An exclusive daily newsletter from           (February 03, 2015)         Issue No. 4138

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Today's Headlines
New in Notifications

NPPA notification dated August 08, 2014 fixing/ revising the prices in respect of 56 formulation packs both ceiling and retail price packs under DPCO, 2013

New in Documents

The complete text of Drugs (Prices Control) Order, 2013

Previous Days News Updates

Corporate News and Features
Divi's Labs net remains stagnant at Rs.221 cr in Q3, investing Rs.500 cr in new facility
Strides Arcolab adjusted standalone net at Rs.97 cr in Q3

New England Biolabs launches new cloning DNA assembly method, NEBuilder HiFi

Okayama University study shows congenital heart defects get benefit from injection of CDCs

Clinical Trials
Opko seeks US FDA approval to begin phase 2a trial for long-acting coagulation factor VIIa-CTP to treat hemophilia

Promega introduces PowerPlex Fusion 6C System for mixture interpretation with forensic casework samples
VUMC to use ArborMetrix's SurgicalMetrix for surgical services to improve quality & patient outcomes

Abbott introduces new options for people with cataracts in US

US FDA approves Shire's Vyvanse to treat adults with moderate to severe binge eating disorder
Eli Lilly net falls by 41% in Q4 to $429 mn
AbbVie incurs net loss of $810 mn in Q4

Health and Insurance
eMedEvents Corporation launches services in India for doctors

Medical Devices
GlobalData says medical device industry may face promising future in India

EUSTM to offer Professional Certification in Translational Medicine programme entrance test on Sept 4, 2015 at Vienna

Launch ceremony of '2015- The Year of API' postponed
WeSchool organises 'ReDx-Redesigning Diagnostics' to address critical healthcare issues in India

Pharma people
Dr Prakash Trivedi elected as new President of FOGSI for 2015

Allied sector
Tube & stick packaging demand in US to exceed $2 bn in 2018: Freedonia study

Fourth pre-grant opposition to Gilead’s Sofosbuvir filed in Delhi patent office

More AMCs to be identified for access to WHO database through Vigiflow software as part of PvPI

Health ministry should ensure rapid execution of prescription audit: Dr Jagashetty

Pharmexcil focuses on improving Indian pharma exports to Myanmar

Geojit BNP Paribas considers pharmaceuticals as safe sector for 2015 investors



Fourth pre-grant opposition to Gilead’s Sofosbuvir filed in Delhi patent office
February 02, 2015, 0800 IST

Stepping up efforts to ensure the access to affordable and effective treatment for people living with Hepatitis C (HCV) in India and the rest of the world, another pre-grant opposition to Gilead’s patent application on Sofosbuvir in India has been filed. This time, the opposition was filed at the Delhi Patent Office by Sankalp Rehabilitation Trust, represented by Lawyers Collective.

This is the fourth pre-grant opposition to be filed against Sofosbuvir’s base patent application. Oppositions filed by I-Mak together with the Delhi Network of Positive People (DNP+), NATCO Pharma Ltd and BDR Pharmaceuticals International Limited are also pending disposal.

Earlier on January 13, 2015, the Delhi Patent Office had rejected Gilead’s patent application on the ground that it did not meet the requirements of Section 3 (d) of the Indian patent law. On challenge before the Delhi High Court, however, it seems likely that the matter will be remanded to the Patent Controller to be heard along with the pending oppositions.

“We have studied the patent application closely and are convinced that it has no merit” says Anand Grover, director, Lawyers Collective. “It fails to satisfy any grounds required to meet the threshold of what is patentable under India’s patent law. Not only is it not new or inventive, it also does not comply with the requirements of Section 3 (d),” he adds.

Globally, there are around 180 million people living with HCV, 12 million of whom live in India alone. A large number of these people will require treatment to prevent liver-related illness which, if left untreated, can be fatal. Sofosbuvir, a once-a-day oral pill, is poised to revolutionise treatment for people living with HCV with cure rates of up to 95 per cent as compared to 65-70 per cent with weekly-injections of Pegylated Interferon, the standard current treatment. Gilead has priced the drug at $84,000 per treatment course in the US. Gilead made $5.7 million on the sales of Sofosbuvir in the first half of 2014 alone.

Without waiting for a patent on Sofosbuvir in India, Gilead went ahead and signed voluntary licences on Sofosbuvir and its combinations with several Indian generic companies back in September 2014. The licences are restrictive not only in the scope of their geographical coverage but also in terms of Gilead’s control over the ability of the licences to buy and sell the active pharmaceutical ingredient, a crucial raw material used in the preparation of medicines. Under the licences, generic versions of Sofosbuvir could cost anywhere between $300 to $900 per treatment.

“We know that even $300 per treatment is too expensive for the average person in India, let alone the poor. Open, unrestricted competition by Indian generic companies was responsible for drastic price reductions in ARV prices which allowed scaling-up of treatment to millions. If people living with HCV across the world have any hope to access affordable treatment it is vital that Gilead not be allowed to manipulate competition to further their profit motives. Treatment should be available for all.” says Eldred Tellis, Director, Sankalp Rehabilitation Trust.

