Clinical Trial Norms Diluted For AYUSH Drugs, Says Amicus; Supreme Court Seeks Centre's Response

On hearing the Patanjali misleading ads case, the Supreme Court today called upon Union of India to answer a contention that Rules with regard to clinical trials have been diluted in relation to AYUSH drugs - particularly in the context of new indications.The matter was before a bench of Justices Hima Kohli and Sandeep Mehta, which was informed by Amicus Curiae Shadan Farasat that substantive changes have been made in the approval mechanism of AYUSH drugs, without any amendments being made to the governing rule ie Rule 158B(II)(A) of the Drugs and Cosmetics Rules, 1945.Referring to Rule 158B of 1945 Rules, the Amicus said that the key difference between traditional and modern/allopathy medicines in terms of regulation is that clinical trials for efficacy of the drugs are not being done in case of traditional medicines. He highlighted the situation particularly with regard to new indications, where in some instances, proof of effectiveness and safety study are not required [Ref: table in Rule 158B(II)(A)].The Amicus further urged that a 2018 government notification has diluted the Rule, without actually amending it: "Now any Ayurvedic drug can be for a new indication without any proof of effectiveness".In the above backdrop, he suggested that there should be proof of effectiveness, even in case of new indications, as it is intrinsically linked to what the drug can do and how it is to be advertised. "Some states were demanding clinical trials...if we don't know the effectiveness of a drug...it's intrinsically connected to what the drug can do and what can we advertise", the Amicus said.In response, Additional Solicitor General KM Nataraj (appearing for the Union) sought time to take instructions.Hearing the counsels, the court recorded in the order, "One of the suggestions [of the Amicus] relates to the substantive changes in approval mechanism of Ayush drugs particularly in the context of new indications, Rule 158B(II)(A) which sets out a table and specifies at serial No.3...learned Amicus hands over a copy of the notification dated 04.07.2018 issued by the Ministry of Ayush, Government of India, which has diluted the aforesaid Rule and has dispensed with clinical trials over new indications...and on the aspect of effectiveness, suggested that proof of effectiveness in the form of pilot study will be required for the drug in question. It is submitted that the aforesaid notification has diluted the rule without any amendment to the rule, which is impermissible in law. The notification is taken on record."Other suggestions given by the AmicusNotably, the Amicus took the court through a note collated by him based on affidavits filed by some states/UTs. He gave suggestions on the following aspects as well:(i) Effective use of existing penalty-mechanismThe Amicus pointed out that the Drugs and Magic Remedies Act, the Drugs and Cosmetics Act and the Consumer Protection Act have existing penalty mechanisms prescribing inter-alia punishment of 6 months-1 year. Yet, states/UTs have exhibited a pattern of not imposing penalties, even if they prosecute. He submitted that the monetary penalties contemplated under the Acts (of which only CPA prescribes an upper limit of Rs.50 lakhs) must be imposed to act at as a deterrent.Calling for the states/UTs' response, the court recorded, "Learned Amicus submits that he has drawn out a chart to indicate the limited extent of penal action taken by States/UTs under the DMR Act, 1954, the DC Act, 1940 and the CPA, 2019. In fact, he states that affidavits filed by the concerned state government show that in most cases, the penalties imposed are nil and the action taken is also very poor. Despite the statutes being in place, state governments and the UTs have been taking these very provisions quite lightly. All state governments are directed to respond to their inaction in imposing penalties and deterrence in compliance of the statutes".(ii) Prior approval of ads before issuance of licenseThe Amicus further pointed out some states/UTs (ie Goa, Jharkhand, NCT of Delhi, Orissa and West Bengal) are following the practice of prior approval of advertisements, as a condition for grant of license. He suggested that the same may be adopted by other states/UTs as well.Accordingly, the court ordered, "Learned Amicus submits that except for states/UT of Goa, Jharkhand, NCT of Delhi, Orissa and West Bengal, none of the states are following the practice of prior approval of advertisement before issuance of license qua the medicine in question, to ensure that there is proper labelling...state governments except those mentioned above shall respond to the aspect highlighted by the learned Amicus".(iii) Need for effective inter-state cooperationNext, the Amicus highlighted that sometimes, consumer complaints are forwarded from one state to another, as the manufacturing unit is located in the other state. He claimed that invariably, once states are forwarding the complaints, the receiving states are...

Clinical Trial Norms Diluted For AYUSH Drugs, Says Amicus; Supreme Court Seeks Centre's Response

Debby Jain

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Clinical Trial Norms Diluted For AYUSH Drugs, Says Amicus; Supreme Court Seeks Centre's Response

Debby Jain

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