India eases access to globally approved drugs, likely to lower costs

India's Drug Controller General (DCGI) has announced that new drugs approved by top regulatory authorities in select countries will no longer require clinical trials in India.

This new regulation is set to fast-track the availability of cutting-edge therapies, such as those for weight loss, Alzheimer’s, and cancer, that have already been cleared in regions like the United States, United Kingdom, Japan, Australia, Canada, and the European Union—countries renowned for their rigorous drug approval processes.

Pharmaceutical companies can now seek regulatory approval to market their products in India if they can demonstrate that the new drugs represent a "significant therapeutic advance over the current standard of care" and have been approved by regulators in any of the six specified regions.

This move is particularly relevant for drugs targeting rare diseases, gene and cellular therapies, new drugs developed in response to pandemics, cancers with specific genetic markers, and those intended for special defense purposes.

This change is expected to speed up the availability of blockbuster drugs in India, including GLP-1 receptor agonists like semaglutide and tirzepatide for treating diabetes and obesity. Other anticipated drugs include donanemab, which helps slow cognitive decline in early Alzheimer’s patients, and cancer therapies like Tarlatamab for lung cancer and Tovorafenib for pediatric brain tumors.

This regulatory change is expected to benefit not only multinational pharmaceutical companies but also large Indian drug manufacturers.

According to a Health Ministry official, “If an Indian company secures a manufacturing license for an international drug, avoiding the need for a local clinical trial could significantly reduce their costs. This cost-saving could then translate into more affordable pricing for these drugs in the Indian market.”

Previously, even if a drug had been approved internationally, companies were required to conduct a clinical trial in India, which had to be sanctioned by a committee under the drug regulator.

The waiver for local trials was initially included in the 2019 New Drugs and Clinical Trial Rules but has not been utilized until now because the drug regulator has not specified which countries' approvals would qualify for the waiver.

The new order, issued on Wednesday, provides that clarity.

Despite the waiver, these drugs will still be subject to "Phase IV post-marketing surveillance" to monitor any serious adverse events once they are on the market.

However, the DCGI's Subject Expert Committee retains the discretion to require a clinical trial if there is scientific evidence suggesting that the new drug might behave differently in the Indian population. "There are certain drugs that may have different effects on the Indian population. If necessary, the committee can insist on a clinical trial, providing written justification for its decision," the official added.

Drugs currently undergoing clinical trials in India, which have already been approved by these international regulators, can also reapply for the waiver, according to officials.

The New Drugs and Clinical Trial Rules 2019 allow for local clinical trials to be waived if a new drug is approved in specified markets, no major adverse events have been reported, a global trial with Indian sites is ongoing, there is no evidence that enzymes or genes in the Indian population affect the drug’s safety and efficacy, and the applicant commits to conducting Phase IV trials.

"The rationale for this waiver is that the drug is likely to perform similarly in both Western and Indian populations. Repeating a clinical trial could be seen as unethical because it denies a group access to the best available medical treatment. However, some drugs may have different effects on the Indian population. Therefore, it should not be a blanket waiver. As long as a committee transparently reviews and provides scientific reasons for granting a waiver, it should be acceptable," said Prashant Reddy T, a lawyer specializing in drug regulations.