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Regulators can’t initiate legal action under DMROA Act against ASU cos for giving ads: Dr JLN Shastri
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Peethaambaran Kunnathoor, Chennai
February 14 , 2023
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Former CEO of the National Medicinal Plant Board (NMPB) and in-charge for the Drug Policy Section at the Union Ministry of Ayush, Dr. JLN Shastri has commented that the regulatory officers of both modern medicines and Ayush medicines are not authorised to invoke provisions of the Drugs and Magic Remedies (Objectionable Advertisement) Act, (DMROA Act) 1954, against Ayurveda, Siddha and Unani (ASU) drug manufacturers for giving advertisements for their drugs making claims of therapeutic effects.
The reason is simple that the term ‘drug’ referred in the DMROA Act is a modern drug and not either Ayurveda or Siddha or Unani drug. The DMROA Act is meant for modern drugs and not for Ayush medicines because the definition is on the term ‘drug’ given under Section 3 of the D&C Act, Dr Shastri said.
“If the authorities want to take an action against a manufacturer for any violation, there should be a provision in the act (DMROA Act) to follow. The DMROA Act does not say any provision to take action against companies on giving advertisements. Moreover, the term drug is defined only in the D&C Act 1940 and the DMROA Act was framed in 1954 only. At the time of framing DMROA Act in 1954, Ayush systems were not in the picture. They were incorporated in the D&C act under Section 3A and 3H in Chapter IV in 1960. But the definition of drug was not redefined in terms of ASU medicines. Until and unless the definition is redefined in respect of Ayurveda, Siddha and Unani medicines, no action can be taken against them because the ASU drugs do not come under the purview of the definition of drug referred under the D&C Act. Similarly, a provision has to be brought in the DMROA Act also through an amendment defining the term drug in terms of ASU drugs. Since it has not been made so far, no provision allows the regulators of modern medicines or Ayush medicines to take action against advertisements on ASU drugs.
Further, the term ‘advertisement’ is also not defined in the drugs and cosmetics act, and there is no provision for advertisement regulation in the D&C Act. The regulations on advertisements on modern drugs are separate. Then how the regulators can take action against advertisements on Ayush medicines, he asks.
While talking to Pharmabiz after delivering a speech in a seminar organised by the herbal and Ayurveda drug manufacturers in Andhra Pradesh, Dr. Shastri said neither the manufacturers nor the regulatory officers understand this point. He said section 3A under chapter IV mentions classical Ayurveda drugs and section 3H mentions proprietary/patented medicines.
Whereas, Section 5C of the DMROA Act clearly mentions that if there is no remedy for the 52 clinical conditions mentioned in the act, one should consult one Ayurveda or Unani specialist. This also means that DMROA Act is for regulating advertisements on modern medicines and not for regulating ASU medicines.
According to him the act gives exemption to Ayush and if any legal action is taken by a regulatory officer, the ASU drug manufacturer can fight against it in the court. Further, DMROA Act clearly mentions the qualifications of the doctors/registered medical practitioners under the MCI Act 1965. This is enough to interpret that DMROA is meant for allopathic drugs and clinical conditions,” he told Pharmabiz.
Dr Sastry said, with a view to prevent advertisements on ASU drugs, Rule 170 was introduced in the D&C Rules a few years ago. But it was banned by the Mumbai High Court and the Delhi High Court. He pointed out that the top level officers in the Ministry of Ayush know the fact that either the D&C Act or the DMROA Act does not provide any scope for advertisement regulations for ASU medicines.
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