NEW DRUGS AND CLINICAL TRIALS RULES, 2019:
In the absence of an exclusive statutory framework, the compensation for the participants of clinical trials in cases whereSerious Adverse Events (SAE) including death has taken place has remained majorly unaddressed. In a positive move, the Ministry of Health and Family Welfare had notified the New Drugs and Clinical Trials Rules in March, 2019.
For years, India has been rallying imposing of very strict obligations on the part of the clinical trial sponsors to provide for compensation to the participants that have suffered adversely and even death in the trials. The present 2019 Rules stipulates that the compensation for grievous injury will henceforth be determined by the Drug Controller General of India after recommendations from the expert committee. The decision shall no longer rest with the Ethics Committee. The Act in a way purports that the Ethics Committee was in no position to adequately assess the damage caused.
The 2019 Rules also makes it compulsory that
The Rules have finalized compensation formulae for SAE and death (based on certain factor such as age, etc.)that also brings about clarity and defines the limit of financial liability on the part of the sponsors in case of certain injuries.
Here is why the Ethics Committee is ill equipped for deciding on the compensation:
A CHAIN OF COMMITTEES BUT TO NO EFFECT:
The need for adequate compensation to the participant of clinical trial that have suffered adversely including death puts a strict obligation on the government to make laws and accompanying rules that zealously guard its people from exploitation by the global pharma industry. It is the government’s duty to protect its most vulnerable section of the citizens.
In 2003, the Government of India constituted an Expert Committee under the Chairmanship of Dr. R. A. Mashelkar, Director General of CSIR to undertake a comprehensive examination of drug regulatory issues, spurious drugs, penalties under the Act and to recommend measures to control the production and sale of spurious drugs. The Committee promptly submitted its report with several ecommendations. A rather sad fact is that none of the recommendation of the Mashelkar Committee was so much as acknowledged leave alone justified with action.
THE ROLE OF THE COMMITTEES:
Subsequent to the Mashelkar Committee, three more committees were constituted. All the three have categorically expressed displeasure at the general state of affairs relating to the clinical trials in India. The Fourth Committee that was set up in 2013 made recommendation for improving existing framework for compensation to the victims.
The Health Ministry,taking cue from the Ministry of Law introduced the Drugs and Cosmetics (Amendment) Bill, 2013 to regulate clinical trials and to provide compensation to victims of clinical trials. The bill did not see the light of the day since the Union chaired by the Prime Minister took a decision to withdraw the 2013 bill in the year 2016.
The bill was subsequently examined by another Parliamentary Standing Committee which ecommended several changes. It felt that though the regulatory framework for ensuring quality, safety and efficacy of medical products including medicines, medical devices, in-vitro medical devices, stem cells, regenerative medicines and clinical trial/investigation is provided in the Drugs and Cosmetics Act, 1940, it will not be appropriate to carry out further amendments in the present Act.
The reason given was that newer areas such as stem cells, regenerative medicines, advanced medical devices and clinical trial investigation cannot be effectively regulated by the existing law.
This is true because the Drugs and Cosmetics Act, 1940 is a vintage piece of legislation that was brought out by the British. It could have not foreseen the tremendous amount of developments that we have made in the last eighty and odd years.
That the Act is inadequate is sufficiently known. Even the courts of law have been constrained to judicially intervene to protect the precious rights of the citizens. This is precisely it is not an overstatement at all to say that the Judiciary has played a substantial role in the policy evolution in the sector.
This is a good time for the government to pay serious attention to major lacunae that prevail such as:
REFLECTION:
Science and technology can diametrically transform life and its quality but if law does not keep pace, it can create imbalances that can adversely affect the life of the citizens. An emerging economy, India first of all needs to have a robust statutory framework that encourages a scientific temper as well as protects the fundamental rights of itspeople. Nothing less than a brand new piece of legislation governing all the modern aspects of the pharma sector is the need of the hour. Are the rulers listening?!
