An exclusive daily newsletter from         (September 16, 2017)         Issue No. 4932

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Today's Headlines
New in Notifications

NPPA notification dated August 16, 2017 fixing Ceiling prices of orthopedic implants (knee replacements) under para 19 of Drugs (prices control) order

New in Documents

Draft Notification on Medical Devices Rules,17oct 2016

Previous Days News Updates

Sandoz announces new data on proposed biosimilar adalimumab

Clinical Trials
Pfizer, Astellas announce positive results from phase 3 PROSPER trial of Xtandi in Patients with non-metastatic CRPC
Researchers turn to creative approaches to battle kidney stones
Oncolytics Biotech begins phase 1b trial MUK eleven of Reolysin in combo with Revlimid/Imnovid in relapsing myeloma patients

US FDA committee recommends GSK's Shingrix for prevention of herpes zoster in adults ages 50 and over
Aspen acquires remaining rights to anaesthetics medicines from AstraZeneca
Caprion Biosciences' Montreal laboratory receives CAP accreditation & CLIA certification

Health and Insurance
Aviacode partners with athenahealth’s MDP programme to offer efficient, cost saving medical coding services

Diagnostics & Devices
Abbott's glucose monitoring technology, FreeStyle Libre system gains reimbursement approval from UK's NHS

Sonoma Pharma begins commercialization of MicrocynAH animal healthcare products in Japan

Experts discuss issues related to timelines for compliance, guidelines under new Medical Device Rules, 2017

Qlik sees data analytics continues to evolve and digitisation to spur efficiency in pharma & healthcare sectors

Aster Prime Hospital enrolls patients for CANTOS international study to reduce risk of heart diseases

Celebration of ‘white coat ceremony' and oath taking for pharmacists by KSPC not as per Pharmacy Act or Drug Act: TNPC

Sri Ramachandra University, Chennai, starts four new paramedical UG courses from this academic year



Experts discuss issues related to timelines for compliance, guidelines under new Medical Device Rules, 2017
September 16, 2017, 0800 IST

Even as the Medical Device (MD) Rules, 2017 are set to come into force with effect from January 1, 2018, industry and legal experts deliberated on some of the contentious issues related to compliance to guidelines which have not been finalised as yet and timelines for its effective compliance.

One such issue is related to the guidelines on essential principles of safety and performance as stipulated in Rule 6 of MD Rules, 2017, which has not been notified as yet and hence the concern is that the companies might not have the time to comply with it as the rules will come into effect in another 3 months time.  

Medical device legal experts R Parthasarathy and Adarsh Ramanujan representing Lakshmikumaran & Sridharan (L&S) Attorneys discussed the issue among other relevant points about the timelines to adhere to the new rules for its effective implementation with 33 pharma companies on the sidelines of a seminar held in Mumbai recently.  The subjects included post grant compliance, data protection, product recalls and product liabilities among others.  

The MD Rules, 2017 are set out to regulate all aspects and activities pertaining to medical devices, namely manufacture of medical devices for sale or distribution, import of medical devices, labelling of medical devices, conducting clinical investigation of medical devices, import/ manufacture of medical devices which do not have a predicate device, registration of laboratories for carrying out test or evaluation of medical devices, sale of medical devices, recall of medical devices and export of medical devices.

Part I of the First Schedule of the MD Rules, 2017 provides the parameters  by which a non-IVD medical device could be classified as Class A / B / C / D. Similarly, Part II of the First Schedule of the MD Rules, 2017 provides the parameters by which an IVD medical device could be classified as Class A / B / C / D. A reading of the parameters laid out in Part I of the  First Schedule of the MD Rules, 2017 suggests that the risk class of a  non-IVD medical device is to be determined by factors such as the level of invasiveness, the duration of use in the body and the duration in the body.

Similarly, a reading of Part II of the First Schedule of the MD  Rules, 2017 suggests that the risk class of an IVD medical device is to be  determined primarily by the impact of the device in the diagnostic process,  in addition to its intended use. The MD Rules, 2017 do not differentiate between non-IVD medical devices  and IVD medical devices in terms of the procedure for obtaining licenses or approvals or the timelines for obtaining the licenses or approvals. The difference in compliance requirements under the MD Rules, 2017 exist in respect of the medical devices falling under different risk classes – A, B, C, or D. The compliance requirements under the MD Rules, 2017 are more stringent for Class C & Class D medical devices as compared to Class A & Class B medical devices. The fee for licenses pertaining to Class C or Class D medical devices is also higher compared to that for Class A or Class B medical devices.

A draft list of non-IVD medical devices and IVD-medical devices along with their risk based classification was issued by the CDSCO on 29th June 2017. It lists out 462 non-IVD medical devices and 250 IVD medical devices along with their respective risk class and intended use.



