The Medicine (Advertisement and Sale) Act 1956 provides the basis for the control of advertisements of medicines, appliances, remedies and skill and services that relate to medical and health claims. The Act also provides for the establishment of the Medicine Advertisement Board which is responsible for the regulation of the said advertisements. The responsibility to enforce the Act rests with the Pharmaceutical Services Division of the Ministry of Health.


THE REGULATION OF ADVERTISEMENTS

The Medicine Advertisement Board is empowered by law to set policies and guidance on advertisements of medicines, appliances, remedies and skill and services that relate to medical and health claims. Accordingly, The Board has issued 2 guidelines to help advertisers in devising advertisement formats which are deemed acceptable and suitable for publication in the various media in the country. The objective of the guideline is to ensure responsible advertising in promoting the sale of medicines, appliances, remedies and skill and services that relate to medical and health claims. The board operates on the premise that advertisements to the general public should be guided by the following principles.

1. Advertisements should help people to make rational decisions on the use of medicines, appliances, remedies and skill and services that relate to medical and health claims.
2. Advertisements should take into account the people’s legitimate desire for information regarding their health.
3. Advertisements should not take undue advantage of people's concern for health.

The Board meets once a month to deliberate on advertisement applications that have been received for the month. The Board discusses each application and may decide on any of the following:

1. Approve an application without any changes.
2. Approve an application with changes.
3. Reject an application as being not suitable for publication.
4. Withhold decision subject to more information from the applicant or expert opinion from related agencies, associations or authorities.

Generally, the advertisers are advised to adhere strictly to principles laid down in the guidelines as the Board uses these guidelines as the basis for all its decisions. Apart from some specific examples, the guidelines are quite general in nature. This is intended and is also inevitable because guidelines of this nature cannot be expected to deal in specific terms issues that may range from simple advertisements to promotional materials that contain complex technical information formulated in highly subjective terms. Advertisements may also differ in the way they are presented to the public. Some try to reach the consumer in simple terms yet some others may employ the use words and statements that are highly exaggerated. So the guideline takes into consideration the aspirations of the advertisers without compromising on its responsibility to ensure only accurate and responsible information reaches the consumer.

Two committees have been formed to upgrade the advertisement guidelines. These committees are Advertisements Guideline Committee for Products and Advertisements Guideline Committee for Services.


THE STATISTICS

Table 1

Table 2

FAST TRACK APPROVAL

The Medicine Advertisement Board (MAB), in its sitting on 19th November 2002, has approved 'Fast Track Approval' process for advertisements of medicinal products/remedies and services that fulfill one of the following criteria.

1. Advertisements that have been approved earlier. (The current application should have either no changes or minimal changes from the approved version).

2. Applications coming up for renewal.

3. New applications that do not go beyond the list of indications as approved by Drug Control Authority. The format of the advertisement also stays well within the framework set by the Act and guidelines.

Tn average, the MAB Secretariat takes about 3-5 working days to process the application and issue an approval. The list of fast track applications and approval are then submitted to the subsequent MAB meeting for its endorsement.

Mn the year 2004, more than 60% of the total number of applications received have been given the approval through ‘Fast Track System’ compared to 55% in the previous year. The year 2004 also recorded a rise in the total number of advertisement applications submitted by the advertisers i.e. 1236 applications. This is 355 applications more than that in 2003. Only applications that need Board’s decision were processed through procedure and brought up to the monthly meeting.


THE CONTROL OF ADVERTISEMENTS

As mentioned earlier, The Medicine (Advertisement and Sale) Act 1956 provides the basis for the control of advertisements of medicines, appliances, remedies and skill and services that relate to medical and health claims. Although the Act goes back in time to nearly half a century, it has not remained static. The needs of the time and its accompanying changes in the field of advertisements have been taken into consideration and the main Act itself has undergone revisions. The Pharmaceutical Services Division of the Ministry of Health is the custodian of this Act and the Division has put into place an enforcement mechanism that is committed to eradicating illegal advertisements. The main objective of this enforcement program is to ensure that the public is not misled by advertisements by irresponsible advertisers and the media. In order to achieve this objective, the Division maintains a monitoring unit and an enforcement unit that investigates wrongdoers and brings them to court.

Monitoring Program

The monitoring program involves scrutinizing all publications from the print media including newspapers both mainstream and vernacular, magazines in all languages, pamphlets and brochures meant for public consumption, promotional materials generated by direct selling companies etc. Apart from this, all advertisements in electronic media including radio, television and internet publications are also not exempted. Monitoring of such an extensive range publications means the Division will need to expand a large amount of its resources for this activity. To overcome problems of inadequate manpower in the centre, enforcement officers from the states also help with the monitoring process. Apart from this, the Division has also come to depend very much on complaints received from the public, advertisers, companies and some non governmental organizations.

Warning letters, Investigations and Legal Actions

The ministry realizes that it needs the cooperation of all parties in ensuring that advertisements remain responsible and the public is not misled by unscrupulous advertisers and media. Therefore, a number of dialogue sessions with the relevant parties have been held in 2004, where the targeted groups were the media and agencies that are directly involved in publishing of medical and health related advertisements. The objective of the dialogue session is to ensure and to educate people on their role and responsibilities as far as medical and health advertisements are concerned. The Ministry will also continue its current plan to educate all other parties such as product owners, agencies and media owners as well as other relevant organizations.

Table 3 shows the summary of all the dialogue sessions held in year 2004.