Further reduce drug prices

Biocon chairperson and managing director Kiran Mazumdar Shaw today raised concerns that the new government's intention to bring down prices of essential drugs by 25-40 per cent could deter manufacturing of such medicines by companies.

After taking charge, Fertilizer and Chemicals Minister Ananth Kumar had stated that he would talk to pharmaceutical companies and try to bring down prices of essential drugs by 25-40 per cent.

"Minister Ananth Kumar's mandate to further reduce drug prices can potentially deter quality drug makers from manufacturing essential drugs," Shaw said on the micro blogging site Twitter.

Mylan Inc.

Mylan Inc., a global pharmaceutical company committed to setting new standards in health care, has launched atovaquone and proguanil hydrochloride tablets, 62.5 mg/25 mg and 250 mg/100 mg, the generic version of GlaxoSmithKline's Malarone tablets.

Challenge for DNA nanotechnology

Using molecules of DNA like an architectural scaffold, scientists have developed a 3-D artificial enzyme cascade that mimics an important biochemical pathway that could prove important for future biomedical and energy applications. In the latest breakthrough, the research team took up the challenge of mimicking enzymes outside the friendly confines of the cell. These enzymes speed up chemical reactions, used in our bodies for the digestion of food into sugars and energy during human metabolism,

Specialty chemicals

Specialty chemicals  are a category of relatively high valued, rapidly growing chemicals with diverse end product markets. Typical growth rates are one to three times GDP with prices over a dollar per pound.

PolyTherics Limited

PolyTherics Limited, a provider of technologies and services to enable the development of better biopharmaceuticals, has announced the formation of a new company, Abzena Limited. The new company has been created to provide a strong group identity across its two wholly owned subsidiaries, PolyTherics and Antitope, following their combination in July 2013.

During the summer PolyTherics’ operations will move from London to the Babraham Research Campus in Cambridge, the current site of Antitope's operations, and thus Abzena's headquarters and major operations will be positioned at the heart of one of the world's leading clusters for biopharmaceutical innovation. It will also grow its operations on the Warwick University Science Park where it maintains a presence following the acquisition of Warwick Effect Polymers by PolyTherics in January 2012.

Boston Lotus Valve System

Results from the REPRISE II clinical trial demonstrated that the Lotus Valve System delivered sustained safety and effectiveness outcomes out to six months, with only 1.1 per cent of patients having moderate paravalvular aortic regurgitation (leaking).  No severe cases occurred.  The data were presented by Professor Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE II trial. The study is evaluating the Lotus Valve System in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement.

The primary device performance endpoint of 30-day mean aortic valve pressure gradient, as assessed by an independent core lab, was met as the 30-day mean aortic valve pressure gradient of 11.5 +/- 5.2mmHg was significantly less than the performance goal of 18 mmHg (P<0.001).  At six months, the mean aortic valve pressure gradient remained low and stable at 11.4 +/- 4.6 mmHg.

An impressive 79.8 per cent of patients had no paravalvular aortic regurgitation by independent core lab assessment. In addition, no cases of severe paravalvular aortic regurgitation occurred in any patient at six months.

The all-cause mortality rate was 8.4 per cent. The disabling stroke rate was 3.4 per cent.
No cases of non-study valve implantation, unplanned use of cardiopulmonary bypass, valve embolisation, valve-in-valve or ectopic valve placement occurred.

China Petroleum and Chemical Industry

Since 15 September 2011, local authorities are required to suspend approval for construction, reconstruction or expansion of projects and activities related to manufacturing or storing dangerous chemicals outside industrial parks, the exception being made for technical reform projects that can save energy and reduce emissions to ensure environmental protection.

The working committee of China Petroleum and Chemical Industry Federation and the Research Centre for Technological Innovation, Tsinghua University, and related research and data collection, has jointly developed the first chemical industrial park evaluation system in China which was due to commence in June 2012.


This system, based on industrial park and industry cluster theories and the Scientific Outlook on Development, includes five areas: comprehensive economic power; infrastructure and facilities; cost of public utilities; environmental protection, energy saving and emissions reduction and independent innovation.

Crude July'14 loadings rise to 3.8 mil barrel

Sources said production of this grade was expected to increase midway through the year and this program is evidence of it, as new oil fields in Chad, especially the Badila field, start to feed into the Doba blend.

"[The monthly Doba export programs] will now be four or five cargoes going forward I think, with new production added," said a trader.

