After decades of lax checks on drugs, particularly those sold locally, the Indian Pharmacopoeia Commission (IPC) is upgrading its regulations to align with international standards for identifying harmful components in pharmaceuticals.
Using their representative lobbyists and a number of other stakeholders, such as directors of drug testing labs, officers at zonal and port offices, and all state drug controllers, the Indian Pharmaceutical Council (IPC), which sets quality standards for medications and their ingredients to guarantee safety and efficacy, has sent a letter to the pharmaceutical industry.
The Indian Pharmacopoeia (IP), which is used by Indian medicine manufacturers, has less stringent impurity restrictions than the US and European Pharmacopoeias.
A book known as pharmacopoeia describes the fundamental quality requirements for all medications dispensed in the nation. This book acts as a guide for drug manufacturers and includes all the information regarding the standards for the efficacy, safety, and quality of medications and their constituents.
Standards from the International Council for Harmonization (ICH), which is used by many nations, are followed by those in Europe and the US. For a variety of reasons, including the financial capability of small and medium-sized businesses, the Indian regulator has been reluctant to embrace ICH norms thus far. But India needs a makeover right now." We are taking all steps required to send a positive message across the globe that India is a hub of drug manufacturing and exports. Hence, we need to follow ICH standards," a government official who was aware of the development stated.
“Last year was not good for the Indian pharma industry as we saw multiple countries leveling allegations against made-in-India drugs. Now, big pharma companies, which already sell to countries that follow ICH standards, are requesting the government to push local firms to follow high standards."
The official went on to say that large pharmaceutical companies will benefit from upgrading to ICH as it will help them grow their business and combat the lack of trust in international markets.
ELEMENTAL IMPURITIES: WHAT ARE THEY? WHAT DAMAGE DO THEY CAUSE PATIENTS?
The most recent notification states that the ICH has been updated to determine the boundaries of specific elementals. Therefore, in accordance with updated international rules, IPC is also updating the current guidelines on "elemental impurities."
Drug products may contain residual catalysts that were purposefully added during production or they may naturally occur as impurities.
To put it another way, there are several sources of dangerous metals found in medications. They may come from leftover compounds from the manufacturing process, or they may originate from machinery, packaging, or even other components of the medication itself. The amounts of elemental impurities in the medication product should be kept within acceptable limits since they don't offer the patient any therapeutic benefits.
These contaminants, which are currently given a free pass, also contain toxic substances, which have the unintended consequence of increasing the risk of fatal diseases like cancer.
India's plans to raise standards
In accordance with the notification, the Indian Pharmacopoeia Commission has begun to substitute elemental impurities for heavy metal testing in the upcoming edition of the Indian Pharmacopoeia, a book that describes the fundamental quality requirements for all medications marketed in India.
Dr. Rajeev Singh Raghuvanshi, the drug controller general of India and secretary cum scientific director of the IPC, sent out a notice stating that “IPC has also started discussions within the expert working group constituted for this subject beside publishing the proposed revisions on the IPC website for inviting public comments prior to their adoption in the IP 2026,"
"To start working on required necessary changes in the quality systems for their readiness and ensuring compliance with the revised elemental impurities standards," the notice's closing plea to government and industry leaders reads.
LONG PENDING BUT WELCOME STEP: SPECIALISTS
Industry insiders praised the action, referring to it as "long pending," but they worry that the pharmaceutical sector may find it difficult to modernize and catch up with international standards.
“(It’s a) good step, but I suspect industry backlash because they will really have to up their manufacturing standards now," said an industry expert who publishes frequently on drug quality and standards.
(Input from various sources)
(Rehash/Priyanka Pandey/MSM)
