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Category: Quality Control

Bangalore January 04, 2014:
While there are a number of drug combinations applications pending to be cleared, an expert panel is considered to be necessary. The central drug regulator has appointed a panel under B. Suresh, who is the president of the Pharmacy Council of India. This panel would function as a committee under the Drug Technical Advisory Board that takes care of the regulation on drug safety related technical matters.

As reported by the officials, many of the combination drugs were reviewed by the New Drug Advisory Committees and expert groups dealt with therapy specific drug combos. In many cases the rationale of the drug combos was questioned by the experts and the permission to market those drugs was at risk. However, as many of these drug combos still exist in the market, there is a need to regulate their use on the basis of standard guidelines.

This panel would be in charge of defining the standard parameters and applying them to separate the drug combinations based on their safety. This would ensure separating the unsafe drug combinations from the safe drug combinations. Although the combination drugs contribute to almost half of the country’s total drug market, most of these drugs are not tested for their safety and efficacy and probably considered as irrational drugs.- IGMPI

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