not have many side-effects. Last year (January-December 2007), Taxim was the fifth largest drug followed by Augmentin.

During the first quarter of 2008, cough and cold medicine Corex was the number one brand with sales of Rs 36.65 crore, followed by painkiller Voveran. During March alone Voveran had marginally higher sales of Rs 10.54 crore as against Corex, which registered sales of Rs 10.49 crore.

Interestingly, the growth of the industry is mainly driven by the chronic segment (like cardio-vasculars, diabetics, central nervous system), which have grown by 17-18% last year. Against this backdrop, offtake of acute segments (anti-infectives, gastro-intestinals, nutritionals) has been slow and grown by 10-15% only, industry experts said.

The domestic pharma market with a size of Rs 35,000 crore is largely fragmented, with many small players. Biggies such as Cipla and Ranbaxy are battling for market shares. For some time now, Cipla has been leading the pack with a market share of 5.64% (during the quarter), followed by Ranbaxy and GSK.

Source:TNN

Monday, October 5, 2009

Pharma industry untouched by recession

The global recession has affected all sectors, expect for the pharmaceutical industry. This leaves a wide choice for the pharmacy students.
This was the opinion of all the heads from the four premier pharmacy associations -- IPA, IHPA, IPGA and AIDCOC -- at a symposium on pharmacy studies held recently at GITAM Institute of Pharmacy.

If this is the scenario, then the young minds who take up pharmacy as study need no longer look at the discipline as fallback option in the event of not securing a seat in medicine or engineering.

Big picture

After a modest beginning, the Indian pharmaceutical industry is today the fourth biggest industry in the world as far as volume or production is concerned and 14th in terms of value. The Indian industry is USD 8.4 billion worth at present. According to the Chairman of Indian Pharmaceutical Association T.V. Narayana the patent regime has brought business worth USD 5 billion and has also triggered the growth of the pharma industry as innovative industry. The patented drugs have recorded a growth of over 37 per cent in the last couple of years.
He says that by 2012, USD 80 billion worth of patent protected drugs in the US would go off patent. The Indian companies are in a position to tap this generic market with reverse engineering skills and low cost factor. The present share of USD 8.4 billion would rise to USD 60 billion by 2020, and this would give fresh opportunity to about five lakh pharmacy professionals.
Prof. Narayana also informed that the much-neglected research and development and DDD (drug, discovery development) sector is also being suitably addressed. “The government has sanctioned about Rs. 150 crore under the Department of Science and Technology for research. The research and DDD segment itself would need about 2 lakh professionals,” he said.

Why India?
Many factors contribute to the growth of the pharmacy sector in India. The factors that mainly contribute are: Vast technical pool and skilled manpower, low cost factor, availability of state-of-the-art facility, vast pool of English speaking manpower, reverse brain drain and vast network of export bases in South America, Africa, Europe and China. India also has the highest number of USFDA (US Food and Drug Administration) approved plants.

Pharmacy study
The pharmacy study in India can be broadly classified into two-year diploma, four-year degree in pharmacy (B. Pharm), two-year post-graduate degree in pharmacy and Pharm D.
While the diploma focuses on hospital and community pharmacy, the degree and PG courses focus on pharmaceutical industry, enforcement agencies and teaching prospects. These apart, the Ph.D programme is always open to the students with research bent of mind.
The Pharm D is the new concept that has been introduced lately. This is a six-year integrated course and students can join after plus two. The syllabus for this course has designed by Pharmacy Council of India (PCI) and is in tune with the international curriculum. Students can join MS programmes in foreign countries after completing this course.

The PCI has also decided to revamp the syllabus for the diploma, degree and PG programmes to suit the industry requirement. Prof. Narayana however, advises the students to take up three-month certificate courses offered by a few pharmaceutical companies to gain experience and gear up for the industry requirement.
He also suggests that students should join pharmacy colleges that are recognised by PCI and are rated by the National Board of Accreditation.
Options

The options for pharmacy students are wide and are well spread within the industry itself. After passing out the students can join any pharmaceutical industry, regulatory and enforcement bodies, community pharmacy, teaching, hospital and clinical pharmacy and research and development sector.
Within the pharmaceutical industry the options could vary from manufacturing to quality control and from regulatory to research and development. “The Medical Council of India has now made it mandatory that all hospitals attached to medical colleges should have a clinical pharmacy department. This regulation would also add up to the job opportunities,” said Prof. Narayana.

