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Indian pharma needs a regulatory surveillance in place to monitor the disposal of unused and date expired drugs. Currently, in the absence of any rules under the Drugs & Cosmetics Rules (D&C Rules), disposal is guided by the Biomedical Waste Management Rules under State Pollution Control Board (SPCB) norms.
It is high time the Drugs and Cosmetics Act (D&C Act) includes a schedule or a dedicated guidance for proper disposal of unused and date expired drugs. Rule 65(17) of D&C Rules only states about not to sell such drugs and to keep aside with proper labeling till its disposal, but does not provide any procedure for disposal of such drugs. However, it follows the norms prescribed under Biological Waste Management Rules.
The D&C Act Schedule P provides the life period of certain drugs and Rule 96 calls to mention the date of expiry on its label as per said schedule. If it is not found under Schedule P, then the date of expiry on the label of drug shall not exceed 60 months from the date of manufacture, provided this period may be extended by the Central Licensing Authority if satisfactory evidence is produced by the manufacturer
This procedure for disposal of date expired drugs needs to be issued by the CDSCO either as a separate schedule to D&C Rules or in the form of guidelines. Going by the profusion of formulations marketed in India, there is a need for a separate schedule to be included in the D&C Act or dedicated guidelines. To this end, it is learnt that various sub-committees were formed under Drug Consultative Committee (DCC) which have submitted their recommendations however, the decision is pending.
The current practice by pharma companies to dispose date expired and unused medicines include returning to manufacturer, landfill, and waste immobilization: encapsulation / inertization, flushing it down the sewer and incineration. Despite precautions associated with these methods, these methods are not that effective.
What we need is a surveillance system to monitor the disposal of such drugs. This is when the government brought in the Track and Trace system to ensure transparency of drug dispatch from manufacturers to chemists and its disposal of such unused and date expired drugs. It will also prevent entry of spurious drugs into the market as all the inventory will be monitored. The manufacturers should keep track of the drugs including those of disposal across the supply chain from the distributor to the pharmacy retail. In the absence of guidance, disposal of expiry dated drugs is a problem.
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