Ms. Mazumdar-Shaw said regulations for clinical trials, especially for "large trials" for vaccines, demand "ridiculous requirements.
Indian clinical trial regulations for vaccines “ridiculous and impractical”, said the Chairman and Managing Director Kiran Mazumdar-Shaw of Biocon, a leading biotechnology, on Thursday.
Speaking at a media conference convened to present the company’s results for the third quarter ending December 31, 2013, which the company released late on Wednesday evening, Ms. Mazumdar-Shaw said regulations for clinical trials, especially for “large trials” for vaccines, demand “ridiculous requirements.” “Believe me, it (the regulation) is absolutely impractical for large trials,” she said. She pointed out that recordings of large trials involving 10,000 patients and more are extremely difficult. “Lay people, with no understanding of clinical trials, are making such recommendations,’ she claimed.
Biocon reported a net profit of Rs. 105 crores during the third quarter, an increase of 14 per cent over the same quarter of the previous year. Consolidated net sales during the quarter amounted to Rs 701.16 crores, 11 per cent higher on an annualised basis.
Ms. Mazumdar-Shaw said “robust growth” during the quarter was made possible by the “surge” in earnings from research services. Referring to Biocon’s pricing strategy for the new drug, CANMAb, which was recently launched, she said, “Roche (which sells a competing product in India), has already slashed its price by half, and our drug is priced 25 per cent below Roche’s.” “We have a huge advantage over Roche in terms of pricing the drug in India,” Ms. Mazumdar-Shaw remarked.