Source: The Hindu

Sunday, September 27, 2009

Indian drug market to triple to $ 20 bn by 2015: Report

The Indian pharmaceutical market is expected to triple to USD 20 billion by 2015 from USD 7.1 billion in 2007 with a CAGR of 12.3%, and move into the world’s top 10 markets. The commercial attractiveness of India as a “market” is a key factor influencing India’s attractiveness as a “clinical trial destination” , says a FICCI-Ernst & Young Report on Compelling Reasons for Doing Clinical Research in India.

The report notes that In 2015, India could be a potential USD 8 billion market for MNCs with patented drugs accounting for nearly 8-10 % of the total market. The reasons are:

The advent of the product patent regime in 2005. The patent infrastructure in the country has been appreciably upgraded over the past few years to support new laws with the addition of patent examiners, decentralization of the filing process and digitization of records. Patent-protected products have the potential to capture up to 8-10 % share of the total market by 2015, implying a market size of USD 2 billion.

The population in the highest income class is expected to grow to 25 million in 2015 from 10 million today, which will drive the affordability of high value patented drugs. MNCs already present are further consolidating their presence in India while new entrants are increasing.

MNCs are increasingly restructuring their operations with global parents increasing their equity stakes in their Indian affiliates. Companies such as BMS and Merck that had exited the Indian market have staged a re-entry . MNCs are acquiring Indian companies to expand their presence, e.g., Daiichi and Ranbaxy.

The FICCI-E&Y report mentions that in addition, India also has a significant cost arbitrage in the conduct of clinical trials, including infrastructure, operational, patient recruitment, drug, manpower , data management and processing costs.

Indian allied service market is growing at a CAGR of 21% as compared to 7.5% globally. The allied services outsourced market in India was estimated to be USD106m (2008) (1), growing at a rate of 21%. Although initially sponsors and CROs were driven to offshore locations due to their cost advantage , the focus has now shifted to the quality of delivery and responsiveness to business uncertainties .

India, due to its proven track record of managing IT/ITES work and growing domain expertise, has emerged as an attractive destination for the entire segment.

The FICCI-E&Y report states that India offers a conducive business environment to meet the emerging requirements of the allied services market . Its cost leadership and system capabilities, coupled with an abundant skilled and English-speaking talent pool, has made it a destination of choice for offshoring allied services

Source: ET Bureau

Big pharma pays billions in fines for bribing doctors

In what seems to be a case of giving the fox the job of guarding the henhouse, the government has decided to curb the practice of bribing doctors for promoting drugs by allowing pharmaceutical companies to self-regulate rather than have a legislation to tackle the menace.

This is despite the fact that more than a quarter of the members of the Organisation of Pharmaceutical Producers of India (OPPI) — an association mainly of multinationals which is estimated to account for 70% of the drug market in India — are subsidiaries of companies that have been penalized in the US for illegally promoting various drugs through inducements for doctors.

The latest to be penalized is pharma giant Pfizer, which on September 2 shelled out $2.3 billion in one of the biggest healthcare fraud settlements.

The charge against Pfizer was that it promoted drugs for usages not approved by the Food and Drug Administration, by inducing doctors to prescribe the drugs by wining and dining them and sending them for exotic trips.

Another big player, Eli Lilly, was fined $1.42 billion at the beginning of the year for illegally promoting a drug, Zyprexa, by funding continuing medical education of doctors through millions of dollars in grants to push them to prescribe the drugs for unapproved use.

Source: TNN 16 September 2009

Wednesday, September 16, 2009

Pharma “has now reached three tipping points”

Healthcare is currently out of balance and so therefore is the pharmaceutical industry, as its fortunes are driven by healthcare systems, virtually all of which are now restructuring, says a new report.

There is a danger that the current pharmaceutical model may become irrelevant in the context of twenty-first-century global health needs, warns the report, from experts at management consultants AT Kearney, who believe that the industry has now reached not one but three interconnected tipping points, concerning what it sells, to whom and how it must be organised.

