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

    • 16 January 2013
    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 s...
  • India's Top Regulator Prepares for a Future Without Branded Medicines

    • 16 October 2012
    The Times of India reports that India's top regulatory official, the drug controller general of India, Dr. G N Singh, eventually wishes to do away with branded or patented medicines in favor of a generics-only system he says will benefit the public before all others. "We want to gradually move towards a future where we will not issue any brand or trade names," The Times reported Singh as saying. "Gradually" may come faster than some pharmaceutical companies may ...
  • Panel Starts Investigation of India's Drug Regulatory Authority

    India's regulatory authority, the Central Drugs Standard Control Organization, has not had a particularly good start to 2012. Accounts of corruption and incompetence have been echoed in numerous reports, and now a panel of experts is set to dig further into the agency in the hopes of recommending needed reforms. The list of purported deficiencies at the agency has grown substantially in recent months. The agency has been accused at various times of exercising lax clinic...
  • As India Moves to Investigate Claims of Collusion, US Could Increase Scrutiny

    Fallout from a report by the Indian Parliament alleging widespread collusion and ineffectiveness at India's Central Drugs Standard Control Organization (CDSCO) continues, as the Indian government has launched a formal inquiry into the allegations, reports Reuters . "The government said in a statement that it had appointed three experts to look at the scientific basis for approving new drugs without clinical trials and to recommend ways of overhauling the approval proced...
  • Scathing Parliamentary Report Blasts India's Drug Regulatory Authority

    A parliamentary report authored by India's Standing Committee on Health and Family Welfare (SCHFW) is blasting the country's Central Drugs Standard Control Organisation (CDSCO), India's drug regulatory authority, calling it a "collusive nexus" between industry, government and medical experts, reports Reuters . The report follows an account published in April 2012 by The Times of India , which reported CDSCO's Drug Controller General of India (DCGI), which oversees su...
  • Report: Indian Drug Regulator's Office Has 'Washed Its Hands From Drug Approvals'

    The Economic Times of India reports the Drug Controller General of India (DCGI), the regulatory body in charge of approving drugs and clinical trials, exists in a state of "limbo" after a series of power struggles and vacancies. The problems are resulting from the formation of New Drug Advisory Committees (NDACs) which were set up to offer regulatory advice to the DCGI, but have instead "over ridden the powers of the drug controller" reports The Economic Times of Indi...