Industrial - Life sciences

Discovery Search Partners built its business through life sciences, but in recent years we have developed a strong foothold in industrial products.  Our initial foray into industrial products was a natural transition as we partnered with companies that supply products to our life sciences partners.  So our early partners included specialty chemicals, test and measurement and laboratory instrumentation providers.

Our success at placing key executives in industrial companies coupled with the growth of some industrial markets has enabled us to broaden our industrial footprint.  Water treatment, semi-conductors, industrial automation and nanotechnology are other growing markets where Discovery Search Partners has enjoyed great success.

Key market dynamics - Pharma

Geographic balance will continue to shift toward pharmerging countries, which are expected to grow at a 14-17% rate through 2014, while major developed markets will grow at 3-6%.  The US will remain the single largest market in the world with revenue just short of $400 million by 2014 while China will grow to become the world’s 3rd largest market for pharmaceuticals during this period.
Therapy area growth will continue to be driven by innovation and areas of unmet need.  In the areas of oncology, diabetes, multiple sclerosis and HIV, annual growth is expected to exceed 10% as new drugs are brought to market, patient access is expanded and funding is redirected from other areas where lower cost generics will be available.

Broad cuts in spending will be applied by public payers to publicreduce growth in drug budgets.  Publicly funded health systems are under increased pressure to reduce growth in drug budgets following the global economic downturn.  Governments seeking to restore fiscal balance will likely apply restrictions or reductions in reimbursements to reduce drug spending.

Peak years of patent expiries will shift major therapies to generic dominance. Products with over $140 billion in revenue will face generic competition in the next five years with therapy areas like cholesterol regulators, antipsychotics and anti-ulcerants being affected the most.
Closer scrutiny of new products will keep product launches in the range of 30-35 products annually but these products will be subjected to more rigorous and complex assessments by payers before being accepted into clinical practice and reimbursed.

In moving beyond 2014 and leading up to 2020, IMS expects to see a continuing shift toward biopharmaceuticals, specialty-driven products and changes in the mix of disease areas of interest.
Discovery Search Partners has an outstanding performance record in pharmaceuticals, biopharmaceuticals and specialty pharmaceuticals.  We have proven expertise across all functional areas, with possibly the deepest experience in R&D where innovation is the critical ingredient driving company success.  Additionally, we have broad therapy experience and can cite numerous placements of note in virtually all therapy areas of interest. 

The US concern

The US concern
With markets in the developed world becoming saturated, multinational drug companies are increasingly looking to emerging economies with large populations for sales expansion and growth.

Powerful pharma lobbies are alleging that India is running riot over intellectual property rights. They feel that a poor IP framework can impede the development of new medicines over the long term by creating an environment that all together stop the pharmaceutical industry from investing in innovation.

They feel that Section 3(d) of the Indian Patent Act undermines innovation. It disallows much of the incremental innovation done on existing treatments from being patented in India. At the same time they point out that it is incremental innovation that has delivered outstanding benefits to patients the world over—whether in the treatment of HIV/AIDS or drugs developed for malaria and other tropical diseases.

The Indian viewpoint
With calls in the US for designating India a priority foreign country (PFC), the worst downgrading of status by the US trade representative for inability to protect IPRs, the Indian government is accusing US authorities of intimidating the Union health ministry over the issue of compulsory licences.

A PFC tag can allow the US to impose unilateral sanctions against India for domestic laws which deny benefits to the US under any trade agreement. According to some officials there seems to be a two-fold agenda behind the "cacophony" emanating from the US.

While pressure is being created on India's health ministry to not consider drugs for compulsory licences , there is also a deliberate attempt to use India to scare away other developing countries like Indonesia and Brazil from introducing legislation to prevent ever-greening of drug patents, like section 3 (d) of Indian Patents Act (IPA),according to a report

Micro Labs & Bal Pharma strengthen operations

Large pharma companies who are keen on emerging markets to support top line growth cannot ignore investments in locations like Baddi in Himachal Pradesh and Uttaranchal along with Sikkim in the north. The two companies from Karnataka, Micro Labs and Bal Pharma which jumped into the bandwagon for strategic investments in the region between 2005 and 2007 still view Baddi and Uttaranchal ,destinations for domestic as well as emerging markets supplies.

On the whole, small and medium size units have a strong presence in Baddi and Uttaranchal primarily to carry on contract manufacturing assignments.

However Kaushik Desai, immediate past chairman, Industrial Pharmacy Division, Indian Pharmaceutical Association (IPA) consider North India particularly Baddi and Uttaranchal now unviable locations for continued investments from a long-term view point.

The region is facing tremendous challenges in terms of accessing and retaining skilled workforce. The regulatory landscape needs to be strengthened considerably. Further, the lack of additional tax benefits make it even more unattractive for companies to consider expansions. This has led pharma companies not to concentrate on these locations or even mull any additional expansions.

