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AYUSH Ministry to act against misleading COVID-19 products

Industry experts express the need for amendments and clarity in existing regulations for AYUSH products in the larger public interest

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Recently, the AYUSH Ministry has issued a letter to Principal Secretary of AYUSH as well as to the Secretaries of States/Union Territories to inform about misleading communication being disseminated about the AYUSH remedies for COVID-19.

The letter, sent on June 2, 2010, by Pramod Kumar Pathak, Additional Secretary, Ministry of AYUSH to the Principal Secretary of AYUSH Ministry stated, ” Adverting your kind attention to the menace of misleading communication about AYUSH remedies for COVID-19 in print, electronic and social media, I would like to inform that the following activities are tantamount to a contravention of legal provisions stated in the order dated April 1, 2020, which states that in the exercise of the powers of the central government, conferred under section 33 P of the Drugs and Cosmetics Act, 1940 directed to all concerned ASU&H, regulatory authorities in the State and Union Territories to stop and prevent publicity and advertisement of AYUSH related claims for COVID-19 related treatment.

And as per the legal provisions and guidelines of NDMA, the authority can take necessary action against persons/ agencies involved in

1) False claims and publicising so-called approval of a research study or product manufacturing about COVID-19, from the Ministry of AYUSH

2) Writing COVID or COVID-19 related claims and name of the Ministry of AYUSH in the labels and containers of AYUSH products

3) Any other false claims or statement about the Ministry of AYUSH and COVID-19

In this regard, the department has instructed the concerned SLAs, Drug Controllers to take necessary actions against such instances of misleading information, fake claims and misbranding under their jurisdiction. As per Section 7 of the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and Section 33-I and 33 – J of the Drugs and Cosmetics Act, 1940, a warning may be issued, and if not complied in one week time then first information report (FIR) may be filed in blatant cases of violation brought to the notice of licensing authority/ drug controller directly or forwarded from the Ministry.

Commenting on this move, Dr Hemant Koshia, Commissioner, Gujarat FDCA said, “Although, the letter has come just now, in Gujarat we have been practising the Drugs and Magic Remedies Act for so many years now. We have around 700 licensed manufacturers of AYUSH in Gujarat. And we take strict action against on any violation of the DMR Act.”

Manmohan Taneja, Assistant State Drugs Controller, FDA, Head Quarter, Haryana, said, “Today, the market is flooded with ayurvedic sanitisers and disinfectants labelled with misleading and false claims such as “helpful in the fight against COVID” and “Protection from COVID” etc. Even ayurvedic capsules/tablets are available in the market with names like “COVID-19 Ayush Kwath”, which mentions on the label that it helps in developing immunity against COVID-19.”

He also said that such actions are punishable and the primary authority responsible for taking cognisance are the AYUSH inspectors.  As notified under Chapter IV-A of the Act, action may be taken by an inspector appointed under Chapter IV of the Act, if the product crosses the line and qualify for the definition given under section 3(b) of ‘the Act’. The punishment provided for offences in Chapter IV are much more than those of Chapter IV-A.”

Experts suggest amendments in DMROA, cite ambiguities

Taneja explained the provisions mentioned under the Drugs & Magic Remedies for (Objectionable Advertisements) Act, 1954, (DMROA), and stated, “There is an obstacle in taking action against such products under the DMROA. To prohibit any person in taking part in the publication of any advertisement of a certain drug for the treatment of a certain disease, disorder or condition its inclusion in the Schedule appended to the DMROA or rules made thereunder is mandatory as per section 3 of DMROA. The Government of India has not so far expressly included any such disease, disorder or condition mentioned in communication under discussion.”

Dr G Selvaraj, Former Director of Drugs Control, Tamil Nadu highlighted, “In the Drugs and Cosmetics Act, 1940 as per Section 33E, for the purposes of this chapter, Ayurvedic, Siddha or Unani drugs shall be deemed to be misbranded if:

(a) if it is so coloured, coated, powdered or polished that damage is concealed, or if it is made to appear of better or greater therapeutic value than it really is; or
(b) if it is not labelled in a prescribed manner; or
(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.

However, he states that there are ambiguities about advertisements in research papers as this is not covered under the DMR Act since COVID-19 is not listed in the Schedule of the DMR rules. So, it is not possible to initiate the legal action unless there are any false claim or misleading claims on the label of the products.

Dr GL Singla, Retired Drug Controller of Haryana, explained, “The license for ayurvedic hand sanitisers and disinfectants don’t stand on legal footings at all. To my mind, neither these products fit into definition of Ayurvedic drug or the patent and proprietors’ ayurvedic medicine given under Section 3 (h) of the Drugs and Cosmetics Act 1940. Can we imagine alcohol or isopropyl alcohol in the strength of around 80 per cent as excipient or stabiliser or preservative to preserve or stabilise neem, tulsi, aloe vera etc., which are otherwise stable herbal drugs? To the best of my knowledge, sanitisers which are presently in the market due to the coronavirus pandemic are to the purpose of hand sanitisation. These formulations bear such uses on their labels to and if we go with this “intended use” of sanitisers, such products are not covered under the ambit of Ayurvedic drug, rather fall under the domain ‘drug’ defined under Section 3(b)(1) of the Drugs & Cosmetics Act.”

He further elaborated, “I fail to understand as to how such alcoholic sanitisers which are basically hand sanitisers can be categorised or manufactured as “Proprietary Ayurvedic Medicine” under the Drugs Act. There is an immediate need for a review of such approvals or licenses issued by the regulators now since the market is flooded with a variety of sanitisers manufactured under ayurvedic, homoeopathic, cosmetics manufacturing license or even without any license. Once labelled as Ayurvedic medicine or as a cosmetic, the law allows it to be sold without any drugs sale license to the consumer. Such products, which can be legally sold in any cosmetic, local grocery shops (without drugs sale license), escape legal scrutiny from drug regulators. The consumer always remains at risk as he/she cannot judge its quality unless it is subjected to drug regulator scrutiny and tested in a quality-controlled laboratory.’

And he suggests, “Manufacturers of such ayurvedic sanitisers composing of mainly ethanol or isopropyl alcohol with minimal percentages of aloe, neem, tulsi etc. cannot be justified under the legislative intend of Rule 169 of the D&C Rules, 1945, which of course allows the addition of excipients such as additives, antioxidants, flavouring agents, chelating agents in permissible limits as prescribed in Indian Pharmacopoeia. Whereas, ayurvedic sanitisers are being sold in the market with ethanol and IPA percentage ranging from 70 to 84, with a prominent mention on the labels. This gives the feeling that they are active ingredients to helpless consumers. The sub-rule 7 of said Rule casts an additional obligation on such manufacturers to ensure rationality, safety and quantity in the use of various excipients of such formulations. The approvals of such products given by the regulators need to be reviewed and revoked in the larger public interest.”

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