By Bijit Das and Reetika Wadhwa
As per the statistics, COVID-19 pandemic has taken more than 4 lakh human lives around the globe. With each passing day, the pandemic is expanding its wings. Several people have lost their lives and many others are battling their way to recovery from the virus which currently does not have any vaccine remedy.
Nevertheless, scientists all over the world are aiming for the quick development of an effective vaccine to beat the disease causing agent so that the people across the world are able to resume their normal social activities without being under the threat of an ailment for which cure still remains mystery.
Drugs in India- Legal Framework in India
In India, the import, manufacture, distribution and sale of drugs is regulated under the provisions of the Drugs and Cosmetics Act, 1940 and Rules 1945 (hereinafter referred to as the “Drugs law”) to ensure that the drugs being regulated are compliant to safe practices as defined by the Drugs law and are of good quality.
New Drugs and Clinical Trials Rules, 2019 (hereinafter referred to as “Rules”) were introduced in India on March 19, 2019 with a view to monitor all new drugs, investigational new drugs which are intended for human use, clinical trial, bio equivalence study, bio availability study. Clinical trial of a new drug or investigational new drug are mandated to be conducted under the guidelines established under the Rules. The Rules aim to promote clinical research in India, have predictable, transparent and effective regulations for such trials and also make faster accessibility of new drugs to Indian population.
Import of Under Trial Drugs for treatment of COVID-19
As the novel form of outbreak has increased the number of victims owing to the viral attack, many drugs/vaccines are being developed and being tested for their viability to beat the virus. As per reports, the Indian Government taking a visionary approach is in the process of easing out the Rules with objective to facilitate easier import of untested drugs undergoing clinical trials in other countries, for ‘compassionate use,’ including treatment for patients suffering from life threatening ailments, COVID-19, rare pediatric disorders and genetic diseases.
‘Compassionate use’ is the use of a new, unapproved drug to treat a seriously ill patient, when no other treatment is available. In the changing circumstances where the adequate medical remedies to cure and treat the COVID-19 infection has gained criticality with increasing number of cases on a daily basis, the amendment to the Rules may serve as a transitory solution allowing the patients access to the medication which may prove beneficial and lifesaving.
The medical institutions including government as well as private hospitals which are applying to the Drug Controller General of India for approval of such import, would be required to explain the rationale for ‘compassionate use’ over ‘available therapeutic options’.
Further, they would also be required to provide a description of the patient’s disease, criteria for selection of the patient, pharmacology and toxicology information for reaching an adequate conclusion that the new drug is reasonably safe at the dose and duration proposed for compassionate use.
The amendment to the existing Rules will be a catalyst in the process of finding a viable treatment for the viral pandemic. However, great caution needs to be exercised to ensure that the safety and health of the patients is in no manner compromised while importing the untested drugs under trial for treatment of COVID-19.