Trading sources have also said the nature of Doba crude was expected to change slightly because of these new oil fields. Doba crude has been selling briskly so far this year with especially strong demand from the US and Japan, sources said.As Doba is a very acidic grade, some buyers use Doba as direct-burning crude for power generation, trading sources said.

Oil major ExxonMobil is operator of the Doba field, with a 40% interest, while Petronas holds 35% and Chevron 25%.

Doba crude is pumped from landlocked Chad through a 650-mile pipeline across Cameroon to the Kome Kribi-1 floating storage and offloading facility, according to Chevron's website.

The grade has a gravity of 21.1 API, a sulfur content of 0.1% and an acidity of 5.18 mg KOH/g, making it a very heavy, acidic crude with a high calcium content of around 250 ppm.

Chemical Dispersants in Oil Spills

 NOAA is awarding these grants using supplemental research funding provided by Congress as a result of the Deepwater Horizon oil spill. The grants, collectively totaling nearly $500,000, were awarded on a competitive basis through a peer-review process that attracted 36 proposals from U.S. and international research teams.

OPKO

Opko Health, Inc., a multi-national biopharmaceutical and diagnostics company, announced that Senesco Technologies, Inc. (Senesco), completed its acquisition of Fabrus, Inc. (Fabrus), an Opko portfolio company focused on expanding the clinical impact of antibodies by addressing drug targets resistant to traditional antibody discovery methods.

Fabrus has been successful in generating antibodies against difficult, therapeutically important cell surface receptors and ion channels resulting in an internal pipeline that includes next generation antibodies targeting cancer and inflammation. It also has collaborations in place with large pharma and biotech companies to discover antibodies to their targets. Dr Vaughn V Smider, founder of Fabrus and faculty member at The Scripps Research Institute in La Jolla, CA, will become acting CEO of Senesco.




In the short term, the business focus of the combined company will be to realize the synergies of the combination, advancing the SNS01-T clinical program and bringing new candidates into clinical development in the next two years.

Gelesis

Gelesis, a clinical stage company developing a new category of therapy to safely treat overweight, obese and diabetic patients, has raised $12 million as it advances the development of its lead product, Gelesis100, toward commercialization, bringing the total amount Gelesis has raised to over $42 million.

GELESIS100 is a smart pill that is designed to treat the physiological symptoms of hunger without surgery, invasive procedures or systemic absorption. To date, Gelesis100 has generated compelling safety and efficacy data through a series of rigorous clinical, preclinical and in vitro studies.

Takeda - Wipro strtegic partnership

Wipro Ltd., the information technology leader has entered into a  strategic partnership with Takeda Pharmaceutical Company Ltd., the largest pharmaceutical company in Japan and one of the global leaders of the industry.

The  strategic partnership will build advanced value in Takeda's operations by consolidating IT platforms across the organisation. As a strategic partner, Wipro will build and maintain an “as-a-service” global platform for Takeda that will drive synergies across its global entities through standardisation of IT architecture.

 Wipro will be primary provider of IT Infrastructure management services covering Takeda’s entities across the world, touching 30,000 users in 16 different languages, operating out of data centers in Asia, Europe and America.



According to Sangita Singh, chief executive Healthcare and Life Science Business Unit at Wipro, the partnership with Takeda is for a business transformation.  Wipro is leveraging its experience in enabling global pharma companies to achieve a leaner & standardized IT workplace and implement newer business models that put patient at the core. We look forward to collaboratively partnering with the Takeda team in enabling this unique platform across its global operations.

Lupus

Lupus has no permanent cure, but can be treated effectively if it is diagnosed early. The awareness levels about Lupus is too little or negligible. Majority of people mistake it as skin or ortho related problem and go for alternative medicines. They approach the specialists only at late stage when the disease reaches its advance stage when body organs are affected, say specialists at KIMS. Diagnosing Lupus disease is still a challenge for the medical fraternity, said rheumatologists on World Lupus day that was observed at KIMS on May 10th.

Symptoms of the disease include frequent headaches, severe fatigue, painful or swollen joints. Most of the times butterfly rashes on the skin are often mistaken for skin diseases. Majority of patients with joint pains neglect it and contact specialists only when the disease reaches advanced stage. Dr Sarath Chandra Mouli Veeravalli, chief rheumatologists at KIMS Hospital, said, “Many a time, patients approach a rheumatologists after two to four years when all other medicines have not worked. They first go to general physicians, dermatologists, orthopaedic and other alternate streams looking for relief. They come to us at a stage where the disease can’t be controlled.


