India has become a signatory to TRIPS. Consequently, a new
patent law has come into effect from January 2005. The new
keyword for the pharmaceutical industry is innovation and
to introduce new drugs, clinical trials are mandatory. They
are to be conducted as per ICH GCP norms. The clinical trials
that have been conducted in India till date have gone well.
For majority of the studies, patient enrollment is a key advantage.
This helps compress the development timeline and data quality
is excellent.
Numerous audits in India are a testimony to level of quality. And data from clinical study in India have been successfully filled with international regulatory agencies. The potential realized at present is a fraction of the possible in India. Consistent with WTO guidelines effective from 2005, India will also offer 10-year tax concessions on revenue to companies making Research & Development (R&D) investments here. These incentives are expected to substantially increase R&D activities of both multinational and domestic biopharmaceutical companies.
Analysts are projecting that total Clinical Research spending in India will increase by more than 30% annually through 2015.
Numerous audits in India are a testimony to level of quality. And data from clinical study in India have been successfully filled with international regulatory agencies. The potential realized at present is a fraction of the possible in India. Consistent with WTO guidelines effective from 2005, India will also offer 10-year tax concessions on revenue to companies making Research & Development (R&D) investments here. These incentives are expected to substantially increase R&D activities of both multinational and domestic biopharmaceutical companies.
Analysts are projecting that total Clinical Research spending in India will increase by more than 30% annually through 2015.
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