How govt plans to ensure faster availability of new drugs

Given the stringent nature of India’s regulatory environment for clinical trials, several pharmaceutical companies have moved their trials out of India.
As a result, only 1.2 per cent of global clinical trials take place in India.

Concerned about the rise of antibiotic resistance and the time it takes for drugs developed abroad to reach Indians, the government is considering holding its own clinical trials.

The trials, to be held by the Indian Council of Medical Research (ICMR), could be the beginning of an overhaul of the clinical trial ecosystem.

The government has rarely ventured into this arena  before.

Clinical trials for new drugs have so far primarily been conducted only by private Indian or foreign drug firms.

But given the stringent nature of India’s regulatory environment for clinical trials, several pharmaceutical companies have moved their trials out of India.

As a result, only 1.2 per cent of global clinical trials take place in India.

Yet it has 20 per cent of the global disease burden.

With so few trials held here, it takes too long for new drugs to be made available to patients.

If, however, the government were to hold clinical trials here to test new drugs on the Indian population, they would reach those who need them much faster.

At a meeting last month, government officials discussed the proposal to set up clinical trial centres at institutions affiliated with the ICMR, replacing the current system.

Currently, trials for new drugs are primarily conducted by private clinical research organisations (CROs).

Officials from the ICMR, the Central Drugs Standard Control Organization, and from CROs discussed the feasibility of opening government clinical trial centres for new antibiotics.

This is just the start. If successful, the model could be replicated for other disease areas too.

The meeting discussed the global regulatory framework and what kind of framework and facilities the ICMR will need to make trials and studies successful, said an official who was present.

“Our hospitals have many patients.

"But the ethical issues for such trials have to be addressed very carefully - the study designs and patient population need to be clearly defined along with the criteria to be used to include or exclude patients,” the official said.

The government is asking the CROs about their own experience before it launches into setting up its own facilities.

Many more such discussions will be held before any final decision is made.

If the proposal gets the green light, it will have to be approved by the Drug Controller General of India.

The idea of setting up government clinical trial centres stems from the fact that most temporary centres face a challenge when a particular project for which it was chosen is completed and the funding dries up.

The ICMR, for example, had created two vaccine trial centres earlier at Pune and Mumbai.

“Once the donor funding finishes, it is difficult to sustain those structures.

"Other countries have clinical trial centres that only do clinical trials.

"It’s time for India to develop something on those lines,” the official said.

Photograph: Adam Jourdan/Reuters