A section of pharma companies in the region stated that issues such as production plants in remote locations, unwillingness of skilled work force to relocate , constant challenge of hilly terrains in terms of transportation and logistics hamper efficiency in terms of time and money.

Moreover the regular findings of not-of-standard quality drugs manufactured has also sullied the reputation of this region. The stark reality is that the highest number of substandard drugs detected by the state drugs control departments across the country is from this region,.

Contract manufacturing - India

With contract manufacturing business losing sheen, greener pastures like Sikkim emerging as better options for many, increased regulatory scrutiny putting pressure on biggies and financial crises engulfing the established firms, the North Indian pharmaceutical industry is facing rough weather.

The so-called excise free zones of Himachal Pradesh and Uttarakhand, the two major hubs of North India, have become less attractive for the pharmaceutical units, portending woes for the entire industry in the region. Now the only remaining hub is the Jammu region.

`In 1970 and 80s, Delhi and outskirts were leading hubs for the pharmaceutical industry, mostly led by small scale and medium players. Then slowly biggies emerged and captured the ground while some existing units diversified. It is learnt that 30-40 per cent of the units in the excise-free zones are ready to sell their business,” according to industry leader Nipun Jain.

The major pharmaceutical units in the region are Ranbaxy, Panacea Biotec, Venus Remedies, Ind-Swift, Ind-Swift Laboratories, Surya Pharma, Dabur Pharma, Jubilant Organosys, Nectar Lifesciences, IOL Chemicals and Pharma. Over the years, unlike Gujarat of Maharashtra, the region has not witnessed the rise of any new player to reckon with, other than Mankind Pharma.

Experimental Drug shows - Resistant leukemias

Research in mice and human cell lines has identified an experimental compound dubbed TTT-3002 as potentially one of the most potent drugs available to block genetic mutations in cancer cells blamed for some forms of treatment-resistant leukemia. Results of the research by Johns Hopkins Kimmel Cancer Center investigators, described March 6 in the journal Blood, show that two doses a day of TTT-3002 eliminated leukemia cells in a group of mice within 10 days. The treatment performed as well as or better than similar drugs in head-to-head comparisons.

More than 35 percent of acute myeloid leukemia (AML) patients harbor a mutation in the gene FMS-like tyrosine kinase-3 (FLT3). Normal FLT3 genes produce an enzyme that signals bone marrow stem cells to divide and replenish. But when FLT3 is mutated in some AML patients, the enzyme stays on permanently, causing rapid growth of leukemia cells and making the condition likely to relapse after treatment.

Many investigators are developing and testing drugs designed to block the FLT3 enzyme's proliferation, several of which are now in clinical trials. So far, their effectiveness has been limited, according to Donald Small, M.D., Ph.D., the Kyle Haydock Professor of Oncology and director of pediatric oncology at Johns Hopkins. Small led a team of researchers who originally cloned the FLT3 gene and linked it to leukemia a decade ago.

RANBAXY BURDEN

Sun Pharma’s seemingly bold acquisition of Ranbaxy was hailed by several analysts and some of the corporate heads as they think Mr. Dilip Shanghvi’s strategy of acquiring poorly performing companies and turning them around may work this time also. Between 1997 and 2012 Sun Pharma made 13 acquisitions starting with the purchase of Caraco Pharmaceuticals. That was the year in which it also bought stakes in two Indian pharma firms namely Tamilnadu Dadha Pharmaceuticals Ltd and MJ Pharmaceuticals Ltd. But in the case of Ranbaxy take over, Sun is facing a different type of hurdle. A belligerent US FDA taking a tough stand on Ranbaxy’s exports from most of its Indian plants to the US market.

 Ranbaxy has been confronting serious issues with regard to exports to the US, its most important market, since 2009. All its Indian facilities exporting drugs to the US have been barred from doing so by the US drug regulator for failing to comply with manufacturing standards. Last year, Ranbaxy also pleaded guilty to felony charges related to drug safety in the US and paid $500 million in civil and criminal fines under a settlement with the department of justice. And its balance sheet has been disappointing for some time. Ranbaxy's consolidated net sales for the year ended December 2013 declined to Rs. 10,604 crore from Rs. 12,253 crore in the previous year and EBDITA to Rs. 1,066 crore from Rs. 2,211 crore. EBDITA

The company's net loss amounted to Rs. 1,012 crore in 2013 as against a net profit of Rs. 923 crore in 2012. The company skipped dividend and its share price declined steadily during this period. Another area of concern for the Sun management will be the handling of huge sales force of the two companies. Sun and Ranbaxy have a combined field staff of about 9,000. Once the merger is completed, many of the sales personnel will end up covering the same doctors, especially in the speciality areas. For Sun Pharma’s plan to turn around Ranbaxy with the operating synergy will have to trim the field force and integrate its supply chain.


