Healthcare in India
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Healthcare in India
Selection of Articles, Opinions, Discussions and News on Healthcare in India from all over the web covering Healthcare Policy, Healthcare Reform, News, Events, #HealthIT , Edipdemics, Chronic Diseases, #mHealth, #hcsmin ,
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Rougher Passage to India’s Drug Market

Rougher Passage to India’s Drug Market | Healthcare in India | Scoop.it

FDA Commissioner Margaret A. Hamburg, M.D., contrasted the craftsmanship and beauty of India’s Taj Mahal with recent lapses in quality by “a handful” of the country’s drug manufacturers during a recent visit there. If the comparison was meant to flatter the domestic pharma executives and regulators with whom she met, they didn’t appear to think so.


Dr. Hamburg and officials from India’s Ministry of Health and Family Welfare pledged cooperation in data sharing and even “medical and cosmetic product and inspections conducted by the other Participant.” That’s no small promise since India is the world’s second largest exporter of prescription and over-the-counter drugs. Yet their formal Statement of Intent conditioned such cooperation “as time and resources allow” and didn’t set specific terms.


In a conference call with reporters today, Dr. Hamburg said implementing the statement was a five-year commitment “already under way” as both countries “have already embarked upon some cross-training activities and started to identify some critical areas for future activities together, so I think progress will be made.”


Indian drugmaker Ranbaxy has come under repeated FDA scrutiny. It agreed last year to pay a $500 million fine for safety and record-keeping violations. More recently, it urged Dr. Hamburg to lift the FDA’s consent decree. Extended as of January, this decree effectively bans four of Ranbaxy’s Indian plants from exporting active pharmaceutical ingredients to the United States. Although Ranbaxy contended that it needed the export activity to fund FDA-sought quality improvements, Dr. Hamburg declined the company’s request.


Domestic Generics

According to the All India Chemists and Druggists Association data reported by Indian newspaper The Economic Times, Mumbai-based Glenmark Pharmaceuticals impacted the Rs 3,000 crore ($483.7 million) Indian diabetes drug market long dominated by multinationals last year. Glenmark racked up Rs 16 crore ($2.58 million) in eight months for its Zitamed and Zita generic versions of sitagliptin


These generics sold 30% cheaper than the Januvia and Janumet branded drugs of market leader Merck & Co., which generated more than $5.8 billion in combined global 2013 sales for Merck and are the subject of a patent dispute between the companies.


Through court decisions and regulatory actions, Indian officials have pressed foreign-based multinationals for lower-cost drugs. These multinationals, however, have argued that Indian actions hinder their ability to do business selling innovative if costlier drugs.

Patent Questions

India’s Patent Office sent shivers through the biopharma industry in 2012 when it revoked the exclusive patent rights held by Bayer for cancer drug Nexavar, and awarded the nation’s first-ever compulsory license to a domestic maker of a much cheaper generic. Industry cringed again last year when India’s Supreme Court rejected patent protection for Novartis’ blockbuster cancer drug Glivec, as the drug faces a 2015 expiration of its first U.S. patent.


The patent decisions, Bagla explained, reflect Indian compliance with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization, of which India is a founding member.


“Western companies need to factor this situation among the risks of doing business in India,” Bagla emphasized. “Some of our clients are limiting their involvement in India due to this. Others are a taking a measured approach to what products and technologies they bring. Very few are walking away from India completely.”


Legal and Regulatory Moves

Last year, the Indian Supreme Court ordered a nationwide halt to clinical trials for 157 new chemical entities, citing the need for stricter ethical standards after seven girls died in a Phase IV trial of an HPV vaccine carried out on children unaware they were under study. The court also shifted responsibility for trials from the Central Drugs Standard Control Organization headed by Dr. Singh, ordering India’s Health Secretary personally responsible for new-drug clinical trials.



This is a summarized scoop of the original which contains a lot more details at http://www.genengnews.com/insight-and-intelligence/rougher-passage-to-india-s-drug-market/77900044/


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Dabur Launches India's First Ayurvedic Medical Journal

As part of its plans to propagate the benefits of traditional Indian form of medicine, leading Ayurvedic healthcare company Dabur India Ltd today launched 'Ayurveda Samvad', India's first Ayurvedic Medical Journal. 

The quarterly journal was unveiled by Shailaja Chandra, General Secretary, AYUSH, Government of India. 

The quarterly publication will cover detailed information on various clinical trials being conducted on Ayurvedic medicines.

Announcing the launch, Dabur India Ltd Ayurveda R&D Head Dr J L N Sastry said the journal would cover the holistic approach on Ayurveda. It would popularise Ayurveda and reach out to the doctor fraternity to propagate messages on the Ayurvedic way of life to manage health and diseases. 

The journal will feature articles covering original scientific studies in the field of Ayurvedic medicines with direct clinical significance, addressing health care issues and public health policy. 


more at http://www.business-standard.com/article/pti-stories/dabur-launches-india-s-first-ayurvedic-medical-journal-114022200250_1.html



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India is the place to be, say home-bound doctors

India is the place to be, say home-bound doctors | Healthcare in India | Scoop.it

After technology sector, it's the health sector in Bangalore that is witnessing a reverse brain drain. Across fields-nephrology, general medicine, pathology, orthopaedics and oncology among others, doctors are returning to India in general and Bangalore in particular.


