Giving a huge thrust to boost the drug regulatory mechanism in the country and ease stakeholders concerns, the Central Drugs Standard Control Organisation (CDSCO) and top drug regulators from across the globe have agreed to cooperate on exploring regulatory opportunities. The Pharmaceutical Export Promotion Council of India (Pharmexcil) states that stronger relation with the global drug regulators is expected to not only strengthen the regulatory framework, but also boost exports from the country.
This strategic decision was taken during an international regulators meet, which was jointly organised by Pharmexcil, All India Drugs Control Officers' Confederation (AIDCOC) and Indian Pharmaceutical Congress (IPC) recently. Encouraging collaboration between the CDSCO and international drug regulatory agencies on key issues and challenges to help address regulatory hurdles and ease up regulatory process was the focal point of this meeting.
It is understood that Pharmexcil plans to constitute an international regulatory affairs task force to drive the key outcomes of the meet. Dr P V Appaji, director general of Pharmexcil informed that keeping in line with the vision to cooperate on various levels, the meeting identified key areas of interest that would help enhance the services for stakeholders.
He said that regulators were keen on exploring opportunities aimed at building regulatory capacity and capabilities. It is understood that serious thought is also being given on partnering with the other on different regulatory aspects and identifying potential areas that can be explored.
He says, “Commerce ministry is keen on addressing the concerns of the stakeholders by providing them with a business friendly environment. Finding key areas for regulatory cooperation is one of the important factors to aid this process. We are very happy with the outcome of this meeting which was highly appreciated by all for bringing relevant regulators together. This also gave us the opportunity to understand the issues and problems faced by the international drug regulators as well along with their expectations from Indian exporters and regulators while doing business.”
He further added that the meeting also discussed on the possibilities of providing international regulatory training to the state FDA personnel, and small and medium scale pharma exporting companies. More than 15 regulators from MHRA, EDQM, Zambia, Ghana, Nigeria, Cambodia, Romania, Hungary, CDSCO were part of this meet which was also attended by Drugs Controller General of India Dr G N Singh.