MoH To Amend Schedule J Of D n C Rules To Curtail Misleading Ads
Mumbai, 25 May 2018: The Union health ministry will soon amend Schedule J of the Drugs and Cosmetics Rules, 1945 to prohibit misleading advertisements for the treatment of ailments which are also under the purview of Drugs and Magic Remedies (Objectionable Advertisements) Act (DMR), 1954 and Rules, 1955.
The thrust of the proposed amendment is to put restriction on advertisements in respect of any drug claiming treatment, mitigation, prevention or cure of diseases covered under DMR.
The main object and the purpose of the Act is to prevent people from self medication with regards to various diseases under the influence of misleading advertisements.
It is learnt that a number of recent advertisements put out by several big and small pharma companies in India for selling their potions, lotions, clinics, tablets and treatment for all sorts of ailments have been found violating the DMR Act. This Act bans the advertising of products that claim to cure incurable diseases such as cancer, diabetes, AIDS, paralysis, balding, etc. For instance Suraksha Pharma had issued advertisement claiming its Kanthari Plus capsules would cure heart block, cholesterol, thyroid, diabetes, obesity, failing eye sight, Alzheimers and even kidney function. The claim was found unsubstantiated. Another company ACU – AID advertised its treatment for a slipped disc without operation or medicine. It also claimed to have cure/solutions for migraine, height deficiency etc. Promises of increasing the height of a buyer is against the rules of the DMR Act.
Drug Consultative Committee under the ministry in its 53rd meeting held last month had deliberated the issue and recommended to constitute a sub-committee under the chairmanship of H Mahapatra, drugs controller, Odisha to look into the matter.
The sub-committee will consider inclusion of provisions like Schedule J of D&C Rules in Ayush as well. Also, the sub-committee will examine the definition of ‘drug’ prescribed in the D&C Act, 1940 with that prescribed in DMR and recommend measures to avoid confusion.
The other members of the sub-committee include NK Ahooja, State Drugs Controller, Haryana, Shobhit, Deputy Drugs Controller, FDA, Madhya Pradesh, Dr N Goswami, State Drugs Controller, Tripura, and a representative from Ayush. Dr. SP Shani, DDC(I), CDSCO, (HQ) will be convener of the panel.
The sub-committee will submit their report within 3months from the date of its constitution. However, the committee is yet to be constituted.
At the meet, DCC also decided that one drugs inspector from CDSCO, one drugs inspector from Gujarat and one drugs inspector from Maharashtra will be exclusively delegated the responsibilities for looking after the misleading advertisements of the drugs by all means (electronic, print, social network etc.). In this regard, official order is likely to be issued from CDSCO. Financial assistance should be provided by the central government.
Further it was suggested to create an official email ID for prompt communications amongst the officials working in this regard and for public comments/suggestions/complaints. Also a time line based approach may be designed to report such misleading advertisements and launching of prosecution, in case of violation, should be fast-tracked.Pharmabiz