No need to fear the regulator: DCGI

Calling upon the industry members to approach the Central Drugs Standard Control Organization (CDSCO) for any complaint or resolving of issues, the Drug Controller General of India, Dr S Eswara Reddy has informed that a special cell has been created to take care of it


New Delhi: The newly appointed Drug Controller General of India, Dr S Eswara Reddy believes that the startups should have a clarity on whether the product they are innovating is completely unique or there is another product in the market with similar features.

Making a point during the panel discussion held as a part of the 6th foundation day celebratory event of Biotechnology Industry Research Assistance Council (BIRAC), he said that the innovators should understand the market for the product they intend to develop. The affordability, quality, and need are important for developing a marketable solution, he said.

Dr Reddy exhorted the industry to contact the regulator. “Don’t fear us, our job is that of a facilitator. We are there to help you,” he said while referring to the comments made by many in the audience about the lack of access to the regulator.

“Innovators don’t seem to be aware of our programmes and the information is not percolating down. Only 15 categories of medical devices have been notified. No license is required to import or manufacture the other devices,” said Dr Reddy while speaking at the panel discussion focused on the topic “Market Pathway: An Exciting Journey”.

Dr Reddy also informed that a cell has been started at the Central Drugs Standard Organisation (CDSCO) for the regulators (PRO cell). He stated that no appointment is required for the contacting the same for any issues.

Dr Reddy who took the charge as DCGI on 21st March, as per health ministry, will continue for the period of three months till regularly appointed person takes charge.