Among the many ways in which the pharmaceutical industry is highly regulated, the management of the waste it generates is always under the lens of environmental regulators. To start with, the industry is responsible for multiple, unrelated streams of waste that must all be processed differently. In many cases, it must be treated before it is disposed of. And to top it all, some of these processes are prohibitively expensive for an individual player.
Asad Warsi, CEO, Eco Pro Environmental Services distils his decades of experience into an all-encompassing review of the waste management operations of the Indian pharma sector.
Waste streams
In the pharma sector, three main types of waste are generated: liquid/effluent waste, packaging waste and drug waste (hazardous/biomedical waste). The latter category may consist of leftover material, off-specification material or product batches that do not meet quality assurance criteria. All of these are generated at the manufacturing unit; apart from this, there are also expired medicines or products damaged after distribution, during storage.
The liquid waste needs to be treated at effluent treatment plants; the sludge generated from this process is hazardous and needs to be sent to Common Hazardous Waste Treatment, Storage and Disposal Facilities (TSDFs), whereas the solid waste, which is the basic bulk drug waste and formulation waste, has to be incinerated.
Incineration
The basic difference between an incineration system designed for pharma/biomedical waste disposal and one designed for any other application is that the former has to be a twin chamber incinerator with a minimum combustion efficiency of 99%. It should have two chambers; the temperature in the primary chamber should be 800±50 °C, whereas in the secondary chamber, a temperature of 1050±50 °C needs to be maintained. This is because if there are any unburnt/carbon particles left over from the primary chamber, they will be incinerated in the secondary chamber. For the latter to have 99% efficiency, it should have a residence time of two seconds.
Earlier, incinerators had to be imported but now, there are a few good manufacturers of quality incinerators in India itself.
Pollution control
Earlier, wet scrubbing systems were prevalent but now, dry scrubbing is in vogue. Ceramic candle filters are being preferred over bag filters.
Pollutants generated during the incineration process are being collected in the form of solid dust. There are prescribed limits for flue gases which emerge from the incinerator; it is mandatory for these to be monitored in the chimney.
Monitoring
There are definite standard operating procedures that need to be followed for incinerators; their monitoring is very stringent. The state and central pollution control boards have access to the above data, and can monitor it online. If any parameter breaches prescribed limits, they can act as per rules and impose environmental penalties.
Liquid waste
Pharma production facilities are mandated to have a zero liquid discharge (ZLD) system, 100% of the liquid waste has either to be recycled or evaporated.
First, all effluents need to be treated as per norms, after which it is sent through a reverse osmosis system that can recover 85-90% of water for reuse. The remaining 10% has very high total dissolved solids; the water part is evaporated and the solid component is sent to the TSDF.
Plastic recycling
EPR is mandatory for the pharma industry. As manufacturers, they have to get registered with the state pollution control board if they are operating in two states, and with the central pollution control board if they are operating in more than two states.
100% of pharma plastic, if collected, is recyclable. Considering the high-stakes nature of the business, high quality, pure plastic tends to be used, which has a high recyclability value.
Saline bottles, syringes and tubes are mostly made of HDPE. At biomedical waste facilities, they are disinfected through autoclaving, segregated, shredded, and autoclaved again before being sent to registered plastic recyclers. This is strictly followed, but in remote areas and small towns, some of this plastic waste will end up going to kabadiwalas as well.
Pan-India model
There are more than 200 common biomedical waste treatment and disposal facilities across the country; each is meant to cover a radius of 75 kilometres. Rates are set by the government. Unfortunately, some people who want to enter this business do not know its nitty gritties.
Healthcare facilities want this service to be provided at the lowest possible prices, and hence lobby the government to have more such facilities. But there are some small districts which have a population of only 25,000-50,000; in such scenarios, a CB WTF is not financially viable.
More facilities will spark off rate competition; this happened some years ago in Haryana and Karnataka. The rate became so low that the service provider did not find it viable to process the waste; they collected it and just dumped it at municipal sites.
The appropriate number of facilities should be decided according to the quantum of waste generation; the collection and monitoring system should be very stringent. The CPCB has developed an app in which all collection vehicles are GPS-linked, and parameters like quantity of waste, waste categories collected from a particular centre and time of collection can be tracked.
Cluster model
Rajasthan has a cluster of a few hundred cloth dyeing units. They have formed an association and constructed an effluent treatment plant with the collected funds. Each unit pays for its operation according to its respective quantum of production.
A similar model will work for pharma production clusters. If x is the volume manufactured per month by a unit, y is how much effluent it will generate and z is what they have to pay for the operation of the ETP per month.
Clusters also need a TSDF of their own. Incineration can be expensive; to reduce cost, we must categorise what stream of waste requires incineration and what can go directly to the landfill.
Can pharmaceutical products/materials spilled during the manufacturing process be recovered and reused?
Yes, they can, if they are not contaminated. But if contamination has occurred, they are considered as hazardous waste and need to be sent to TSDFs for incineration. This material cannot be sent directly to landfills. As per the rules, only the ash after incineration can be sent to TSDFs.
Is there a collection system in place for expired medicines?
When a pharma company signs a contract with a distributor, it mandates that the latter is responsible for collecting the entire quantum of expired medicine. Major players in the pharma industry are 100% compliant; smaller companies may not be so.
Earlier, pharmacists and chemists would dispose of expired medicines in the municipal waste itself. In Indore, 100% waste of pharma waste generated is sent to a common biomedical waste treatment and disposal facility. Across the country, about 80-85% of expired stock is being collected by distributors, but yes, there are smaller companies which still resort to crude dumping. This is an area where strong interventions and a regulatory framework are required.