How Green are Indian Drug Manufacturing Sites?

Over a month ago, a letter went out to European Commission President Jean-Claude Juncker from about 80 people involved with public and community health in India.

Their demand of the EC was to include environmental criteria in their overseas factory inspections so that communities living close to medicine factories were not affected by discharges into the environment.

“We call on you to address pollution from drug manufacturing in the upcoming EU strategic approach on pharmaceuticals in the environment (PiE) by extending Good Manufacturing Practices (GMP) to also include environmental criteria, as this would provide an opportunity to oblige pharmaceutical companies to tackle polluting practices throughout their supply chains, including in third countries such as India,” the letter said.

Life-saving drugs should not be made at the cost of worker and community health, says Shweta Narayan with Community Environmental Monitoring, a signatory to the letter.

“GMP norms look at the safety and quality of the medicine and not the impact of pharmaceutical residues on environment,” she says.

Industry will pay attention only if it becomes part of regulatory protocol where non-compliance would affect business, says Narayan, explaining their letter to an overseas authority.

Pollution by drug companies has long been a sore point, but the call for action has gained momentum as Governments lock down on antibiotic resistance. Public health workers and scientists are raising the issue of PiE as the exposure to pharmaceutical residue could cause resistance in the case of antibiotics. Irrational use and exposure to antibiotics could render the medicine ineffective. So, even a routine fever becomes life-threatening if the medicine is unable to bring it down. Governments are presently scrambling to control the use and abuse of human and veterinary antibiotics. And addressing PiE fits into this global plan.

Red alert

The letter to the EC alleges that “lives of many people living in India’s pharmaceutical manufacturing hubs, such as Hyderabad, the capital of the southern Indian state of Telangana, Baddi Barotiwala Nalagarh Industrial town in the foothills of Himachal Pradesh, SIPCOT Cuddalore in Tamil Nadu, have been blighted by rampant pollution.”

India’s Environment Ministry classifies pharmaceutical manufacturing as a “red category” activity owing to the hazardous waste it produces, the letter says, adding that “Active Pharmaceutical Ingredient (API) discharges from factories are currently not regulated, and enforcement of existing pollution norms is extremely inadequate..”

The EU cannot turn a “blind eye” the letter says, as local and multinational drugmakers operate in India, making products for local and foreign markets. Despite legal action by the community, the letter alleges, “Pharmaceutical companies keep on polluting in impunity, because they are allowed to do so by their customers in the EU and US.”

A bulk-drug maker (unwilling to be named) clarifies that companies are working towards zero-discharge plants that do not release pollutants into the environment. Indian regulatory norms have become more stringent, he says, adding that implementation is key.

But production vs environment could become a balancing act for smaller units, he adds, as clean technology is more expensive and it becomes difficult to transfer cost in the case of medicines.

Tackling AMR

Anti-microbial resistance (AMR) is a global concern even in regions that don’t make these medicines, says Ravi Uday Bhaskar, Director-General with the Pharmaceuticals Export Promotion Council of India. A comprehensive solution is required to tackle resistance, he says, without targeting a country or industry.

An overseas study found five major contributors to AMR, says the Indian Pharmaceutical Alliance’s DG Shah and pharmaceuticals came after the municipal corporation (releasing sewage that could have antibiotic residues from human excreta), hospital waste, animal husbandry and agriculture. India could reflect a similar pattern, he says.

Having brought out an AMR Benchmark report, Jayasree K. Iyer, Executive Director with the Netherlands-based Access to Medicine Foundation, says that companies need to be incentivised to invest in a robust environmental risk management strategy to manage PiE and be transparent about these processes and results.

India and China will always be at the heart of such discussions given their high production levels, says the bulk-drug maker. So, it is in the domestic industry’s interest to clean up its act, with support from Government on the cost involved, he suggests, hoping to bridge the gap between the business of making medicines and the health concerns around it. – The Hindu Business Line