A quagmire of procedures and technicalities has left two regulatory offices in a state of indecision on the disposal of pharmaceutical wastes while imminent harm that the lethal waste poses to people in its immediate atmosphere will not linger in wait for a decision.
Presently it’s been a month since the Drug Regulatory Authority (DRA) sent a proposal to the National Environment Commission (NEC) for endorsement of a list of hazardous and non-hazardous pharmaceutical waste in order to go about with the disposal.
“For the disposal of the pharmaceutical waste, NEC needs to endorse it,” DRA’s Drug Controller, Sonam Dorji said.
NEC Chief Environment Officer Tenzin Khorlo said they have to do the listing and a thorough study to endorse the DRA proposal. “Ultimately disposal mechanism will come up and definitely, NEC as per the mandate of the Act will definitely come up with the thing,” he said.
Unlike in the past the health facilities now have their own way to dispose medical wastes (both pharmaceuticals as well as hospital waste) but after the NEC Waste Management Act, they have to go through NEC as it is the regulatory body for waste management.
And therein lies the entire basis for contention.
DRA officials said as an implementing agency they have done everything accordingly including deep pit burial but some have to be burnt because it does not decompose.
“Some wastes require burning but NEC notified that it is not allowed,” a DRA official said.
Since then there were no NEC notifications on the Dos and Don’ts to suggest or recommend preferred solutions that are permissible and in line with the environmental laws.
“When they notify ‘not to-do’, they have to notify what has to be done in a written form, not only to the DRA but also to the health ministry (MoH),” the DRA official said.
The DRA official said “There are guidelines for the waste management and manual long before NEC knew about it and health facilities were following them”.
The NEC chief environment officer Tenzin Khorlo said whether it is hazardous or non-hazardous, current practice of deep burial pit will suffice for the entire problem. “NEC’s stand is, with or without listing they should have the clear-cut strategy for the hazardous waste, how they are going to manage it and same with non-hazardous as well.”
Even if the medical waste is listed hazardous and non-hazardous, a possible option DRA can opt for is incineration, which means they have to come for the NEC clearance.
“That is why we encourage them to do the study and the quantity to be burnt,” said Tenzin Khorlo. “Gradually, NEC will come up with the listing of hazardous and non-hazardous,” he said.
For now, DRA will have to continue with the current practice.
The NEC officer said, “we don’t have any other option and as an implementing agency they should come up with their ways. Deep-burial pit is also World Health Organization (WHO) recommended.”
“With the existing waste in the country, currently we don’t think there is a need to practice incineration,” said Tenzin Khorlo.
The DRA said they reviewed their proposal looking at all the developed and developing countries and listed the items for NEC endorsement. Along with that the DRA also came up with the guidelines on how to dispose of the waste.
Another DRA official said there should be proper notifications saying they (NEC) are not able to do and it will be done later after experts arrive from outside.
“NEC is custodian of the regulation and when Rules and regulation were passed by NEC we have developed the list and the guidelines based on that,” said the DRA official.
The DRA office in the meantime is also hounded by all the health facilities who have been writing to them since they have to give a record for the expired medicines to ensure that there is no misuse.
According to the WHO, waste generated by health care activities includes a broad range of materials, from used needles and syringes to soiled dressings, body parts, diagnostic samples, blood, chemicals, pharmaceuticals, medical devices and radioactive materials.
Poor management of health care waste potentially exposes health care workers, waste handlers, patients and the community at large to infection, toxic effects and injuries, and risks polluting the environment. It is essential that all medical waste materials are segregated at the point of generation, appropriately treated and disposed of safely.