NO
LOCAL CLINICAL TRIALS FOR NEW DRUGS – SCIENCE & TECHNOLOGY
News: India's
Central Drugs Standard Control Organisation (CDSCO) has issued an order
permitting the waiver of local clinical trials
- It is for specific new and novel
drugs already approved by regulators in countries with stringent quality
control standards.
What’s
in the news?
- In a significant move aimed at
expediting access to new medications, India has decided to waive off local
clinical trials for drugs that are globally approved.
- This decision has
far-reaching implications for the healthcare sector,
pharmaceutical industry, and patient care in India.
Background:
- The Central Drugs Standard
Control Organization (CDSCO) has identified certain conditions
under which new drugs that have been approved by stringent
regulatory authorities (like the US FDA or EMA) can bypass local
clinical trials.
- The primary goal is
to provide faster access to essential medications, especially those
required to treat life-threatening conditions and rare diseases.
The Central
Drugs Standard Control Organization (CDSCO) is the Central Drug
Authority for discharging functions assigned to the Central Government under
the Drugs and Cosmetics Act. CDSCO has six zonal offices, four
sub-zonal offices, 13 port offices and seven laboratories under its control.
Major
functions of CDSCO:
Regulatory
control over the import of drugs, approval of new drugs
and clinical trials, meetings of Drugs Consultative
Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of
certain licenses as Central License Approving Authority is exercised by
the CDSCO headquarters.
Key
Points:
- Emergency Use and Rare Diseases: The
policy is particularly relevant for drugs designed to treat rare diseases
or conditions where no alternative therapy exists.
- Regulatory Confidence: The
waiver applies to drugs that have already undergone rigorous testing and
approval processes by established international regulatory bodies.
About
Clinical Trials:
- Clinical trials involve enrolling
participants who meet specific criteria to test the safety and efficacy of
drugs, medical devices, or procedures.
- In India, the Indian Council
of Medical Research (ICMR) oversees the Clinical Trials
Registry-India (CTRI), a free online public-record system for
registering clinical trials.
- Launched in 2007 on a voluntary
basis, it became mandatory for all trials to register with the Drug
Controller General of India (DCGI) in 2009.
What
are the Potential Benefits?
- Faster Access to Medications: One
of the most significant advantages is the rapid availability of
life-saving medications to patients.
§ In
urgent cases, every day counts, and local trials can delay the process
considerably.
- Cost Efficiency:
Conducting clinical trials is resource-intensive, involving significant
expenditure.
§ By
waiving local trials, costs can be reduced, potentially lowering the overall
price of the drug.
- Encouraging Innovation:
This move may attract global pharmaceutical companies to the Indian
market, fostering a conducive environment for innovation.
§ It
could lead to quicker introduction of new therapies and advanced treatment
options.
- Improved Healthcare Outcomes: Faster
access to new drugs can improve healthcare outcomes, particularly in cases
of diseases that are hard to treat with existing medications.
What
are the Challenges associated with Waiver offers?
- Safety and Efficacy: The
primary concern is ensuring that the drugs are safe for the Indian
population. Genetic, dietary, and environmental differences can influence
drug efficacy and safety.
§ Thus,
careful consideration is necessary to ensure that globally approved drugs are
suitable for local use.
- Regulatory Vigilance: Continuous
monitoring and post-marketing surveillance are essential to track the
drugs' performance in the Indian population.
- Adverse effects or new safety
issues need to be promptly addressed.
- Ethical Considerations: The
waiver raises ethical questions about patient rights and informed consent.
- Ensuring transparency and patient
awareness regarding the drugs they are being prescribed is imperative.
- Dependency on Foreign Approvals: Over-reliance
on foreign regulatory approvals may weaken local regulatory standards over
time.
- Strengthening the CDSCO's
capabilities should remain a priority.
- India's decision to waive off local
clinical trials for globally approved new drugs is a progressive step
towards enhancing healthcare access and outcomes.
- The policy presents numerous
advantages, particularly in terms of speed, cost, and innovation, it must
be implemented with stringent safeguards to address safety and ethical
concerns.
- A balanced approach that leverages
global advancements while ensuring local relevance and patient safety is
crucial for the long-term success of this initiative.
Drug Controller General of India(DCGI)
- DCGI is responsible for approval
of licences of specified categories of drugs such as blood and
blood products, IV fluids, vaccines and sera in India.
- It comes under the Ministry of Health
& Family Welfare.
Source: https://www.hindustantimes.com/health/health-talk-why-india-waiving-off-local-clinical-trials-for-globally-approved-new-drugs-is-good-news-101723302179188.html