In views of mounting concerns over the way the Rs 1,500 crore Clinical Resear­ch Organisation (CRO) industry operated in India, the central drug regulator has announced regulatory framework to ensure adherence to globally accepted Good Clinical Practice (GC­P) norms. The CRO indus­try is estimated to reach ab­out $1 billion in 2012 given India’s emergence as a preferred destination for clinical trials.

The central drug regulator or the Drug Controller General of India (DCGI) has been under pressure to establish and enforce standards in view of more and more clinical trial work shifting to India given its cost advantage.

The CRO industry body, Association of Indian Clinical Research Organisation (ACRO), president and cha­irman of Veeda Clinical Research, Apurva Shah said, “Regulation is welcome sin­ce it would help scale up India’s potential as a CRO destination. The inspection infrastructure, however, ne­eds to be educated to be ab­le to enforce standards.”

A senior health ministry official said the DCGI has taken the first big step by announcing guidelines for drug inspectors to conduct inspection of clinical trial sites, audit CRO facilities involved in clinical trial and information to investigators, as also establish a communication set up for clinical research firms about procedures for inspection and follow-up of action.

“The guidelines cover en­tire gamut of issues invo­lved in the clinical trial ins­pec­tion. It aims to verify GCP compliance to protect rights, safety and well being of the subjects invo­lved in clinical trial; to veri­fy the credibility and inte­gr­ity of clinical trial data ge­ne­rated; and to verify the co­mplian­ce with various re­gu­latory provisions as per Dru­gs & Cosmetics Rules,” he added.

Shah at ACRO, the CRO industry body said, “For long there has been a demand for bringing in guidelines to govern the industry. Global pharma majors see a lot of merit in India but with guidelines initiated they would have greater faith and confidence in the system. I am confident the guidelines would help only increase the CRO business inflow into India.”

He, however, asserted that the only concern was the need to ensure that drug inspectors entrusted with the task of enforcement of these guidelines were trained enough to track defaults.

Jubilant Life Sciences, a leading player in the CRO segment declined to comment on the issue.

As regards the timing of the inspection, guidelines prescribed that it can be carried in normal circumstances before, during or after a clinical trial is completed.

However, as per the requirement but under specific circumstances unannounced inspection too might be conducted. It can either be routine or on a specific information or complaint basis thus offering lot of discretionary powers to inspectors.

The broad set of questions under the ambit of inspectors would range from asking question on the nature of study, data irregularities, complaints, and vulnerability of subjects.

According to a recent Thomson Reuters study the global figures for clinical trial recruitment highlight a dramatic shift away from the US and toward Asia Pacific. The report said, “In 2002, 53 per cent of patients recruited globally were in North America; in 2008 that figure was down to 32 per cent. Asia Pacific saw an increase from 6 per cent to 11 per cent over the same period, while Europe showed marginal growth from 14 per cent to 17 per cent. Meanwhile, the number of new molecules in development by generic companies, particularly in India, reflects a strong inclination to invest in R&D.”