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With an intention to tighten the noose around manufacturers of pharmaceuticals who make false claims on their products by giving misleading advertisements, the Central Drugs Standard Control Organisation (CDSCO) is planning to make the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 harsher and the enforcement mechanism more stringent to enable the licensing authorities to crack the whip on errant advertisers.
With this move, the CDSCO will shortly recommend for amendment in Section 3 of DMROA to control the manufacturers from giving tall claims on drugs manufactured by them. Once the recommendation is approved by the Union health ministry, the contents of the advertisement will be brought under the regulatory purview, it is learnt.
The Drugs Consultative Committee under the Drugs Controller General of India will discuss the proposals on the 20th of August in Goa. The proposals were submitted to the DCGI in last year by the sub-committee constituted by the DCC in 2018. According to sources, Dr. V G Somani, the new drugs controller general of India, will preside over the Goa DCC meeting on Tuesday. The report was submitted to the former DCGI, Dr. Eswara Reddy, by the chairman of the sub-committee, Prashanta Mahapatra, former drugs controller of Odisha.
According to highly placed sources, the report of the sub-committee proposes for tougher punishments for the violators of the provisions of the DMROA Act. Because of lack of stringent penalty norms, false claims on the efficacy of drugs are increasing. The report suggests stringent actions against tall claims by manufacturers.
It is further learnt that the report recommends for strict evaluation of the contents of the advertisement by the licensing authorities. For making any claim on the drug with regard to a treatment or cure or on disease, before making advertisement the contents of the same has to be cleared by the licensing authority who has given approval for manufacturing and marketing the drug. Currently, there is no such law to screen the subject matter of the advertisement, says SLAs.
Another recommendation is that Schedule J of the D&C Rules 1945, which contains a list of diseases and ailments which a drug may not claim to prevent or cure, should be harmonized with the list of diseases mentioned in Section 3 of the DMROA, which describes 54 diseases and conditions. There are differences in these lists of diseases which need to be made equal and harmonious.
According to Narender Kumar Ahooja, a member of the sub-committee and the drugs controller of Haryana, once the report becomes a law, stringent penalties can be expected on manufacturers to reduce false and misleading advertisements. He said the amendment will give more powers to the licensing authorities to tackle the menace of false advertisements on drugs. Ultimately the new policy decision by the CDSCO will be beneficial for the public, he said.
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