India's primary drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) is reaching out to all regional and state drug regulatory bodies under its supervision, reminding them that they cannot approve new drugs or new fixed dose combinations (FDCs) and giving sponsors of unapproved, marketed drugs 18 months to obtain approval from CDSCO.
In a letter dated 15 January 2013, Drugs Controller General of India G.N. Singh reiterated that by law, CDSCO must grant manufacturing licenses for new drugs and FDCs, or the combination of two or more already-approved drugs in a single dose.
The letter comes several months after a scathing report from the Indian Parliament that all but accuses the regulator of failing to do its job to approve new drug products and conduct thorough reviews.
Singh's letter references the report, adding that it found that "some of the State Licensing Authorities have issued manufacturing licenses for a very large number of FDCs without prior clearance from CDSCO."
"This has resulted in the availability of many FDCs in the market which have not been tested for efficacy and safety," Singh observed. "This can put patients at risk."
Singh's observations aren't new. The letter goes on to note that five years ago, regulators withdrew almost 300 FDCs from the market after finding that they had been approved without prior authorization from CDSCO. That withdrawal is still in the process of being litigated.
Regulators have also issued "repeated statutory directions under Section 33P" to state regulators informing them that they cannot grant licenses for new drugs or FDCs, apparently to little effect.
Still, the scope of the problem presents problems for CDSCO. Singh's letter announces that manufacturers will have 18 months to prove to CDSCO that their drugs are efficacious and safe. After that time, "Such FDCs will be considered for being prohibited for manufacture and marketing in the country," it adds. No further FDCs will be allowed to come onto the market without prior approval from CDSCO.
The "very large number" of unapproved drug products that may wish to be tested by CDSCO has the potential to overwhelm its staff, which the same parliamentary report explained is already over-burdened, under-funded and otherwise ill-equipped to meet its basic duties as a regulator.