Former State Drugs Controller, FDA Karnataka |
Presently working as Legal Consultant for Pharma field |
Email ID: jagashetty@gmail.com
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Last Updated on October 2, 2024 by The Health Master
A regulatory surveillance system must be in place for Indian pharma to keep an eye on the disposal of unused and expired medications.
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.
The Drugs and Cosmetics Act (D&C Act) needs to include a schedule or specific instructions for how to properly dispose of unsold or expired medications.
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 for the label to mention the date of expiry 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.
To dispose of expired and unused medicines, pharmaceutical companies currently return them to the manufacturer, place them in landfills, immobilize the waste through encapsulation or inertization, flush it down the sewer, or incinerate it.
Despite precautions associated with these methods, these methods are not that effective.
Also read | Disposal of expiry dated drugs: Guidance document is needed
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 the 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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