Indian Pharma mkt valued at Rs 55,000 cr in FY09

The total size of Indian pharmaceutical industry, excluding exports and government purchases, stood at Rs 55,454 crore in the last fiscal, the Lok Sabha was informed today."As per the information available with the department through ORG-IMS, April (2009)MAT, value of Indian pharmaceutical market is Rs 55,454 crore," Minister of State for Chemical and Fertiliser Srikant Jena said while replying to a written query.The total value includes retail pharmaceutical market at Maximum Retail Price (MRP), generic and companies not tracked by ORG, hospitals and institutional sales excluding government procurement, direct doctor purchases, over the counter (OTC) products and diagnostics, Jena said."In addition to this, Indian pharma industry's export was worth Rs 38,433 crore in 2008-09," the minister added.The total size of the domestic industry in 2006-07 fiscal was at Rs 43,904 crore and in 2007-08 it was Rs 50,410 crore.

Healthcare industry to double in value by 2012: KPMG

Propelled by rising income levels as well as changing demographics and illness profiles, particularly with a shift from chronic to
lifestyle diseases, the Indian healthcare industry is estimated to double in value by 2012 at $14.2 billion and more than quadruple by 2017, says the latest Indian Healthcare edition of KPMG’s Global Infrastructure – Trend Monitor. According to the report, this is likely to result in considerable infrastructure challenges and opportunities. Of the 32 Indian states that the report considers, the six states of Maharashtra, Rajasthan, West Bengal, Uttar Pradesh, Tamil Nadu and Andhra Pradesh are estimated to represent approximately 50 per cent of the expenditure for the 2009-2013 period. Speaking on the release of this report, Pradip Kanakia, head of markets and healthcare services, KPMG, said, “While the Indian healthcare system has grown manifold over the past few years, it has yet not been able to keep pace with the rapid rise in the population. One example of that is the availability of hospital beds in our country – against a world average of 4 beds per 1000 population, India lags behind at just over 0.7 presently.” Thus, there is a dire need to introduce some radical reforms in the healthcare infrastructure development process. For instance, use of PPP models on a larger scale and foreign investments are some which could be considered. The report suggests that there is a growing need to deal with the issues of urban healthcare infrastructure as rural to urban migration has significantly increased the demand for these services. The report also looks into the fact that the Indian healthcare system is controlled by respective state authorities, presenting an opportunity to improve responsiveness to healthcare needs at a more local level. Ameeta Chatterjee, director - corporate finance, KPMG, said, “There has been an increasing awareness of private sector involvement in meeting the requirement of the country’s health services requirement. The Indian solutions that will evolve need to be focused on developing affordable, low cost basic healthcare services with scalability and sustainability as key drivers.” The report suggests that there is opportunity to improve responsiveness to the country’s healthcare needs at a more local level due to uneven focus on healthcare infrastructure in India This can be attributed to the healthcare system in the country which is controlled by respective state authorities. The variety of organizational structures and processes in healthcare delivery may result in greater inequalities between geographical areas. There is a growing agenda to deal with the issues of urban healthcare infrastructure as rural to urban migration has significantly increased demand for these services.

Three Indian biotech cos get nod to develop swine flu vaccine

NEW DELHI: India’s drug regulator has given approval to three domestic biotech firms to start tests and analyses to develop a vaccine for swine flu,
or the H1N1 virus, which killed hundreds across the globe this year, subsequently classified by the World Health Organisation as a “pandemic”. Bharat Biotech, Panacea Biotech and Serum Institute will now be able to procure seed strains from labs in the US and UK, but will have to follow the strict bio-safety standards mandated by the Drugs Controller General of India (DGCI). Novartis AG had claimed last month that it has successfully produced the first batch of vaccines for the virus, but the global markets are yet to see a product. The WHO had recently said that a fully licensed swine flu vaccine might not be available until the end of the year. In India, however, producing the vaccines may take more time. “We have given approvals to three Indian companies to get seed strains from the US-based Center for Disease Control and the UK-based National Institute for Biological Standards and Control (NIBSC) to start preliminary research,” DCGI Dr Surinder Singh told ET. According to Dr Singh, the domestic companies are expected to take at least six months before they apply for an approval for the next stage of trials. Once the companies submit their preliminary test and analysis data, they will have to apply for potency test, pre-clinical trials and finally clinical trials before launching the medicine in the market. The WHO has said countries could use emergency provisions to get the vaccines out quicker if required. In India, the Drugs and Cosmetics Act (DCA) has a provision through which the government can allow relaxations in launching of a drug or a vaccine in the country if there is an emergency. However, such provisions are used only after weighing the risk and benefit ratio. At present, the government has no plans to evoke any such provision as there is no community-wide spreading of the virus reported in India, Dr Singh said. He added that by September, global companies might be able to roll out a vaccine in the country.

DCGI, India to set up own labs to test new drugs

NEW DELHI: India’s top drug regulator Drug Controller General of India (DCGI) has identified six labs to test new drugs before launching them in the
market. It is now looking at public-private-partnership (PPP) models to build infrastructure and better testing facilities in order to keep a vigil on the quality of drugs. Currently, the drug regulator gives marketing approval to new drugs based on the evaluation of the clinical trial data submitted by them. Testing of new drugs by a government agency will give more quality assurance to the consumer. “We have identified six government labs that can be used for testing new drugs. Now, we are in talks with some private labs for tie-ups to develop the infrastructure of these labs, so that they can be used for testing new drugs,” a health ministry official said. DCGI is also planning to test spurious drug samples, collected from the market, in the labs. “Drug inspectors have collected around 24,600 samples of spurious drugs from across the country. However, only 30-40% of the collected samples could be tested due to lack of manpower and facility. A PPP model would allow private laboratories to bring in more manpower and upgradation of facilities in these labs,” the official said. The government is looking at a revenue-sharing model with private labs to upgrade the labs. While the government will fund the projects, the private companies will bring in manpower and expertise, he added. According to official estimate, there is a substantial increase in the number of new drug applications received by the drug regulator annually. While DCGI received only around 1,200 application for new drugs in 2005, it received 1,600 applications in 2007 and 1,750 in 2008. In 2009, the drug regulator has received 920 applications for new drugs within the first six months. “While the number of applications has gone up, monitoring the quality of drugs in the market is a challenge that we have to face,” the official said.