New Delhi: Paving way for faster launch of breakthrough therapies for conditions like cancer and rare diseases, the Union government Wednesday ordered that certain categories of drugs which have already been approved in specified developed countries can be directly launched in India without local clinical trials.
The countries included in the list are the US, UK, Japan, Canada, European Union and Australia.
The decision came through an executive order specifying the names of the countries under rule 101 of the New Drugs and Clinical Trials Rules (NDCT), 2019. Under this rule, the Drugs Controller General of India (DCGI) can specify certain countries for considering waiver of local clinical trials for approval of new drugs.
However, over the past 5 years, since the NDCT’s implementation, the government had not listed the countries from where drugs could be considered for exemption from local clinical trials, despite a push from the foreign drugmakers.
In the order issued Wednesday, DCGI Rajeev Singh Raghuvanshi said the names of the countries were now being specified in exercise of the powers conferred under rule 101.
However, the order, a copy of which is with ThePrint, restricts the categories of drugs that can be considered for the local clinical trial waiver. These include orphan drugs for rare disease, gene and cellular therapy products, new drugs used in pandemic situations, new drugs used for special defense purposes and new drugs having significant therapeutic advances over the current standard care.
“This has been a long pending demand from the global pharma companies and the decision will not only help in quick launch of life-saving innovative drugs in the country but also bring down their costs to patients,” a top official in the Union health ministry said Thursday.
As of now, several crucial drugs are launched 5-20 years after being approved in the US and European Union, the official pointed out.
The drugs which were not yet launched in India but needed by patients here could be imported following licenses issued by the DCGI, but it meant that patients had to pay custom duty on such drugs, barring some exceptions.
A senior official from the Central Drugs Standard Control Organisation (CDSCO) underlined that the countries, which have been specified under rule 101 are those with the most stringent drug regulatory regimes.
He added that every application received under this waiver will be vetted either by the DCGI or a subject expert committee under the CDSCO.
Officials also said that the latest order will promote research by Indian drugmakers, enabling them to collaborate with global pharma majors to manufacture, market or distribute the drugs locally.
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Several launches delayed
Launches of several drugs like Zolgensma — a blockbuster gene therapy used to treat spinal muscular atrophy, a disease that causes muscle-function loss in children, and considered one of the costliest drugs globally — by Swiss pharma giant Novartis, and dengue vaccine QDenga by Japanese firm Takeda, have been delayed in India due to insistence on local bridging studies.
Bridging studies are meant to provide clinical data on efficacy, safety, dosage and dose regimen in a new region.
During the Covid pandemic, Covishield vaccine by AstraZeneca — manufactured by Pune-based Serum Institute of India — had also been approved in India after completing bridging trials here.
Some drugs for the viral disease, such as Remdesivir by Gilead and later Paxlovid by Pfizer, however, had been given emergency-use authorisation by the drug regulator without conducting local trials during the pandemic.
Industry suggests removing conditions
In response to a query by ThePrint, the Organisation of Pharmaceutical Producers in India (OPPI), a network of global pharma companies, said that it welcomes the decision to grant waiver of requirement of local clinical trials for drugs, subject to conditions.
“OPPI and its member companies remain committed to collaborating with the government to ensure that Indian patients benefit from the latest advancements in medicine as swiftly as possible, maintaining a balance between safety, efficacy, and expedited access,” said Anil Matai, OPPI Director General. “This progressive move will significantly benefit both domestic and foreign drug manufacturers by expediting the approval process and facilitating faster access to essential medications for Indian patients.”
The organisation, Matai said, has been advocating for this notification.
The inclusion of specific categories like orphan drugs and gene and cellular therapy products, would address critical and unmet medical needs, he addded.
“However, while this is a commendable beginning, we believe that extending these waivers to a broader range of therapeutic categories will further enhance access to cutting-edge treatment,” Matai said.
OPPI has now urged the government to consider additional therapeutic areas where “similar waivers could significantly impact patient access”.
“Moreover, it is pertinent to understand how the criterion for ‘new drugs having significant therapeutic advance over the current standard care’ is defined and implemented. This could set a precedent for recognising and adopting breakthrough therapies that offer superior clinical benefits,” Matai told ThePrint.
(Edited by Zinnia Ray Chaudhuri)
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