India’s Pharma Exports May Reach $20 bn by 2020: ASSOCHAM

Export of pharmaceutical products from India is likely to cross $14. billion (bn) mark this year and may reach about $20 bn by 2020, thereby registering a compounded annual growth rate (CAGR) of about eight per cent, according to an ASSOCHAM-TechSci Research joint study.

“However, growth in pharmaceutical products’ exports from India may decline by almost half i.e. from the level of CAGR of about 15 per cent clocked during 2010-14 to about eight per cent during 2015-2020 on account of delay in regulatory approvals in top markets of the US, Russia, Africa and others,” highlighted the study titled ‘IPR in pharmaceuticals: Balancing, innovation and access,’ jointly conducted by ASSOCHAM and TechSci Research.

“Consolidation of pharmacy players is leading to an increase in pricing pressures for generic companies existing in the US market which is expected to result in decline in year-on-year growth of pharmaceutical exports from India over next five years,” highlighted the ASSOCHAM-TechSci Research study.

Besides, a steep decline in currency in emerging markets like Africa, Russia, Ukraine and Venezuela is expected to add woes to drug manufacturing companies that supply pharmaceutical drugs to that region and are unable to generate high revenues on account of selling their drugs at a low priced currency.

India is the largest supplier of medicine to the US. Pharmaceutical exports from India to the US rose from $3.4 bn in 2013 to $3.7 bn in 2014, mainly due to increasing demand for high quality generic drugs in the market.

However, growth rate for exports of pharmaceutical products from India to the US is declining, due to increasing US Food and Drug Administration (USFDA) scrutiny on the quality of pharma products coming from drug manufacturing plants located in India.

In order to boost growth rate of exports to the US, Indian companies will need to leverage their compliance to the USFDA regulations.

The exchange rate crisis in the country is affecting pharmaceuticals market in Russia. As such, stabilization of currency is of utmost importance in generating revenues through exports.

In addition, many Indian companies are operating through the Pharmaceutical Benefits Program (PBP) and hospital tenders, for supplying vital and essential drugs, for which prices are then regulated by the Russian government.

Similarly, India's exports of pharmaceuticals to Africa are being affected due to port delays and prolonged custom valuation.

“Pharmaceuticals’ exports are a major factor contributing to growth of this industry in India with the US and few fast growing markets like Brazil, Mexico, Russia, South Africa and in South-East Asia emerging as the main export markets for generic drugs,” said D.S. Rawat, secretary general of ASSOCHAM while releasing the study.

“India’s pharmaceutical industry has transformed from being mainly a generic manufacturer to providing complex drug formulations to foreign markets thereby registering a significant growth,” said Mr Rawat.

“Pharmaceutical market in India is being driven by rapid socio-economic changes, rising sedentary lifestyle amid people and expected growth in number of people suffering from obesity, diabetes, cardiac problems and other related ailments,” he added.

Further, with a view to benefit and drive the growth of pharmaceutical research and innovation in India, the ASSOCHAM-TechSci Research study has recommended for data protection to be introduced as an Intellectual Property Right.

It has also suggested for digitisation of IPR for pharmaceuticals in India to strengthen online processing and maintenance of information database thereby making the process more systematic and convenient.

Though it would require allocation of more personnel for patent examinations and training sessions to be organised as part of resource development module, the study has emphasised that efficient management of IPR filings would help in building a stronger IPR framework in India.

India’s pharmaceutical market may reach $20 bn this year and about $55 bn by 2020 from about $18 bn as of 2014 thereby clocking a compounded annual growth rate (CAGR) of over 22 per cent.

Pharmaceutical sector in India will register higher growth during the course of next five years (22 per cent) as compared to a CAGR of about 14 per cent clocked by the sector during 2010-14.

New drug target for diabetes discovered

Washington: In a breakthrough, Indian-origin scientists have identified a potential new therapeutic target for controlling high blood sugar - a finding that could help millions suffering from type 2 diabetes worldwide.

Researchers showed that lipid molecules called phosphatidic acids enhance glucose production in the liver.     These findings suggest that inhibiting or reducing production of phosphatidic acids may do the opposite.

"This study establishes a role for phosphatidic acids in enhancing glucose production by the liver and identifies enzymes involved in the synthesis of phosphatidic acids as potential drug targets," said senior author of the study, Dr Anil Agarwal, from the University of Texas.

These observations were made while studying a mouse model of lipodystrophy, a rare metabolic disease in which the body is devoid of fat.

Lipodystrophy patients often develop diabetes and accumulate fat in the liver because of an imbalance in the body's ability to properly regulate lipids and glucose. The causal gene, AGPAT2, which is involved in the synthesis of phosphatidic acid and triglycerides, was removed in the mice, resulting in rodents with generalised lipodystrophy.

The research team then examined what impact this genetic manipulation had on phosphatidic acids and glucose production.

"We expected the levels of phosphatidic acids to go down. However, in examining the livers of these lipodystrophic mice, we unexpectedly found high levels of this lipid class," said Agarwal.

