| Dr Sauren Das |
Clinical research enterprise was estimated to reach $1.6 billion by various marketing analysis firms like Frost & Sullivan, Ernst & Young etc. But unfortunately all the estimates and analysis met an uninvited roadblock enforcing sharp dip in the research sector. The decisions made by the Supreme Court, constitution of new laws and policies by Ministry of Health and Family Welfare to regulate research in India were more regarded as knee jerk reaction to the petition filed by non-profit group organisation. The laws were in place well before the whole fiasco burst and took the center-stage.
Having said that, amendments in regulations are necessary and most welcome – they bring in control and sanctity to any task that we perform. However, these regulations must be implementable, practical and in sync with the global standards.
In the field of clinical research the rules and regulations have always existed. Any new ones must focus on the benefits to the end user – that is the patient. This patient can be one of us or one of our family members. The patient must be given the benefit of doubt and be given the best available treatment. In the ever-evolving environment/ scene of medicine, each day ushers in a new disease or a different type of an old disease and the physician must have access to a variety of treatment options to manage diseases of such diversity including new drugs that are still being tested as some times these are the last resort left to the doctor
The inconvenience, social –cultural practice, pain, suffering and misery of a patient must be considered while framing or amending the rules. The rules while controlling the process of management of the patient should not curb and tie the hands of the physician so tightly that he has no elbow room to treat his patient. A simple case of hypertension may be managed by one anti-hypertensive in one patient while it may require two or even three different such medications to manage the second similar patient. And, if we do not conduct trials of new medications we will not have access to those second and third medication.
Safety is definitely to be considered at any cost. There is no doubt about that. In fact, many of the anti-cancer drugs are like double-edged swords – cutting both sides. All of them have beneficial and adverse effects. In spite of that, they are still used because they do bring in relief and cure to the suffering patient while giving a handful of adverse events. The adverse events are managed and taken care of. The patient gets a longer life and a better quality of life too during that period. Majority of the new drugs which are currently used in the field of oncology are in the market only after rigorous clinical research, many of these having Indian participation. Clinical trials conducted yesterday have given us better medicines today. And, to get better medicines for tomorrow we must conduct clinical trials today.
A research product today is a medicine tomorrow. A few bad apples in the basket must be handpicked and taken care of rather than tying the basket or shunning the entire basket.
Clinical trials today bring a ray of hope, not only in the face of the patient but also on the faces of many current and future patients. A plethora of allied and industries today support towards getting that better medicine for our people in India. You name it – the IT, data management, laboratories, logistics, courier, storage, and even translating agencies, are all actively contributing. We cannot curb and squeeze all of them at one go.