Qlik sees data analytics continues to evolve and digitisation to spur efficiency in pharma & healthcare sectors
September 16, 2017, 0800 IST

Qlik, a global business intelligence provider, has sighted opportunities in the pharmaceutical and healthcare sector in India. This is primarily because the company has seen that India has the ability to leapfrog other mature markets going by the data literacy that helps to accelerate the growth.
Data analytics continues to evolve and this allows both pharma and healthcare to stall an unforeseen crisis. Its predictive approach can identify potential critical situations at pharma production plants. For healthcare providers, during medical emergencies data analytics is seen to dramatically improve the overall healthcare outcomes.
In the international arena, Qlik is much accepted. For instance at the University Hospital in Gothenburg, the largest in northern Europe, doctors were able to gain a holistic overview of the overall patient condition. The differentiated approach significantly improved the number of favourable medical outcomes and reduce complications in treatment, but also reduced the hospital’s annual expenditure by around €750,000. At an Australian hospital too, Qlik was deployed to identify data from disparate parameters such as incident, hospital activity, and ward roster to identify the falls that typically occurred in and around the geriatric wards. This insight helped the hospital to reduce fall incidents by 40% and the cost of care in these wards by 5%, and increase patient satisfaction.
“These examples serve to highlight the prominent role that data analytics can play in adding value to stakeholders in the pharmaceutical and healthcare supply chains. In India, Lupin and Wockhardt have deployed Qlik. The two companies are able to monitor critical events in real-time, and accurately identify inefficiencies to take corrective actions as swiftly as possible.
“Our data analytics can be easily accessed by any business user. With the rapid digitisation that has taken place in India in the last couple of years, the country is showing a readiness to adopt data analytics to drive its growth and strengthen its position as an emerging technological powerhouse”, Souma Das, Managing Director, Qlik India told Pharmabiz in an email.
Customers using Qlik Sense, QlikView and Qlik Cloud, have an understanding to explore data that enable them to make better data-driven decisions. The acceptance of Qlik is a proof that the Indian market is ready to make the analytical leap and reap the benefits that a data-led approach can bring, he added.
Sharing the Wockhardt experience with Qlik, Das said that the company required a data analytics solution which was transparent, easy to use, agile and scalable to enable better decision-making. Qlik, with its successful track record in delivering the best outcomes, was naturally the preferred choice for Wockhardt hospitals in the country.
Huge volumes of data was extracted from disparate sources, to generate strategic insights. Revenue evaluation and better MIS (management information system) for financial data also allowed effective cost optimisation measures. Pricing analysis and cost audits aided the organisation to significantly decrease its operational expenditure, said Das.
Lupin Pharmaceuticals deployed Qlik to analyse data across its supply chain, finance, and research and development departments, with a view of optimising its operations and driving rapid, fact-based decision-making. “The Qlik-powered Lupin Enhanced Analytical Portal (LEAP) helped the company to integrate and analyse massive volumes of data from various internal and external data sources and information systems, while minimising the total cost-of-ownership,” he said.



Aster Prime Hospital enrolls patients for CANTOS international study to reduce risk of heart diseases
September 16, 2017, 0800 IST

Hyderabad-based Aster Prime Hospital has enrolled patients for a multi-center global study involving nearly 50 countries under the project called CANTOS trial.

According to hospital authorities, this project is being conducted to study the role of anti-inflammatory agents that can counter fatal heart conditions like stroke and heart attacks. These fatal conditions are created by blocked arteries and this is termed as atherosclerosis. This study was published in August 27 issue of New England Journal of Medicine and simultaneously presented at the European Society of Cardiology, Barcelona.

Explaining about the significance of CANTOS study, Dr Paul Ridker of Massachusetts General Hospital Boston, who is also the principal investigator for this study, says, “CANTOS looked at inflammation alone as a cause for heart attacks because Canakinumab reduces only inflammation and not cholesterol levels. Patients who received 150mg dose of this medicine had a 15 per cent lesser chance of developing heart attack/ stroke. In addition there was a reduction of death from various cancers.”

It has been common knowledge for decades that one way to reduce heart attack is to keep his cholesterol levels low. But that is only part of the story. About half of the heart attacks happen to those who have considered normal levels of cholesterol. Trials showed that even people who do not have high cholesterol levels benefit from cholesterol lowering statin drugs. Another effect of statins is to reduce inflammation, the suspicion has been that this is the protection is coming from. But the cholesterol lowering properties of statins have made it impossible to isolate this effect.

According to Dr. C. Raghu, Director and Senior Interventional Cardiologists at Aster Prime Hospital, CANTOS is important because this is a new way of treating coronary artery disease inhibiting inflammation. The medication Canakinumab is a new type of medicine called monoclonal antibody. The only down side of this study was there were significantly more deaths from infection among those who received Canakinumab.