The first tipping point relates to the move from therapies to service models. The pharmaceutical sales model has always assumed that prescribing doctors are the primary decision-makers, and that prescribing decisions are based solely on their perception of patient need, say the report’s authors, Jonathan Anscombe and Michael Thomas. But now, increasingly, the doctor is being constrained or influenced by formularies, guidelines, IT systems and financial mechanisms, driven by payers and regulators or by provider organisations responding to payer costs and political pressures.

Payers’ priorities vary considerably, but their growing influence is changing the traditional assumption that volume is not elastic to price. Bodies such as the National Institute for Health and Clinical Excellence (NICE) define where a drug is used in the care pathway based on clinical cost-effectiveness, and often relegate expensive drugs to second-, third- or even fourth-line treatments even if they have high efficacy as a first-line treatment. Also, more and more, drugs’ usage moves from treatment to prevention as they decline in cost.

For payers, the availability of marginally more effective but much more expensive treatments is far from compelling, especially given that with many drugs, patients simply fail to take them as directed. What would, however, be compelling for payers is a service model that enables therapies to be administered with high compliance and can be proven to result in fewer admissions, the authors suggest. It would be even more compelling if this could be demonstrated in the payer’s specific care system and target population - positioning a therapy in this context dramatically increases its value, they say.

The second tipping point concerns the US market which, although still dominating the industry, is failing and will continue to do so - whatever the outcome of President Barack Obama’s health reform plans – as mechanisms to limit access to medicines based on cost-effectiveness inevitably spread.

At the same time, healthcare demand is shifting rapidly towards the developing world. The incidence of developed-world diseases is increasing dramatically in emerging markets, and most of them are moving towards some form of comprehensively funded healthcare system, as soon as they can afford it. However, they will not be prepared to pay western-style prices.

The industry must view emerging markets in a new light, not just as an opportunity for lowering R&D costs or demonstrating market commitment but as a source of low-price, breakthrough innovation, the authors advise. If the global pharmaceutical industry does not respond to these challenges, then local companies surely will, they warn.

The third tipping point relates to the fact that the traditional model of a globally integrated pharmaceutical industry is becoming too large, unwieldy and unfocused. Successful drugmakers of the future will shift from being R&D- to market-driven, and their challenge will be to decide on which therapy areas they should focus.

The shift towards mass-market solutions also introduces a dramatically different dynamic to the supply chain, where costs become a key profit driver, and there will be further emergence and consolidation of highly-efficient outsource manufacturers, the authors predict. Managing contractual relationships with these providers will become a core competence for pharma, and a major driver of profitability, they add.

Shifts in distribution strategies will also accelerate, and the current move from wholesale distribution towards direct-to-pharmacy will shift again to direct-to-patient, they forecast.

The authors conclude that several different types of pharmaceutical companies, all with different competencies, will operate in the space currently occupied by integrated firms. For example, value-delivery companies will focus on specific therapies in certain countries and gear value propositions in response to local market needs, while health innovatorss will develop and leverage technologies in as many applications as possible to gain a return on investment at a reasonable cost, and supply-chain firms will focus on optimising operating efficiencies. The truly connected pharmaceutical company will have to decide which of these functions it wishes to deliver, and which firms it needs to partner with to deliver other services, they say.

Source: Lynne Taylor in Pharmatimes

Monday, September 14, 2009

Pharma Evolution

In the year 754, Arabian pharmacists opened in Baghdad what was to be the first known drugstore in the world. Soon thereafter many more drugstores would pop up here and there throughout Europe and by the 19th century, these drugstores spread to North America and evolved into bigger drugstores and eventually into pharmaceutical companies.

The discoveries of penicillin and insulin brought great excitement to pharmaceutical companies during the 1920’s and 1930’s and led to mass distribution of these medicines. During the 1950’s, huge growth in the industry took place with the development of sophisticated manufacturing processes. New drugs were continually being researched and produced and several years after the second world war, the demand for drugs like the first oral contraceptive was phenomenal in the 1960’s. This new drug, “The Pill”, was pretty much responsible for ending the baby boomer era.

