Export quality concerns: Can India’s pharma industry ensure safe medicines through self-regulation?

Pharma News: India’s Health Minister has appealed to the pharmaceutical industry to take immediate action in ensuring the quality of medicines. Speaking at the closing ceremony of the Indian Pharmaceutical Association’s Global Pharmaceutical Quality Summit in Mumbai, Dr Mansukh Mandaviya, emphasised the need for a self-regulatory body to uphold the reputation of India as the “Pharmacy of the World.”

The summit provided a platform to address a pressing concern: the questionable quality of medicines exported from India. Tragic incidents involving the deaths of children who consumed cough syrups contaminated with toxic substances, such as ethylene glycol and diethylene glycol, raised serious doubts about the safety and efficacy of these products.

Dr Mandaviya acknowledged the pivotal role played by the Indian pharmaceutical industry during the Covid-19 crisis, highlighting India’s contribution of approximately half of all global vaccine supplies and one-fifth of all generic medicines. However, he stressed the importance of maintaining this reputation through unwavering commitment to quality.

While India’s direct exports to Australia amount to $475 million annually, it is important to note that contract manufacturing in India facilitates the production of numerous products for major U.S. and European companies. These goods are then distributed globally, including to Australia.

Lat year, Australia agreed to recognise approvals gained by Indian products in major markets, including the European Union, the United Kingdom, and the United States. Furthermore, the nation committed to expediting assessments of manufacturing facilities. Dr Mandaviya welcomed this cooperation and encouraged pharma companies to seize the opportunity to enhance quality standards collectively.

Highlighting the issue of compromised quality, Dr Mandaviya made it clear that the government maintains a zero-tolerance policy toward those who undermine the integrity of medicines. Stringent actions have been taken against companies involved in such malpractice. However, Dr Mandaviya called for assistance from the industry, urging pharmaceutical companies to establish a self-regulatory body dedicated to monitoring product quality.

During the event, Shri. Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance, stressed the need for continuous investments in quality systems, technology, and talent, considering the rapid evolution of the overall healthcare landscape.

While the government press release provided limited information on Dr Mandaviya’s vision for the self-regulatory body and its practical implementation, the Health Minister assured that companies with a history of product failures would be audited. He also urged regional industry players to provide guidance and support to companies in need of improvement. However, he firmly stated that companies showing disregard for quality have no right to operate.

Dr Mandaviya’s impassioned plea to the pharmaceutical industry serves as a wake-up call, urging stakeholders to prioritise quality control and collaborate in maintaining India’s stature as the “Pharmacy of the World.” The establishment of a self-regulatory body could potentially revolutionise the industry, ensuring that medicines produced in India meet the highest standards of safety and efficacy for export to Australia and internationally.

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