Layoffs in the sales force can only help to save on salaries and overheads by way of lower cost of travel, prescription promotion and administration costs. To address all these adverse and sensitive issues may not be that easy for the company management for some years.

Bayer to acquire China-based Dihon Pharmaceutical

Bayer to acquire 100 per cent of the shares of China-based Dihon Pharmaceutical Group Co., Ltd., a privately held pharmaceutical company specializing primarily in over-the-counter (OTC) and herbal traditional Chinese medicine (TCM) products.

Dihon is a leading player in China's OTC industry with products such as Kang Wang for the treatment of dandruff and other scalp disorders and Pi Kang Wang, an anti-fungal cream, as well as TCM product Dan E Fu Kang for the treatment of various women’s health indications.

Financial details have not been disclosed. The transaction is subject to fulfilment of certain conditions, including merger control clearance, and is expected to close in the second half of 2014.

MYDICAR treatment

MYDICAR treatment involves a one-time outpatient infusion in a cardiac catheterization laboratory, similar to undergoing an angiogram. MYDICAR is designed to restore levels of an enzyme known to play a key role in the progression of heart failure.

Heart failure is the inability of the heart to pump blood efficiently due to weakening and enlargement of the ventricles. Nearly 6 million individuals are currently diagnosed with heart failure in the United States according to the American Heart Association (AHA). Despite optimal guideline-directed therapies employing a wide range of pharmacologic, device and surgical options, many heart failure patients deteriorate over time. 

The long-term prognosis associated with heart failure is worse than that associated with the majority of cancers, with a mortality rate of approximately 50 percent at five years following initial diagnosis. In the United Sates, over 1 million primary heart failure-related hospitalizations and over 280,000 heart failure-related deaths occur annually.

 The estimated direct cost of heart failure in the United States in 2012 was greater than $60 billion, over half of which was related to repeated hospitalizations. The one- and six-month readmission rates after heart failure-related hospitalization are close to 25 and 50 percent, respectively, and there is growing pressure on hospitals to reduce readmissions for heart failure.

Plants - Restructuring

In the Middle East gas field development is continuing at a rapid pace, recording an average annual growth rate of about 9%  between 2000 and 2011, according to the International Energy Agency. Qatar and Iran represent almost 60% of the total regional supply. As ethane and liquefied petroleum
gas (LPG) are good feedstocks for petrochemical plants as well as condensates for refineries,
the recovery of liquids from natural gas is an added value.

It is worth noting that a typical regional condensate such as North Field Condensate (NFC) – being light (°API 57.95), sweet (0.23% sulfur content), and low in metals content – is an excellent raw material for a hydroskimming refinery. In addition, growing availability of feedstocks and low-priced
natural gas provide competitive advantages for additional capacities in the Middle East.

Strong growth of petrochemical and oil  demand in Asia, driven mainly by increasing population and high economic performance, is making this area an attractive market for major players. According to the latest release of the ICIS database (2013), oil consumption is expected to increase at a higher rate than supply, resulting in a growing deficit over the next few years.

Based on 2012 statistical trade data, northeast Asia shows a deficit of about 950,000 tonnes of mixed xylenes while maintaining a surplus of benzene (577,000 tonnes) and toluene (almost 260,000 tonnes). The SAP region records a shortage of 165,000 tonnes of toluene, a surplus of benzene (753,000 tonnes) and mixed xylenes (almost 70,000 tonnes). In addition, the spread between benzene, toluene, xylene (BTX) demand and supply should grow over the next few years unless additional
investments are made in petrochemical capacity.

Therefore,in this context, it is interesting to analyse a hypothetical hydroskimming refinery located in the Middle East and exportoriented towards the Asian market. For this type of plant, reformate represents the key interface between the refinery and petrochemical plant, as it is the most important
component for gasoline blending as well as a precious feedstock for BTX production

Drug trade for patient safety

Pharmacy Council of India (PCI) should strengthen itself to govern state pharmacy councils effectively. A meeting between IPR Yatra pharmacists and Dr B Suresh, president, PCI was held in October, 2013 in Mysore in which certain issues were raised like the need to strengthen each state pharmacy council in the country with the introduction of an online registration process, appointment of pharmacy inspectors, amendments in Pharmacy Act and the implementation of Pharmacy Practice Regulation.

Kerala State Pharmacy Council was found to be an ideal state pharmacy council in India and Maharashtra Food and Drug Administration(FDA) is strictly implementing the D&C Act. Therefore other states need to follow the same pattern. Among other relevant issues to be raised are that D&C Act and Drug and Magic Remedies Act are not strictly implemented in our country. In order to implement it, drug license issuance to traders need to be done online through out the country and linkages should be developed between state pharmacy councils and PCI.

Pharmacists can play a big role in drug stores by discouraging irrational use of medicine which if not followed can lead to adverse drug reactions, toxicity and contra indication thus affecting patient’s life.

