Clinical trials to include Indian subjects, a welcome decision says CRO

By Flora Southey contact

- Last updated on GMT

(Image: Getty/Niyazz)
(Image: Getty/Niyazz)
Clinical trials conducted outside of India – which test drugs for the Indian market – must include Indian subjects, according to a ruling in India last month.

The technical committee meeting​ held on September 25, 2017, was led by the director general of health services Jagdish Prasad, and decided that “any firm intending to market a new drug which is being developed outside the country, should include Indian patients.”

In the same meeting, it was determined that trials already approved in ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) countries, such as those in the US, Europe, and Japan, will be reviewed on priority by the Drugs Controller General of India (DCGI).

CRO perspective

The ruling will affect clinical research organisations’ (CROs) recruitment procedures for drug trials intended for the Indian market.

According to CRO George Clinical – which conducts clinical trials globally, including India – the decision will boost the effectiveness of medicines marketed in the country.

“This is an important move in determining the efficacy of drugs marketed in India,” ​said the firm’s managing director Vanaja Krishnan.

“After a series of events that impacted negatively on the sector in India in the early part of this decade, the decisions reached in the technical committee meeting reflect India’s harmonisation with international trial requirements,” ​she said.

Krishnan said the decision will encourage drug firms to include India​ in global trials. 

“It shows a reinvigoration of confidence in the clinical trials environment in India, and will encourage the inclusion of India in global trial programmes,” ​she explained.

“Global sponsors will again consider India as an important part of their research and development programme.”

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