Delhi High Court Pulls Up CCRH Over Clinical Trials

New Delhi: The Delhi High Court pulled up the Central Council for Research in Homoeopathy on Tuesday for not giving details of clinical trials of APT combination it was carrying out for fighting COVID-19 infection, and said it looked as if the CCRH was waiting for the fourth wave to occur before doing anything.

A bench of Justices Hima Kohli and Subramonium Prasad was irked that CCRH had filed an affidavit in response to a plea by two doctors seeking clinical trial on Arsenicum album–Phosphorus-Tuberculinum (APT) combination to prevent COVID-19.

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It said the affidavit contained "bald and vague allegations" against the petitioners but no details of the studies or research it was carrying out.

"What studies or research are you doing? Which combination (of homeopathic) medicines have you researched? Why are you not telling us? What kind of process are you researching? When will it bear fruit? You don't utter a word about it in your affidavit. It looks like CCRH is waiting for the fourth wave (of COVID-19) to do anything," the court said.

It warned CCRH not to file such "aggressive affidavits" making allegations against petitioners in the future, saying "what was the need for these allegations".

The bench directed CCRH to file a fresh affidavit indicating when it commenced the eight trials that it claims to have begun, in collaboration with whom and what stage they are.

The bench noted that unlike CCRH, the Delhi government has filed an affidavit indicating the research it has commenced in October this year using three homeopathic medicines after obtaining clearance from the Institutional Ethics Committee and Clinical Trial Registration, India.

Delhi government, represented by its additional standing counsel Jawahar Raja, told the court that the sample size of its trial was about 18,000 persons and it was likely to be completed by January/February 2021.

It also told the bench that it has distributed Arsenicum album 30, as prescribed by the Ministry of Ayush, to contain the COVID-19 infection.

The Delhi government affidavit was filed in response to the court's query on the last date, November 19, as to by when its study would be completed.

Advocate Suvidutt Sundaram, representing the two doctors -- Kerala-based Dr Ravi M Nair and West Bengal-based Dr Asok Kumar Das, told the bench that they have "unofficially" distributed the APT combination of medicines to around 3,000 patients.

The court, however, was not impressed by the submission, saying people taking these medicines does not validate the combination.

The submission on behalf of the two doctors was made in response to the court's query as to what they have done to carry out research or trial of the APT combination.

On the last date of hearing, the Delhi government had told the court that the two doctors' proposal for clinical trial of the APT combination of homeopathic medicines has been principally approved subject to adherence to AYUSH Ministry guidelines.

It had also told the court that there was also a need for a go ahead from the Institutional Ethics Committee (IEC), inclusion of patient information sheet and written consent form and registration of trial with Clinical Trials Registry-India.

The two homeopathic doctors, in their plea filed through Sundaram, have sought that doctors be allowed to dispense homeopathic medicines as supplement to allopathic ones, to treat for COVID-19, if so desired by the patients.

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