The moot problem that has come to the fore is that even people from the medical fraternity know too little about the early symptoms of the disease.  This is because the medical curriculum does not have a detailed mention of Lupus and most of the scientific evidence is gathered from studies conducted in European and American countries. In India more than one million people are afflicted with Lupus. And there is a very little awareness about this disease not only among the common public but also among the doctors.”

Lupus is mainly seen in female patients. Doctors say that there is no defined age for Lupus as it can strike anyone at any age. It is more common in 15 to 45 years. It is also found in the post-menopausal stage but the number is very less.

Dr Padma, a dermatologists, said, “The rashes in Lupus are very typical. Yet most of the skin specialists, who are not aware, are not able to guide patients properly. Skin rashes are only the beginning of the larger disease and require aggressive treatment. It must not be allowed to flare up; hence the patient is on a very prolonged medication. Once the medication begins, it is important to not switch to alternative methods of treatment as it can prove detrimental.”

There are over 70,000 people suffering from Lupus in Andhra Pradesh and rheumatologists are trying to generate a database where they can share experiences and learn to tackle the disease.

Cancer-killing bomb

Biomedical engineering researchers have developed an anti-cancer drug delivery method that essentially smuggles the drug into a cancer cell before triggering its release. The method can be likened to keeping a cancer-killing bomb and its detonator separate until they are inside a cancer cell, where they then combine to destroy the cell.

The technique uses nanoscale lipid-based capsules, or liposomes, to deliver both the drug and the release mechanism into cancer cells. One set of liposomes contains adenosine-5’-triphosphate (ATP), the so-called "energy molecule." A second set of liposomes contains an anti-cancer drug called doxorubicin (Dox) that is embedded in a complex of DNA molecules. When the DNA molecules come into contact with high levels of ATP, they unfold and release the Dox.

The surface of the liposomes is integrated with positively charged lipids or peptides, which act as corkscrews to introduce the liposomes into cancer cells.

As the liposomes are absorbed into a cancer cell, they are sealed off from the rest of the cell in an endosome - a compartment that walls off all foreign material that gets into a cell.

The environment inside an endosome is acidic, which causes the Dox liposomes and ATP liposomes to fuse together, as well as to the wall of the endosome itself.

Meanwhile, two other things are happening simultaneously. First, the ATP liposomes spill their ATP into the Dox liposomes, releasing the Dox from its DNA cage. Second, the walls of the Dox liposomes create an opening in the endosome, spilling their Dox-rich contents into the surrounding cell - leading to cell death.

In a mouse model, the researchers found that the new technique significantly decreased the size of breast cancer tumors compared to treatment that used Dox without the nanoscale liposomes.

Immune system against viruses

University of British Columbia scientists have uncovered an intricate chain reaction in the body's immune system and have used the knowledge to develop a new treatment against harmful viruses. Viral pandemics, such as the coronavirus that caused the deadly SARS outbreak in 2002, have caused hundreds of deaths in Canada, yet effective anti-viral drugs are rare.

Pharmacists - H1 implementation

In a memorandum recently submitted to the ministry, it brought to the notice of the ministry that pharmacists are facing several practical difficulties due to the ambiguities in the implementation of Schedule H1.

It has been contested that clarity is being sought after on the eligibility of prescribing medicines as it has been observed that homoeopaths, ayurvedic medicine practitioners and allopaths can prescribe medicines in states like Maharashtra.  Since states follow different rule contrary to what has been mandated by the Medical Council of India (MCI) Act, which rule would be applicable and what is the judiciary's perspective on the same is being sought after, as per the memorandum.

The purpose of Schedule H1 has not been understood by the public and that only pharmacists have the onus of maintaining the register is ironical. Besides this, due to the shortage of MBBS doctors in many parts of the country, medical store owners will produce fake bills by putting names of doctors on the bill and rake in profits at the cost of patient safety.

If fake bills are made in the name of physicians, the offenders will have a free hand in evading actions from the state regulatory agencies and Income Tax department. Also, physicians from other systems of medicine can also take advantage of this lacunae and this will encourage quackery.

As per the memorandum, Maharashtra government's drugs department is not able to explain clearly the role of registered medical practitioner in Allopathy, Homoeopathy and Ayurveda streams of medicine. Government of India has formed several administrative units for governing drug trade like the excise department for narcotics and psychotropic substances; department of pharmaceuticals for drugs pricing; Food Licensing authority for food products; health department, Central Drugs Standard Control Organisation (CDSCO) for regulating drug quality and Schedule H1 drugs; and Competition Commission of India (CC) for enforcing healthy competitive practices.