“It is unfortunate that generic companies in India, who once played David to MNC’s Goliath have now chosen to go down this road. As civil society, we will continue to use pro-public health provisions to further access to medicines,” adds Grover.

Earlier this month Gilead was granted marketing approval for Sofosbuvir in India in a record time of four months and 10 days. “While we welcome the government’s swift regulatory approval to bring this much needed medicine to India, this alone will not help wide access to life-saving medicines. Our focus is now on fighting against any patent protection to Gilead” adds Tellis.



More AMCs to be identified for access to WHO database through Vigiflow software as part of PvPI
February 02, 2015, 0800 IST

Around 40 ADR Monitoring Centres (AMCs) out of the 150 are in the process of getting identified for registration with the Vigiflow software which is meant to report adverse drug reaction (ADR) data to World Health Organization (WHO) database on a consistent basis, as a part of the Pharmacovigilance Programme of India (PvPI), informed an official associated with the development.

Of the 150 AMCs set up under the PvPI, 110 centres have the Swedish software Vigiflow which helps in accurate reporting of ADRs with the help of Technical Data Associates (TDAs) working in 82 centres as of today. They are working in coordination with Indian Pharmacopoeia Commission (IPC) Ghaziabad for final analysis and reports.

TDAs are accountable to collect information from the patients, perform follow up with them, enter information in the prescribed software (Vigiflow) and sending them to IPC for further analysis and documentation. IPC has been assigned to update information on ADRs that is being reported in India from across all its centres through VigiFlow to the Uppsala Monitoring Centre (UMC) in Sweden, which is WHO's collaborating centre for international drug monitoring.

Vigiflow is a software given to the PvPI free of cost and prescribed to AMCs based on their efficiency to deliver in terms of frequency and quality of reports. Drug Controller General of India (DCGI) is the authority to identify the AMCs to further train them on using Vigiflow software and thereafter authorise password to them for linking with the data base of WHO called as Vigibase.

Pharmacovigilance as a science and specialty is slowly picking up in the country but research and reporting outcomes are limited. Experts inform, "Effective communication of the safety data to the general public is a key challenge which need to be addressed on a war footing. Letter writing, package insert warnings are some of the conventional methods used for communication of pharmacovigilance knowledge."

It has also been given to understand that there has also been lack of methodological approach and the specialty of pharmacovigilance has been more hospital focussed than community focussed. Single-centered studies has been done versus multiple centres and a lot of research on the subject remains unpublished are some of the key drivers fueling the demand for an effective pharmacovigilance programme in India.



Health ministry should ensure rapid execution of prescription audit: Dr Jagashetty
February 02, 2015, 0800 IST

The Union health ministry should make sure to work towards the swift implementation of prescription audit across the Indian healthcare sector.  This will prevent indiscriminate medicine usage and stall multi-drug resistance besides control medical expenditure, according to Dr BR Jagashetty, National Advisor, (Drugs Control), and Project in-charge for the implementation of two schemes of Central Drugs Standards Control Organization (CDSCO).

With the Medical Council of India which has issued guidelines on standard prescription format, there is also a need for an audit of prescriptions . It would work in sync with the objective of achieving patient safety, he added.

Prescription audit will provide stringent supervision across hospitals, nursing homes and clinics. It would create an environment of transparency, effectiveness and accountability among the medical professionals in the country.

These days, advising several drugs for a simple health disorder is in vogue. For instance, a range of multi vitamin supplements are provided in a prescription. There are also names of ethically promoted nutraceuticals which are suggested along with anti-inflammatory, antibiotics, anti-pyretic medicines. The need for rationalisation of medicines is to be analysed. For lifestyle disorders, doctors seem to prescribe common nutritional supplements which are claimed to be for control of cholesterol and for diabetes. In many cases, such products are beyond the affordability ambit of the patients.

Yet another aspect of audit should be to study the diagnostics prescribed by medical specialists. Pathology tests along with x-rays, CT-MRI scans are advised at repeatedly for simple disorders and diseases which is a cause for suspicion among educated patients, stated Dr Jagashetty.

Drugs constitute a mere 15 per cent of medical costs but it is the diagnostic costs and consultation fees for every visit to the same doctor which constitute a major part of the medical cost.  There is no  control on the mushrooming of path labs and diagnostics centres. Therefore, government should immediately consider a prescription audit for the benefit of the patient population, Dr Jagashetty pointed out.

Although the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) could stall brand promotion by pharma companies to the medical community, there is need to scrutinise the  operations of the pathology and diagnostic labs which are all based on doctor’s prescription, more often, unnecessary drugs and diagnostic tests add to the patient costs, said Dr. Jagashetty.



Pharmexcil focuses on improving Indian pharma exports to Myanmar
February 02, 2015, 0800 IST

The Pharmaceutical Export Promotion Council of India (Pharmexcil) is focussing on improving Indian pharma exports to Myanmar. As part of this initiative, the council is planning to organise expo-cum-BSM (buyer-seller-meet) in Yangon from 19-21st February 2015.