This led to the identification of new targets involved in the production of phosphatidic acids. The buildup of these lipid molecules was due to an increase in the levels of two enzymes in the liver, diacylglycerol kinase and phospholipase D. Researchers also discovered a marked increase in glucose production in the livers of the lipodystrophic mice.

The lack of normal insulin signaling in these lipodystrophic mice led to unrestricted production of phosphatidic acid, Agarwal said, contributing to development of hyperglycemia, or high blood sugar.

Besides revealing a new potential therapy to test for treatment of diabetes, the study's findings may have implications in understanding how cancer develops.

Increased phosphatidic acid levels may play an important role in a metabolic pathway that supplies energy to cancer cells.

Lead author Dr Shireesha Sankella plans to test the inhibitors of diaclyglycerol kinase and phospholipase D in cultured cells and in animals to understand the molecular mechanisms for increased glucose production by phosphatidic acids in liver and cancer cells.

The study was published in The Journal of Biological Chemistry.

Solar fridge for vaccines could play key role in aid efforts

London: Delivering life-saving vaccines in remote areas of developing countries could soon be possible with UK scientists developing new solar-powered fridges.
 

Engineers have developed a prototype system that could keep vaccines cool until treatment, a PTI report said quoting a release by the Edinburgh University .
 

Dr Giulio Santori of the University of Edinburgh School of Engineering, who is leading the project, said, "We are very pleased by the encouraging results obtained so far on the proof-of-concept prototype."
 

"We are now seeking to develop a first generation commercial version which combines the solar thermal and adsorption based technologies," Santori said. Tests show that the proposed system, designed at the University of Edinburgh and tested in collaboration the Italian National Research Council's ITAE research institute, can produce up to 5 kilogramme of ice each day.
 

The solar fridges can store vaccines between 2 and 8 degree Celsius for as long as three days, the target set by World Health Organisation, it said.
 

Under normal operation ice is stored for the following day, when a new cycle starts. Scientists believe this shows that the technology could be employed in remote areas.
 

Solar refrigeration could benefit the majority of third world countries, owing to high levels of sunlight available.     The technology is also compliant with the requirements of the main humanitarian organisations in supporting aid operations in areas affected by catastrophic events, the
university said. Thousands of children in third world countries die every day from diseases that are preventable by vaccination.
 

Researchers believe the technology could have a huge impact in countries where delivering humanitarian aid is compromised by fuel shortages and high  temperatures.

New eye layer may help treat blindness

London: An Indian-origin scientist in the UK has discovered an ultra-thin layer hidden deep in the eye that may help cure blindness caused by glaucoma.

The new layer in the human cornea, discovered by Professor Harminder Dua, of Nottingham University, plays a vital role in the structure of the tissue that controls the flow of fluid from the eye, research has shown.

The findings could shed new light on glaucoma, a devastating disease caused by defective drainage of fluid from the eye and the world's second leading cause of blindness, researchers said.

The latest research shows that the new layer, dubbed Dua's Layer, makes an important contribution to the sieve-like meshwork, the trabecular meshwork (TM), in the periphery of the cornea.The TM is a wedge-shaped band of tissue that extends along the circumference of the angle of the anterior chamber of the eye.

It is made of beams of collagen wrapped in a basement membrane to which trabecular cells and endothelial cells attach. The beams branch out randomly to form a 'meshwork'. Pressure within the eye is maintained by the balance of aqueous fluid production by eye tissue called the ciliary body
and drainage principally through the TM to the canal of Schlemm, a circular channel in the angle of the eye.

Defective drainage through the TM is an important cause of glaucoma, a condition that leads to raised pressure in the eye that can permanently affect sight, researchers said. Around 1 to 2 per cent of the world's population yearly have chronic glaucoma and globally around 45 million people have open angle glaucoma which can permanently damage the optic nerve - 10 per cent of whom are blind, researchers said.

The latest research sheds new light on the basic anatomy of Dua's Layer, which is just 15 microns thick but incredibly tough. Comprised of thin plates of collagen, it sits at the back of the cornea between the corneal stroma and Descemet's membrane.

By examining human donor eyes using electron microscopy, the researchers were able to look at Dua's Layer beyond the central part of the cornea to shed more light on its features at the extreme periphery of the cornea.

It is hoped the discovery will offer new clues on why the drainage system malfunctions in the eyes of some people, leading to high pressure.

The research was published in the British Journal of Ophthalmology.

Dogs too suffer from obsessive compulsive disorder!

Washington: Man's best friend can also suffer from obsessive compulsive disorder, say scientists who have identified four genes that are connected to OCD in dogs.   

Researchers said few breeds of dogs exhibit particularly high rates of OCD. These include Doberman Pinschers, bull terriers, Shetland sheepdogs and German shepherds, according to a report.

OCD is an anxiety disorder characterised by intrusive thoughts that produce uneasiness, apprehension, fear, or worry; by repetitive behaviours aimed at reducing the associated anxiety; or by a combination of such obsessions and compulsions, PTI reported.