Global GMP norms - Gearing

To serve compliance and regulatory needs of the fast growing life science community in India, UL and US FDA have also extended their Cooperative Research and Development Agreement (CRADA) for five additional years, extending the agreement till 2019. US FDA’s CRADA with UL is the only learning technology agreement of its kind between US FDA and a private sector company.

The extended CRADA agreement between US FDA and UL is designed to address training needs that include topics related to international inspections, import and export of products that fall under US FDA purview and intra agency and intra government co-operative agreements. It also involves access to the FDA’s Office of Regulatory Affairs online curriculum via ComplianceWire, which is UL EduNeering’s cloud-based learning platform.

Designed specifically for Indian life science industry, the Learning Management System (LMS) called Compliance Wire is built on a cloud- based model which helps reduce IT and validation costs. Capable to cater globally in 34 languages, the system helps in audit readiness for training records while being fully secure and complies with US FDA’s electronic signature governance requirements. Equipped to provide SOP management, it adapts well to the strategic agility of the growing business needs of organizations.


With the coming of Obama Care and exports of generics, Active Pharmaceutical Ingredients (APIs) and finished drug products from India to the US projected to grow by 40 per cent, Indian life science companies are in dire need of achieving regulatory compliance to minimize organizational risk and improve quality and business performance through training on GMP compliance.

Chemists and Druggists - Demands

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

Some of the pharmacists and shop owners in rural and semi urban areas may find it difficult to have online registration of narcotic drugs as they are not computer literate. And the other issue is with regard to enforcement of Schedule H1 to curb the indiscriminate use of antibiotics and some other drugs. AIOCD points out that pharmacy owners are being harassed by the drug control officials for not maintaining proper records for the sales of drugs covered under the new Schedule.


As per the Schedule H1, a separate register for these drugs needs to be maintained as it includes anti TB drug and habit forming drugs. Regulatory authorities need to enforce these two conditions but they have to be flexible for some time considering the practical problems faced by a large section of the trading community. At the same, the demand to allow unqualified persons to dispense medicines at the retail counters is not acceptable considering the fact there are several thousands of pharmacists available in the country and many more are coming out every year from country's pharmacy colleges.  

Self-decontaminate - Cloths

the U.S. Naval Research Laboratory (NRL) Center for Biomolecular Science and Engineering, is making materials that capture entire classes of contaminants, then break them down into something harmless. Her technology is stable and can be used for clothing, air filters, or even coated on windows and vehicles.

Today's filters are carbon—like in your water pitcher at home, or in military suits and gas masks. Carbon is great at capturing and holding contaminants—but they're still there.

 U.S. Marines moved in on Baghdad in 2003, they were wearing hot, unbreathable, full-body suits day and night. When they were finally able to take off their Mission Oriented Protective Posture (MOPP) gear, you can imagine how it felt to have air circulation for the first time in weeks—and then you can just imagine the smell.

industry could use such filters to reduce ammonia smells in hospitals and improve air quality around  industrial process. Air purification technology could be in the ductwork of the building, it could be on stack gases for exhaust from industrial processes.

Because her material also works when wet, You can capture the organics out of your waste stream and make your water safe.

industry could use such filters to reduce ammonia smells in hospitals and improve air quality around industrial processes. "Air purification technology could be in the ductwork of the building, it could be on stack gases for exhaust from industrial processes."
Because her material also works when wet, "You can capture the organics out of your waste stream and make your water safe." She's already proven, with perchlorate, that she could help industry and federal agencies monitor and cleanup water pollutants.


Read more at: http://phys.org/news/2014-04-materials-self-decontaminate-purify-biofuel.html#jCp

industry could use such filters to reduce ammonia smells in hospitals and improve air quality around industrial processes. "Air purification technology could be in the ductwork of the building, it could be on stack gases for exhaust from industrial processes."
Because her material also works when wet, "You can capture the organics out of your waste stream and make your water safe." She's already proven, with perchlorate, that she could help industry and federal agencies monitor and cleanup water pollutants.


Read more at: http://phys.org/news/2014-04-materials-self-decontaminate-purify-biofuel.html#jCp

Opportunity's for Global pharma

With its fast-growing, young population and projected  combined pharmaceutical market value of US$80 billion  in 2017, the Association of South East Asian Nations (ASEAN) presents a great opportunity for the global pharma industry. A common market for financial services will be one of the major components of the ASEAN Economic Community when it takes effect at the end of 2015.

These markets are  developing at markedly different speeds and are characterized by contrasting macro-economic factors.

While  Taiwan and Singapore are both relatively small, with growth limited by the size of these island nations, Indonesia, Thailand and the Philippines are fairly large emergent pharmaceutical markets, with large populations and steadily growing economies.

