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 Amicus

Notably, 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-mechanism

The 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 license

The 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 cooperation

Next, 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 not taking action.

The court found merit in this submission and ordered: "Data collated by learned Amicus shows that in some cases, in case of Chhattisgarh, Gujarat, Delhi, West Bengal, large number of complaints were forwarded to other states...but there is no data furnished by the receiving states of the complaints as to the action taken on the complaints received, which leaves the consumer feeling helpless and in the dark regarding the action taken. Ministry of Ayush must setup a dashboard for all states to furnish details of complaints received and referred to another State Licensing Authority for action, and the action taken by the concerned SLA, so that the data comes into public domain and can be made available to all consumers".

The dashboard will also help in resolving the "serious complaint" made about lack of action taken reports at the time of prosecution under DC Act, the court said.

(iv) Tie-up between GoI and ASCI for addressing complaints

The Amicus also drew the court's attention to Government of India's MoU with Advertising Standards Council Of India (ASCI) to develop Grievances Against Misleading Advertisements (GAMA). It was submitted that post 2020, the MoU seized to operate and the number of complaints plunged.

A suggestion was made that the mechanism should be re-initiated as it worked very well.

Senior Advocate Amit Sibal, appearing for ASCI, supplemented the Amicus by stating that ASCI does suo motu monitoring of ads in case they are misleading. He emphasized that ASCI has handled 60,000 complaints since its inception.

"In the area of TV and print, ASCI analyzes [...], gives recommendations to advertiser in case it needs to modify its ad...the level of compliance with ASCI's recommendation, in TV and print ads, is 98%. The balance 2% is then what ASCI gives to statutory authorities and departments to deal with...for digital ads, the level of compliance is 78-80%...for healthcare, it's 88%", Sibal said.

On behalf of the Union, it was informed that the Ministry of Consumer Affairs has setup a National Consumer Helpline Portal and GAMA portal has been integrated with the same.

Hearing the counsels, the court recorded in the order: "during the tenure of the MoU (2018-2020), 2573 complaints related to health sector were registered out of which 2505 were resolved...the partnership between ASCI and the Ministry helped in increasing the number of complaints, in view of the positive response received from the department. Whereas, in the past 4 years, the complaints have dwindled".

It was also noted that only 132 complaints were received by the Ministry in the past 2 years, out of which 116 have been disposed. "The number of complaints received itself is abysmally low, what to speak of the disposal...the complaints which were over 2500 between 2020 and 2022 have dwindled to 132, which itself speaks much about the manner in which the Ministry has been bringing the aforesaid website to the notice of the public at large for them to utilize the services", the court said.

Ultimately, the court directed MCA to file a response on the aspect of dwindling of complaints, especially as ASCI used to perform due diligence and acted suo motu, but the Ministry only acts when it receives a complaint.

Case Title: Indian Medical Association v. Union of India | W.P.(C) No. 645/2022

Click Here To Read/Download Order

Also Read: Supreme Court Asks Uttarakhand Govt To Finalize Decision On Suspension Of 14 Patanjali Products In Two Weeks

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