Myanmar, the eastern neighbour of India (also called as Burma earlier) has been long neglected and not much focus was given towards this country due to political uncertainty and military dictatorship. But during the past few years now, things are fast changing with much improved business environment prevailing in the country.

Particularly, the demand for healthcare products in the country is very high due to aging population. As India has already proven its might in high quality generics all over the world, Myanmar is now looking at India for its medicinal and healthcare imports.

Since the year 2011, Indian bulk drugs, formulations, herbals and Ayush products are being increasingly exported to Myanmar. India recorded a growth of 27 per cent in its formulations exports from Rs.375.46 crore, in the year 2011-12 to Rs.831 crore in the year 2013-14. Similarly in herbals, India recorded a growth of 71 per cent and improved its exports from Rs.0.16 crore in the year 2011-12 to Rs.0.9 crore in the year 2013-14.

On the other hand, India’s exports to Myanmar have recorded a negative growth in bulk drugs and Ayush products. Exports of bulk drugs from India to Myanmar have dipped to Rs.5.26 crore in the year 2013-14 from Rs.9.29 crore in the year 2011-12.

As there is a huge demand for generic medicines in Myanmar, India wants to grab the opportunity to improve its pharmaceutical export business to the country. At the same time the council is looking to establish a long term partnership between Indian pharma entrepreneurs and business community in Myanmar. As part of this, Pharmexcil with the support of department of commerce, government of India is planning to organise an expo-cm-BSM at Hotel Park Royal in Yangon from 19-21st February.

The main aim of this expo is to promote Brand India Pharma Campaign and to attract more investments in pharma sector as well as to improve Indian generic exports to this high potential market. “Our aim with this expo-cum BSM is to create a huge opportunity to interact with local buyers/distributors and large number of doctors from various parts of Myanmar for creating awareness about India generics. Further, Ministry of Commerce has directed Council to include related segments like pharma consultants, pharma education, pharma engineering, medical devices, drug testing labs, pharma institutions etc. in order to give the effort a composite outlook and create opportunities strategically. Using such platforms Indian pharma companies can build much better business links as well as share views and give suggestions to resolve in there are any issues relating exports or imports,” informed Dr P V Appaji, Director General of Pharmexcil.



Geojit BNP Paribas considers pharmaceuticals as safe sector for 2015 investors
February 02, 2015, 0800 IST

Geojit BNP Paribas, a financial trading major, sees that Indian pharma and healthcare are safe bets for the investors. These sectors for the last several years have given excellent returns to the investors.

Pharma and healthcare are relatively immune to the vagaries of economic growth and therefore in the context of low global economic growth projected for 2015, the pharmaceutical industry appears to be a safe bet, said Dr V K Vijayakumar, Investment Strategist, Geojit BNP Paribas.

More importantly, Indian pharmaceutical industry’s proven competence and its clear comparative cost advantages are well documented. Globally, Indian drug industry is third in volume, though only 14th in value.

Quoting the McKenzie research report, he said that Indian pharma  is likely to be the second in the world by 2020, behind only the USA. It could be a $40 billion industry by 2020. With 150 manufacturing sites approved by the US FDA, India is fast becoming a hub for manufacturing generics. The industry has 60,000 generic brands across 60 therapeutic categories. Indian pharma industry exported drugs worth $ 14. 84 billion in 2013-14.

One sector which is likely to do very well is the healthcare sector including pharmaceuticals.

With rising income, the domestic market and developing economies appear attractive markets for Indian pharma. The industry’s growth rate which was 9 per cent during 2000-2005, has jumped to 14 per centduring 2009-14. Sustained economic growth, rising income levels and supportive medical infrastructure facilitated this growth, said Dr Vijayakumar.

Going forward, increasing affordability due to rising incomes and increasing insurance coverage will facilitate the industry’s fast growth. The growth of the pharma industry in developed markets is likely to slowdown, he said.

A near certainty for 2015 is global growth scarcity. China is decelerating fast; Euro Zone is nearing stagnation; Japan is struggling and commodity exporting Emerging Markets like Russia and Brazil are reeling under commodity crash. In this scenario of global growth scarcity, coupled with abundant liquidity, there are only limited investment destinations that can attract capital. With the Indian economy on a structural and cyclical uptrend, Indian equities are likely to continue their superior performance in 2015 also. It would be reasonable to expect around 15 per centreturns in 2015. Of course, as always, some sectors will out-perform. The difficult task is to identify the potential winners, noted Dr Vijayakumar.

About 40 per centof the industry’s growth in the next 10 years is expected to come from emerging markets. Indian pharma industry is uniquely placed to capitalise on this great growth potential. In a favourable environment characterised by pragmatic pricing policies, the industry has the potential to achieve explosive growth culminating in a market size of $55 billion in 10 years.

Pharmaceuticals has given excellent returns to investors during the last several years. The industry returned 43 per centin 2014 on top of 22 per centreturns in the difficult year 2013. Going forward, the prospects appear brighter. There are proven names in the industry which have rewarded investors handsomely. The same companies are likely to sustain their performance in the years ahead, informed Dr Vijayakumar.





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