‘Not A Regulatory Body’: Indian Pharmacopoeia Clarifies It Only Sets Standards For Drugs, Doesn't Enforce Them

Last Updated:June 04, 2025, 10:26 IST

The clarification comes in the wake of increased global scrutiny of Indian-made drugs

Impurities are small amounts of unwanted substances that may be present in a drug. (Shutterstock image for representation)

The Indian Pharmacopoeia Commission (IPC) has issued a clarification on its role amid growing concerns over impurities in medicines and the quality of drug manufacturing in India, News18 has learnt.

In a notice issued by the apex authority titled “Clarification on impurity limits published in the Indian Pharmacopoeia", it mentions that the IPC “is in receipt of enquiries from various stakeholders…" and hence, it has been issuing the clarification.

The IPC, which is responsible for setting the official quality standards for medicines in India, made it clear that while it defines the standards for impurities in drugs, it is not involved in approving or regulating new medicines. It said that responsibility lies with regulatory bodies like the CDSCO (Central Drugs Standard Control Organisation) and State Licensing Authorities.

Both government departments, the Indian Pharmacopoeia Commission (IPC) and the apex regulatory agency, CDSCO, are headed by Dr Rajeev Singh Raghuvanshi.

What Are Impurities in Medicines?

Impurities are small amounts of unwanted substances that may be present in a drug. While some impurities are acceptable within strict limits, their control is crucial to ensure the safety and effectiveness of medicines.

The IPC sets impurity limits based on global standards and scientific data submitted by drug manufacturers. These limits are meant to serve as guidelines for making safe medicines, but final approval is always in the hands of the drug regulators.

What does the clarification say?

According to the notice dated May 30, IPS said its main function is to publish the Indian Pharmacopoeia (IP)—an official reference book that sets voluntary standards for the identity, purity, and strength of drugs. It clarified that if companies want to deviate from these impurity limits, they can do so with proper scientific justification and approval from the regulatory authority. Also, the notice tells manufacturers that they should not rely only on IPC limits for new drug products or combinations — they must consult the proper authorities for regulatory approval.

“The IPC is an autonomous institution under the Ministry of Health & Family Welfare that is solely responsible for setting official drug standards… The IPC does not have any role in the regulatory review and approval of new drugs in India…the CDSCO and/or state licensing authorities are competent to take regulatory decisions."

The clarification comes in the wake of increased global scrutiny of Indian-made drugs. Experts had raised questions about whether the IP includes adequate impurity limits for commonly used medicines. However, IPC, in the notice, has reiterated that it works in a consultative and advisory capacity, not as a regulator or certifying body. “Impurities may be considered by the regulatory authority, provided it is supported with valid scientific justification and relevant data," it said.

The notice, signed by Raghuvanshi, also pointed out that “it is clarified that, in any case, the IPC does not have the mandate to approve or endorse impurity specifications…" Moreover, it added, “the IPC, being a standard-setting organisation, is also not responsible to express opinion or recommendation in such regulatory matters."

In fact, it has asked drug-makers and stakeholders “to engage with the IPC by submitting scientific evidence to support monograph revisions, wherever required, to promote harmonisation with global standards".

Himani Chandna

Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India's COVID-19 battle, she brings a seasoned perspective. She is particularly pass...Read More

Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India's COVID-19 battle, she brings a seasoned perspective. She is particularly pass...

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