In a recent move to bring advanced therapeutics to India, the Drug Controller General of India (DCGI), who heads the Central Drugs Standard Control Organization (CDSCO), waived clinical trials for therapeutics already approved in the US, the UK, Japan, Australia, Canada, and the EU.
This waiver applies to the following categories of drugs and therapeutics
- Orphan Drugs for Rare Diseases
- Cell and Gene Therapy products
- New Drugs used in Pandemic situation
- New Drugs used for Special Defense purpose
- New Drugs having significant therapeutic advancement over current standard care
At present, therapeutics approved outside of India require clinical trials to be approved for use in the country. This recent step taken by the DCGI opens doors to blockbuster drugs and therapeutics against rare diseases that have been approved by foreign regulators without the need for clinical trials in India. However, the DCGI still reserves the rights to mandate clinical trials where it feels trials on Indian population may yield different results.
“As per Rule 101 of New Drugs and Clinical Trials Rules, 2019, the Central Licensing Authority, with the approval of the Central Government, may specify, by an order, the name of the countries, from time to time, for considering waiver of local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under Chapter V of the said rules,” the Drugs Controller General of India (DGCI) said in an order issued on August 7, 2024.
The notice clearly specifies two different provisions drug makers can avail if their products are already approved in the mentioned foreign countries. The first is a waiver of local clinical trials for approval under Chapter X and the second is a permission to conduct a clinical trials under Chapter V.
Will Side Effects be Monitored?
Yes. Regardless of the clinical trial waiver, all approved therapeutics will undergo a mandatory “Clinical trial Phase IV post-marketing surveillance” said officials.
What about therapeutics currently undergoing Clinical trials?
Drug makers of therapeutics undergoing trials can reapply for a waiver.
How does this benefit companies and patients?
- Indian pharmaceutical companies with a license to manufacture an international drug company product can expect to benefit from reduced investment in Clinical Trials
- Multinational big pharma companies can also expect to benefit from being able to bring their products to the Indian market
- Since the costs involved in clinical trials have been bypassed, the public may benefit from lowered drug price and greater accessibility
References:
- https://cdsco.gov.in/opencms/opencms/en/Home/
- https://indianexpress.com/article/health-wellness/new-drugs-cancer-weight-loss-alzheimer-faster-globally-9503358/
- https://indianexpress.com/article/india/government-waives-clinical-trial-drug-9503304/
