The Drugs Controller of India has decided to eliminate the requirement for local clinical trials for many international drugs. This move aims to make these medications more accessible and affordable in India, speeding up their availability and lowering costs for public health programs.
**In Short:**
The Drugs Controller of India has waived the local clinical trial requirement for several international drugs. This new rule allows drugs from the USA, UK, EU, Japan, Australia, and Canada to receive market authorization in India without needing local clinical trial data. The aim is to speed up the availability of life-saving medications and reduce costs, making these drugs more accessible and affordable in the Indian market.
**In Short:**
The Drugs Controller of India has waived the requirement for local clinical trials for several international drugs to address delays in bringing life-saving medications to the country. Previously, medicines approved by regulatory authorities like the US, UK, and EU faced delays in India due to the need for local clinical trial data.
The new rule applies to:
– Orphan drugs for rare diseases
– Gene and cellular therapy products
– New drugs for pandemic situations
– New drugs for special defense purposes
– New drugs with significant therapeutic advantages over current treatments
This move is expected to make advanced treatments for conditions such as cancer and rare diseases available more quickly in India.
The new waiver on local clinical trials for international drugs will help lower public procurement costs for state governments and schemes like DGHS and Ayushman Bharat. Dr. Viranchi Shah from the Indian Drug Manufacturers’ Association welcomed the move, noting it will expedite the approval and availability of innovative medicines in India.
For example, a drug for breast cancer type 3 that isn’t currently available in India could now be approved and launched more quickly.
However, there are concerns about the illegal entry of weight-loss medications like Ozempic and Mounjaro into Indian pharmacies, bypassing regulatory checks. Ozempic, approved by the US FDA in 2017 for diabetes and in 2021 for obesity under the brand Wegovy, and Mounjaro, used off-label for weight loss, are not yet available in India despite being recommended for obesity treatment.
