Regulatory Focus™ > News Articles > Report: India to Withdraw Any Drug Not Marketed Within Six Months of Approval

Report: India to Withdraw Any Drug Not Marketed Within Six Months of Approval

Posted 16 January 2013 | By

India's primarily drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has notified all of its state licensing authorities that any drug product that fails to launch within six months after its approval should have its permissions and licenses to market canceled, reports PharmaBiz.

The move loosely mirrors the practices of other regulatory bodies, including the US Food and Drug Administration (FDA), which can withdraw exclusivity for second-to-market generic products that are not marketed soon after approval.

India's proposal, however, would go much further than that.

Under Indian law, manufacturers need to submit to regulators periodic safety update reports (PSURs) every six months for the first two years after their initial approval, and thereafter once annually. The reports contain the aggregate safety information for a product, and are critical in assessing the product's use in real world conditions.

But regulators can only assess these PSURs if they're made available, they said, and in many cases they aren't.

"It has been observed many times that the manufacturers do not launch the product even after years of getting approval from this office and the manufacturers do not submit the required PSUR, while the drug does not remain a new drug after a period of four years," the drug controller general of India, G.N. Singh, wrote in his letter. "Therefore the assessment of safety and efficacy of such new drug in the post marketing scenario remains incomplete," he said.

In essence, after that four-year period, the drug is no longer new despite regulators knowing next to nothing about it or its effects on the wider public.

PharmaBiz reports that regulators hope to change this by withdrawing approval for any product not marketed within six months of its date of approval, presumably with the intent that the products are subject to testing and the manufacturers complete the PSURs on a regular basis.

It is unclear whether companies would need to go through the entire approval process again to regain permission to market, or whether an expedited or immediate process would suffice.


Read the PharmaBiz report.

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