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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The UPA regime: A Decade of massive healthcare reform

The UPA regime: A Decade of massive healthcare reform | Healthcare in India | Scoop.it

Winston Churchill once said, "Healthy citizens are the greatest asset any country could ever have." The UPA's effort to invest in citizen's health deserves better coverage and notice than it has attracted so far.


As we inch towards the end of United Progressive Alliance's (UPA's) second term, it is important to look back and reflect on what was accomplished and what is still to be achieved. If health indicators are any yardstick, then the UPA's thrust on social healthcare has led to improved health of citizens and set the stage for future reforms.


In 2004, when UPA came to power, expenditure on public health was around Rs 7,500 crore. This has now almost quadrupled to Rs 27,000 crore. In the beginning of UPA's regime, the National Rural Health Mission (NRHM), known to be "the most ambitious rural health initiative ever", was initiated.


The NRHM was formed to provide effective healthcare delivery to our rural population, especially women and children. The latest data shows that in the last 10 years, infant mortality rate (IMR) has come down from 58 per 1,000 to 44. This is further set to decline sharply.


During the National Democratic Alliance's regime, the IMR declined at a snail's pace of 1.3% annually, whereas now this deceleration is happening at 6.4% per annum.


With government focusing on early and periodic health screening of children through its Rashtriya Bal Swasthya Karyakram, children's health indicators could improve further.


With the Janani Suraksha schemes, institutional deliveries through skilled birth attendants have increased rapidly. Approximately 12 million deliveries per year are taking place at no expense to the beneficiaries. This is followed by cash incentives and other benefits.


As a result of such initiatives, the maternal mortality ratio of India has been reduced by 50% from 390 in 2000 to 200 in 2010.


Providing government-run health insurance to below poverty line (BPL) workers and their families through Rashtriya Swasthya Bima Yojana (RSBY) is yet another milestone achieved by the UPA government.

The objective of RSBY is to protect BPL households from major health expenses that could wipe out their life's savings.


This scheme allows inpatient treatment up to Rs 30,000 per year, and since its inception in 2008, around 35 million families have enrolled in the programme. This scheme has been praised by global leaders for its unique, innovative and inclusive business model.


Making India free from the blot of polio is another achievement of the UPA. This was only possible due to massive immunisation and awareness efforts of the government. Nevertheless, the government should be in surveillance mode as we are surrounded by nations that are still afflicted by polio.


Due to improved life expectancy, the average Indian would live five years longer than he would have had a decade ago. An increase in life expectancy will be a driver of economic growth, as it happened in Japan, which saw an increase in life expectancy by 13 years after World War II, followed by rapid economic growth.


This is a battle half-won. We have people falling into the trap of poverty and indebtedness due to escalating healthcare cost. The government should speed up its intention to provide free medicine to all through public hospitals and health facilities.


more at http://economictimes.indiatimes.com/opinion/comments-analysis/the-upa-regime-a-decade-of-massive-healthcare-reform/articleshow/29430774.cms


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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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Hospital warned against deal with stem cell banks

The couple, unaware that Hiranandani did not allow any other service provider to collect stem cells, had made an arrangement with LifeCell International. They had paid an advance of Rs 60,000 for the banking, that lasts up to 21 years. A complaint was lodged in June 2012, after which a probe was ordered by the Competition Commission of India (CCI). 

Hiranandani's refusal came when the couple went to seek permission to allow the LifeCell representative to collect the stem cell on the day the baby was born. Stem cells must be collected shortly after a baby is born. Hiranandani cited its tie-up with Cryobank for denying entry to another company representative on its premises. The couple tried to reason with the hospital and then decided to shift to SevenHills Hospital, Marol, for the delivery. 


The body, while penalizing the company 4% of its annual turnover of the last three years, said the hospital should behave ethically towards patients. It said the hospital's arrangement was based more on a commission model rather than competition and that was "against the spirit of health services". CCI found that Cryobank was paying the hospital Rs 20,000 for every patient who opted for stem cell banking. This practice is common in the industry. 

The industry hailed CCI's decision. "Patients deserve to be given a fair choice. The industry is new and such pacts can hamper its growth," said Meghnath Roy Chowdhry, secretary, Association ofStem Cell Banks of India (ASBI). Gynecologists said most city hospitals affiliate more than one player though the practice may be different for nursing homes. "Each company may have something better to offer. As doctors we only explain the benefits and disadvantages of storing stem cells, but beyond that the choice is with the patients," said Dr Suchitra Pandit, president, Federation of Obstetric and Gynecological Societies of India. 


more at http://timesofindia.indiatimes.com/city/mumbai/Hospital-warned-against-deal-with-stem-cell-banks/articleshow/30817366.cms


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Why is India’s healthcare system in such a sorry state?

Why is India’s healthcare system in such a sorry state? | Healthcare in India | Scoop.it

R Srinivasan’s credible government document on healthcare in India titled ‘Health Care in India – Vision 2020’ draft published in 2004, sub-titled ‘Issues and Prospects’, has suggested four criteria that make a just healthcare system 


1. Universal access, access to an adequate level, and access without excessive burden.

2. Fair distribution of financial costs for access and fair distribution of burden in rationing care and capacity and a 
constant search for improvement to a more just system.

3. Training providers for competence empathy and accountability, pursuit of quality care and cost effective use of the results of relevant research.

4. Special attention to vulnerable groups such as children, women, the disabled and the aged.
 
Srinivasan's  draft is dated; but the criteria are relevant even today as India’s healthcare system remains in a very sordid state.


A recent study by IMS Institute of Health Informatics (19 July, 2013) has revealed that 72 percent of the rural Indian population has access to just one-third of the country’s available hospital beds while 28 percent of urban Indians have access to 66 percent of the total beds. The study also notes that those living in remote pockets have to travel more than five kilometres to access an in-patient facility, 63 percent of the time.


Evidently, the country’s historical spend on healthcare, apart from immunization programmes, has not been enough. WHO statistics show the total expenditure on health is 4.4 percent of the GDP, for a population of 1.27 billion. As a result of a low healthcare spend and lack of special attention towards this sector and absence of concrete regulatory policies, India’s healthcare system is in shambles.


Here is a picture of the current healthcare scenario:
 
Universal Access and Financial Costs: The IMS study noted that long waiting time and absence of diagnostic equipment at public facilities has caused an increasing number of patients to rely on private healthcare facilities.  Quality of treatment is also a reason why patients switch to private centres. However, this shift from public to private care is posing an affordability challenge to poor patients.
 
Training and distribution of Health workforce: Statistically speaking, Indian cities have four times the number of doctors and three times more nurses than in rural areas. Meanwhile, almost 80 percent of the medical colleges are located in South and West India. The direct impact is a dearth of trained professionals practicing in rural India.






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