To help make medicines manufactured outside India more accessible and affordable in the local market, the Drugs Controller of India has announced the waiver of the requirement for clinical trials for several international drugs and medicines.

These internationally developed drugs may receive market approval in India without submitting local clinical trial data.

Under the new rules, Rule 101 allows countries such as the US, UK, EU, Japan, Australia and Canada to “consider exemption of local clinical trials for approval of new drugs under Chapter X and to permit conduct of clinical trials under Chapter V of the said Rules”.

Official sources in the Directorate General of Health Services said, “Currently, many drugs that are already approved from regulatory authorities like the US, UK and the European Union are not available in India due to regulatory requirements under the Drugs and Cosmetics Act. Local clinical trials need to be conducted to generate efficacy data locally before they are allowed for market use in India.”

This step has been taken because the government feels that there is delay in launching many life saving medicines in the country.

It is proposed to exempt the following categories of drugs from clinical trials in India:

• Orphan drugs for rare diseases
• Gene and Cellular Therapy Products
• New medicines to be used in pandemic situation
• Use of new drugs for special defence purposes
• New medications that have significant therapeutic advantages over current standard care

According to official sources, “The most sought-after and latest medicines that will help treat cancer, rare diseases like SMA and DMA, and autoimmune conditions will be available in India quickly.”

He said, “This decision will be helpful for state governments and in reducing public procurement prices under schemes like DGHS and Ayushman Bharat.”

Dr Viranchi Shah, national president of the Indian Pharmaceutical Manufacturers Association (IDMA), said, “This is a welcome move. It enables approval of new drugs based on the results of clinical studies conducted in some developed countries, subject to some due diligence. This will help in speedy approval and launch of such innovative drugs in India.”

For example, a drug for breast cancer type 3, which is not available in India, may now be available after accelerated approval of MUA (market use authorisation).

Official sources also said that in some cases, final phase four trials may be mandatory for these drugs.

The growing demand for weight-loss drugs among wealthy Indians has led to a worrying trend: drugs such as Ozempic from Denmark’s Novo Nordisk and Monjaro from the US’s Eli Lilly are entering Indian pharmacies illegally, bypassing regulatory scrutiny.

The US Food and Drug Administration (FDA) approved Ozempic for the treatment of diabetes in 2017, while a higher-dose version under the brand name Wegovy was approved in 2021 for the treatment of obesity.

However, Monjaro, approved for diabetes, is often used off-label for weight loss. But both these drugs are not available in India despite being recommended by doctors to treat obese patients.