• 9 December 2010
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GEAC approval for transgenic corn trials

The Genetic Engineering Appraisal Committee (GEAC), the apex regulatory body for biotechnology-related products in India, has approved Monsanto India's request to conduct seed production research trials for transgenic corn lines. The trials - Hishell and 900M Gold (Events MON 89034 x NK 603) - will be held at Kurnool and West Godavari in Andhra Pradesh, at the company's leased land.

The committee noted that the purpose of the trials is to evaluate seed production of transgenic corn lines event MON 89034 and event NK 603; under confined open field conditions, involving taking note of pollen dehiscence and flowering behavior, that would help in working out the staggering requirements for the stack hybrid development.

Also, the study may help in understanding the flowering time pattern of the transgenic corn lines with event MON 89034 and event NK 603, under confined field conditions. Total required area for each location will be 0.98 acres for two plantings.

Approval for GM cotton export
In its 104th meeting, the Genetic Engineering Appraisal Committee (GEAC) has noted that the export of genetically modified (GM) cotton does not require its approval. The regulatory body that met on November 15, 2010 in the Ministry of Environment and Forests discussed the subject, and concluded that GEAC does not have any role in exports.

The Committee noted that GEAC has been receiving a number of requests for export of approved Bt cotton events to Pakistan. The intended purpose of export is for research/field testing. The need for obtaining such approvals was discussed, wherein the Committee opined that approval from GEAC is not necessary, as it is the responsibility of the importing country to take such decisions.

Therefore, export of Bt cotton seeds can be allowed, subject to the exporter obtaining approval of the competent authority of the importing country; and approval from National Biodiversity Authority, Chennai, as per the provisions of Biological Diversity Act, 2002.

In view of the above stated facts, exporters are not required to obtain approval of GEAC prior to export of Bt cotton seeds, expressing approved events. However, information on export may be submitted to GEAC for records.

India gears up to counter swine flu
According to Union Ministry of Health and Family Welfare, the government has granted license to six pharmaceutical companies for manufacturing two drugs for swine flu treatment. Besides that, three other companies have already been permitted to manufacture vaccines for its prevention.

The Minister of Health, Ghulam Nabi Azad recently made this announcement in the Parliament, stating that the drug Oseltamivir and its formulation for treatment of H1N1 (swine flu) is being manufactured by Cipla, Hetero Drugs, Natco Pharma, Ranbaxy Labs, Strides Arcolab and Cadila Pharma. Another drug for the purpose, Zanamivir, is being manufactured by Cipla.

Also, for prevention of H1N1 (swine flu), licenses to manufacture influenza (H1N1) vaccine have been granted to Serum Institute of India, Cadila Healthcare and Bharat Biotech. Besides that, there is the much-awaited Pandyflu vaccine from Panacea Biotec, to be launched any time soon.

Licenses for manufacture and sale of medicines in the country are granted by the State Licensing Authorities appointed by State governments, under the provisions of the Drugs & Cosmetics Act, 1940.

RIBN to enhance Russia, India ties
In a bid to encourage joint biotechnology initiatives between Russia and India, an agreement on Russia-India Biotech Network (RIBN) was signed and exchanged in the presence of the then chief minister of Andhra Pradesh, K Rosiah, by Prof Raif Vasilov, president, Russian Biotechnology Society & CEO, Russian Bio-industry Association; and Dr BS Bajaj, convener, BioAsia 2011 and secretary, Federation of Asian Biotech Associations (FABA). RIBN will be a dedicated online platform to effectively facilitate collaboration between the Russian and Indian biotech communities.

“RIBN will act as a dynamic platform to bring together Russian and Indian biotechnology communities - both business and science. Later, other countries could join this platform, making it the first global professional networking system. The first phase of the platform is functional from October 2010, and it would become fully-operational during BioAsia 2011 in February 2011,” said Prof Raif Vasilov.

The interested Russian companies will be able to browse through the profile of their Indian counterparts, and interact with them to understand their activities in detail and vice versa.

“RIBN will facilitate business partnering throughout the year, in addition to offering business support services like databases, online seminars, placements, exchange programs, facility visits, trade delegations,” said Dr BS Bajaj.Jubilant clocks 988 crore in Q2 FY2011
Jubilant Life Sciences, formerly Jubilant Organosys, an integrated pharmaceutical company, and the largest custom research and manufacturing services (CRAMS) company in India, announced financial results for Q2 FY2011. In the second quarter of FY2011, consolidated revenues for the company was 988 crore, registering a growth of six percent; with international business contributing 62 percent to the top line.

