Hyderabad: Pharmaceuticals Export Promotion Council of India (Pharmexcil), which is part of the ministry of commerce, on Thursday called reports by sections of foreign media—citing a study of a lobby group linking Indian drug makers poor environment controls to the development of drug-resistant bacteria or superbugs—as “fabricated" and “backed by vested interests" to malign the Indian pharma industry—the world’s largest producer of antibiotics.
Changing Markets, Europe-based environment watchdog—in its latest report titled ‘Superbugs in the Supply Chain-How pollution from antibiotics factories in India and China is fuelling the global rise of drug-resistant infections’—said direct sampling of water from three antibiotic manufacturing factories operated by Aurobindo Pharma Ltd, Orchid Chemicals and Pharmaceuticals Ltd and Asiatic Drugs and Pharmaceuticals Pvt. Ltd were found to be resistance hot-spots.
The study, widely reported by Western media outlets, said out of 34 sites tested, 16 were found to be harbouring bacteria resistant to antibiotics.
“At four of the sites, resistance to three major classes of antibiotics, namely the cephalosporins, carbapenems and the fluoroquinolones, was detected. At eight of the sites, resistance to cephalosporins and fluoroquinolones was detected. At a further four of the sites, resistance to either cephalosporins or fluoroquinolones was found," the report added.
The report singled out Aurobindo, alleging the company as a “recidivist polluter" at its plants in India and importer of raw materials used for making antibiotics from dirty factories in China.
Changing Markets asked the National Health Service (NHS), the publicly funded national healthcare system for UK, to blacklist Aurobindo from participating in supply tenders of antibiotics.
Aurobindo rejected the charges made against the company in the study.
The company spokesperson said all its plants are regulatory compliant and designed for strict environmental standards, including zero discharge.
Pharmexcil concurs with Aurobindo.
“We agree with the fact that there is a serious threat to public health from the emerging superbugs, which is due to various reasons, including environmental control, and the government of India and the Indian drug regulator have announced measures to curb irrational use of antibiotics," said P.V. Appaji, director general of Pharmexcil.
“But the problem with this report is that it has several inaccuracies and misrepresentation of facts, which leads us to suspect the objective of the report itself," Appaji said.
Appaji said Pharmexcil has conducted a preliminary study to check the veracity of the study and found several discrepancies.
The report says a high level of antibacterial resistance is observed in test samples collected near Unit-VII of Aurobindo, which produces antibiotics such as penicillin, cephalosporin, carbapenem and fluoroquinolone.
“To our surprise Unit-VII—except for fluoroquinolone—doesn’t produce none of the antibiotics stated in the report, and fluoroquinolone constitutes only 2% of the total production and dedicated for formulation," Appaji said.
Pharmexcil said it also found no evidence of wastewater discharged into the nearby surrounding of Unit-XI in Pydibhimavaram in Srikakulam.
Appaji said all the plants mentioned in the study are US Food and Drug Administration (USFDA), EU and the Medicines and Healthcare Products Regulatory Agency, or MHRA, compliant and are facing regular audits by the respective agencies, in addition to being subjected to Indian drug regulators and pollution control boards.