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Source-This post on New Regulations for Drug Approvals in India has been created based on the article “India’s regulator allows faster access to drugs approved globally: Why this can bring down cost, get you closer to emerging therapies” published in “The Indian Express” on 12 August 2024.
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Context – The Drug Controller General of India (DCGI) has introduced a new rule that streamlines the drug approval process. Now, if a drug is approved by leading regulators in the United States, United Kingdom, Japan, Australia, Canada, or the European Union, it will not need to undergo additional clinical trials in India.
What is the difference between Current Vs New Approval Process?
Current Process – Companies must still conduct clinical trials in India for drugs approved elsewhere. These trials need approval from a committee under the drug regulator.
New Process – Clinical trials can be waived if a drug shows a major improvement over existing treatments and is approved by top foreign regulators.
A detailed article on Issues with the drug regulatory system in India can be read here.
What are the Criteria for Waiver?
According to the New Drugs and Clinical Trial Rules 2019, local trials may be waived if:
A) The drug is approved in specified markets.
B) No major adverse events have been reported.
C) A global trial with Indian sites is ongoing.
D) There is no evidence that Indian enzymes or genes affect the drug’s safety and efficacy.
E) The applicant commits to conducting Phase IV trials.
What are the safeguards put in place by the new regulation for drug approval?
A) Post-Marketing Surveillance Requirements – Even though local clinical trials are waived, drugs approved under this new mechanism must still undergo “Phase IV post-marketing surveillance”. This monitoring tracks serious side effects and ensures drug safety, while allowing faster access to new treatments.
B) Authority for Local Trials – If there is evidence that a drug could have different effects in the Indian population, the DGCI’s Subject Expert Committee can still mandate local clinical trials to address any specific responses.
What is the significance of New Regulations for Drug Approvals?
1) Waiver for Ongoing Trials – Drugs in clinical trials in India but approved internationally can now apply for a waiver, streamlining their approval process.
2) Faster Access to Treatments – The new rules will speed up access to treatments for rare diseases and specific cancers. Popular drugs for diabetes, obesity, Alzheimer’s, and cancer will be available sooner. This update is important for treatments of rare diseases, gene therapies, pandemic needs, and special defense purposes.
3) Benefits for Drug Manufacturers – The new regulations will lower costs for local trials, benefiting both international and Indian drug manufacturers. Indian companies may offer drugs at lower prices, improving patient access and reducing financial strain on pharmaceutical firms.
Question for practice
What distinguishes the Current Approval Process from the New Approval Process? What are the implications of the New Regulations for drug approvals?
