DCGI asks SLAs to take steps to strengthen regulator-stakeholder relations
To ensure effective implementation of the Drugs and Cosmetics Act (D&C Act) throughout the country, the drug controller general of India (DCGI) has asked the state licensing authorities (SLAs) to take steps to strengthen their relation with the stakeholders through more collaborative efforts for better regulation.
Through this initiative, the centre wants the SLAs to build a symbiotic relation with all the stakeholders so as to attain their objective of providing safe, efficacious and high quality medicines to the patients of this country. DCGI is said to be laying out a strong plan that focuses on frequent interactive sessions between the drug regulators and the stakeholders, for enabling better understanding of the regulatory requirements to the stakeholders and also to help the regulators in analysing the compliance related issues faced by the industry.
Considering the need and the importance of this exercise in stabilising the drug regulatory system of this country, this matter will be raised by the DCGI, during the upcoming drug consultative committee (DCC) meeting that is expected to be held in mid-February in Delhi.
Dr G N Singh who is the DCGI pointed out that as a regulator one of the biggest concerns they always face is lack of understanding of the regulatory norms by the stakeholders leading to non-compliance.
He said, “We are constantly working towards formulating better ways to ensure safety of the patients through availability of safe and effective medicines. We find that one of the best ways to achieve this is by involving the stakeholders directly in this process through thought sharing and interactive process. Today we have found that there is a lacunae in the regulator-stakeholder relation which is looked upon with doubt and mistrust, which needs to be changed for the better.”
Dr Singh further stressed that during the meeting he will put special focus on the need to involve the stakeholders in various programmes and debates relating to the regulatory challenges faced by them to get a better perspective of the issue. DCGI also plans to ask the SLAs to conduct workshops and seminars with the stakeholders on a routine manner to understand their queries and act upon them instantly when needed.