Context: The Union government has authorised the exemption of local clinical trials for approval of new drugs under Rule 101 of the New Drugs and Clinical Trial Rules, 2019.
Major highlights
- Under the Rule 101 of the New Drugs and Clinical Trial Rules, 2019, the CDSCO, with Union government approval, can issue orders specifying the name of the countries for considering waiver of local clinical trials for approval of new drugs.
- The government has decided to waive the requirement for clinical trials in India if the drugs are approved in the U.S., the U.K., Japan, Australia, Canada, or the European Union.
- A set of five categories for new drugs has been specified that will be considered for waiver in the Indian market. They include:
- Drugs for rare diseases: These often lack sufficient patient populations for local trials. (https://compass.rauias.com/current-affairs/indias-fight-against-rare-diseases/)
- Gene and cellular therapy products: Cutting-edge treatments that require speedy approval.
- New drugs for pandemic situations: To address urgent public health crises.
- New drugs for special defence purposes: For military personnel.
- Drugs with significant therapeutic advancements: To provide patients with better treatment options faster.
Significance:
- Enhanced drug accessibility for patients and for research.
- Drugs manufactured outside India will be more accessible and affordable in the local market.
- Address the critical and unmet medical needs and accelerate access to innovative therapies to the patients in India.
- By aligning with approvals from established regulatory bodies in other countries, India is moving towards global harmonisation in drug approval processes.
Central Drugs Standard Control Organisation (CDSCO):
- The Central Drugs Standard Control Organisation (CDSCO) is the Central Drug Authority in India.
- CDSCO is responsible for many functions under the Drugs and Cosmetics Act, including:
- Approving new drugs and clinical trials
- Setting standards for drugs
- Controlling the quality of imported drugs
- Coordinating the activities of state drug control organisations
- Granting licences for certain specialised categories of critical drugs, such as blood and blood products, IV fluids, vaccines etc.