AYUSH medicines: Without trials, no way to tell what are misleading claims

Noting that current provisions for penalty were being under-utilised and complaints weren’t being transferred between states, the court directed union AYUSH ministry to create a centralised portal where people can register complaints.

The court asked the AYUSH ministry to create a central portal for registering and tracking complaints. There was also a general direction to states to follow-up on complaints and improve inter-state coordination, according to persons in know of the matter.

When it comes to approval of AYUSH therapies, the court noted that trials for safety and efficacy are not needed, unlike allopathic medicines. The Drugs and Cosmetics Act and various rules under it stipulate phase I, II, and III trials for approval of new allopathic medicines or equivalence studies that have to be conducted for generic versions.

Most AYUSH drugs however, according to the Act, can be approved based on the rationale provided in authoritative texts of that particular stream. Safety trials have to be conducted only for formulations that use around 60 specific ingredients listed in the act, such as snake venom, snake head, heavy metals such as arsenic and mercury, and compounds such as copper sulphate. For licensing of drugs containing these ingredients and traditional drugs used for new indications, proof of effectiveness has to be provided, according to the Act.

“The court specifically raised the issue of diluting the rule that required proof of effectiveness when using the drugs for new indications. Otherwise, the only proof required for granting approval is what is said in the texts,” the person quoted above said.

The court also noted that even the existing provisions for penalty — under drugs and cosmetics act, drugs and magic remedies act, and consumer protection act — are under-utilised by states. Actions have been initiated by very few states, such as Maharashtra, Karnataka, and Gujarat among others. Penal action or prosecution has been initiated by states in around 400 instances. It was also pointed out that most states do not cancel or suspend licenses as a way of penalising companies for making false claims. Very few states such as Delhi, Odisha, Jharkhand, Goa, and West Bengal have done this.

And, there were instances where no action could be taken because the advertiser could not be traced. This could be prevented by the 2018 rule under drugs and cosmetics act which states that ads for AYUSH drugs must be cleared by the state licensing authority where the manufacturer or corporate office is located. A unique identification number has to be provided, which most states do not do yet.

The status of complaints and actions taken by the Uttarakhand government are not immediately known. Uttarakhand is one of the drug manufacturing hubs in the country and the case by IMA was filed on the basis of advertisement of products whose manufacturing licenses had been suspended by the state government.