The topic of clinical trials and India has been making headlines lately. I recently did a very good interview with Drashan Kulkarni regarding the Indian Supreme Court and it’s actions against some clinical trial companies here. Another interview with Darshan regarding the Indian government considering FREE drugs for all can be found here. This blog post will basically highlight some of the advantages and disadvantages of conducting clinical research in India.

The first set of ethics rules for research in human formulated by the international medical community was established in 1964 by the WORLD MEDICAL ASSOCIATION (WMA) in the Declaration of Helsinki (Declaration). The WMA is an international organization representing physicians and was founded in 1947. The organization was created to ensure the independence of physicians and to work for the highest possible standards of ethical behavior and care among them, at all times.

India is making a name for itself in the international pharmaceutical arena as a preferred destination for leading pharmaceutical companies to conduct clinical trials and it is challenge for both the government and the private sector, to create a balance between ethics and trade. The Indian government has played its part by standardizing the regulations governing the conduct of clinical trials and the private sector, which includes pharmaceutical companies and contract research organizations, has succeeded in conducting global clinical trials in India.

An increased awareness of good clinical practice requirements and stronger desire for international acceptability of research carried out in India have brought favorable changes in the attitudes of Indian clinicians towards participation in clinical trials. Investigators are eager to take part in clinical trials and execute the protocols of US, Japanese and European drugmakers.

According to a joint study by international consultancy Ernst and Young, and the Federation of Indian chambers of commerce and industry, India now participates in over 7% of all global phase 3 and 3.2% of all global phase 2 trials. Furthermore, a report by another market research firm says that the clinical trial outsourcing market in India is forecasted to grow at a compounded annual growth rate of over 30% during 2010-2012 to around and 600 million by 2012. In this context, the changing regulatory framework for clinical trials in India as well as the advantages and challenges of carrying out trials in this market will be examined further.

In India, the central government, via the central drugs standard control organization under the ministry of Health and family welfare, largely works in developing standard and regulatory measures for drugs, diagnostics and devices, laying down regulatory measures by amending acts and rules, and regulating the market authorization of new drugs– all in effort to standardize clinical research in India and bring safer drugs to the market.

Apart from specific elements of the Indian market that attract global players; the main aspect that has put the country at an advantage is the notable momentum adopted by the Indian Council of Medical Research and CDSCO in tandem with global regulatory guidelines . One must keep in mind that India’s involvement in global GCP (Good Clinical Practice) has only existed since the past decade.

With the number of clinical trials being conducted in India increasing rapidly, the regulatory bodies recognized the need to frame guidelines and regulatory approval processes in order to be on par with international standards. The DTAD, for example ,endorsed the adoption of GCP guidelines for streaming clinical studies, which have been incorporated into governing clinical trials. The CDSCO has made the guidelines available to the public on its websites in order to ensure a level playing field.

Some of the main advantages of carrying out clinical trials in India are:
-Strong availability of study subjects across major therapeutic segments.
-High level of ICH GCP AND US food and drug administration standards compliance (since 2001, The DCGI has implemented conformity to ICH, GCP and good laboratory practice guidelines. Generally, most competent authorities, including the US FDA, will find the standards of Indian clinical trials acceptable).
-High quality of research professionals (India has a strong reputation for graduating students in the medical and scientific fields. The government is involved in curriculum development at major universities and students pursuing these fields of study are given financial incentives to study in India).
-A favorable regulatory environment that allows the conduct of global trials, duty-free imports of drugs intended for use in trials bioequivalence studies for export of data.
-Cost competitiveness (depending on the number of patients and investigators, and the advantage over a similar trial in Europe or the US).
-Increasing prevalence of diseases.

Approval of clinical trial documents from both the IRB (Institutional Review Board or ethics committee)/or IEC and DCGI is mandatory to initiate a study. Because India’s potential as a major hub for global clinical research has been acknowledged, the regulatory bodies have to elevate themselves to meet international standards, and they are facing some challenges. Some of the major issues that have been recognized as areas in need of improvement are explained below.

Lengthy Approval Timelines
International phase 1 clinical trials with new chemical entities developed in a foreign country (First –in-human trials) are not allowed in India. Moreover, clinical trial applications submitted to the DCGI where the DCGI office does not have the competency to review such protocols are sometimes referred to outside agencies such as the ICMR, the BARC, the DBT, the AERB and /or the GEAC for their review and expert opinion. This process results in larger review times. When this occurs, the additional time involved is unpredictable. Occasionally, these referred bodies do not have the competency to review the submitted protocol, therefore expert committees are constituted to review the protocol and other submitted documents. Ample time is taken to constitute such committees. This committee must then overcome some other hurdles such as the fact that expert committee members must be available to meet at a joint forum. The decision is usually not taken during a single session, therefore multiple sessions are required. Furthermore, queries raised during such meetings take a significant amount of time to be drafted and circulated to the applicant’s response. Finally, the committee has to meet again to review the documents submitted to make the final decision. As one can clearly see, the approval timelines for these trials is no walk in the park, even in India.