Biotech sector report

ITs 2 AM in the night. Just finished making the biotech sector report, in retrospect. The financial analysis still needs to be done. Was planning to start marketing. That remains a plan . Dunno if tomorrow will be IT quiz . The IT project meet was quite successful with work allocation and architecture getting finalized. Divided work ito 6 parts...sixy sixy sixy

Genetic Engineering Approval Committee (GEAC)
Specifies the rules for the manufacture, use/import/export and storage of hazardous microorganisms genetically engineered organisms or cells, 1989.
http://www.envfor.nic.in/divisions/csurv/geac/biosafety.html
Drugs and Cosmetic Rule(8th Amendment),1998
Revised guidelines for research plants & guidelines for toxicity and allergenicity evaluation of transgenic seeds, plants and plant parts,1998
Guidelines for generating preclinical and clinical data for rDNA vaccines, diagnostics and other biologicals,1999
Report of the Task Force on Recombinant Pharma

Department of Biotechnology (DBT) http://dbtindia.nic.in/

Monitoring and Evaluation Committee (MEC)

Review Committee on Genetic manipulation (RCGM).

Drug Controller General of India (DCGI) http://www.cdsco.nic.in/html/central.htm

Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control 0rganisations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

4. Identification of sector Impact factors:
Increasing middle class purchasing power in India: Middle class can purchase costlier vaccines for children which have fewer side effects. This will increase the net margin for biotechnology companies. From the following table one can extrapolate the growth in vaccines. (bold).

Biocon has made significant capital expenditure and its profitability depends on the competition with Chinese players in the statins market. Another important factor is the opportunity from drugs which are coming off patent in the US market.