The New Drugs Bill: A missed opportunity for reforms in Ayush

The Bill takes regressive steps on the issue of drug safety

Over the past decade, the practice of traditional medicine in India has been plagued by scandals ranging from misleading advertising to the adulteration of drugs with chemical painkillers and heavy metals.

The recently unveiled New Drugs, Cosmetics and Medical Devices Bill, 2022, presented an opportunity to reform the law on this aspect but unfortunately the drafters of the Bill have largely stayed away from significant reform.  

Some history may help in setting the context for the challenges in regulating the Ayush industry. In 1940, when the parliament enacted the Drugs Act, the definition of “drugs” in that law excluded Ayurvedic and Unani (Ayush) medicines. One of the likely reasons for this was that unlike modern medicine, it was not possible to “standardise” traditional medicine. Since Ayush drugs are prepared from plants and herbs with little knowledge of the “active pharmaceutical ingredient”, the same cannot be quantified. Without quantification, there cannot be standardisation, and without standardisation, there is no question of manufacturing products of “standard quality”.    

In 1964, the government brought Ayush drugs within the purview of the Drugs & Cosmetics Act, 1940, but once again without standardisation. The law required manufacturers of traditional medicine to merely ensure  that their drugs were in accordance with the formulae laid down in traditional texts recognised by the law. The law neither required data about safety and efficacy nor standardisation on parameters such as purity. It was a half-baked approach to regulation.

Matters got worse in 1982 when the law was mysteriously amended to introduce the concept of “patent & proprietary” Ayush drugs, which allowed for the creation of new Ayush medicines using ingredients mentioned in the traditional texts. For all practical purposes, these were new drugs whose safety and efficacy should have been evaluated just like modern medicine — through rigorous randomised double blind clinical trials. Unfortunately, those requirements were never introduced at the time.  

The new Bill 

The new Bill now requires Ayush drugs to meet the “standards of identity, purity and strength specified in Ayurveda or Siddha, or Sowa- Rigpa or Unani Pharmacopoeia of India”. This requirement has existed since 1995 in the Drugs and Cosmetic Rules; the drafting committee merely relocated it from the rules to the main law. In our opinion, this is largely pointless for two reasons. First,  Ayush pharmacopoeias are exceptionally vague and a far cry from the rigorous standardisation introduced by modern pharmacopoeias, like the one published by the Indian Pharmacopoeia Commission for modern medicine. Second, most Ayush products in the market are “patent or proprietary” and are anyway not included in the Pharmacopoeia.  

On the issue of clinical evidence for safety and efficacy, instead of requiring all “patent & proprietary” Ayush medicines to undergo the same testing and evaluation in clinical trials for modern medicine, the new Bill creates a confusing new category called “innovative drug of Ayurveda or Unani”. According to the new Bill, these medicines will have to be tested in accordance with the guidelines to be laid down by a new body called the “Scientific Research Board” (SRB) which will be staffed by Ayush experts. It is not clear as to why these drugs cannot be approved by the same experts approving modern medicine. There is an inherent conflict of interest here because the SRB will likely be under the Ministry of Ayush and will be tasked with mainly approving “new drugs” developed by Ayush research councils funded by the Ministry of Ayush. These councils have a woeful track record in developing new drugs and given that the Ministry of Ayush is under pressure to justify the funding it is given, the SRB will likely be pressured to cut corners during the approval process.  

On well-known safety issues such as the presence of dangerous quantities of heavy metals in Ayurvedic drugs, the Bill actually takes regressive steps.  Section 108(a) of the new Bill treats this issue in a cavalier manner by reducing the punishment for this offence to a mere fine of  Rs 50,000 despite the dire health consequences. According to the current law, which is an order issued under Section 33EEB, persons violating the guidelines on heavy metals can be jailed for six months and fined Rs 10,000. Causing harm to patients due to heavy metal contamination deserves to be punished with jail time and not a mere fine.  

The drafting committee for this new Bill has missed a golden opportunity to push the Ayush industry into the world of rigorous modern science. The minister will do well to scrap the proposed Bill and appoint a credible committee to go back to the drawing board and address these structural regulatory issues. 

Thakur was the whistleblower in the Ranbaxy case, and Reddy is a lawyer specialising in drug regulation