This time period also ushered demands for drugs like heart medications and high-blood pressure medicines. Another popular item on society’s drug shopping list during this time period was the MAO Inhibitors, Thorazine and Haldol along with tranquilizers. These new drugs brought about a revolution in the use of psychiatric medications. Valium became the most widely prescribed drug in history from 1963 onward, at least, until public controversy about patients becoming addicted to it began to stifle its use. Then there was the Thalidomide tragedy during the 1960’s, a new tranquilizer used by pregnant women that caused severe birth defects. With the introduction of new marketing techniques like the internet and other medias during the 1990‘s, drug purchases became possible directly from drug producers by consumers and as a result, drug advertisements on radio and television began to flood the market.

In 1997, the FDA relaxed the previously stiffer requirements that drug producers thoroughly explain the side effects and adverse reactions of drugs in their advertisements, which greatly accelerated pharmaceutical sales. The next big seller was the much sought after antidepressants, especially Prozac. Today, there are more than 200 major pharmaceutical companies researching and producing a constant flow of drugs onto the market. One thing that helps keep the flow going is the fact that doctors will many times receive incentives to prescribe medications. If you find that hard to believe, you should know that the president of the American Psychiatric Association recently admitted that in general, it is rather common for psychiatrists to accept bribes and kickbacks from drug companies to push their products. Another common complaint against pharmaceutical companies is disease mongering or the act of encouraging medical professionals to create new disorders that will require new medications.

Billions of dollars are invested in expensive medications, while very little interest exists in investing in treatments for sicknesses in countries with little or no money to spend on drugs such as malaria in Africa. A private consulting firm known as Bain & Company reported that the cost of discovering, developing and marketing each new drug was nearly $1.7 billion in 2003. In order to save money, pharmaceutical companies will sometimes re-formulate an existing drug, give it a new name and release it as something “new and improved” to people who are desperate to improve their health. The cost of producing these types of drugs are less than $200 million, a big savings by comparison. The world spent $643 billion on prescription drugs in 2006. Pfizer's pill for cholesterol, Lipitor presently tops the list as best-selling drug in the world. With annual sales of $12.9 billion, this drug has been at the top for five years in a row. In the United States, 3.4 billion total drug prescriptions are written every year with new blockbuster drugs to be released in the near future.

A big part of pharmaceutical companies success is that they commonly spend a huge amount of money on advertising and marketing. In the US, drug companies spend $19 billion a year on marketing campaigns. Besides marketing, pharmaceutical companies hire sales representatives to speak directly to physicians while they are at work in their offices and clinics, encouraging them to write prescriptions and leaving with them bundles of samples and other gifts. Drug companies spend $5 billion a year sending these drug reps to visit doctor’s offices. They also hire thousands of lobbyists to influence politicians in the direction of leniency toward drug manufacturing laws and stricter policies against frivolous drug lawsuits. Drug companies spent $855 million in the 8-year period of 1998 to 2006 on lobbying activities. Lawsuits against pharmaceutical companies are being filed on a daily basis for drugs they produced that have serious side effects, like heart attack, stroke, paralysis and even death. Drug making is big business, with some sad consequences at times.

Source: Suzanne Leavitt in examiner.com

Sunday, August 23, 2009

Codex Alimentarius

A scenario of drug dealers selling vitamins could become the norm soon, because of a set of “guidelines” used by the World Trade Organization (WTO) to resolve disputes.

These Guidelines are called the Codex Alimentarius (Food Cleanliness Codes). Because the WTO will use these guidelines to resolve disputes, countries which don’t accept the Codex, and make it law, will be penalized in international trade disputes for non compliance!

As most countries are either members of the WTO, or are trying to become members, this is one way of forcing the world to undemocratically submit to rules that will destroy the health of populations – but make billions in profit for the pharmaceutical cartel (which is of course owned by the world richest families, who are already trillionaires).

The section of the Codex that deals with nutritional supplements changes the classification of vitamins, minerals, phytonutrients, amino acids, and anything else necessary to sustain good health, from being foods, to being drugs. In other words, they would be controlled and regulated, and our access to these – essential ingredients for life – would only be via prescription from a doctor.

