• 11 July 2011
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Vaccines approvals increase in India

There has been a conisderable increase in efforts to tackle a number of prevailing viral infections in the country and this is evident from the presence of the various awareness programmes. Also, there has been an increase in the approvals that have been granted to various companies for manufacturing vaccines, thus providing more options to the suffering population. At least six companies have got permission from the Central Drugs Standard Control Organization (CDSCO) for manufacturing 12 viral vaccines in India. These vaccines target major infectious diseases such as poliomyelitis, pandemic influenza and rabies, which affect a large chunk of population in India.

To increase the number of alternatives to tackle polio, approvals were given to manufacturing of three vaccines. Hafkine Bio Pharma, Mumbai, received permission from CDSCO to manufacture bivalent polio type 1 and type 3 vaccine (live oral) to check poliomyelitis. New Delhi-based Panacea Biotec was granted permission to manufacture two vaccines, including a oral poliomyelitis vaccine (type 1, 2 and 3) aimed at active immunization against polio and also received permission for manufacturing bivalent polio type 1 and type 3 vaccine live oral for immunization against type 1 and 3 poliomyelitis. To counter the deaths resulting from the H1N1 pandemic in India, CDSCO gave permission to four companies for manufacturing various vaccines with different compositions targeting different age groups. Panacea Biotec was given a go-ahead on Nov 8, 2010 for manufacturing the inactivated H1N1 split virion vaccine (both adjuvanted and non-adjuvanted) for immunization against H1N1 pandemic influenza.

Other firms including, Ahmedabad-based, Cadila Healthcare, received permission on May 11, 2010, to manufacture inactivated Influenza vaccine (whole virion) IP, a pandemic influenza (h1n1, monovalent vaccine) for active immunization against H1N1 virus in age group of 18 years and above. The Serum Institute of India (SII), Pune, was granted permission on June 18, 2010 for manufacturing influenza vaccine (live attenuated freeze dried) for intranasal route to contain influenza diseases caused by pandemic (H1N1). SII was also given permission to manufacture swine A/H1N1 influenza vacine inactivated against the influenza. Hyderabad-based Bharat Biotech International on Sep 30, 2010 received permission to manufacture adjuvanted H1N1 vaccine (inactivated)-HN-VAC for active immunization for H1N1 pandemic influenza.

India, China are hubs for generic drugs

North America and Europe have traditionally been the major pharmaceutical producers. However, in recent years, because of increased demand from local population and low production costs, several new markets such as India, China, Brazil and Russia have emerged. The growing pharmaceutical infrastructure in these emerging markets is spurring the demand for high-purity water systems, thus creating opportunity for water management companies. In addition, many developed and developing nations are imposing stringent effluent standards on the wastewater that is discharged from drug manufacturing facilities, in order to prevent contamination of water streams.

New analysis from Frost & Sullivan, called 'Global Water Market Outlook: Strategic Analysis of Water and Wastewater Management in the Pharmaceutical Industry', revealed that the market for water and wastewater treatment equipment in the pharmaceutical industry recorded revenue of 3,105 crore in 2010 and this is expected to reach 5,625 crore in 2017. The Asian market for water and wastewater treatment equipment in the pharmaceutical industry is expected to grow at a compound annual growth rate of 16.5 percent from 2010 to 2017. Pharmaceutical companies in North America and Europe are outsourcing certain portions of the drug production process to Asian countries and are keen to focus more on R&D.

Biocon explores an oral insulin deal

Biocon, which is in R&D alliances with Sanofi Aventis and Bristol-Myers Squibb, is looking to capitalize on its present relationship to chalk out an oral insuline deal. An oral insulin deal cannot be ruled out between these firms as it is a very innovative delivery method for insulin. Oral insulin will prove to be a game changer for insulin patients worldwide, when it passes through all clinical trials and hits the market.

The value of the insulin deal between Biocon and Pfizer was one of the highest grossing deal in the field of biosimilar drugs. However, a deal for oral insulin would fetch a far greater value as compared to the Biocon-Pfizer deal.

The Indian insulin market is presently estimated to be worth 700 crore. The launch of oral insulin will certainly eat into this revenue after the first few years of its launch. A deal with a NDDS with respect to oral insulin will benefit the pharmaceutical industry in India and provide increased global standing to all Indian R&D for novel drug delivery systems.

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