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Legal Issues in Cro

In: Business and Management

Submitted By naveenmetta
Words 675
Pages 3
Clinical trials, for any pharmaceutical company are significant, as they serve as the back bone in Research and development of new medicines and their standardization for the advantage of human population. In developed countries the conduct of clinical trials in more transparent and heavily regulated. However, the conduct of clinical trials in India come with lot of risks, as a lot of people are uneducated, no rules of compliance by the government. India was considered as the economical and feasible place to conduct these clinical trials, as the laws pertaining for the same were not stringent.
Clinical Trials: A clinical trial is a scientific investigation to evaluate the effect of new drugs or vaccines other than health interventions, by administering these to human volunteers. They are generally bio medical or health-related research studies in human beings that follow a pre-defined protocol. In 2005 amendments were made on Drugs and Cosmetics Act, 1945, which allowed big companies to start their clinical trials in India. After that, there are number of incidents resulting in death of people participating in such clinical trials, particularly women, aged and even mentally challenged people, across the country. Due to this, the Drugs and Cosmetics Act Amendment Bill 2013 was brought forth in order to strengthen the drug regulatory system and create a central authority for managing drug and medical device approval. The non-conducive climate for clinical trials within India had a big impact on the conduct of clinical trials, which had led scientists to bring drug development research to other regions across the globe. There has been more than a 50% drop in clinical trials after stringent regulations were put in place last year. This had resulted in closing down of few CROs across India, putting the future of many more in doubt.
As the Indian economy is booming, thanks to pro-industrial vision of NDA government, many foreign companies are seeing India as a gold mine to start their business. The government had also set forth certain rules under the Drugs and Cosmetics Act for carrying out clinical trials in India.
As I intend to start my career as a project manager in any contract research organization, which deals with conducting clinical trials for big multinational pharmaceutical companies, my company and I need to strictly adhere to the following rules of D&C Act.
Rule 122-DAB:
Legal Provisions: Free Medical Management
Under this rule, the clinical trial subjects are ensured free medical management, as long as required in case of an injury occurring to him/her. If the injury is due to the trial, then financial compensation will be given to the subject as the licensing authority insists. This compensation would be paid directly from by the Pharmaceutical Company or through my CRO.
Compliance requirements for my Organization:
My organization need to prepare a set of possible types of injuries or side effects that could occur to the clinical trial subject. We need to forecast the budget for the same using secondary research and submit the reports to the parent organization. Further, we need to document our daily activities for the same. The subject can hold us liable for any type of injury caused to him/her while undergoing the trial.

Regulating Authorities:
CDSCO (Central Drug Standard Control Organisation) and DCGI (Drug Controller General of India). Within the CDSCO, the DCGI regulates pharmaceutical and medical devices, under the gamut of Ministry of Health and Family Welfare. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). It is divided into zonal offices which do pre-licensing and post-licensing inspections, post-market surveillance, and recalls when needed.
There is no clarity as to which authority to appeal in case of the trial subject feels that the organization is breaching the rules of the Act.
(There are other rules under this Act dealing with licensing authorities, ethical committee and rules under schedule Y, which I would be elaborating the same fashion as above for the final report)

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