These departments need to be coordinated under the purview of Drugs and Cosmetics Act, 1940. The memorandum seeks clarity whether there is any effort made for coordination of these departments and is it feasible for the retailer to understand and grasp the technicalities involved in understanding various laws governing drug trade of the land.

AstraZeneca and MRC

AstraZeneca and the Medical Research Council (MRC) today announced that they have entered into a groundbreaking collaboration aimed at better understanding the mechanisms of human disease. The collaboration will see the creation of a joint research facility at AstraZeneca's new R&D centre in Cambridge in the UK.

The AstraZeneca MRC UK Centre for Lead Discovery will sit within the new AstraZeneca site at the Cambridge Biomedical Campus, due to be completed in 2016. It will see world class MRC-supported researchers working side-by-side with scientists in AstraZeneca's high throughput screening group, identifying new methods to better understand a range of diseases and potential treatment options.


As part of the collaboration, which will run for an initial period of five years, academic researchers will benefit from unprecedented access to over two million molecules in AstraZeneca's compound library, as well as its state-of-the-art high throughput screening facilities at the new site. Research proposals will be submitted to the MRC that will independently assess and select the best scientific proposals from a broad range of therapy areas and diseases.

 The MRC will fund up to 15 screening projects per year to be carried out at the Centre for Lead Discovery. AstraZeneca will have the first option to enter a negotiation to license any resulting drug discovery programmes of relevance to the company's therapeutic areas of interest. If this option is not used, the academics can negotiate with other parties.

Skin care segment

The skin care segment has shown tremendous growth and emerged as a potential investment area for players in recent years, according to a study by Frost & Sullivan.

From treatment of common skin care diseases, the skin care industry has evolved to the age of cosmetic and anti-aging treatments. The overall skin care market is expected to grow with the rise in demand of various skin care services. Factors like global warming, anti-aging solutions, new product innovations, growing media influence, etc. are driving this market, it points out.

Boosted by growing consumer demand, rise in disposable incomes, lifestyle related disorders, craze for cosmetic surgeries, obsession for young-looking skin, low cost of treatment, and booming medical tourism, the skin care market in India is likely to expand and emerge as a potential investment area for players.

The market for anti-aging solutions has also become vibrant in India with rising concerns about beauty and looks. Nowadays, more young people are visiting doctors and dermatologists to improve and maintain their youth. The craze for cosmetic surgeries has put India among the top five countries in the world to perform surgical procedures like Lipoplasty, Rhinoplasty, and Bhleroplasty, etc. The demand for non-surgical procedures like Botox, Hyaluronic acid treatment, and laser hair removal is also very high.

The prevalence of skin disease in India is 10 to 12 percent of the total population with Eczema and Psoriasis being the major contributors. Due to pollution, ultraviolet light, and global warming, photosensitive skin disorders like tanning, pigment darkening, sunburn, skin cancers, and infectious diseases are increasing at a faster pace. A one percent reduction in ozone leads to a two to four percent increase in the incidence of tumors.

FDA - Budget -2014

The U.S. Food and Drug Administration is requesting a budget of $4.7 billion to protect and promote the public health as part of the President's fiscal year (FY) 2014 budget. Industry user fees would fund 94 percent of the proposed budget increase, including new fees to support the landmark Food Safety Modernization Act (FSMA) and strengthen the FDA's ability to oversee imported food.

The remainder of the budget increases would support programs which are necessary to preserve the safety of medical products and meet the agency's growing duties. Recognizing the need for fiscal constraint, the budget includes spending cuts in several areas, including a $15 million decrease in budget authority for human drug, biologics, and medical device programs.


"These are tight budget times, and the FDA budget request reflects this reality," said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. "Our budget increases are targeted to strategic areas that will benefit patients and consumers and overall strengthen our economy. Through the good work of the FDA, Americans will receive life-saving medicines approved as fast as or faster than anywhere in the world, confidence in the medical products they rely on daily, and a food supply that is among the safest in the world."

USA Role - Pharmaceutical Industry

The pharmaceutical industry, one of the most profitable industries in the United States, plays a significant role in the world pharmaceutical industry as well.

The US is the world’s largest market for pharmaceuticals and the world leader in biopharmaceutical research. The US firms conduct 80 per cent of the world’s research and development in biotechnology and hold the intellectual property rights to most new medicines.

