Inviting Comments On Pharmaceutical Marketing Guidelines For Indian Pharma Industry

The Department of Pharmaceuticals (DoP) in the Ministry of Chemicals and Fertilizers has come up with a Uniform Code of Marketing Practice for Indian Pharmaceutical Industry. Carrying on from the guidelines issued by the Medical Council of India regarding behaviour of physicians, the new code shall be voluntary for first 6 months after which time it may be made compulsory.

Formerly, The OPPI code of conduct ( effective since 1st January 2007) set out the guidelines to be followed for promotion of prescription drugs to the health care industry.It was based on the IFPMA code and incorporated local region ( India) specific guidelines. Most of the older guidelines are repeated here, but the new code of marketing practice goes many steps forward in regulating Physician- Medical Rep encounter, distribution of samples and setting up of a better complaint redressal mechanism.

Ten Important and Comment-able Points in the Code:

1. Brand names of products of other companies must not be used in comparison unless the prior consent of the companies concerned has been obtained.
2. All promotional material issued by a product authorization holder or with his authority, must be consistent with the requirements of this Code. :comment: 'Unauthorized" Promotional Material need not conform to any code.
3. Where a pharmaceutical company pays for or otherwise secures or arranges the publication of promotional material in journals, such promotional material must not resemble editorial matter.:comment: Better control of marketing masquerading as educational content.
4. The names or photographs of healthcare professionals must not be used in promotional material. :comment: This is repeated from the recently issued MCI's guidelines. The critical point here would be differentiating educational content from promotional content, a very difficult proposition at best.
5. Extremes of format, size or cost of promotional material must be avoided.: :comment:  Now this is an interesting one. Will we soon have limits of size and costs in pharma marketing projects?
6. Audio-visual material must be accompanied by all appropriate printed material so that all relevant requirements of the Code are complied with.::comment: This could kill digital pharma marketing in India. Any ideas?
7. Samples should be provided directly to prescribing authority, shall be limited to prescribed dosages for three patients and in response to a signed and dated request from the recipient. Each sample pack shall not be larger than the smallest pack presented in the market.
8. The (medical/educational) events (for doctors) have to be organized in India only and all expenses..., must be incurred only for the events held in India.
9. Companies must not organise meetings to coincide with sporting, entertainment or other leisure events or activities.::comment: This is a totally uncalled for limitation. Why shouldn't healthcare professionals attend meetings because of the IPL being held at the same time?
10. Outline of a detailed Complaint Lodging and Redressal mechanism (Committee for Code of Pharma  Marketing) to ensure following of the marketing code.::comment: A much needed mechanism which also requires better publicity, as it allows private citizens to complain about unethical or illegal pharma marketing practices.

The Department of Pharmaceuticals has invited feedback on these guidelines by 30th June, 2011. Kindly go through the complete document here (pdf) and comment below.

Also see:

The Medical Council of India guidelines on industry–physician relationship: Breaking the conspiracy of silence (PDF document)