3 min read.Updated: 06 Oct 2019, 10:19 PM ISTLeroy Leo,Neetu Chandra Sharma
CPCB is examining industry lobby’s plea to change effluent treatment norms as they are affecting drug production schedules
Manufacturers seeks exemption for bulk drug makers from a fresh approval process
New Delhi: The Central Pollution Control Board is examining a proposal to change effluent treatment norms for pharmaceutical companies after a submission by an industry body seeking tweaks to existing regulations that are acting as hurdles to manufacturing.
“We have got the proposal through Central Pollution Control Board (CPCB). The CPCB is already examining the matter. We haven’t taken any decision so far. When we will get the technical report from the CPCB, we will review the proposal," C K Mishra, secretary, Ministry of Environment, told Mint.
The Indian Drug Manufacturers’ Association (IDMA) had submitted a proposal to the government about two months back, seeking exemption for bulk drugs manufacturers from a fresh approval process for making changes to product mix at manufacturing facilities if the amount of effluents discharges is same or lower.
Under current norms, pharmaceutical companies have to go through a fresh approval process every time they want to make a change to the product mix, a process than can take as long as four months. For increase in production or addition of equipment, it could even be eight months or more, the industry association said in its submission, a copy of which was reviewed by Mint.
“Due to current norms, we lose export orders as the fresh approval process takes months," IDMA secretary general Daara B. Patel said.
The government soon also plans to hold a consultation with the industry, state pollution control boards, and the CPCB on what should be done to reduce the time taken for environment approval, a senior government official said, on condition of anonymity.
However, while industry bodies are seeking a reduction in the time for environmental processes to improve pharmaceutical production, there is also an equal clamour for not diluting the norms as India, according to various reports over the last one decade, is a hotbed for anti-microbial resistance.
“Improperly treated antibiotic residues cause dual damage by causing antibiotic resistance and environmental pollution. It is very important to regulate and keep a strict check on the waste disposal done from drug companies. In 2018, the CPCB set standards and guidelines for pharmaceutical establishments to adhere regarding disposal of waste," A.C. Dhariwal, former director, National Centre for Disease Control (NCDC) told Mint.
In 2018, the NCDC, keeping in mind the environmental and health hazards from industrial waste from pharmaceutical companies, wrote to the ministry of environment asking them to keep a strict vigil on antibiotic manufacturing companies that are disposing of industrial waste without proper treatment and contributing to antimicrobial resistance.
A study published by a Swedish Institute in 2009 showed that 90 pharmaceuticals units in Andhra Pradesh, at Patencheru near Hyderabad, were pumping 21 different pharmaceutical ingredients into the stream, Agarwal pointed out.
More recently in 2016, the European Public Health Alliance (EPHA) published a sombre report derived from on-the-ground investigation in India, revealing extremely high levels of antibiotic resistant microbial in water bodies near various pharmaceutical manufacturing sites.
Currently in India, all pharmaceutical manufacturing companies need clearance from the CPCB or its attached offices in order to start manufacturing drugs, so as to ensure that the effluents from the factories conform to standards laid down by the apex environment board.
According to CPCB, the solid wastes are either to be segregated and safely preserved by generators at their premises or disposed of in accordance with procedures, which are to be approved by the CPCB on a case by case examination and assessment.
“While the government has formulated guidelines for waste disposal from pharmaceutical companies and rules exist, the implementation is really weak. Waste coming out of pharmaceutical companies is hazardous in many ways. One of the major problems is superbugs, which are resistant to major antibiotics," said Ravi Agarwal, Director, Toxics Link, an NGO working for environmental causes.