Guj FDCA to propose harmonisation of all global regulatory bodies

With an aim to propagate harmonisation of regulatory bodies and to have a uniform set of rules to govern all regulatory bodies in the world, the Gujarat Food & Drugs Control Administration (FDCA) will soon submit a proposal to the Union health ministry to advocate this cause at the international level. The idea to have a common regulatory body came up during a DIA conference that was held in Ahmedabad recently.

The Guj FDCA wants the Indian government to promote and represent  its support at the international level through Drug Information Association (DIA), a neutral, non-profit, global, professional association. That will help in harmonisation of regulatory requirements and in recognising considerable synergy between domestic and international policy.

H G Koshia, commissioner, Food & Drugs Control Administration (FDCA) informed, “It is necessary that we adopt some kind of regional specific guidelines like ICH guidelines to avoid confusion and conflict of interest. It will help in reducing both unwarranted contradictory regulatory requirements and repetitive applications of similar requirements by multiple regulatory bodies.”

He said that as of now there are lot of double standards that is being followed which can be avoided if there is a common guideline for all the regulatory bodies. He stressed that adopting common guidelines will not only help in having co-ordination but also in developing collaboration on activities with various international organisations and governments on international standards which will help in enhancing public health and improve government efficiencies.

He added, “I think the Indian government should seriously consider advocating this cause. Once people will start discussing and brainstorming on this issue things will start to progress pro actively.”

He informed that his office would soon take up this issue to the appropriate body at an appropriate time. The government needs to support the cause by sending an official letter to the DIA supporting this cause. If majority of the countries support this cause through inter country co-operation it would be possible to have a draft guideline on the same.