The Indian health ministry has announced that certain drugs approved for use in territories such as the EU and US will be automatically approved in India without a further native clinical trial taking place, in a bid to give patients faster access to new medicines.
The new Drugs and Clinical Trials Rules 2019 were announced by the Ministry of Health & Family Welfare (MHFW) on Monday 25 March.
The new rules allow drugs licensed in the EU, US, Australia, Canada and Japan to be introduced to Indian patients without further testing taking place, provided the associated trials included Indian patients.
This also applies to bio-availability, bio-equivalence, new drug and ethical regulations relating to clinical trial and biomedical health research.
Application review times have been shortened under the new clinical trial regulations
Trial application review times have also been shortened. Applications relating to drugs manufactured in India must now be approved or rejected by the Drugs Controller General of India (DGCI) within 30 days, or 90 days for drugs developed outside the country.
Academics who do not hear from the DCGI in this period can assume their application has been approved and may begin their research.
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India has the second-largest population in the world and the highest disease burden, but completes less than 1.2% of clinical trials globally, according to the Indian Society for Clinical Research (ISCR).
ISCR president Dr Chirag Trivedi said: “We thank the Ministry of Health & Family Welfare and Central Drugs Standard Control Organisation (CDSCO) for notifying the Rules which were long coming and will go a long way in reassuring local and global stakeholders about India’s commitment to building a robust regulatory and clinical research ecosystem.”
Indian clinical trial regulation will now define orphan drugs
The new regulations have also defined orphan drugs for the first time, as medications intended to treat conditions which affect fewer than 500,000 people in India.
These drugs will be subject to less stringent regulations than others due to the significant unmet medical need associated with them. This includes the waiving of application fees for orphan drug trials, in the hopes this will encourage more trials for rare diseases in India.
Trivedi said: “It is incumbent on all those involved in clinical research to publicise the new Rules so that we can have more clinical trials in India. Our patients are waiting.”
In January 2019, the Indian government caused controversy when it removed a clause in MHFW legislation which mandated that the sponsor of a clinical trial was obligated to pay 60% compensation in the incidence of death or permanent disability to a patient.
An amendment in the new Rules states that companies will now pay the total amount once it has been ascertained that the death or disability occurred as a direct result of the trial. Beforehand, compensation had to be paid upfront and was not recoverable by the sponsor even if investigations later revealed that the death or disability was not caused by the trial.