With this study, doctors at Aster Prime Hospital are now well versed in administering new anti-inflammatory therapies to patients. “Current pharmaceutical interventions are designed to slow the progression of atherosclerosis and focus only on reducing cholesterol. However, studies have reveled additional role of inflammation in atherosclerosis. Therefore, it becomes imperative for medical researchers to explore relevant and critical anti – inflammatory agents that can reduce and counter atherosclerosis. Aster Prime is proud to participate in this international study and we look forward to achieving some path breaking results that can change the landscape of atherosclerosis therapies,” says Dr. Raghu.



Celebration of ‘white coat ceremony' and oath taking for pharmacists by KSPC not as per Pharmacy Act or Drug Act: TNPC
September 16, 2017, 0800 IST

Criticizing the yearly celebration of ‘white coat ceremony' and oath taking by fresh pharmacists, which is an initiative of the Kerala State Pharmacy Council (KSPC) while issuing registration certificates to the pharmacists, the Registrar of the Tamil Nadu Pharmacy Council (TNPC) has said that the program is a creation of that state council and not as per Pharmacy or Drug Act.
“It is absolutely an unwanted thing and against the Pharmacy Act and the Drug Act. Neither the D&C Act/Rules nor the Pharmacy Act demands such a ceremony while issuing registration certificates”, said Dr. Tirumalai Elango, the Registrar of TNPC.

He asked if the registrations are done by online and the certificates are also issued to the pharmacists by online, how can this white coat ceremony be conducted by a state council. There is no need to call the candidates to the council office.

Reacting to the several programs being conducted by the neighboring state council, Dr. Elango, who is an expert in pharmacy and drug laws, said that the oath taking is usually done by a fresh pharmacist, after receiving the registration certificate, at his/her home. According to him, it is not possible to conduct a ceremonial procedure in Tamil Nadu because more than 25,000 certificates are registered and issued per day.

Quoting various provisions in Pharmacy Act and D&C Act and Rules, Dr. Elango, the veteran pharmacy regulator, said that by conducting white coat ceremony, the state pharmacy council is essentially acting against the existing laws. Reference about white coat and badge for a dispensing pharmacist is mentioned in Schedule N of the D&C Rules, and no reference about it in the pharmacy act. So, a state pharmacy council need not take such a risk to conduct white coat ceremony to fresh pharmacists every year.

However, the long experienced registrar said, observance of such a ceremony cannot be blamed as it will create a confidence in the pharmacists to become part of the healthcare system. He further said oath taking by a pharmacist means that a fresh pharmacist must read the ‘pharmacist’s oath’ while he is at home, not in public.

When the state drugs controller was contacted for clarification, K Sivabalan, the DC in Tamil Nadu, said reference about white apron and name board (badge) is about the dispensing pharmacists in the hospital pharmacies, and not about the dispensers in the medical stores. He added that no mention of dress code was there in the D&C Rules about a pharmacist in a community pharmacy.

Whereas, when contacted B Rajan, president of KSPC, who introduced the white coat ceremony for the first time in India, said KSPC is conducting the ceremony as per the state rules. Government of Kerala introduced KSPC Rules 2012 which mandates white coat ceremony and oath taking while the newly registered pharmacists receive their certificates.



Sri Ramachandra University, Chennai, starts four new paramedical UG courses from this academic year
September 16, 2017, 0800 IST

The Sri Ramachandra University in Chennai will start four new undergraduate (UG) paramedical courses from this academic year. Sources from the university has informed that the four courses are B.Sc. Bioinformatics, B.Sc Health informatics, B.Sc Data Sciences and B.Sc Environmental Health Sciences.
Environmental Health Sciences is a four-year course with one year internship, others are three-year courses with six month internship. Regarding eligibility to join, sources said students with plus two and equivalent qualification with physics, chemistry, biology, mathematics, botony, zoology and computer sciences can apply.

Students of bioinformatics can join other universities in India and abroad for higher studies in biomedical sciences, molecular biology, biotechnology, bioinformatics, human genetics and other life science programs. The student who completes this programme will be highly skilled analyst in biological data, informatics and computation programming.

Health Informatics students can do PG program & research (PhD) such as bioinformatics, biomedical informatics, clinical informatics, applied informatics and other interdisciplinary domains. Such specialists are in high demand in healthcare services.

Data sciences students can do PG programme & research (PhD) such as data sciences, bioinformatics, medical bioinformatics, clinical informatics, applied informatics and other interdisciplinary domains. There is high demand for such specialists in healthcare services.

Environmental health sciences students can do P.G. course in India and abroad in environmental sciences, public health, molecular biology, biotechnology, bioinformatics, human genetics and other life science programmes. They will become skilled technologists in water, air, food quality testing, disease surveillance and environmental management and conservation.





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