It is high time the archaic Drugs and Magic Remedies (Objectionable Advertisement) Act 1954 is revised by the government as the over five-decade old law does not have any relevance for the present situations, opined noted regulatory expert and CSO, Ayurvidye Trust, Bangalore, Dr DBA Narayana.
The Act needs to be reworked because no review has been made since the Act was passed in the 50s. There are issues of weak implementation of the Act which has led to harassment, potential area for unfair practices, corruption, and unnecessary prosecution in cases of ASU medicines which provide approved indications as per ancient text on the product labels. Therefore it is high time the government revises the Act, said Dr Narayana.
There is an urgent need to review the Act and convert it into a positive regulation which would specify information to be provided on labels/cartons/leaflets/billboards and advertisements. There is need to provide detailed guidelines on the nature and content of advertisements specifically preventing exaggerated, misleading advertisements but permitting authentic information by way of advertisements, he added.
Dr. Narayana said that Drugs & Magic Remedies (Objectionable Advertisements) Act 1954 (DMRA) and Rules were enacted way back in the 1950s when medical and pharmaceutical sciences had not developed. It was a time when patients were exploited by quacks and use of talisman, kawacha and such magical remedies were in abundance. In such a scenario, the Act was enacted which had strict prohibitory regulations related to advertisements, prohibited advertisements related to childbirth, women’s diseases, treatment of severe infections and certain other diseases like cancer, rheumatism, diabetes and hypertension. The Act had a schedule in which a list of diseases were included for which even a qualified doctor was not allowed to advertise or put up notice boards in front of their clinic.
But now, significant scientific developments have taken place in medical, biological, pharmaceutical and molecular biology fields. This has led to development of large number of effective drugs to treat the diseases listed in DMRA schedules. Effective treatment with over 50 drugs are now available to treat even cancer. Moreover management by safe and effective drugs from both allopathic as well as Ayurveda Siddha and Unani medicines are possible for a number of chronic and acute problems. Information technology has made access to medical care even in the remote areas. There is increasing awareness by patients and their relatives who are keen to have details of drugs prescribed, he said.
But when claims on the benefits of medicines are regulated by the Drug Controllers and the drug laws do not permit advertisements of prescription medicines, patients often do not get the necessary care and denied information that are required to ensure compliance and efficacy of the same. This is where government needs to revise the DMRA to ensure pruning the list of diseases and aligning the new regulations with provisions of Drugs and Cosmetics Act, Food Safety Standards Act, etc., Dr Narayana said.