Dogs with OCD may display behaviours such as incessant tail chasing, repetitive shadow stalking and relentless paw chewing.
Since dogs are genetically simpler than people, researchers turned to these canines in their search for OCD-related genes, 'Discovery News' reported. Elinor Karlsson, a computational biologist at the Broad Institute at Harvard University, and colleagues began by sequencing and comparing a large section of the genomes of 90 Dobermans that had OCD with 60 that didn't. They also searched for genes that looked the same in all of the Dobermans but that differed between that breed and
others.
When they had zeroed in on several suspicious areas of the genome, the researchers compared the suspect Doberman genes with genes from a sample of the three other breeds that also suffer higher-than-usual rates of OCD. Those analyses pinpointed four genes that have unusually high rates of mutations in dogs with obsessive and compulsive behaviours.
The genes implicated in the new study play roles in pathways that have also been connected to human OCD, Karlsson said, suggesting that dogs could provide a helpful model system for developing better treatments for people. The study was published in the journal Genome Biology.

Common HIV drug can kill HPV causing cervical cancer

London: In a world-first clinical trial, scientists have found that a commonly-used HIV drug can kill off the human papilloma virus (HPV) that leads to cervical cancer.

The trial was led by The University of Manchester in UK with Kenyatta National Hospital (KNH) in Nairobi. Researchers examined Kenyan women diagnosed with HPV positive early stage cervical cancer who were treated with the antiviral HIV drug lopinavir in Kenya.

The study looked at 40 women with both high and low-grade pre-cancerous disease of the cervix and the antiviral drug, normally used orally to treat HIV, was self-applied directly to the cervix as a pessary.

The results showed a high proportion of women diagnosed with HPV positive high-grade disease returned to normal following a short course of the new treatment, a report said.

The women were treated with one capsule of the antiviral drug twice a day for 2 weeks.

Repeat cervical smears showed a marked improvement within one month of the treatment although after three months, there was a definite response.

Out of 23 women initially diagnosed with high-grade disease, 19 (82.6 per cent) had returned to normal and two now had low-grade disease giving an overall positive response in 91.2 per cent of those treated. Furthermore, the 17 women initially diagnosed with borderline or low-grade disease also showed similar improvement.

Photographic images of the cervix before and after treatment showed clear regression of the cervical lesions and no adverse reactions were reported.

"For an early stage clinical trial the results have exceeded our expectations. We have seen women with high-grade disease revert to a normal healthy cervix within a comparatively short period of time," said Dr Ian Hampson from the Manchester University's Institute of Cancer Sciences, according to a PTI report.

"We are convinced that further optimisation of the dose and treatment period will improve the efficacy still further," Hampson said.

"Current HPV Vaccines are prophylactics aimed at preventing the disease rather than curing or treating symptoms. Other than surgery, as yet there is no effective treatment for either HPV infection or the pre-cancerous lesion it causes which is why these results are so exciting," added
Dr Lynne Hampson from Manchester University.

"Further work is needed but it looks as though this might be a potential treatment to stop early stage cervical cancer caused by HPV," Lynne said.

Spit-test can predict risk of depression in teens

London: Cambridge scientists have identified the first biomarker for clinical depression after they found that high levels of stress hormone in spit can indicate a serious risk of developing psychiatric disorders in teen boys.
 

Teenage boys with symptoms of depression and raised levels of the stress hormone cortisol are up to 14 times more likely to develop major depression than those without these traits, researchers found.
Clinical depression affects one in six people at some point in their lives. Until now, doctors have lacked a biomarker for clinical depression, partly because its causes and symptoms are so varied.
 

"Through our research, we now have a very real way of identifying those teenage boys most likely to develop clinical depression," said Professor Ian Goodyer of the University's Department of Psychiatry who led the study.
 

"This will help us strategically target preventions and interventions at these individuals and hopefully help reduce their risk of serious episodes of depression and their consequences in adult life," Goodyer said. The researchers collected spit samples from hundreds of teenagers and measured levels of cortisol in the saliva, as well as self-reported information on symptoms of depression.
 

This they used to divide the teenagers into one of four groups depending on their cortisol levels and symptoms of depression.
 

After following the group for 12 to 36 months, they were then able to work out which group was most likely to develop clinical depression and other psychiatric disorders. They found boys with high levels of cortisol and depressive symptoms were 14 times more likely to develop clinical depression than those with neither. In girls, however, this difference was less marked.
 

Girls with high cortisol and depressive symptoms were four times more likely to develop clinical depression than those with neither, suggesting gender differences in how depression develops.
 

The researchers hope that having an easily measurable biomarker - in this case, raised cortisol plus depressive symptoms - will allow primary care services to identify boys at high risk and consider new public mental health strategies for this part of the population.
 

"This new biomarker suggests that we may be able to offer a more personalised approach to tackling boys at risk for depression," said co-author Dr Matthew Owens.
 

The study was published in Proceedings of the National Academies of Science.