Revenue from pharmaceutical and life science products and services (PLSPS) was estimated at 850 crore; contributing 86 percent to the total revenues of the company, mainly driven by 11 percent growth in active pharmaceutical ingredient (API) business and 50 percent growth in dosage forms. The life science products with revenues at 657 crore contributed 67 percent and the remaining 193 crore was from life sciences services.

The products business saw a good volume growth of 13 percent; and revenues visibility in the services business is encouraging though volatility persists due to slow regulatory approvals of the customers.
Agri and performance polymers (APP) business witnessed a very strong growth of 29 percent in sales at 138 crore. This segment contributed 14 percent of total company's consolidated revenue.

Growth was mainly driven by robust sales in agri-products, which was up 98 percent to 69 crore.
In Q2 FY2011, EBITDA was 164 crore, as compared to 192 crore during the same quarter last year, with margins at 16.6 percent. EBITDA margins in PLSPS segment were at 19.4 percent and at 12.6 percent in APP segment. Net profit showed growth of 42 percent at 82 crore as against 58 crore in the same quarter last year.

Panacea Biotec reports 52% growth
Panacea Biotec, a leading vaccine manufacturer in India, has announced a growth of 52 percent in net turnover, at about 252.60 crore during the quarter ended September 30, 2010, as compared to about 165.80 crore for the corresponding period of previous financial year.

The company noted that pharmaceutical formulations export grew by 285 percent; whereas domestic pharmaceutical formulations grew by 18 percent in this quarter. The company registered formulations segment net turnover of about 83.60 crore, as compared to about 61.10 crore, during the corresponding period of previous financial year, registering a growth of 37 percent.

The vaccines export grew by 68 percent. The company further said it has registered vaccine segment net turnover of about 169 crore, as compared to about 104.70 crore, during the corresponding period of previous financial year, registering a growth of 61 percent. The company reported substantial growth of 842 percent in its profit-before-tax (PBT); at about 28.60 crore, as compared to about 3 crore, during the corresponding period of previous financial year. The company reported significant growth of 692 percent in its profit-after-tax (PAT) at about 17 crore, as compared to about 2.1 crore, during the corresponding period of previous year.

Uniform code for pharma marketing
Union Minister of State for Chemicals and Fertilizers Srikant Kumar Jena on November 25, 2010 announced that Department of Pharmaceuticals (DoP) is currently examining the possibility of framing a Uniform Code of Pharmaceutical Marketing Practices, which would be adopted voluntarily.

This comes after recent reports in the media claimed unethical marketing practices of certain pharma companies. Keeping in view seriousness of the allegations made in the media reports, the DoP felt the need to take up the matter in the interest of consumers, as such promotional expenses extended to doctors had direct implications on the pricing of drugs and its affordability.

After discussing the issues with pharmaceutical associations and industry, the department has been able to persuade most of the associations to have a code of ethics. Organization of Pharmaceutical Producers of India and Indian Drug Manufacturers' Association have informed that, they along with Confederation of Indian Pharmaceutical Industry, Federation of Pharma Entrepreneurs, Indian Pharmaceutical Alliance and SME Pharma Industries Confederation have worked out the 'Uniform Code of Pharmaceutical Marketing Practices'.

Bioeconomy workshop stresses on global ties
The bioeconomy concept involves a systematic approach to exploit information on biological systems for a sustainable production of renewable raw materials, for use in different economic sectors. Keeping that in view, a two-day workshop on bioeconomy was organized jointly by Government of India's Department of Biotechnology (DBT), and Germany-based Bioeconomy Science Center (BioSC) on November 23-24, 2010, in New Delhi.

This Indo-German partnering workshop aimed at introducing Indian partners from academia, industry and stakeholder groups; to the bioeconomy concept, and its realization by the BioSC, to gain valuable insights into the Indian version towards this topic, and to match interests, in order to pave the way for strategic Indo-German partnerships in bioeconomy. Collaborative R&D and future roadmap was the key topic of discussion at the event.

The workshop saw a number of speakers delivering talks on the different aspects of bioeconomy.

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