Despite concerns over counterfeiting and low efficacy of generic products, IPR protection and manufacturing standards are improving thanks to effective national regulations, foreign investment and joint-ventures with multinational companies. Malaysia and Vietnam are small pharmaceutical markets, typified by rapid economic growth, increasing foreign investment and support from national government. These five markets have significant OTC sectors and rapidly expanding generic sectors, and present previously untapped populations for potential foreign pharmaceutical companies.

With impressive economic indicators being tempered by the limited population size,the Singaporean pharmaceutical market to exhibit a high level of growth.   The volume of trade in pharmaceuticals flowing in and out of Singapore is disproportionately large compared with the size of the country, due to its status as a distribution centre. The country exports a large amount of pharmaceuticals, although the majority of this total is from re-exported goods.

Thailand's pharmaceutical market is estimated to grow at a low double-digit CAGR in US dollar terms between 2012 and 2017. Thailand will have the eighth largest pharmaceutical market in the Asia Pacific region in 2017. In per capita terms, Thailand is projected to have the eighth highest rate in the Asia Pacific region by 2017.Thailand’s pharmaceutical market was valued at US$ 3.6 billion in 2011, with Thailand’s pharmacy market growing at a rate of 7.2 per cent .

Ban Policy - Drugs

The move is part of a stringent drug ban policy being prepared by the ministry. The report further said that over a dozen drugs, including anti-allergic Buclizine and anti-asthma doxofylline, have been recently removed from the markets of some developed on grounds of safety. Buclizine and doxofylline are not allowed for sale in countries such as US, Canada, Britain, Australia. Formulations of both buclizine and doxofylline are widely prescribed by physicians in India and marketed by a number of top Indian companies.

The government is also planning to set up an expert committee to weed out such harmful drugs and irrational fixed dose combinations including certain muscle relaxants, painkillers, anti-depressants and antispasmodics from the market. It is estimated that almost 45 per cent of all the drugs marketed in the country today are FDCs.

The move is in the background of the Ranjit Roy Chaudhury committee’s recommendation that India should have a list of drugs not approved in the country of origin and those which have been banned or withdrawn in several countries.

The safety of drugs sold in the Indian market has been an issue of great concern for the health ministry for some time now. Ensuring safety of drugs in the market is the prime responsibility of a regulatory authority in any country and India has been striving to achieve this goal for some years now with not much success.

The matter has come to the notice of the health secretary of the Union Territory and action is being taken against the offenders. It is possible that in other states and Union Territories where drug administration is weak, more such violations must be taking place. Therefore, formation of a Central Drug Authority can only possibly guarantee a uniform policy in the matter of issuing drug licenses and availability of safe drugs in the country.

Brain Research Centre - Indian Institute of Science (IIsc).

Pratiksha Trust formed by Infosys Executive Vice-Chairman Kris Gopalakrishnan and his wife Sudha Gopalakrishnan will invest Rs.225 crore to set up a Brain Research Centre in the campus of Indian Institute of Science (IIsc).

The facility would be dedicated to study the numerous aspects of the functioning of the brain with specific goals to find cures for neurodegenerative conditions and diseases that are accelerated by old age.

The Centre is a joint effort between Pratiksha Trust which will grant Rs.225 crore over 10 years for the establishment and functioning of the facility for brain research. Further, it will receive support from the Centre for Neuroscience and other research facilities at IISc and collaborate with various research hospitals across Bengaluru, according to a statement issued by Pratiksha Trust.

To guide the Centre, an international Scientific Advisory Board has been set up with Nobel Laureate, Prof. Torsten Wiesel as Chairman. Professors Stanley Fahn, Columbia University; Sangram Sisodia, University of Chicago; John Morris, Washington University, St. Louis; and Giovanni Frisoni, University of Geneva are among the members of the Scientific Advisory Board. The Board will help in initiating the operations of the Centre, set research goals, and guide the Centre in its initial years.

The facility will also work for a better understanding of relative functions of the brain as well as leveraging the existing understanding of its functioning to create better models of computing, according to the statement from the Trust.

To ensure an alliance between medical research and computing, the Trust will also fund the setting up of three chair professorships each in the Departments of Computer Science at IISc and at Indian Institute of Technology, Madras (IIT Madras).

According to Gopalakrishnan, trustee, Pratiksha Trust, said,"The human brain is one of the world’s biggest mysteries, which is yet to be fully understood by man. By funding and creating this Centre with IISc, we are working towards creating a globally recognized, world-class research facility that will be at the cutting-edge of research on the human brain.

Lab chemicals purification - Methods

Physical methods
Filtration: Filtration is a mechanical method used to separate solids from liquids or gases by passing the feed stream through a porous cloth, sheet or membrane, which retains the solids and allows the liquid to pass through.