The latest report on the US healthcare industry forecasts the country’s pharmaceutical market value to climb from $359 billion in 2012 to $476 billion in 2020, increasing by 33 per cent over the eight year period.

The expansion of the insured population, prompted by the introduction of Patient Protection and Affordable Care Act (PPACA), will play a key role in driving US pharmaceutical market revenue up by a third by the end of the decade, the report adds.

With the PPACA (commonly known as Obamacare) extending health insurance to 32 million more Americans by 2016, patient pools and the demand for drug therapy are expected to increase significantly, driving up healthcare expenditure and pharmaceutical revenue as a result.

Like many other countries around the world, the US is expected to experience growth in its elderly population, climbing from a 19 per cent share of all Americans in 2012 to more than 22 per cent by 2020. The expansion of the 60 and over age demographic is another factor that will inevitably drive the US pharmaceuticals industry, owing to the corresponding increase in healthcare demand.

Reflecting the dynamic changes taking place in the US pharma industry , the International Pharmaceutical Expo (INTERPHEX), the leading annual trade event dedicated to the pharmaceutical and biopharmaceutical industry, will be taking place from March 18-20 at the Javits Center in New York City.

Caffeine - Alzheimer's disease

As part of a German-French research project, a team led by Dr. Christa E. Müller from the University of Bonn and Dr. David Blum from the University of Lille was able to demonstrate for the first time that caffeine has a positive effect on tau deposits in Alzheimer's disease. The two-years project was supported with 30,000 Euro from the non-profit Alzheimer Forschung Initiative e.V. (AFI) and with 50,000 Euro from the French Partner organization LECMA. The initial results were published in the online edition of the journal "Neurobiology of Aging."

Tau deposits, along with beta-amyloid plaques, are among the characteristic features of Alzheimer's disease. These protein deposits disrupt the communication of the nerve cells in the brain and contribute to their degeneration. Despite intensive research there is no drug available to date which can prevent this detrimental process. Based on the results of Prof. Dr. Christa Müller from the University of Bonn, Dr. David Blum and their team, a new class of drugs may now be developed for the treatment of Alzheimer's disease.

Caffeine, an adenosine receptor antagonist, blocks various receptors in the brain which are activated by adenosine. Initial results of the team of researchers had already indicated that the blockade of the adenosine receptor subtype A2A in particular could play an important role. Initially, Prof. Müller and her colleagues developed an A2A antagonist in ultrapure and water-soluble form (designated MSX-3). This compound had fewer adverse effects than caffeine since it only blocks only the A2A adenosine receptor subtype, and at the same time it is significantly more effective. Over several weeks, the researchers then treated genetically altered mice with the A2A antagonist. The mice had an altered tau protein which, without therapy, leads to the early development of Alzheimer's symptoms.

In comparison to a control group which only received a placebo, the treated animals achieved significantly better results on memory tests. The A2A antagonist displayed positive effects in particular on spatial memory. Also, an amelioration of the pathogenic processes was demonstrated in the hippocampus, which is the site of memory in rodents.

Roche with good start in 2014

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. 

Group sales rose 5% in the first quarter, driven by demand for cancer medicines (in particular the HER2 breast cancer franchise, Avastin and MabThera/Rituxan), as well as Actemra/RoActemra for rheumatoid arthritis. Sales of Xeloda, a chemotherapy drug, were lower as the product is now off patent and faces generic competition in the United States and Europe. In the Diagnostics Division, strong sales growth was driven mainly by Professional Diagnostics with demand for immunoassays in clinical laboratories. 

Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World  Model Health OrganisationLists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy. 


In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

IMPERFECT POLICY

After a gap of 18 years a new pharmaceutical pricing policy is going to be notified by the Central government once that is cleared by the Union Cabinet. The Group of Ministers (GoM) approved the policy draft on last Thursday to bring formulations of 348 bulk drugs under price control as against 74 drugs and their formulations in the 1994 drug policy.

A major deviation in the new policy is the adoption of market based pricing for fixing formulation prices instead of cost plus formula followed currently. Under the new system, the prices of drug products will be fixed on the basis of the average price of all brands in a therapeutic segment that has more than one per cent market share. Another major change in the policy draft is the exemption of bulk drugs from the ambit of price control. By expanding the list of price controlled formulations in the new policy.

GoM said that the span of control in the pharmaceutical industry would be 30 per cent as against 18 per cent currently. As per the 1994 drug policy, the companies were also allowed to raise prices up to 10 per cent every year in case of all drugs other than the 74. And as a matter of right, the companies have been jacking up the formulation prices of more than 500 drugs which are outside price control even when their costs remained static or dropped.

