Petitioner sought permission to continue Human Embryonic Stem Cell Therapy for FSHD. Directions issued to clinic to submit details to CNSDC within a week for investigation. Challenge to constitutional validity of 2019 Rules reserved.
Interim direction not to impede treatment; clinic to submit details to CNSDC within one week.
This page shows the compact analysis of this judgement. The full analysis — procedural history, issue-by-issue holdings with ratio and obiter, advocates, and paragraph-level evidence for every claim — is being added to the record in batches and will appear here when this judgement has been through it.
$~48
* IN THE HIGH COURT OF DELHI AT NEW DELHI
CORAM: HON’BLE MR. JUSTICE VIBHU BAKHRU O R D E R
% 15.04.2019
being administered the Human Embryonic Stem Cell Therapy. According to the petitioner, the said treatment is helping the petitioner and the discontinuance of the said therapy would severely jeopardise the petitioner’s condition. The petitioner is also conscious of the fact that the said therapy may not be a recognised therapy, and the products being administered to the petitioner may not have the approval of the concerned authority. Mr Chetan Sharma, learned senior counsel appearing for the petitioner also states that the petitioner is fully aware of the risks being taken by him.
(w) “new drug” means,―
(i) a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims; or
(ii) a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or
(iii) a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or
(iv) a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the
Central Licencing Authority; or
(v) a vaccine, recombinant Deoxyribonucleic Acid (rDNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug;
Explanation.― The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licencing Authority and the drugs referred to in sub-clauses (iv) and (v) shall always be deemed to be new drugs;
VIBHU BAKHRU, J
APRIL 15, 2019 MK
2 issues framed by the court
Whether the petitioner can continue with Human Embryonic Stem Cell Therapy under an interim order pending the investigation of the new drug rules applicability.
Whether the petitioner seeks to challenge the constitutional validity of the definition of 'new drug' in Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019.
1 provisions across 1 enactments
Aditya Bhatia
Union of India
GNCTD
Vibhu Bakhu
As recorded by the court registry
A petition under Article 226 of the Constitution asking a High Court to issue a writ against the State or a public authority in a civil matter.
Judgements on the same questions, provisions and authorities, from every court
