In a letter written on 11 October, the department asked Indian Drug Manufacturers’ Association (IDMA), Organization of Pharmaceutical Producers of India (OPPI), Indian Pharmaceutical Alliance (IPA) and other associations to urge their members to put a check on pharmaceutical pollution.
“While the standards are awaited, it is crucial that the pharmaceutical industry should understand the linkage between pharmaceutical pollution and AMR (anti-microbial resistance), and accordingly start working towards making their manufacturing process more sustainable," the department said in its letter, a copy of which was reviewed by Mint.
The Central Pollution Control Board (CPCB) has set up an expert committee to draft standards for antibiotic residue in industrial effluents, and the draft is now close to finalization, the department said in the letter.
“The DoP decided to urge the industry to be ready before the CPCB standards are put in place. It is only a directive, not an order because pollution is the environment ministry’s subject," a government official said.
The department highlighted forecasts that India could bear a “huge environmental load due to pharmaceutical pollution" in the future as it, along with China, produces 80-90% of medicines for the world, the letter said.
“It is encouraging that the government is looking at pollution and quality of manufacturing... I can tell you that our member companies are all adhering to the guidelines around pollution," OPPI director general Kanchana T.K. told Mint.
IDMA Secretary General Daara B Patel and IPA secretary general Sudarhan Jain said the associations have informed their members about the letter and asked them to be more vigilant about pharmaceutical pollution.
“We will discuss with our experts to work out our action plan," Patel told Mint.
Antimicrobial resistance (AMR) refers to the ability of microorganisms like bacteria, viruses, and some parasites to become immune to antibiotics, antivirals and other medicines, making standard treatments ineffective and infections persistent.
By 2050, around 10 million lives a year and a cumulative $100 trillion of economic output will be at risk due to the rise of drug-resistant infections, according to estimates from a report supported by the UK government and the Wellcome Trust in 2016.
Misuse and overuse of antibiotics in humans and animals, and waste from hospitals and pharmaceutical companies are viewed by experts as the causes for AMR.
Multiple researches over the last decade have showed that pharmaceutical effluents, especially from units manufacturing active pharmaceutical ingredients, have high levels of antibiotics that could potentially make India a hotbed for antimicrobial resistance.
A report by Finland-based financial firm Nordea and the Changing Markets Foundation in January 2018, pharmaceutical companies in Hyderabad continued to discharge untreated or inappropriately treated waste water into the environment, and that local and national authorities were failing to get the situation under control.
The report was a follow-up to another research by Nordea in February 2016 highlighting pollution in the region.
To be sure, the government had come up with a National Action Plan on AMR in 2017 with a multi-pronged strategy to tackle the issue, one of which was to develop standards for antibiotic residue in industrial effluents. As per the letter by DoP, the CPCB is now close to finalizing the draft standards.
The global pharmaceutical industry has also formed the AMR Industry Alliance to provide sustainable solutions to curb antimicrobial resistance. The alliance has over 100 biotech, diagnostics, pharmaceutical companies, including Aurobindo Pharma and Cipla.
“The government and companies need to work together on formulating and following the correct norms to tackle this problem. However, we need to steer clear of knee-jerk policy change that will either poorly impact the country’s ability to produce and export drugs, while ensuring that we create a time bound scientifically backed plan for it," said Charu Sehgal, partner and leader for life sciences and healthcare sector at Deloitte India.