On January 23, 2020, the Union Ministry of Environment, Forests and Climate Change (MoEFCC), notified draft environmental standards for the bulk drug and pharmaceutical manufacturing industry. The proposed standards aim to limit the concentration of antibiotics and other toxins in effluents from the bulk drug manufacturing sector.
At the outset, it is important to mention that the standards proposed by the MoEFCC are a welcome change from the direction environmental regulations have been taking in the recent past. It puts India among the few countries in the world to acknowledge and to initiate corrective action on pollution from Big Pharma. That said, why is pollution from drug-manufacturing a concern for the common Indian citizen? Moreover, can passing strict environmental laws alone solve the problem?
India fulfils 20% of the global demand for medicines and antibiotics. This means 20,000 of the 100,000 tonnes of the pharmaceutical products consumed globally every year are manufactured in our own backyard. The Patancheru-Bollaram industrial estate in Telangana is the largest bulk drug manufacturing site in India, followed by the Baddi Industrial area in Himachal Pradesh and the SIPCOT Industrial Estate in Cuddalore, Tamil Nadu. Low manufacturing costs have historically made India a coveted pharmaceutical production hub and the industry has also benefited from sustained government support in recent decades.
However, the growth of the sector has come at a cost to the environment. Toxic chemicals are used extensively to manufacture drugs. Several studies have reported the contamination of air, water and soil in and around bulk drug manufacturing facilities in Patancheru, Baddi, Cuddalore and other places. Among these, Hyderabad has been a subject of several national and international investigations, some of which have found the groundwater in the region to be contaminated by toxins including lead, cadmium, arsenic and vanadium in concentrations several-thousand-times higher than those prescribed by the WHO and the Bureau of Indian Standards.
In addition to toxic emissions from manufacturing, an equal threat is posed by antibiotic pollution. Active pharmaceutical ingredients (APIs) are released into the environment during the drug-manufacturing process. In the case of antibiotics, the release of untreated APIs in wastewater streams has been shown to contribute to the spread of antimicrobial resistance (AMR). AMR occurs when bacteria, fungi, viruses and parasites evolve resistance to common antibiotics, rendering them ineffective and thus making once curable infections like tuberculosis harder to fight off, or even impossible.
In fact, India carries one of the world’s largest burdens of drug-resistant pathogens, including the highest burden of multi-drug-resistant tuberculosis. An estimated 130,000, or 27%, of the world’s tuberculosis cases occur in India. This is twice the number of cases in China, which has the second-highest number of people with tuberculosis globally. Two million deaths are projected to occur in India due to AMR by the year 2050.
In 2019, the National Green Tribunal (NGT) commissioned a study of the Musi river to determine the extent of antibiotic pollution. In its report to the NGT, researchers from BITS Pilani-Hyderabad observed that all 90 bacterial strains they had isolated from 54 water samples were multi-drug-resistant; some of them were even extensively drug-resistant, a ‘higher’ category.
The case of industrial pollution in Hyderabad’s Patancheru-Bollaram was first filed in 1990. Various arms of the judiciary have passed orders and made observations on the issue since. The original case sought remedial action under Article 32 of the Constitution, asking for the government to provide drinking water to the people affected by industrial pollution in the region. In October 2001, the Supreme Court transferred the case to the Andhra Pradesh High Court, which further transferred it to the NGT in 2013.
In 2017, the NGT passed an order after observing that the state had failed to improve the groundwater quality even after decades of litigation. The NGT directed the Telangana government to restore all water bodies, supply drinking water to all affected villages and recover the cost from the industrial units. However, the directions of the NGT have yet to provide any relief to the residents, forcing the NGT to pass a strongly worded judgement on November 16, 2019, threatening coercive action against Telangana State Pollution Control Board officials.
Given the background of poor commitment to implementation of even court orders, the new proposed standards are a much-welcome intervention. However, successful pollution mitigation policies depend primarily on an efficient monitoring infrastructure and reliable data generation. Indian regulatory agencies fare poorly on both these counts.
For example, the Antimicrobial Resistance Surveillance and Research Network, established by the Indian Council of Medical Research to generate “nationally representative reliable data on AMR”, comprises six nodal and 16 regional labs with capacity to test and analyse drug resistant pathogens in epidemiological settings. However, none of the labs in the network currently have the capacity to test for drug-resistant pathogens from industrial discharge. This stands to be the key challenge in effectively implementing the new standards.
In addition, our pollution monitoring agencies are afflicted by a range of challenges – from inadequate workforce and poorly trained personnel to crumbling infrastructure. The hope would be that a portion of the Rs 4,400 crore the Centre has allocated towards the National Clean Air Program will be infused into reinforcing such administrative lacunae.
In 2015, a high-level committee recommended the establishment of bulk drug manufacturing zones or mega parks across the country threatening to put a further burden on the environment. It is thus important to ensure that the government remains steadfast in its ambition to empower India’s regulatory agencies to crack down on pollution in pharmaceutical supply chains. By doing so, it will ensure that the industry is both held accountable for its negative impact and that it preserves access to global supply chains and export markets in the future.
Another key element is to ensure robust implementation with regular controls and enforcement measures, including closing factories that have been found to be noncompliant and imposing high fines against the companies that operate them. Without robust implementation and enforcement, the ambitious rules will only be a smoke-screen for unsustainable practices.
T. Mohan is a practising advocate based in Chennai.