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Health ministry to establish e-enabled structure for regulating sale of medicines

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Aiming to ensure availability of right drugs that meet the standards of quality to the patients, curbing anti-microbial resistance (AMR) and also regulating the supply of medicines through online/internet to persons or other entities in and outside India, the Union Health Ministry will soon establish a robust e-enabled structure for regulating sale of medicines in the country.

In this regard, the ministry proposes to develop an electronic platform which will be developed and maintained by an autonomous body under the Union ministry of health and family welfare.

All manufacturers will be required to register themselves with this portal and enter data relating to sale of drugs on the said e-platform to different distributors i.e. the stockists/wholesalers or otherwise with batch number, quantity supplied and expiry date of the batch. All stockists/wholesalers or other distributors will, also be required to register themselves on the said portal and enter details of stocks received and supplied by them to further distributors or retailers. The data can be entered both through online and by using mobile phones.

The pharmacies located in rural and other remote areas can upload the data either through mobile phones or through internet at least once every fortnight. No retailer/chemist/e-pharmacist outlet shall be permitted to sell any medicine/drug unless such pharmacy is registered on the e-portal. The retailers i.e. the chemists and druggists or e-pharmacy outlets will be required to enter all details of the medicines/drugs received, sold, returned to the manufacturer or disposed of in any other manner.

As per the proposal, no sale by e-pharmacy shall be permitted to be carried out by any person or entity unless it has a licenced brick and mortar facility in each of the Licencing Authority’s jurisdiction. No dispensing/sale of drugs shall be permitted by any entity beyond the area for which a licence has been granted.

Medicines other than drugs included in Schedule H, H1 and X will be dispensed or made available/distributed to any person only against prescription of a registered medical practitioner. However, in case of a few identified medicines, any other person specifically authorised (such as ASHA) to distribute a particular class of medicines may do so. The details of medicines dispensed will be entered in the e-platform and bills will be generated through the system. Such details will include prescribing doctor’s Registration number (MCI or State Medical Council or the Dental Council of India) or other authorised person’s identity number, the name and registration number of the dispensing chemist and the quantity supplied, etc. Details of other than the patient name and identity shall not be necessary in case of drugs not included in Schedule H, H-I or X.

The details of patient authorised person, etc. shall be kept confidential and shall not be disclosed to anyone other than the Central and State Drug Regulators or other officers authorised by the Central or State Governments. The details could, after removing the confidential information, be also made available to the Pharmacovigilance Programme of India (PvPI).

Hospitals and other clinical establishments or other authorised persons, both in the public sector and the private sector, shall be required to enter details of medicines dispensed or distributed/issued/made available to patients as also details of any adverse reaction, etc. and such data shall be kept confidential and made available only to PvPI and the regulator in the manner specified above.

At the backend, a system of audit by regulators for ensuring compliance with the Drugs and Cosmetics Act, 1940 and Rules thereunder will be developed. The audit will be facilitated through offsite analysis. The information collected may also be used by the Ministry of Health and Family Welfare, Government of India for such purposes as considered necessary in public interest. No export of anti-bacterial or any habit forming drug shall be permitted against internet orders.

Any person or entity proposing to export other medicines/drugs on the basis of internet orders shall be required to be registered with the CDSCO and details of such registration will need to be mentioned in the invoice when exporting such medicines/drugs. An appropriate revenue model will be developed so that the organisation responsible for maintaining the portal and rendering such other assistance as may be entrusted to it, becomes self -sufficient.

The revenue model could comprise a small transaction fee of not more than 1% of the total cost of medicines subject to a ceiling of Rs.200 per prescription, to be paid online by pharmacies/ e-pharmacies/ wholesale /retail distributions, etc., a small amount of registration fee and renewal fee as may be determined by the Government from time to time shall also be payable by manufacturers/ pharmacies/hospitals/ clinical establishments, etc.

With effect from the date, the new rules come into force, it will be mandatory for all new pharmacies to register with CDSCO on payment of such fee as may be prescribed. Existing pharmacies will get a transition period of two years for registration with the online portal. Such existing pharmacies which register within first six month will be required to pay 60% of the fee prescribed for such registration.

