Indian drug manufacturers have 18 months to test drugs not approved by India’s Central Drugs Standard Control Organization (CDSCO) for efficacy and safety or they will be pulled from the market.
The drugs came to market after state drug licensing authorities issued manufacturing licenses to makers of fixed-dose combinations (FDCs) that were not cleared by CDSCO, according to a notice released last week.
“This is a welcome move,” Chinu Srinivasan, co-convener of the All India Drug Action Network, told In-Pharmatechnologist.com.
The state commissioners are and were just acting careless and irresponsible, Srinivasan added, noting that when state commissioners will respond to the CDSCO notice is a matter of “who will blink first.”
Some of these drugs were approved as "new drugs" per Rule 122E of India’s legislation governing the regulation of drugs, called the Drugs and Cosmetics Act of 1940. The rule seemed to offer state licensing authorities a loophole whereby they could issue manufacturing licenses without CDSCO approval.
History of Issues
The problem of unapproved FDCs has persisted for years. In 2007, CDSCO called on state drug controllers to withdraw 294 FDCs licensed without approval from the Drugs Controller General of India (DCGI), but the manufacturers stayed the order in the Madras High Court and the drugs were never withdrawn.
More recently, however, India’s Ministry of Health and Family Welfare ordered state governments in October to instruct their drug licensing authorities to not approve manufacturing licenses for companies that have yet to be evaluated by the DCGI.
Those orders came after a report from India’s Parliament last summer found that the high number of unapproved FDCs on the market could be putting patients at risk. The report also alleged that CDSCO was colluding with industry in some of its approval decisions and that drugs were being approved without local clinical trials.
Since the report, CDSCO has asserted its regulatory control with a flurry of action. The regulator unveiled a system for faster drug recalls , a guideline for unannounced inspections of clinical trial sites, and the establishment of a competent authority to oversee API exports. India’s Minister of Health and Family Welfare Ghulam Nabi Azad also launched a committee of three experts to look into CDSCO’s procedures for approving drugs.