Following the Ministry of Ayush’s move to curb misleading medicine advertisements by manufacturers, the Association of Manufacturers of Ayurveda Medicines (AMAM), has called for a total review of Drugs & Magic Remedies (Objectionable Advertisement) Act 1954 (DMRA) and Rules.
Problems with DMRA are that no review of the regulations was undertaken since the act was passed six decades ago. Its implementation is weak and cannot be enforced effectively. Non disclosure of information to patients about medicines will place them under the mercy of the doctors. It will result in access to only expensive drugs with no information on dose and duration. This will lead to the usage of medicines and treatments shrouded in mystery. It would also lead to unnecessary prosecution of manufacturers which provide medicines for approved indications as per granthas on the product labels, pointed out Pradeep Multani, president, AMAM.
“There is an urgent need to review DMRA. The government has enforced the Competition Commission Act which will take care of all such claims/advertisements that impinge and create unfair trade practices”, Multani told Pharmabiz in an email.
The current regulations of Drugs & Cosmetics Act and Rules which underwent amendments on the definition of misbranded products and related penalties/punishments are based on Dr Mashelkar committee report. Similarly the Food Safety Standards Act (FSSA) has guidelines for nutrition claims. Advertisements Standards Council of India (ASCI) is reviewing all complaints related to advertisements, he added.
In view of these, the DMRA needs to be reviewed and scrapped altogether. If this is not possible, then DMRA should be revised into a positive regulation titled as Drugs and Cosmetics Advertisement Standards Act. It can provide detailed guidelines on the content of advertisements to prevent exaggerated, misleading advertisements but permit authentic information through this medium, stated Multani in his communication to the government.
There is need to delete the list of diseases where advertisements are not permitted. AMAM has called for information to be provided only by qualified medical experts. Further, the government needs to review the advertisements and penalties including compensation to those affected by the exaggerated statements on the labels, he said.
In the last 60 years since the DMRA was enacted, drastic changes have taken place including development of effective drugs to treat and cure diseases which are listed in DMRA schedules. Information technology has enabled easy access to data for patients on diseases and drugs. Therefore, it is a Right to Information period and not days for prohibiting access to legitimate information. Moreover guidelines for claims should be scientifically backed by clinical studies for both foods and drugs.
“Since we opted for ethical marketing, we won’t be impacted from the proposed monitoring of Ayush advertisements. We have stayed away from the advertisement route for all our proprietary and other therapeutic products,’’ said Dr. Vijendra, general manager, regulatory, corporate affairs, Himalaya Drug Company.