| This suggestion has been put forward to enable the streamlining and simplifying of the procedures for drug approval. It is also expected to help companies achieve regulatory compliance with high levels of clarity and accountability. |
| According to Radhika Choudary, executive director, ABLE, "Today, biotechnology products need to seek approvals from four regulatory authorities in a cumbersome manner. There is an urgent need to provide logical linear progression in the approval system and eliminate the overlapping and duplication of procedures. It is also essential that the authorities adopt guidelines that have checks and balances to ensure stringency and standardisation of regulatory processes." |
| The trend to outsource R&D capabilities in biotechnology to India, is increasing. This represents a tremendous opportunity for Indian companies. In India alone there are estimated to be over 200 research institutes and universities involved in biotech research with over 150 private sector companies working in different segments of biotech research, manufacturing and marketing. |
| "The biotechnology industry in India is evolving and therefore needs to have regulatory norms that demonstrate both transparency and accountability to build a strong sector. Recent media reports alleging procedural lapses by companies are unfair and misleading about the Indian biotechnology industry. It is important that such perceptions are corrected through implementing regulatory systems that have clarity and high standards of evaluation. Or else, this can have a negative impact on industry growth and can severely curtail the speed of development," Ms Choudary added. |
| ABLE was set up as a forum that would generate a symbiotic interface between the industry, the government, academic and research bodies, and investors and to build brand equity for the industry in the global market place. |
Top Section
Explore Business Standard