The principal national drug authority for India - the Central Drug Standards Control Organization (CDSCO) has announced that the new drug should be launched for marketing within a period of six months from obtaining the license from CDSCO.
CDSCO reviews the new drug applications under the Drugs and Cosmetics Rules, 1945 and grants the permission to manufacture a new drug. Based on the permission received from CDSCO, manufacturer obtains manufacturing licence from the concerned State Licensing Authorities.
As per schedule Y, Periodic safety Update reports (PSURs) of new drugs are required to be submitted every six months for initial 2 years and then annually for subsequent 2 years. However CDSCO observed that the manufacturers do not launch their products even after years of getting approval from the authority and do not submit required PSUR, while the drug does not remain new drug after a period of 4 years. The assessment of safety and efficacy of such new drugs in post marketing scenario remains incomplete.
Therefore CDSCO has decided that in case manufacturer fails to launch the product for marketing in the country within a period of 6 months from obtaining the permission from CDSCO, the permission will be treated as cancelled.
For information refer http://www.cdsco.nic.in/
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