Crystallization: Crystallization is a novel purification process. Generally, crystallization for purification process operates at lower pressure and temperature. In this process the energy consumption is low. In analytical and synthetic chemistry work, purchased reagents of doubtful purity may be recrystallized e.g. dissolved in a very pure solvent, and then crystallized, and the crystals recovered, in order to improve and/or verify their purity.

Centrifugation:  Centrifugation is a process in which light particles are revolved over high speed with the help of electric motor so that the fine particles which do not settle at bottom would settle down.

Evaporation: Evaporation is used to remove volatile liquids from non-volatile solutes which cannot be done through filtration due to the small size of the substances.

Solvent extraction: Solvent extraction removes an impurity or recovers a desired product, by dissolving it in a solvent in which other components of the feed material are soluble.

Adsorption: This technique is used to remove impurities from chemicals by trapping it on the surface of solid adsorbents such as activated carbon which forms strong physical bonds with the impurity. It is not easy to remove very minute particles by filtration because such particles tend to clog the mesh. In such cases use of a filter aid that can selectively adsorb minute impurities is recommended. Any filter aid will do if it is porous, hydrophilic or solvophilic and has a rigid lattice. Celite, diatom earth and activated clay are frequently used. Activated charcoal has a wide surface area and can adsorb many organic compounds and is frequently used to remove smelly substances (in most cases organic compounds) from the air or water. Silica gel can adsorb water and is widely used as a desiccant.

Chromatography: This technique employs adsorption and desorption on a packed bed of a solid to purify multiple components of a single chemical.

Distillation: Distillation is the most commonly applied separation technology. This technique is based on the difference of boiling point of a chemical and the impurities present in it. Separation of liquid mixtures into components is accomplished by fractional distillation. The principle of fractional distillation can be explicable by use of the boiling point-composition diagram.

India’s chemical markets

India's market for chemicals is estimated at US $ 35 billion. Owing to the increasing wealth of the Indian population and accumulated needs, analysts expect further growth in the future, a new market report by Germany Trade and Invest says.

According to German Trade and Invest survey report, India's chemical industry, although on a back foot compared to the European or American industry leaders, is still on a growth curve. The country is estimated to be the world's 12th largest producers of chemicals and expected to profit from its emerging economy and consumer demand. The IIP index of industrial production for chemicals rose by 2.3 per cent within the last year.

An even higher growth is expected for the current year, mostly driven by a post-crisis rise in market demand of automotive supplies, building and construction and consumer goods.

The Ministry of Chemicals and Fertilizers estimates the country's chemicals market at US $ 35 billion (US $ 20 billion of which are the market for basic chemicals while the speciality chemicals market is rate with US $ 9 billion). The Indian Chemical Council has even projected the Indian chemical markets to reach a total US $ 68 billion market (basic chemicals US $ 33 billion, speciality chemicals US $ 17 billion). Both still expect a big potential for growth in the Indian chemicals market.

Hospira recalls seven lots of Propofol injectable emulsion

Hospira, Inc., one of the world's leading provider of injectable drugs and infusion technologies and a global leader in biosimilars, has announced the nationwide recall of seven lots of Propofol injectable emulsion, USP, to the user level due to a glass defect located on the interior neck of the vial, which was identified during a retain sample inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates were also identified in vials upon further analysis.

In general, injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate. Capillaries, which may be as small as the size of a red blood cell, may become occluded. Chronically, following sequestration, particulate matter may lead to granulomatous formation, most likely in the lungs. Long term clinically meaningful impact is low if a patient has normal lung function. While extremely rare, embedded stainless steel may put a patient at risk from MRI (strong magnetic field exposure) as particulate, if in the lung, could potentially dislodge and be pulled through tissue. To date, Hospira has not received reports of any adverse events associated with this issue for these lots.

The affected lots were distributed nationwide to distributors/wholesalers, hospitals and clinics from August 2013 through December 2013. The lot numbers affected by the recall are: Propofol injectable emulsion, 1%, 200 mg / 20 mL (10 mg/mL).

On April 2, 2014, Hospira notified its customers via recall letter that the company had implemented corrective actions to the manufacturing process to prevent recurrence

DISSO ASIA 2014 - Mumbai

The Society for Pharmaceutical Dissolution Science (SPDS) will be holding  its second annual international convention , DISSO ASIA 2014 on May 5 and 6, 2014 at The Lalit in Mumbai. The event will promote introduction of new technology, innovation and would have deliberations on various issues related to Dissolution.Eminent professionals from the pharmaceutical industry will be taking part in the event.

The event is being organized under the Chairmanship of Dr. Nandakumar Chodankar, CEO & Promoter (Director on Board) at ASolution Pharmaceuticals Pvt. Ltd and the Organizing Secretary, Dr. L. Ramaswamy, the managing director of Sotax India Pvt. Ltd.


 The scientific sessions are programmed and executed under the chairmanship of Dr. Mangal Nagarsenker, HOD & Professor of Pharmaceutics, Bombay College of Pharmacy, and Mumbai.

