The pharmaceutical industry, especially the drug development process, worldwide is exposed to modern regulatory standards, evolving a number of novel concepts in the entire spectrum of its research activities. Whether it is ICH guideline or the regional GCP laws, all these demand complete professional work procedures and attitude. The basic concept of contract research organisations (CROs) is purely the result of these new requirements and a byproduct of this changed work attitude. Although developed countries, where research-based pharmaceutical companies always focused on the global reach of their discoveries, could catch up with this concept at an early stage, contract research in India took long to evolve with the local set up.
Though India has really stepped into the area of contract research, there are still not many entities, which could really make their presence felt in the domestic pharma industry. Since the concept was quite new to the domestic pharma sector, pioneers like Quintiles, Siro, Lotus, and few others had to stick with their foreign clients till recently. However, the first Good Clinical Practice (GCP) guideline, which was brought out by the government has really enthused these companies as it has prompted even local pharma companies to turn towards the contract research organisations (CROs) to get their drug development trials done.
Currently the country has around 20 CROs including the new MNCs which have entered into the country. But, the major concern among them at present is how successfully they can penetrate into the minds of the local industry as a desired shift from the traditional research and development attitude of the Indian companies only will help them to build upon their domestic dreams.
However, Dr Chetan Thamhankar, general manger, Siro Clinpharm, one of the leading CROs in the country, which was established in 1995, is of the view that undertaking contract research and completing it to the perfection - what is required by the GCP and the ICH - is not an easy task. Hence, only companies who have thorough experience and expertise at various stages and parts of the job can do it successfully, and there are lot of learning curves which a CRO to undergo, he says.
"Still, the increased awareness of GCP requirements, stronger desire of international acceptability of research done in India has brought favourable changes in the attitude of clinicians in India towards participation in clinical trials. Investigators are eager to take part in GCP clinical trials and are also wiling to adhere to constraints of the protocol," Dr Tamhankar feels.
Even as many of the new CROs are yet to put the business on a growth track, after the government''s move into framing the regulatory code and infrastructure, a number of research-based multinational pharma companies have shown interest in conducting clinical trials in India. This has eventually inspired not only local CROs but even leading multinational CROs also to set up local outfits here.
Currently in India, specifications of schedule Y of Drugs and Cosmetics Act guide clinical trials legislative requirements.
The GCP guideline announced by the Union Ministry of Health, which was drafted by Central Drug Control Department and Indian Council for Medical Research (ICMR) for research in human subjects, is essentially based on Declaration of Helsinki, WHO guidelines and ICH requirements for GCP.
The Department of Science and Technology has also taken initiative for establishing quality requirements by setting up National Board for Accreditation of Testing and Calibration Laboratories for clinical and diagnostic laboratories (NABL), which are essential part of the clinical trial procedures.
As the legal prerequisite for the conduct of clinical trails, the DCGI acts as nodal office for approval of clinical trial applications. Schedule Y of Drugs and Cosmetics Act is the guiding principle for requirements of submissions. All phases of trials could be approved, though the DCGI office would be keen to know status of test product elsewhere in the world. It is easier to obtain approvals for next phase of clinical study with respect to already completed phase elsewhere in the world.
More than often, DCGI office would seek clarification from the sponsors, which are typically done by personal presentation of scientific data by the sponsor person with technical staff in DCGI office.
The timeframes could be anywhere between 45 days to 90 days for completion of entire process. However, applications of drugs on infectious diseases, especially related to HIV may take longer. This could happen as DCGI office may refer such protocols to ICMR or other government bodies for consultation or advice.
Since the Ethics Committee approval is a must requirement for conducting clinical trials, the country has opened up significantly in that area as well with most teaching hospitals now have well constituted ethics committees that comply with ICH requirements for composition.
Dr Tali Gill, Senior Research Manager of Simbec Research Ltd said the country is yet to pick up the concept of CROs in its full sense and to understand the importance of it, the companies were bit sceptical about sharing information with an outsider. But, it is changing slowly, he said.
However, at the stage of this evolution, the government and regulatory authority along with the industry have to learn many more things while the advancements what the industry and the regulatory standards globally deals upon. The learning process is already started in the country and the subcontinent is poised to grab the opportunities.