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Ramesh Shankar
Wednesday, January 12, 2022, 08:00 Hrs  [IST]

The world is now going through the toughest of all times with the coronavirus spreading like wildfire in the entire length and breadth of the world without any discrimination of rich or poor. The pandemic, which was originated at Wuhan Province in China in November 2019, has so far infected a whopping more than 30 crore people in the world. And more alarmingly, it is not showing any sign of abating. In India, more than 3.5 crore people have so far been infected with this deadly disease and almost half a million have lost their lives, and it is still counting. Obviously, the world is scrambling for a new drug to defeat this pandemic which has unleashed untold miseries to the world. The development of vaccines has provided some kind of succor, but still the world is looking for a proper medicine to kill this deadly virus. Several clinical trials are going on in different parts of the world in this regard. It is under these circumstances, the Union Health Ministry has initiated measures to amend the New Drugs and Clinical Trial (ND&CT) Rules, 2019 to enable manufacturing of unapproved new drugs while it is still under development. The Ministry has now received the Drugs Technical Advisory Board (DTAB)’s nod in this regard. DTAB is the highest authority under the Health Ministry on technical matters related to drugs in the country, and the Ministry generally accepts the recommendation of the Board.    

In India, clinical trials of new drugs and vaccines, and their approvals, are governed by the New Drugs and Clinical Trials Rules, 2019. These rules provide for ‘accelerated approval process’ in situations like the one we are facing now. In such situations, there is a provision for granting approval to a drug that is still in clinical trials, “provided there is a prima facie case of the product being of meaningful therapeutic benefit”. Accelerated approval may also be granted to a new drug if it is intended for the treatment of a serious, or life-threatening condition, or disease of special relevance to the country, and addresses unmet medical needs. It is also a fact that there is a provision that a new drug, or a vaccine, can be considered for approval if “remarkable” effectiveness is reported even from phase II clinical trials. Now, the DTAB has recommended “that the proposed provisions for (grant of license to manufacture and stock of new drug which is under clinical trial) is considered appropriate for drugs/vaccines being developed for emergency/life-saving/Covid-19 and similar such conditions of public health importance”.  To allay any fears about the safety of the patients, the Board while recommending the amendment has put a condition that such drugs should be marketed, sold and distributed only after clearance of clinical trial results. There can be no two opinions that presently we are facing an absolutely abnormal healthcare crisis arising out of the outbreak of coronavirus, and the entire world is looking for an efficacious and safe drug. Extraordinary circumstances demand extraordinary decisions from the regulators. So, the DTAB’s out of the box decision is a welcome move. It will go a long way in removing the gap between the development of a new drug and its distribution to the last mile destination.


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