Pharma regulators concerned over adverse drug reactions

Secretary, department of pharmaceuticals, Dr V K Subburaj and Dr G N Singh, drug controller general of India, have stressed on the need to eliminate causes leading to adverse drug reactions (ADRs)


In the next 10 years the number of pharma manufacturing units will rise by six times from current level of 12,000 units and it becomes all the more important for India to see that while its drugs manufacturing and their exports registered a manifold increase with no suspicion in their content and quality.

This was stated by the secretary, department of pharmaceuticals, ministry of chemicals and fertilizers, Dr V K Subburaj while inaugurating a Conference on ‘Pharmacology: R&D for Minimizing ADRs and Role of Pharmacists' under aegis of PHD Chamber of Commerce and Industry on September 23 at New Delhi.

Mr Subbaraj pointed out that ADRs (Adverse Drug Reactions) happen due to multiple reasons as variety of stakeholders are involved in drugs administration and therefore, the time has come when India is required to put in a place a sort of regulatory mechanism that can keep an eye to curb the menace of rising ADRs as the tendency that prevails currently is to hush up such cases.

"America for example, set out to address this issue way back in 1962, consequently little number of cases of ADRs are reported there though India also awake to this fact in 1982, we have achieved little progress to contain ADRs. This is because it has not been able to create an effective mechanism to address the issue", said Mr Subburaj.

According to him, no definite and effective statistics and estimates are available as to how many cases of ADRs happen each year while in America such statistics are accurate and the system in place, India therefore, needs to emulate such a country to address the issue of ADRs with an effective monitoring system in place.

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