The new pharmaceutical policy leaves as much as 70 per cent of the drug products marketed in the country outside any kind of price control. Definitely this is a policy intended to benefit the pharmaceutical industry and not in the interest of the patient community. Organization of Pharmaceutical Producers of India representing foreign drug companies and Indian Pharmaceutical Alliance, a body of top dozen Indian companies are not happy with new policy as they consider the profitability of their member companies may be hit.


By taking average of prices of all brands in a therapeutic group for price fixation can bring down prices of some products of MNCs and top Indian companies. Because, product prices of these companies are very high whereas prices of many medium and small scale companies are much lower.

FTA with EU

The free trade agreement between Indian government and the European Union is expected to be finalized by the middle of this month. Since it is going to be a major trade agreement between India and a group of developed and powerful countries of Europe, various provisions of the pact need to be carefully examined by experts before signing the same. EU is understood to have incorporated some provisions relating to intellectual property rights into the proposed trade agreement and fears are being expressed that Indian government may overlook such provisions hurting the generic drug industry of the country.

The concern expressed by some of the independent groups on these clauses, therefore, need to be seriously looked into. It is possible that India may agree to a clause in the agreement, stipulating that mere suspicion of patent infringement by an Indian drug maker could lead to seizure of the company's bank accounts and immovable properties. Injunctions could also be issued against intermediaries and third parties such as suppliers, drug distributors and medical procurement agencies for infringement of intellectual property rights.

These provisions in the draft agreement are currently under negotiation and the drug industry and healthcare activists have taken up the issue with the government.

The IP provisions in the FTA could be dangerous for Indian drug companies as that may probably block the export of generic medicines from India, a lifeline for millions of poor people living in the developing and developed world. By allowing medicines to be seized, detained and destroyed by the EU authorities would ultimately lead to abusive practices by the multinational drug companies.

Chemist - Shops

the Mumbai chemists withdrew the agitation and shops are open without any time restrictions. But most of the chemist shops still do not have a pharmacist at the counter all the time. And the the FDA commissioner has not stopped his state wide inspection of chemist shops to see that pharmacists are present at the retail counter all the time.

Most of state governments in the country have miserably failed to ensure implementation of section 42 of the Pharmacy Act ever since the section was added to the Act. This section came into effect on September 1,1984 to end the practice of running  medical shops without qualified persons. The state pharmacy councils and drug control departments of Andhra Pradesh, Karnataka and Kerala had also conducted similar raids against retail chemists for violation of Section 42 in the past. But the practice continues even today and most of the 6 lakh retail chemist shops in the country are still being managed by salesmen with some superficial knowledge of medicines. Absence of a qualified pharmacist at the counter can definitely affect the quality of service by way of unprofessional counselling leading to wrong dispensing and over medication.

This needs to be strictly curbed in the interest of public health. Section 42 is an ideal piece of legislation and all the developed and most of the developing countries have the practice of keeping full time pharmacists at retail counters. In India, owners of chemist shops are blocking the implementation of the Section from the very beginning. Their objection to have a full time pharmacist at the counter is the 'unbearable' costs of appointing a pharmacist throughout the working hours in a chemist shop. That may or may not be true. But, when anyone venture into a business he cannot bypass the existing laws governing that business. And the enforcement agencies cannot be blind to perpetual violation of the provisions of any Act.


Therefore, both Centre and state governments have to seriously ponder about this lingering issue and have to come out with a right solution without any more delay.

AstraZeneca board rejects Pfizer proposal

The Board of AstraZeneca Plc has rejected Pfizer's fresh proposal which raised an indicative value of £50 ($84.47) per AstraZeneca share, as against earlier offer of £46.61 ($76.62) per share of AstraZeneca.

The financial and other terms described in the Proposal are inadequate, substantially undervalue AstraZeneca and are not a basis on which to engage with Pfizer. The large proportion of the consideration payable in Pfizer shares and the tax-driven inversion structure remain unchanged. Accordingly, the Board has rejected the Proposal.

Leif Johansson, chairman of AstraZeneca, said: “AstraZeneca continues to invest significantly in research, development and manufacturing in the U.K., Sweden and the US. We are showing strong momentum as an independent company, in particular with our exciting, rapidly progressing pipeline, which the Board believes will deliver significant value for shareholders. Pfizer’s proposal would dramatically dilute AstraZeneca shareholders’ exposure to our unique pipeline and would create risks around its delivery. As such, the Board has no hesitation in rejecting the Proposal.”