Why would the WTO do this? For the same reason that most things happen: money.

If you are taking nutritional supplements you are very unlikely to need or want drugs. That’s a real good reason for the pharma cartel to find a way to stop you from getting your vits.

On both sides of the Atlantic, politicians in office are voting for Codex Alimentarius. That means that elected representatives are stopping us from getting the essential nutrients we need for life.

These politicians are making it so that we will not be able to give anything close to a meaningful dose of vitamins in a health crisis – the likes of which will be upon us in a few short months. Even the terrestrial media is predicting the outbreak of Mexican flu pandemic this winter. and guess what? Roche has already made billions on pre-sales, of the symptom-suppressing Tamiflu – which heals nothing.

Did you know that Under Codex Alimentarius, any quantity of a vitamin larger than the RDA is considered potentially toxic and is illegal to sell? This, despite the fact that for decades many people have taken 100 times the RDA of Vitamin C (10 grams per day), even when they have been healthy – and a lot more if they’ve had a virus.

Food manufacturers want a very low RDA so they can say that their food contains 100% of the required amount of Vitamin C (and other vitamins), even though this is a lie. The pharma cartel wants to stop people from preventing and curing colds, flus, and other viral diseases with Vitamin C, so they can make billions of dollars every year selling cold and flu drugs that give only symptomatic relief – as Roche just did with Tamiflu. And they give no assurance that these will have any effect against Mexican flu!.

The aims of Codex Alimentarius are clearly defined: Statements on the curative effects of vitamins and other natural remedies will be banned and made a punishable offense. In the future, the distinction between a foodstuff and a medicine will be made by the pharma cartel itself, and not by governments. In other words, the pharma cartel will have the power to say vitamin C is a drug and can only be sold with a perscription!

Using this new legislative edict, the pharmaceutical industry will extend its own markets as it sees fit.

At present, the pharmaceutical industry in Germany has succeeded in classifying 500 milligrams of vitamin C, in pill form, as a medication requiring a prescription. If the pharmaceutical industry had its way, smaller amounts of vitamin C will be classified in the same manner.

The strategic aims of “Codex Alimentarius:

1. The distribution of health information concerning vitamins, amino acids, minerals and other natural products for the prevention and treatment of diseases will be banned globally.
2. The sale of vitamins and other natural products which exceed the guidelines of this Codex commission (which are arbitrary and far too low) will be prohibited globally.
3. Countries that fail to apply these laws will be punished by international economic sanctions.


Source: http://www.goodfitnesstips.com/2009/08/13/the-codex-alimentarius-and-the-wto/

Saturday, August 15, 2009

Pharma Medical Rep sales reporting on Mobile Phones

PRAvenue reports that MobiQuest, India based leading provider of Enterprise VAS, has changed the way pharmaceutical companies track and manage their on-field medical representatives. The company's product MobiSales for Pharmaceuticals industry has moved the highly complex, paper driven, non-accurate and cumbersome process of medical rep field activity reporting to a seamless real time system using basic mobile phones.

Moving from the current traditional paper based process that involves collecting field data, track daily visits, measure sales performance and do any sales forecasting to a mobile phone that every Sales Representative would carry. The idea behind the concept is- if the complete reporting application can be moved to his mobile phone, each transaction and his complete day activity can be updated from field in real time to central servers.

The product operates in two parts; the application is loaded on basic mobile phones of the sales force. The easy and intuitive GUI of the MobiSales product helps a basic worker to update / enter data on the phone. With fields and activity labels predefined, it is quite simple and fast. The data instantly gets updated in the central servers. The second part of the application is a full blown workflow and reporting system on the web to manage, track the field force and create forecasting and other relevant business reports.

Is it cost effective? Yes says Sabina Kamal, COO, MobiQuest "The best part is that the product does not require a huge capital investment in smart phones, it can run on basic Rs. 2000-3500 phones with GPRS connectivity. It is a highly cost effective and saves huge time. No paper, no data entry, no loss of data and above all it helps keep track of field force, avoids duplication, non-accurate data and delays in filling paper reports."

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