Financial Daily from THE HINDU group of publications
Friday, Sep 03, 2004
Financial Daily from THE HINDU group of publications Friday, Sep 03, 2004 |
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Industry & Economy
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Bio-tech & Genetics Call for single regulatory agency for biotech products Our Bureau
Bangalore , Sept. 2 THE Association of Biotechnology Led Enterprises (ABLE), representative body of biotechnology industry, on Thursday urged the Government to create a single regulatory agency for bio-pharmaceutical products. This would not only help in streamlining and simplifying the procedures for approval of drugs but will also help companies to achieve regulatory compliance with high levels of clarity and accountability. "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," said Ms Radhika Choudary, Executive Director, ABLE. The biotechnology industry in India is evolving and therefore needs to have regulatory norms that demonstrate both transparency and accountability in order to build a strong sector. Recent media reports alleging procedural lapses by companies were unfair and misleading about the industry. It was important that such perceptions were corrected through implementing regulatory systems that had clarity and high standards of evaluation. Or else, this could have a negative impact on industry growth and could severely curtail the speed of development, Ms Choudary said. An estimated 200 research institutes and universities were involved in biotech research with more than 150 private sector companies working in different segments of biotech research, manufacturing and marketing, she said.
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