India’s top drug regulator is calling on manufacturers that received unauthorized drug approvals and manufacturing licenses to prove the safety and efficacy of their marketed drugs by August 31.
According to a notice posted Monday , CDSCO (Central Drugs Standards Control Organization) in January set an 18 month deadline for these manufacturers to provide information on the safety and efficacy of their unauthorized FDCs (fixed-dose combinations) but “so far hardly any such manufacturer have approached” CDSCO with their findings.
The new deadline all but guarantees that these manufacturers will not conduct new clinical trials to test their drugs. The manufacturers were supposedly issued licenses for their new drugs from state authorities without the approval of the DCGI (Drugs Controller General of India), CDSCO said.
The unapproved FDCs were uncovered in a Parliamentary report released last summer that found a high number of the drugs could be putting patients at risk.
Clinical Trials in India
The Parliamentary report also laid out a number of drugs that were supposedly approved in India without clinical trials and which spurred the Indian Supreme Court to begin overhauling the country’s clinical trial regulations and policy.
That action caused CDSCO to begin reviewing its own policies and calling for the creation of new ethics committees, annual inspections of clinical trial sites , new patient compensation rules , and to plug other loopholes .
Nidhi Saxena, chairman and CEO, of Karmic Lifesciences, acknowledged the country's regulatory difficulties last week at DIA’s annual meeting in Boston. But she said that “reforms are taking place” that will make the system more rational over the next six to eight months. She also said the new regulations could include the registration of CROs (contract research organizations).
India is poised to become the world’s 10th largest market for pharmaceuticals by 2015.