CDSCO to create 1,500-member scientific cadre to fast-track drug approvals

New Delhi | Mumbai: The Central Drugs Standard Control Organisation (CDSCO), the regulatory body for the Indian pharmaceutical sector, is in the process of creating a 1,500-member scientific cadre to speed up approval timelines for new drugs and meet global standards.

Value Chain Impact

"Approximately 40% of the workforce will be engaged on a contractual basis and may have global industry experts as advisers," India's drug regulator Rajeev Singh Raghuvanshi said on Monday in Mumbai. Scientists could also be brought on board on deputation.


The cadre will have experts in the fields of microbiology, biochemistry, biotechnology, biostatistics, project management and all other areas that impact the value chain, he said.

The decision assumes significance since the treatment paradigm is shifting to new modalities such as cell and gene therapy and highly targeted anti-cancer or autoimmune disease drugs.

Addressing the staff shortages, Raghuvanshi said, this will help the regulator speed up approvals and bring its operations at par with the US Food and Drug Administration or make it even better.

"The main thing, which we are always criticised for, is about the timelines (for approvals). And my timeline issue is purely because of the resources. So, if we get all these resources, the timeline would actually become better. It can be better than the US FDA," he said. "From the expertise point of view also, if you are flexible enough to tap anybody from the global platform, then I don't have a problem," he added.

Raghuvanshi said experts can be engaged from not only the government system but from abroad too. Subject expert committees have engaged industry experts who have experience in drug development, he said.

The Indian drug industry has for long taken a critical view of the unpredictable approval timelines for new drugs. At times, these approvals take well over a year, which is a costly delay for companies.