The event shall comprise plenary lecture, poster exhibits and panel discussion exhibits.

DISSO ASIA 2014 has been specifically designed for all the professionals from R&D, QA and QC as well as the Academia. Around 200-250 delegates are expected to participate in this event. Last year, Disso India 2013, which was the first mega event focussing on dissolution was also well attended by delegates from industry and academia. 

Future holds - Cell research

According to experts, stem cell research holds great promise for improving human health by restoring cellular and organ function damaged by degeneration and various injuries. At the same time it also raises several scientific, ethical and social issues in the development of such applications. Apart from challenges of using the right kind of stem cells in the most appropriate way for a particular disease, there are also issues related to the use of human embryos to create human embryonic stem (hES) cell lines, potential for commoditization of human tissues and cells with inherent danger of exploitation of underprivileged people, and challenges related to prevention of human germ-line engineering and reproductive cloning.

There are also potential dangers of tumourigenicity with use of these cells keeping in view their potential for unlimited proliferation and possible introduction of genomic changes during in-vitro manipulations also limitations related to immunological tissue incompatibility between individuals. Research in this field, therefore, needs to be regulated with special attention to these issues.

Stem Cell

There are more than 40 research institutes, hospitals and firms involved in stem cell research in the country. And the Central government has recognized stem cell use  as a niche area of medical research and initiated the process of promoting it by allocating funds for infrastructure development and operational activities. Although stem cell technology holds out huge potential as a science, it raises many ethical, legal and policy issues which are of concern to the government and the public. And that calls for a regulatory framework to promote and develop this as a responsible science. But, no nation has notified a set of rules including India to regulate this sector so far.

Subsequent to that, the health ministry had set up a National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) and an Institutional Committee for Stem Cell Research and Therapy (IC-SCRT) to regulate and oversee the activities of this sector. Institutions and investigators carrying out research on human stem cells must be registered with NAC-SCRT through IC-SCRT. This is the first step towards streamlining the stem cell research in the country.



A significant change incorporated in the revised document is that guidance cover only stem cell research, both basic and translational, and not therapy. That would mean any stem cell use in patients must be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine, and not offering it as therapy. Stem cells are still not a part of standard of medical care in India or elsewhere.

Paediatric urology on April 19-20

The departments of paediatric surgery and urology at the Sri Ramachandra University are jointly organizing a paediatric urology – live operative & urodynamics workshop on 19th & 20th April.

Laproscopic kidney surgeries performed by various national and international experts will be telecast in the workshop to around 200 delegates from different parts of the country, sources informed.

Mini-PCNL, a novel technique to remove kidney stones without surgery will be demonstrated live, by experts in this field. A urodynamic workshop is also being conducted to teach urodynamic techniques in children.

R&D market -Challenges

The Research and Development market has seen the greatest changes over the last 10 years within the industry. With big pharma wrestling to adapt a formerly successful model that each year is producing decreased levels of output, we are now amidst the middle of the cycle with a move away from investing in single large-scale R&D sites to diversifying interests across geographic regions, technologies and partnering firms.

This approach is leading itself to increased open innovation, out-licencing and in-licencing of technology, and outsourcing models that drive down development costs and even partnering and profit sharing arrangements.

The downsize of this approach has obviously been that it has decentralised regulation and increased the number of different methodologies used- meaning that many projects have a unique set of challenges and a greater degree of variants between timelines.

This model, however, has matured over the past couple of years and we are now seeing a solution that enables increased innovative output from the R&D industry, whilst maintaining a more standardized approach to R&D and, crucially, approaches to measure effectiveness and ROI.

This CPhI Pharma Insights Report examines the current trends in evaluation, adoption and partnering solutions that have been implemented across the industry to drive greater innovations and cost efficiencies.

Pharma - Blackmail

The US government may take the advisory of the Chamber  seriously considering its tremendous influence on the US government and it will have to act accordingly against India.  The charge against India is that it consistently denied  adequate and effective  protection for intellectual property rights to international pharmaceutical companies operating in India.

Global pharmaceutical firms have been putting pressure on  the US government for some years to act against India for  producing and exporting several cheap generic drugs to the US and many other markets. The provocation for the US Chamber now to take such an unfair stand against India is the set of decisions relating to pharmaceutical patents by the Indian judicial system and patent authorities since last two years. In 2012, India issued its first ever compulsory license to domestic drug company, Natco Pharma Ltd, for a kidney and liver cancer drug, Nexavar, patented by Germany's Bayer AG.

The move was strongly objected by the German multinational. In 2013, the Supreme Court rejected the patent claim of Novartis for Glivec, an anti cancer drug, after a seven year old legal battle with Indian authorities. The apex court was only right in upholding  the Section 3(d) of the amended Indian Patent Act which prohibits  evergreening of a drug patent by the inventor company by making some incremental changes to the original molecule.

