The government's proposal to levy a hefty fine of Rs. 20 lakh along with a 10-year imprisonment for carrying out clinical trials without permission from the regulatory authority has been welcomed by the Clinical Research Organizations (CROs) in the country. But they are apprehensive about its implementation in absence of a legislation.

The new bill to regulate the clinical trials market is delayed even after the Union minister for health and family welfare Dr.Anbumani Ramdoss introduced it in the Rajya Sabha last month .

According to VR Kannan, pharma consultant, the punishment is absolutely necessary and unethical trials should never be allowed to happen. However certain companies undertake pilot study to promote usage and experience with the drug. The study is also referred to as 'user trial' for products which already approved for marketing in India and available on prescription. Some physicians who are 'slow-takers' are prompted to use the drug early by this study. The pilot study is conducted under surveillance by the practicing physician and the medical advisor of the marketing company. The trial outcome is to enhance the user experience.

"The drug pilot study is critical for the company and therefore would the proposed warnings of the government include this category," queried Kannan.

"Going by our experience during audits of international trial sites in the country, a dedicated Bill could have little impact. There should be prime importance given to stringent high quality internal practices maintained while conducting a patient study. Therefore, at any cost the onus is on the sponsors who need to stress high quality practices for business growth which is a challenge going by the present practices. What is required is education and awareness besides continuous emphasis on quality processes," stated Dr. Ashwin Naik, director, Vaatsalya Healthcare, leading a clinical trial audit company.

Unethical practices will continue even if government imposes the strictest punishment. A case in point is the Pre-Natal Diagnostic Technique (PNDT) Act violations, added Dr. Naik.

It's a great proposal by the government since it will bring in some amount of accountability and scare unscrupulous elements from conducting unapproved clinical research. There have been instances of some unapproved trials, certain extensions of trials, amended protocols etc. in the country. We need inspections and audits on a regular basis and the inspectors should be authorized to issue warning letters and the DCGI machinery should gear up to track the offenders.

Frequent audits and inspections by the Authorities will usher in some amount of discipline amongst the clinical trial fraternity. Warnings, punishment and blacklisting of errant and fraudulent clinical researchers will definitely pave the way for India to join the elite clinical research professionals in the world and bring in the much needed confidence and trust of the entire world, stated Dr Ramananda Nadig, president, Triesta Sciences, Health Care Global, a CRO for Oncology .

There are 120 CROs in the country. The prominent 20 include Lotus Labs, Manipal AcuNova, Veeda, Synchorn, ACT, IGates, Clininvent Research, ClinTec International, Dr Lal PathLabs, GVK Biosciences, Jubilant Clinsys, Vimta Labs, Lambda Therapeutics, Quintiles, Pfizer, GlaxoSmithKline, Wyeth, Merck and Reliance Clinical Research Services. According to the CROs, India is much-sought after for trials because of the low cost for conducting the study, naïve population and scores of hospitals.

The presence of poor and illiterate volunteers make the country an ideal platform to conduct trials and earn the quick buck. The time is ticking fast for disasters to erupt at trial sites because of the prevalence of unethical practices. Therefore a need for a legislation and punishment procedure are a must. The government should swoop down on the law breakers, stated a section of senior government hospital official.