Medico News India

Drugs Controller General of India, ET HealthWorld

Hyderabad: Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi on Thursday said bringing down regulatory intervention in the system and making it simpler is a priority for the drug regulator.

The DCGI is the apex authority in the country responsible for approval of licences of specified categories of drugs such as blood and blood products, intravenous fluids, vaccine and serum. It functions under the Directorate General of Health Services (DGHS) of the Ministry of Health.

Delivering a lecture at the CSIR-Indian Institute of Chemical Technology (IICT), on the occasion of National Technology Day, he said there are currently many licences and interventions present in the system with a scope of making it much more simpler.

“Our (DCGI) current priorities for a couple of years, the first being, (we) want to reduce the regulatory intervention in the system. There are lot of licences and interventions. There is a scope of making it much more simpler. That is one area where I have to work,” he said.

Raghuvanshi, who was appointed to the top post in February, said another priority area is to improve the subject experts committee where organisations like IICT can help in terms of bringing in new specialists into the domain.

He said regulation should be made more research centric. DCGI will also aim to constantly keep increasing its footprint in the digital space, he added.

Asked about measures to address the issue of cough syrups manufactured by some Indian companies facing problems over quality in foreign countries, he said various measures are being taken, including making interventions in the supply chain for the raw material that may be responsible for such standard.

Dwelling further, he said audits have been conducted in every company that has been implicated in such cases. Some of these firms have been closed down because of the issues that they had, he said.

“Parallel to that, we are actually running a campaign for space audits (audit of facilities) throughout the country to identify those units which have potential to fall into these kind of issues,” Raghuvanshi said.

On the United States Food and Drug Administration (USFDA) initiating the regulatory process after a pause presumably due to the pandemic, he said Indian companies that are operating their business in the US are ready for that.

“The good part is most of these companies doing business in US are all upgraded. They have come to that level of systems and procedures which is required,” he said.

He further said the apex drug agency has an MoU with the US regulators and that the latter informs them whenever they come to India. “We participate in that as observer,” the DCGI further said.

  • Published On May 11, 2023 at 06:13 PM IST

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