Making medicines cheaper is a politically sensitive issue in India as many patented drugs are too expensive and unaffordable for most people. Yet, Indian government has not brought the patented drugs under any price control and the percentage of patented drugs marketed in the country is steadily on the rise especially after the amended Patent Act came into effect in 2005. MNCs obtained several hundreds of patents for drugs since then from the Indian patent offices although many of them are not for new molecules.

The US government should note that any obstructive action in this regard can have a very adverse impact on the trade relations between the two countries. India needs to strongly resist if the US government resorts to any such inappropriate action and support Indian pharma. Indian pharmaceutical companies also have an international obligation of making available generic drugs to poor patients in the US and several other countries.  

India and other emerging markets

Economic Value derived above is based on dynamic assumptions which are likely to change during the course of development. Hence repeating this exercise at regular intervals is a prudent strategy.

Tornado  analysis is a tool used to identify the most impactful or most sensitive assumptions. Number of competitors in the market, probability of success, time to market launch and development costs are the key areas that companies should focus their energy on to maximize drug’s commercial potential.

Managing environmental challenges in India and other emerging markets, While the above process is fairly robust, the real challenge in developing drugs for emerging markets is the understanding of the local environmental and regulatory aspects.

 
Controlled pricing for patented products in India on the basis of procurement prices in UK, Canada, France, Australia, and NZ adjusted for per capita GDP ratio is under discussion by government authorities

Medicines Patents Pool (Gilead for HIV drugs) - voluntary patent licensing to generic companies in exchange for royalties is a new workaround to tackle stricter patent laws in India

Lack of clarity on Orphan status or Breakthrough designation viz-a-viz developed markets continues to be a challenge in designing clinical development strategy for emerging markets

Differential pricing both Inter and Intra country is a viable strategy being pursued for drug pricing in this part of the world. Compulsory Licensing of the patented drugs in countries like India, China, Brazil and Thailand is a known risk impacting the drug pricing.

Clinical trial cost escalations due to compensation issues, audio-visual informed consent and tighter pharmocovigilance cannot be undermined in expense estimations.

Pharma and Chemicals market

The demand for pharmaceuticals is going to be the major driving force for the growth of Indian chemical markets. Pesticides as well as colours and paints also showed an exceptional market performance. The Indian annual market for pharmaceuticals was estimated with Rs 563.7 billion (US $ 12.8 billion) for 2009/2010 by the Centre for Monitoring Indian Economy. Pesticides went up by eight per cent to Rs 136.9 billion (about US $ 3 billion), about the same size as the market volume of colours and paints.

Most basic chemicals showed a significant drop in market volume. Only Benzol though a comparatively small market segment, showed a good growth value. Especially synthetic resins (- 6 per cent) and caustic soda (- 21.6 per cent) performed poorly.

The market for Urea, soaps and cleaning agents remained more or less stable. Analysts predict strong growth rates, driven by a growing domestic demand.

The Indian market for pharmaceuticals is expected to grow by an average rate of roughly 20 per cent per year up to US $ 74 billion in 2020. Experts feel that increasing prosperity will also sharpen the Indian population's interest in strong trademarks. Drugs against diabetes and gastric ulcer are expected to show highest growth rate on the Indian market. Since the Indian average expenditure for personal hygiene products is about US $ 3.4 per year, analysts expect a big growth potential for cosmetics in the near future.

Patents - Utility

The Section 3(d) of the Indian Patent Act, amended six years ago, has already prohibited patenting of insignificant or minor improvements of known compounds. The Section has also given opportunity to anyone to object a patent before and after it is granted. It is this crucial section of the amended Patent Act that has prevented pharmaceutical companies from obtaining patents in India for  crucial section substances that are not actual inventions such as combinations or minor modifications of formulations of known compounds.

Frivolous patent filings are done by the companies to prevent and delay generic competition that could lead to lower prices and thus greater access to essential medicines. There is no doubt that granting patent protection for pharmaceutical substances involving only incremental innovation is against the public interest as such research does not involve any huge expenditure or time line unlike in the case of a new molecule.

A 20 years market exclusivity for any incremental innovation cannot be justified as powerful pharma companies charge any price for such products by strongly promoting them at the cost of patients. Currently, there is no price control on patented products world over. Take the case of Glivec, the high priced anti cancer drug of Novartis. 

Dispute on its patentability is on for the last more than five years. Although it is a clear case of incremental innovation, Novartis is not willing to give up its claim for patent and now it has approached Supreme Court. Since the amended Patent Act was notified in 2005, there are several where patent applications are being opposed by generic companies on patentability. Considering these facts, any move by the MNC lobby to influence the commerce ministry to circumvent the Section 3(d) has to be resisted. Doha declaration on TRIPS agreement and public health had confirmed the flexibilities allowed to WTO members to define patentability in the national laws.