According to information obtained by News18, the long-pending step of tightening impurity standards in medicines in India is set to come into effect soon. The Indian Pharmacopoeia Commission (IPC) is updating rules for testing medicines for harmful substances to align with global standards, a major shift from the current lax testing, especially for medicines sold in the country.
The IPC, the agency responsible for setting quality standards to ensure safety and efficacy of medicines and their ingredients, sent notices to pharmaceutical companies through their representative lobby groups and multiple stakeholders, including state drug controllers, directors of drug testing laboratories and officials of regional and port offices.
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“The IPC is in the process of adopting elemental impurity requirements consistent with other international pharmacopoeias,” the IPC’s latest notice, seen by News18, said.
The impurity limits adhered to by Indian pharmaceutical companies as per the Indian Pharmacopoeia (IP) are less stringent than those in the European Pharmacopoeia and the United States Pharmacopoeia.
A Pharmacopoeia is a book that outlines the basic quality standards for all medicines sold in a country. It contains all the details of the requirements for the quality, safety, and efficacy of medicines and their ingredients, and acts as the rule book for drug manufacturing.
European and US standards follow the International Conference on Harmonisation (ICH) guidelines that are adopted by many countries. Till now, Indian regulators have been reluctant to adopt ICH standards for various reasons, including financial capacity of small and medium-sized enterprises. But now India needs reforms. “India is taking all necessary steps to send a positive message across the world that it is a pharmaceutical manufacturing and export hub. Hence, we need to follow ICH standards,” said a government official familiar with the development.
“Last year was not good for the Indian pharmaceutical industry as several countries came under fire for Indian-made medicines. Now, major pharmaceutical companies that sell medicines to countries that already follow ICH standards are urging the government to encourage local companies to adhere to the higher standards.”
The official added that the ICH upgrade would help big pharmaceutical companies expand their business and combat a lack of trust in the global market.
What are elemental impurities and how do they harm patients?
According to the latest notification, ICH has been revised to determine the limits for some elements, therefore, IPC is also revising its current guidelines on “Elemental Impurities” in line with the revised global guidelines.
Elemental impurities in pharmaceutical products can come from a variety of sources, including being residual catalysts intentionally added during synthesis or being present as impurities.
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Simply put, toxic metals in medicines can come from a variety of places. They can be residues of the chemicals used to manufacture the medicine, or they can come from the equipment used during production, the packaging, or other parts of the medicine itself. Since elemental impurities do not provide any therapeutic benefit to the patient, the levels of elemental impurities in medicines must be kept within acceptable limits.
These impurities, which have been tolerated until now, include toxic impurities that can cause deadly diseases such as cancer as side effects.
How India plans to improve standards
As per the notification, the Indian Pharmacopoeia Commission has begun the process of making testing for elemental impurities mandatory, replacing testing for heavy metals, from the next edition of the Indian Pharmacopoeia, a book that outlines basic quality standards for all medicines sold in India.
“The IPC has published the proposed revisions on the IPC website and will seek public comments before adopting them in IPC 2026, besides initiating discussions within the Expert Working Group constituted for this issue,” said the notification sent by IPC Executive Director and Scientific Director Dr Rajiv Singh Raghuvanshi, who is also the Drugs Controller General of India.
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The notice concludes by urging industry and government officials to “begin addressing any necessary changes to their quality systems to ensure compliance with the revised elemental impurities standards.”
Long-awaited but welcome step: experts
Industry experts have hailed the move as “long overdue”, but are concerned the pharmaceutical industry may struggle to upgrade to catch up with global standards.
“It’s a good step, but I think there will be a backlash from the industry because now they’ll really have to raise manufacturing standards,” said an industry expert who has written extensively about pharmaceutical quality and standards.
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