Shareholders are strongly advised to take no action. There can be no certainty that an offer will be made nor as to the terms on which any offer might be made.

Genaric Exports - Pharma

Indian pharmaceutical industry received yet another blow to its reputation from the US FDA when it charged Wockhardt Ltd of  manipulating data related to production trials of drugs at its two Indian factories, which had earlier been banned from shipping medicines to the US. The Wockhardt factories located at Waluj and Chikalthana in Maharashtra had to halt exports to the US sometime ago. The US FDA in a letter to the company stated that the lack of reliability and accuracy of data generated by Wockhardt’s laboratory is a serious cGMP deficiency that raises concerns about the integrity of all data generated by the company.

 Data integrity issues at drug manufacturing plants attract severe penal action from the US FDA and other international regulatory agencies. The US regulator further said that the company had not only violated standards of manufacturing practices but also misguided the regulator. These are serious charges on a company like Wockhardt which earns a substantial part of its revenue from exports to various developed markets and the US is perhaps the most important destination among them.

Aushadi Stores - Success in India

To make a people oriented programme like Jan Aushadi a success in a country like India, support of state governments, medical practitioners and other stakeholders is crucial. One of the main reasons for the slow progress of Jan Aushadi is the lack of this support from the state governments and medical profession. Perhaps, Gujarat is one state that has given some support by launching the Jan Aushadhi stores in a few government hospitals.

The state government is also motivating doctors working in the government hospitals to prescribe unbranded generic medicines to the patients. Most of the other state governments have not extended such support to this programme as yet. However, state governments like Andhra and Kerala have launched their own subsidised medicine programme by setting up  government owned chains providing both branded and unbranded drugs at 20 to 25 per cent lower than the market prices. These regional initiatives,no doubt, have their own merits but what is required is to make the national programme a success throughout the country so that generic drugs will be available at uniformly lower prices to all. Regular procurement of quality drugs at low prices is an important task for the success of this scheme.


The department’s decision to source generic drugs from private sector manufacturers is thus a step in right direction. But the move to restrict such purchases to only from firms having an average annual turnover of Rs. 10 crore in the last three years is not fair. This will keep several small players having reputation of makers of quality drugs out of the programme. The procurement should not be too restrictive as that may discourage competition and lead to high procurement prices.

MNC's - Images

GSK is not the only MNC which has been found to be indulging in such unethical and illegal activities in recent years. In mid 2011. Pfizer agreed to pay $14.5 million to the US government to resolve False Claims Act allegations related to its marketing of the drug, Detrol. This was the last of the 10 whistleblower suits filed in the District of Massachusetts and two other districts against the company beginning in 2003.

The other nine suits against Pfizer including the one on painkiller, Bextra, were settled or dismissed in 2009 as part of the US government’s global resolution with Pfizer, under which the company agreed to pay $2.3 billion to resolve civil claims and criminal charges regarding a few other drugs. Eli Lilly and Abbott were also reportedly involved in illegal marketing of certain drugs and agreed to make payments to the US government in the recent past.


Apart from the financial implications caused by the government actions, the MNCs have also suffered major dents to their credibility after these incidents. In India, a large number of essential drugs are being imported and sold by MNCs at very high prices as the country has not yet imposed any control on prices of patented drugs. Considering good track record of most MNCs in discovering modern drugs for several human ailments in the past should they adopt such a disgraceful path for maintaining high profits? This is a question to be pondered by the top managements and shareholders of these corporations.

FDI - India

India’s attempt to regulate increasing inflow of foreign direct investments into the pharmaceutical sector does not seem to yield the desired result as yet. Although government allows 100 per cent FDI in pharma sector through automatic approval route in new projects and investments in the existing companies only through the Foreign Investment Promotion Board approval, there has been a steady rise in the number of acquisitions of large Indian pharmaceutical companies over the last ten years.

The first major acquisition in pharma sector was in 2008 when the Japanese giant, Daiichi Sankyo, took control of India’s largest pharma company, Ranbaxy Labs for $4.6 billion. Another major acquisition was of Shantha Biotechnics by the French pharma company Sanofi-Aventis. And the most recent FDI investment was for acquiring Indian generic drugs company, Agila Specialties, by the US based MNC Mylan Inc for a sum of Rs. 5,168 crore.