Portability will be established with the existing softwares/e-platforms, etc. developed by NIC/other Departments of the Central Government/State Government, etc.

An initial grant and the minimum human resources will be provided by the Ministry of Health and Family Welfare to the identified autonomous body and expenditure incurred on this count will be met from the Consolidated Fund of India for an initial period of two years. The autonomous body will generate its own resources for meeting all its operational requirements beyond two years.

The ministry has now invited suggestions/comments from the stakeholders and public by April 15, 2017.

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A New Technique Makes It Possible to Regrow Bones

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Combining New Technologies

A research team from Northwestern University and the University of Chicago just repaired a hole in the skull of a mouse by regrowing “quality bone.” This breakthrough could render bone-grafting techniques obsolete, drastically improving the outcomes of people with severe skull or facial bone trauma. The technique regenerated the skull bone and the blood vessels it needed for its support in only the injured area more rapidly than past methods and without developing scar tissue.

The researchers achieved a successful result in their experiment by combining technologies. First, they harvested the mouse’s skull cells and then engineered them to produce a potent bone growth-promoting protein: BMP9. They next used a hydrogel created by biomedical engineering professor and research team member Guillermo Ameer as a kind of temporary scaffolding. With this in place, the harvested cells were delivered and remained contained within the affected area.

A schematic representation of the experimental design. Credit: Northwestern University
A schematic representation of the experimental design. Credit: Northwestern University

The skulls of the mice in the study didn’t reject the cells because they were harvested from their own bodies. BMP9 was the chosen protein because it not only promotes the rapid growth of bone cells, but also improves the creation of blood vessels in the surrounding area, which is essential to support healthy bone tissue.

This research demonstrates the possibilities of safe in vivo bone regrowth, a process that is far faster than growing bone outside of the body. It would also be fairly easy for other doctors to adopt, according to Ameer: “[The process is] surgeon friendly, if you will, and not too complicated to scale up for the patients.”

Success on Multiple Fronts

Defects and injuries in the facial bones or skull are very challenging to treat. They often require doctors to graft bone from elsewhere in the patient’s body, such as their ribs or pelvis. Not only is that process painful for the patient, it can be difficult for the surgeon if the injured area is large or if the graft must be contoured to the cranial curve or the angle of the jaw. However, if this new approach proves workable, that process may become a thing of the past.

The technique demonstrated in this research was successful in several key ways. The regenerated bone was higher quality than the bone created using other techniques; the scaffolding confined the bone growth to a specific area effectively; the healing process was faster than that observed following other techniques; and areas of old and new bone were continuous and uninterrupted by scar tissue. All of these results suggest tremendous potential for the treatment of people suffering from aggressive cancers attacking the face or skull or victims of car accidents or other serious traumas to the head and face.

While Ameer did caution that the technology remains years away from potential application in humans, he also noted that the team is optimistic: “We did show proof of concept that we can heal large defects in the skull that would normally not heal on their own using a protein, cells, and a new material that come together in a completely new way. Our team is very excited about these findings and the future of reconstructive surgery.”

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Researchers Might Have Located the Brain Switch Responsible for Autism’s Social Struggles

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For people diagnosed with one of the many disorders associated with autism, connecting with others socially ranges anywhere from being somewhat difficult to near impossible.

Now researchers have traced the region in the brain where a faulty gene becomes a faulty neural pathway to explain how a certain form of this condition develops, and the discovery could lead to more effective and personalised treatment in the future.

Scientists at Beth Israel Deaconess Medical Centre in Boston, Massachusetts, turned their focus to a set of genes known to be linked with autism, and discovered how it affected specific pathways in the brain – and also how to turn its affect off in mice.

Autism isn’t a single condition, but rather describes a spectrum of behaviours and characteristics related to how a person senses and interacts with their environment.

As such, it’s typically given the banner term autism spectrum disorder (ASD), and can include individuals who have extreme difficulty interacting socially and struggle to communicate verbally and non-verbally.

