(28th Apr, 2014); In their last meeting, Drugs Technical Advisory Board (DTAB) raised the issue of wide variation in the quality of generic drugs manufactured in the country by small scale sector. The generic medicines of lower quality have not been found effective in patients.
Dr. Jagdish Prasad, Chairman of DTAB, in his address raised the issue of quality of generic medicines. He stated that complaints have been received from various areas that the drug products manufactured by many of the Indian Drug Manufacturers, which might otherwise be of as standard quality, have not been found to be effective by the consumers because of low bioavailability. And that's why, it is necessary that the drug manufacturers should have an R&D Laboratory in their own premises or get affiliated to such a laboratory, so that the drugs manufactured by them have comparable therapeutic efficacy.
The promotion of generic drugs would only be effective if their efficacies are comparable to the products manufactured with the approval of the Drugs Controller General India (DCGI).
He further suggested that a meeting of the representatives of the drug manufacturers associations, pharmacologists and representatives of R&D centres may be convened by the office of DCGI to find out the ways and means so that the manufacturers have necessary arrangements either in house or with tie up with some R&D centre to test the efficacy and stability of the products before these are marketed.
The committee is also asked to suggest changes, if any, under the Drugs and Cosmetics Rules, 1945 to ensure that the generic drugs available to the public are of comparable quality and the patients develop confidence in the use of the generic drugs.