The government had cleared this deal a couple of months ago. Now, Sanofi is understood to be planning to acquire a medium size company, Elder Pharmaceuticals. FDI in the pharma sector has more than doubled to $1.07 billion during April-August period of this year as against an FDI of  $487 million during April-August 2012, as per the latest data of the Department of Industrial Policy and Promotion. Over 96 per cent of the total FDI in the sector between April 2012 and April 2013 has come into brownfield pharma projects. The situation is scary as MNCs already control 35 per cent of the domestic pharmaceutical business.

The pharmaceutical trade

The pharmaceutical trade in the country has been in a protest mode for some years now by often calling for shut down of shops either in a state or nationwide raising various issues. These agitations launched by the trade bodies have not brought any relief to the grievances of the traders but only caused some inconvenience to the patient community.

This is because some of the demands raised by trade bodies are unreasonable and not probably very ethical. Now, All India Organisation of Chemists and Druggists is planning a nationwide shut down of retail medical shops on March 28 to press its demand for allowing retail drug store owners with more than two years of experience to dispense medicines. A representation in this regard has been already submitted to the Union law ministry,

Union health ministry and Drug Controller General of India early this month. As per section 42 of the Pharmacy Act, only a qualified pharmacist registered with the State Pharmacy Council is authorized to dispense medicines in retail medical stores. Although this section came into effect on September 1,1984 to end the practice of running medical shops without qualified persons, most of the medical stores are being run in the country without the presence of a pharmacist.

Untested - Drug's

Central Drugs Standard Control Organisation last week came out with a stand that it will not review or recall the 33 controversial drugs found to have been approved for marketing in the country during 2008-10 without clinical trials by the Parliamentary Standing Committee on health & family welfare. The conclusion of the Parliamentary Standing Committee was that  a collusive nexus existed between medical experts, pharmaceutical companies and the CDSCO officials while approving drugs for marketing in the country.

The report of the panel also pointed out the unethical deals between the pharmaceutical companies and the regulatory officials in getting approved the unsafe drugs in India. The CDSCO is of the view now that approvals granted by the competent authority were 'in order' and there was no need to re-examine the approvals or recall any  drug from the market on grounds of errors in approval process. Therefore, there will be no action with regard to these 33 drugs unless some specific instruction come from the Union Health Ministry.
 
An expert committee has been constituted to suggest measures to improve the functioning of the office of CDSCO and DCGI soon after Standing Committee’s report came out last month. The three-member committee is headed by V M Katoch, director general of the Indian Council of Medical Research. This committee is also expected to look into specific cases against medical experts and suggest actions to be taken by the Medical Council of India.

The health ministry has  to remember that there was tremendous  pressure from the public interest groups and independent medical experts for taking immediate action to suspend marketing of these drugs circulating  in the country. The fact is that these drugs, without assessing their safety and efficacy, are already there in the market and are being prescribed by the physicians. It is quite difficult to estimate how many people might have already injured and suffering due to intake of such untested drugs. No drug control administration should ever dare to allow the pharma companies to market any medicine without proven efficacy and safety. 

TRIALS & TROUBLE

The three phase clinical research lasting for three to four years involving thousands of human volunteers in multi locations is the most costly part of new drug discovery for a pharmaceutical company. Any of the potential drug candidates can be abandoned during the trial period if the adverse drug events are beyond the acceptable limits. It is a high risk activity requiring millions of dollars and pharmaceutical companies usually make sure that trial reports reaching the regulatory authorities are favourable. No new drug can be approved for marketing without submission of trial reports and their scrutiny by the regulatory authorities.

It is this situation that caused several deaths and fatal injuries during trials in the last three to four years. An inquiry conducted by the Union health ministry in May 2011 thus revealed that 671 deaths occurred during trials conducted by different companies in 2010. And only in three cases, some compensation was given to the relatives of the victims by the pharma companies or CROs. It is from here the problems started for clinical research in the country.

The Supreme Court took a serious note of this state of affairs and had made some scathing remarks on the health ministry’s neglect in this matter. The health ministry subsequently notified the rules and procedures for fixing compensation to the victims of trials giving legal backing to the existing guidelines. The rules thus notified by the government under Drugs & Cosmetics Rules had put the DCGI as the final authority in the matters relating to the compensation in the cases of deaths and injuries during trials.

DCGI also became strict in granting approvals for clinical trials. In case of compensation to victims of trials, MNCs and CROs should not have reasons to complain. That is a standard practice anywhere in the world. What is actually disturbing the pharma companies is the reluctance of DCGI to grant approvals for trials. And it is a fact that from 2012 number of approvals for drug trials came down sharply