The behaviours are often noticed in children – mostly boys – around the ages of 2 or 3, and can include heightened sensitivity to everyday sounds or sensations, intense focus on a particular subject, and repetitive body movements such as hand flapping or pacing.

While the conditions vary in prevalence across the globe, a study conducted in 2012 estimated on average ASD affected 62 out of 10,000 individuals.

As recently as the 1950s, autism was misunderstood as the result of a lack of motherly love and affection, but today it’s thought there are a variety of genes that contribute to its characteristics.

One of those genes could be UBE3A, which when accidentally copied a few too many times can give rise to isodicentric chromosome 15 syndrome – a chromosomal disorder that researchers have recently linked with ASD.

On the other hand, those who don’t have the gene develop a condition called Angelman syndrome, which causes developmental disabilities, jerky hand movements, seizures, and increased sociability.

“In this study, we wanted to determine where in the brain this social behaviour deficit arises and where and how increases of the UBE3A gene repress it,” said researcher Matthew Anderson.

In previous research, Anderson and his team engineered mice with extra copies of the UBE3A gene, which resulted in impaired social interactions, reduced squeaking, and an increase in repetitive behaviours such as grooming.

Now, looking more closely at how the genes behaved inside their cells, the scientists discovered that UBE3A interacts with 598 other genes.

They then turned their attention to other genes previously associated with ASD, and mapped the interactions between them and UBE3A.

It turns out that having too much UBE3A shuts down members of a family of genes called the cerebellin group, which contribute to the functioning of the connections between nerves called synapses.

When the researchers deleted one of the cerebellin genes – called CBLN1 – inside neurons with a certain type of synapse, they recreated the same characteristics seen in mice with too much UBE3A.

“When we deleted the gene and were able to reconstitute the social deficits, that was the moment we realised we’d hit the right target. Cerebellin 1 was the gene repressed by UBE3A that seemed to mediate its effects,” said Anderson.

Further experiments supported the hypothesis that seizures in those with ASD, especially in those with isodicentric chromosome 15 syndrome, were directly responsible for impairing sociability.

The team found that deleting UBE3A didn’t stop the seizures, but it did remove the consequence of social impairment.

In other words, having a little extra UBE3A – as some people with ASD have – can result in severe loss of socialising behaviours following mild seizures.

Lastly, the researchers mapped the location in the brain where UBE3A was being affected by the seizures, finding it in a rather odd location.

“Most scientists would have thought they take place in the cortex – the area of the brain where sensory processing and motor commands take place – but, in fact, these interactions take place in the brain stem, in the reward system,” said Anderson.

The exact spot is a group of neurons in the midbrain called the ventral tegmental area, which is known to play a key role in motivation, falling in love, and addiction.

Importantly, using engineered receptors that they could plant into the nerves, they found it was possible to switch the nerves on and off, increasing sociability.

We should be clear that the method was restricted to specially engineered lab mice, and inserting neural switches into humans isn’t currently a medical possibility.

But the finding does provide a target to study for other potential forms of treatment.

“It has a therapeutic flavour; someday, we might be able to translate this into a treatment that will helps patients,” said Anderson.

It might not help every individual on the spectrum, but understanding how our brain gives rise to the variety of characteristics making up ASD could bit by bit provide options for those who find socialising difficult.

This research was published in Nature.

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Smoking causes glaucoma, other eye diseases: Doctors

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As cases of glaucoma show a rising trend in India, opthalmologists blame smoking as one of the major reasons behind it.

Besides glaucoma, several other eye diseases, such as age related macular degeneration (AMD), can also be caused or aggravated due to smoking, but only 10-20 per cent people are aware of these facts, they said.

Stating that lifestyle matters a lot for eye-related diseases, the doctors said research papers have proved that smoking increases the risk of AMD and glaucoma.

“Smoking is very much connected to age-related macular degeneration (AMD), cataract, glaucoma, diabetic retinopathy and dry eye syndrome,” Kamal B. Kapur, from Sharp Sight Group of Eye Hospitals, told IANS.

