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For the Indian biotech and pharmaceutical sector, the issue is not the global crisis or an economic slowdown in the country, but the stifling regulatory environment.
The approvals procedure is very cumbersome in India, with the Drug Controller General of India (DCGI), Central Drugs Standard Control Organisation (CDSCO) and Drug Regulatory Authorities (DRAs) responsible for regulating most aspects of bio-pharma, said Mr Sujay Shetty, Executive Director — Pharma Life Sciences at PricewaterhouseCoopers (PwC).
In most countries, a single central body like the US FDA and the MHRA in the UK, is responsible for reviewing the data and granting permission to start clinical trials.
According to Mr Shetty, India is becoming an increasingly attractive destination for clinical trials or drugs manufacture , since the number of patients in the country is quite large. It also has well-trained investigators and relatively lower cost of operations.
The sector is going through a rough patch with approvals taking a lot of time. In the manufacturing sector, approvals take just over a year, whereas for clinical trials it takes anywhere between 12 and 18 months.
“In this stifling environment, innovation cannot happen especially in an era of drying drug pipelines globally. Companies in India need to innovate and create value for themselves,” Mr Nitin Deshmukh, CEO — Private Equity at Kotak told Business Line on the sidelines of the Bioinvest 2011 meet sponsored by the Association of Biotech Led Enterprises (ABLE).
“While there is a long queue for mergers and acquisitions in this sector, pricing has become the challenge in the wake of global recession,” he added.
Kotak is the largest private equity fund in the private sector offering $1.5 billion, of which $100 million has been invested in biotech and life sciences companies.
Mr Shetty said: “In India, by contrast, the Institutional Biosafety Committee (IBSC) reviews the data before forwarding it to the Review Committee on Genetic Manipulation (RCGM) for additional reviewing and approval. The central government should therefore review and rationalise the roles and responsibilities of the ISBC, RCGM and DGCI in order to streamline and simplify the approvals procedure.”
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