On an average big medical hospital chains in the city each get 8 to 10 applications every month from Indian doctors in the US, the UK, Canada, Australia and Singapore. "I interview one doctor a week. And in the last six months I have got 12 applications for jobs from doctors abroad. They are all in their 30s," says Dr H Sudarshan Ballal, medical director, Manipal Hospitals.


The scene is no different at Sparsh Hospital on Narayana Health City campus where chief orthopaedic and hospital head Dr Sharan Patil scrutinizes at least 10 applications every month from doctors in the UK, Australia and the US.

"There is no bigger canvas to paint yourself than in medicine. Two decades ago when doctors left India, the opportunities were few. Today opportunities outweigh frustrations. After the training, they want to return," says Dr Patil, who himself spent five years in the UK before returning to the city to become a doctor-entrepreneur.


Ten of the 40 orthopaedicians at Sparsh are those who have returned from abroad. "I began to feel I was making no difference in my job and decided to leave Australia. I find it more satisfying here. But it is good to study and train abroad for some time," says Dr A Thomas, spine surgeon, who practised for five years at St George Hospital, University of South Wales.


Hospital honchos are seeing the trend only in the past five years. In many hospital chains of Bangalore, the entrepreneurs are doctors themselves who left practice in the dream country where they were and came back home.

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Amendments to Drug Act Simplify Access to Pain Medicines

Amendments to Drug Act Simplify Access to Pain Medicines | Healthcare in India | Scoop.it

Millions of Indians suffering chronic pain will get better access to pain medicines following changes in India’s drug law, Human Rights Watch said today. On February 21, 2014, the Rajya Sabha, the upper house of parliament, approved amendments to the Narcotic Drugs and Psychotropic Substances Act (the Drug Act) that  the lower house had approved a day earlier.

The amendments eliminate archaic rules that obligated hospitals and pharmacies to obtain four or five licenses, each from a different government agency, every time they wanted to purchase strong pain medicines. As Human Rights Watch documented in a 2009 report, “Unbearable Pain: India's Obligation to Ensure Palliative Care,” this resulted in the virtual disappearance of morphine, an essential medicine for strong pain, from Indian hospitals, including from most specialized cancer centers.

“The revised Drug Act is very good news for people with pain in India,” said Diederik Lohman, senior health researcher at Human Rights Watch. “These changes will help spare millions of people the indignity of suffering needlessly from severe pain.”

Patients who experience severe pain without access to adequate treatment face enormous suffering. Like victims of torture, these patients have often told Human Rights Watch that the pain was intolerable and that they would do anything to make it stop. Many said that they saw death as the only way out and some said they had become suicidal.

The amendments to the Drug Act give the central government authority to regulate so-called “narcotic drugs,” require a single license to procure morphine and other strong opioid medications, and charge one government agency, the state drug controller, with enforcement. The government introduced the amendments to the Drug Act in 2012.


more at http://www.hrw.org/news/2014/02/21/india-major-breakthrough-pain-patients


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Indian Clinical Trial Reforms Take Shape as Report Condemns HPV Vaccine Trials

Indian Clinical Trial Reforms Take Shape as Report Condemns HPV Vaccine Trials | Healthcare in India | Scoop.it

As questions continue to be raised over the policies governing clinical trials in India, new regulations and amendments to the country's pharmaceutical laws are now coming to light.


Specifically, India’s CDSCO (Central Drugs Standards Control Organization) is looking to crack down on unauthorized trials and is now calling for sponsors to reveal payments made to CROs and trial investigators.


A recent announcement by CDSCO says that information in respect of the payments made by the sponsor to the investigator for the conduct [of the] clinical trial should be made available


Formal and legal agreements between sponsors, CROs (contract research organizations) and investigators should be decided prior to the start of the trial and define the relationship in terms of financial support, honorariums, fees and other payments, the order says.


Source and Further reading: http://www.outsourcing-pharma.com/Clinical-Development/Indian-Clinical-Trial-Reforms-Take-Shape-as-Report-Condemns-HPV-Vaccine-Trials

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Genetic labs, counselling centres under health department's lens

Genetic labs, counselling centres under health department's lens | Healthcare in India | Scoop.it

The absence of adequate checks on genetic labs and genetic counseling centres functioning in the state has prompted the health department to inspect them for possible misuse of sex determination technology.

Sonography centres have to submit form 'F' which gives details of a pregnant woman undergoing an ultrasound scan. Similarly, genetic counseling centres must maintain form 'D' while genetic laboratories need to fill form E.

However, 'health officials have been lax in inspecting the records at these centres', states the letter issued by the state health department to civil surgeons and civic health officials in the city on August 3.

Health authorities said the genetic labs have Pre-implantation Genetic Diagnosis (PGD) facilities, which allows testing of the embryo before implantation and hence the daily monitoring of their functioning is crucial.

state health official, on the condition of anonymity, said, "The fact is that there has been no monitoring of genetic labs and genetic counseling centres functioning in Maharashtra. So, we have ordered civil surgeons in rural areas and civic health officials in cities to carry out inspection of such labs and centres and report to us every day."

Asaram Khade, a consultant to the state government on Pre Conception and Pre-Natal Diagnostics Techniques (PCPNDT) Act, said, "We have started consolidating the exact number of genetic labs and genetic counselling centres functioning in the state. We have issued orders to civil surgeon and municipal corporation health officials to inspect these centres and report to us about the same in the format prescribed.

Like inspection of form F, officials have been told to report to us the daily scrutiny of form D meant for genetic counseling centres and form E for genetic labs."

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