Kapur said that people who do not smoke, but become passive smokers, also are prone to develop AMD.

Glaucoma is a disease that damages eye’s optic nerve, while AMD causes loss in the centre of the field of vision. In dry macular degeneration, the centre of the retina deteriorates. With wet macular degeneration, leaky blood vessels grow under the retina.

AMD begins as a loss of central vision which makes it difficult to read and see fine details. Over time, vision loss increases significantly.

Mahipal Sachdev, Chairperson and Managing Director of city-based Centre for Sight, said: “Vision loss due to smoking does not have any symptoms like many other eye diseases, but a dilated examination can detect eye diseases in their early stages before vision loss occurs.”

Some other types of eye-related problems caused by excessive smoking include cataract.

“People, who smoke in excess like 10 cigarettes a day, have up to three times the risk of cataract as non-smokers. Similarly, there is a strong nexus between glaucoma and smoking,” said Sachdev.

The doctors said that there is a special need for awareness among people about the strong link between smoking and vision loss.

“In the first place, smoking has to be brought down, which actually leads to the damage of not just lungs and throat but gradually, the eye nerves also get damaged,” said Samir Sud, a city-based ophthalmologist.

Talking about the dietary habits, he said that nutrients such as Omega-3 fatty acids, zinc and vitamins C and E might help ward off age-related vision problems such as macular degeneration and cataract due to smoking.

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Chennai: Malaria vaccine awaits clinical trials

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However, the menace continues to prevail, causing diseases like malaria and dengue.
The vaccine created by the team of scientists, which has completed the pre-clinical trial (animal experimenting), will induce an immune response comprising of antibodies.

 The vaccine created by the team of scientists, which has completed the pre-clinical trial (animal experimenting), will induce an immune response comprising of antibodies.

Chennai: Fogging and using mosquito coils and nets are only a few among various methods many use to protect themselves from mosquitoes.

However, the menace continues to prevail, causing diseases like malaria and dengue. Therefore, as a means to check malaria transmission, a team of scientists from New Orleans, USA, has invented a vaccine targeting the sexual development of malaria parasites in the mosquito vector.

Vector-borne diseases account for 17 per cent of the estimated global burden of all infectious diseases, according to reports of the World Health Organisation (WHO), and are a major public health problem, particularly in tropical and sub-tropical regions. Some of these diseases are fatal if not treated, while others leave patients disfigured and disabled.

The vaccine created by the team of scientists, which has completed the pre-clinical trial (animal experimenting), will induce an immune response comprising of antibodies. “When a mosquito bites a human being, it will pick up parasites mixed along with the antibodies.

The antibodies will prevent the parasites from further developing,” said head of the team, Prof. Nirbhay Kumar, Professor of Tropical Medicine and Director of the Vector Borne Infectious Diseases centre, Tulane University, New Orleans, US, at the sidelines of the 13th conference on vector and vector borne diseases, jointly organized by the National Academy of Vector Borne Diseases, with the Central University of Tamil Nadu.

“Over the course of 20 years of working on this vaccine, we have found that the vaccine induced immunity is able to prevent parasite transmission in mosquitoes by over 95 per cent,” he added.

As the team is now seeking collaboration with industries to take it to clinical trials – which include three phases – they are hopeful that the effectiveness is seen even as the trial size increases.

“So many are today infected and dying from malaria, which is a controllable disease waiting to be eliminated. We hope for the vaccine to help in the same,” he stated.

School kids should be involved in keeping vector borne disease under control
While vector borne diseases account for a large percentage of deaths globally, involvement from the entire community is the need of the hour, opined Dr Soumya Swaminathan, Director-General of the Indian Council of Medical Research (ICMR) and secretary of the department of health research, Government of India, during the 13th conference on vector and vector borne diseases, jointly organised by the National Academy of Vector Borne Diseases, with the Central University of Tamil Nadu.

Calling for the involvement of all citizens, especially schoolchildren, to keep vector-borne diseases such as malaria and dengue under control in India, she said that their involvement is crucial for the sustainable control of these diseases, which are growing threats to public health in both urban and rural areas.

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