By now, it is clear that the Ramdev-led Patanjali Ayurved launched its purported Covid-19 cure preparations without following due process. Hours after the saffron-clad yoga guru addressed a press conference in Haridwar extolling the benefits of the alleged medicines, the Ayush ministry said it was not aware of the claims and details of the studies carried out to test the preparations. An April 11 notification made it mandatory for an organisation to apprise the ministry before publicising any drug or research related to Covid-19.
Subsequently, the Uttarakhand government, which green lighted the sale of the preparations, also clarified that the company had not mentioned that they were going to be marketed as a Covid-19 cure while applying for a licence.
Despite these clear violations, India’s drug regulator, the Central Drugs Standard Control Organisation, is yet to issue a categorical directive prohibiting the sale of the concoctions.
For those following the working of the drug regulator, this should not come across as a surprise. The regulator, with a long chequered history, has failed to rise up to occasion in the current pandemic as well. Not only has it been slow to take key decisions, it has been opaque in its functioning.
Still, considering the range of Patanjali Ayurved’s violations and what is at stake, a more proactive role was in order this time.
Experts have raised serious concerns over the nature of the clinical trials that the company claims to have undertaken to test the drug. First, the company seems to have included patients with mild and moderate disease in its study and concluded its efficacy on the basis of disappearance of symptoms unlikely to be shown by such patients at all.
Then there are also questions about the organisation, a private institute, where the trial was conducted. Not only does institute seem to have almost no prior experience in conducting clinical trials, it has in the past run into trouble with the authorities for violation of rules.
But it is not just the drug regulator that seems to be going easy on Ramdev and his company. On April 1, the Ayush ministry had issued an order stating that “publicity and advertisement of Ayush-related claims for Covid-19 treatment would attract penal action under the National Disaster Management Act. While the Act has been invoked on multiple occasions since the outbreak of the pandemic to book several journalists, Ramdev has been going around giving television interviews and advertising his product without any seeming consequences at all.
If anything, the controversy seems to have given a substantial amount of free publicity to Patanjali Ayurved and its preparations. With Covid-19 cases surging in India and no explicit ban on the preparations, this could lead to disastrous consequences for India’s health.