The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has alleged that a conspiracy is being hatched by certain vested interests to contain Indian pharmaceutical exports to the global markets. The council said there have been false reports doing rounds in certain international media about Indian pharma companies becoming breeding grounds for ‘antibiotic resistant bacteria’ which is absolutely false.
“India has become a global leader in the export of high quality generic medicine to various markets including USA, UK, Europe and other regions like Latin America and Africa. As there is intense competition going on in the international market, certain interest groups are hatching conspiracy to contain Indian exports by creating fear among the international community about ‘drug resistant bacteria’ (Superbug). We have cross checked and verified with the Indian companies and no company in the mentioned units by the International media is manufacturing antibiotics,” clarified Dr. Appaji, Director General of Pharmexcil.
Recently, a London based media named ‘Bureau of Investigative Journalism’ has published a report titled “Revealed: How dirty production of NHS drugs helps create superbugs”. In the report, it claimed that dirty production methods being practiced by Indian pharma companies fuelling the rise of superbugs. To support the story, the media also cited the results of tests carried out by ‘Changing Markets, a campaigner of environmental and social issues, on the water samples collected near drug companies in India.
According to the media report, it is alleged that water samples originating from a manufacturing plant of Aurobindo Pharma in Hyderabad were found to be producing the highest level of superbug. However Pharmexcil rubbished these allegations as baseless and said the Indian pharmaceutical industry is controlled by a strong regulatory mechanism for GMP (Good Manufacturing Practices) and environmental controls.
“More than 631 sites of Indian pharma manufacturing companies are EU GMP compliant, while 605 sites are registered with USFDA. Approximately 1400 manufacturing units of major Indian Pharma companies are WHO GMP certified. A majority of these manufacturing units are registered in strongly regulated markets like USA and EU and are regularly facing audits from respective FDAs of these countries and complying with all their requirements,” informed Appaji.
Ravi Uday Bhaskar, a senior drug controller and additional executive director of Pharmexcil also said that the Indian pharmaceutical industry is controlled by a strong regulatory mechanism for GMP and environmental controls. “The state and central drug regulating bodies perform regular audits so as to ensure the adherence to the regulatory compliance. Not just Indian regulatory, the manufacturing units in India are regularly audited by several international customers for environment, health and safety (EHS) systems of manufacturing units. It looks that the recent report has selectively targeted Indian lead exporters from the country to defame its pharma industry,” observed Uday Bhaskar.