Regulating toxins in the pharma Industry!

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To:

H. Kharkwal

Shri C. K. Mishra

*This petition has been closed*

Did you know that Antimicrobial Resistance (AMR) claims over 700,000 lives around the world? This number is expected to touch 10 million by 2050 of which two million will be Indians. Currently, India carries one of the largest burdens of drug-resistant pathogens worldwide, including the highest burden of multidrug-resistant tuberculosis. Annually, more than 50,000 newborns are estimated to die from sepsis due to pathogens resistant to antibiotics.

So what is AMR? AMR occurs when microorganisms like bacteria, fungi, viruses, and parasites that cause infections to evolve resistance to antibiotics. As a result, the antibiotic used to treat infections is no longer effective, limiting the treatment options available and therefore making the most common infections more difficult to treat.

India is the second-largest bulk drug manufacturer in the world accounting for over 20% of the global exports. Active Pharmaceutical Ingredients (APIs), as well as other chemical ingredients, are released into the environment during their manufacture, use, and disposal. In the case of antibiotics manufacturing, the release of untreated APIs in wastewater streams has been shown to contribute to the spread of antimicrobial resistance (AMR).

In manufacturing hubs like Hyderabad, concentrations of antibiotics detected in the Musi River, which flows through the city center, were 1000 times higher than the usual concentrations found in rivers in developed countries.

To address this, the Ministry of Environment, Forests and Climate Change (MOEF&CC) have notified the draft Environmental Standards for Bulk Drug and Formulation (Pharmaceutical) Industry on the 23rd of January 2020. The amendment primarily aims to limit the concentration of antibiotics and other toxins in effluents from the bulk drug and formulation industry. In addition to tackling AMR, the proposed standards by the MoEF&CC also aim at addressing the issue of toxic chemicals and heavy metal pollution from the bulk drug manufacturing sector.

Considering the current state of affairs in the pharma sector, these proposed changes are a much welcome intervention.

The draft notification of the standards is open for public comments until March 23rd 2020. It is important to let the ministry know that they are doing the right thing and that that proposed standards should be passed without any dilution or changes.

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If the government follows through with the ambitious approach set out in the draft rules, India will be at the forefront of global efforts to tackle AMR as a result of pollution from drug manufacturing!

Sources:

http://moef.gov.in/g-s-r-44-e-date-23-01-2020-environment-protection-amendment-rules-2020-inviting-commentssuggestions-on-environmental-standards-for-bulk-drug-and-formulation-pharmaceutical-indu/
‘Superbugs in the Supply Chain: How pollution from antibiotics factories in India and China is fuelling the global rise of drug-resistant infections’.
https://epha.org/wpcontent/uploads/2016/10/Superbugsinthesupplychain_CMreport.pdf

Subject (required):

Dear (cc ),

Email body

I am are writing to you in response to the ministry’s draft notification, Environment Protection Amendment Rules 2019 announced on the 23rd of January 2020 with proposed environmental standards for bulk drug and formulation (pharmaceutical) industry.
 
It is encouraging to know that this announcement comes against the backdrop of a global epidemic of drug-resistance that claims over 700,000 lives annually, projected to touch 10 million by 2050. Over 100,000 tonnes of pharmaceutical products are consumed globally every year and India accounts for 20 percent of global exports of generics.
 
As a citizen concerned about the public health impacts of pharmaceutical pollution I welcome proposed standards. If the government follows through with the ambitious approach set out in the proposed standards, India will be firmly at the forefront of global efforts to tackle AMR as a result of pollution from drug manufacturing.
 
I am are also encouraged to note that, in addition to tackling AMR, the proposed standards also aim at addressing the issue of toxic chemicals and heavy metal pollution from the bulk drug manufacturing sector. While this is a truly groundbreaking step, one significant concern remains the proposal to incinerate the sludge containing antibiotic residues. Incinerators in India are poorly managed and are known for their hazardous impacts on human health and the environment. Alternative techniques such as bio-processing of reducing antibiotic levels in sludge should be explored for treatment.
 
State pollution control boards have been facing several challenges when regulating pollution from the pharmaceutical manufacturing sector. The new stringent standards would be practically redundant in the absence of a robust implementation framework.  The CPCB and the MoEF&CC should invest in building the scientific and monitoring capacity of state pollution control boards so as to ensure the effective implementation of the standards.
 
I take this opportunity to make the following recommendations:
 i. The proposed standards in this draft notification should be passed without any dilution.
ii. The provision to incinerate waste sludge should be reconsidered and alternate techniques of managing the same should be explored.
iii. The current pollution monitoring mechanisms in the country are not adequately equipped to enforce existing environmental laws. The monitoring and enforcement capacity of the State Pollution Control Boards and Pollution Control Committees should be enhanced to meet internationally acceptable scientific standards.
iv. The monitoring process should include independent health impact assessments in areas affected by pharmaceutical pollution.
v. Ensure the participation of impacted communities in environmental monitoring.
iv. Efforts should be made to ensure that all states develop their state action plans on AMR as mandated under the National Action Plan on AMR 2017.
vi. Incentivize and ensure transparency in the Indian pharmaceutical sector supply chain by urging manufacturers to:
  a. Publicly disclose the results of environmental risk assessments and monitoring for all products.
  b. Regularly publish a searchable list of all sites that manufacture a company’s products and audit results for each factory, including full names of authorized production units, processing facilities, and sub-suppliers.

The proposed standards are not only a crucial step to showcase India’s commitment to the global effort in tackling AMR but also of its leadership among the developing countries on the issue of AMR.

Hence I urge the ministry to notify the draft standards at the earliest.

Sincerely,

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