The Drugs Controller of India has introduced a significant change to help make international drugs more accessible and affordable in the local market. This change means that certain drugs developed outside of India can now be approved for use in the country without needing to go through local clinical trials.
New Rule to Speed Up Drug Approvals
Under a new rule, India has granted permission to countries like the USA, UK, EU, Japan, Australia, and Canada to have their drugs approved in India without the need to conduct local clinical trials. This new rule is outlined in Rule 101, which allows for the waiver of local clinical trials for new drugs under specific conditions.
“Currently, several medicines already approved from regulatory authorities like the US, UK and EU are not currently available in India due to regulatory requirements under the Drugs and Cosmetics Act. There is a need for conducting a local clinical trial to generate efficacy of data locally before they are given market use authorisation in India,” stated official sources from the Directorate General of Health Services.
Categories of Drugs Eligible for Waiver
The government believes that many life-saving drugs are delayed in being launched in India due to the lengthy approval process. To address this, the following categories of drugs are proposed for a waiver of clinical trials in India:
– Orphan drugs for rare diseases
– Gene and cellular therapy products
– New drugs used in pandemic situations
– New drugs for special defense purposes
– New drugs that offer significant therapeutic advantages over current treatments
“The most sought-after and latest medications that would help treat diseases like cancer, rare diseases like SMA and DMA, and autoimmune conditions will become available expeditiously in India,” according to official sources.
Potential Benefits for Patients and Government Programs
This decision could also help reduce the cost of these drugs for state governments and public health programs like DGHS and Ayushmaan Bharat.
Dr. Viranchi Shah, National President of the Indian Drug Manufacturers’ Association (IDMA), expressed support for the move. “It is a welcome move. It enables approval of new drugs based on results of clinical studies done in certain developed countries, subject to certain due diligence. It will help early approval and launch of such innovative medicines in India.”
Example: A New Hope for Breast Cancer Patients
For example, a new drug for treating breast cancer type 3, which is currently unavailable in India, could now be swiftly approved and made available under this new rule. However, official sources mentioned that in some cases, final phase four trials might still be required after the drug is approved.
Concerns Over Unregulated Weight-Loss Drugs
Meanwhile, a surge in demand for weight-loss medications among affluent Indians has led to a concerning trend. Drugs like Ozempic from Denmark’s Novo Nordisk and Mounjaro from America’s Eli Lilly are being illicitly imported into Indian pharmacies without proper regulatory checks. Both drugs are not yet available in India, although doctors often recommend them for obesity treatment.
This new rule by the Drugs Controller of India could pave the way for such important medications to be made legally available in the country, offering new hope for patients who need them.
