The marketing landscape for pharmaceutical products is unlikely to remain the same in India in the days to come. Indications are that the federal government is all set to enforce uniform marketing code to ensure ethical marketing practices across the country.  

The Department of Pharmaceuticals (DoP) under the Ministry of Chemicals is currently reviewing the final draft of marketing rules for pharmaceuticals and the order announcing the enforcement date is due out any time now, according to reports.

It is not that India does not currently have marketing guidelines for pharma products. It does. However, it is a voluntary system. No penal provisions exist for violators.

In November 2014, India introduced the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) and implemented the first draft for a period of six months beginning January 1, 2015. Following a review, DoP extended the trial for a year and brought the medical devices industry under its purview.

While extending the voluntary code again for a second time “till further orders,” DoP reminded the pharma marketers that the government would be forced to make the rules mandatory if the industry failed to self regulate.

The voluntary rules restricted drug and device makers  from offering hospitality to any doctor, healthcare professional or their family. It also proposed medical practitioners bear their own expenses if participating as a delegate in a CME, conference or seminar organized by a pharma company.

So far as funding of medical research is concerned, drug makers can do it through approved institutions but the details should be fully disclosed. It listed stringent provisions for promotional activities and supply of free medicine samples to doctors, among others.

The government, however, found the voluntary UCPMP guidelines failed to deliver as instances of violations became rampant. Moreover, healthcare campaigners have long been demanding stricter laws to end the “unholy nexus” between pharma companies and medical professionals which is proving detrimental to patients’ interests.

The new regulations, reportedly, put no bar on drug makers from holding sponsored trips for medical professionals to attend educational conferences and scientific workshops, provided the firms keep all the records including the minutes, expenses and the agenda of such meetings open for verification.

The draft of the proposals, which has been worked out after consultation with the health ministry, Medical Council of India and other stakeholders, however, limits the marketing spend for drug promotion drastically. For example, the value of gifts and other incentives extended to medical professionals and chemists is restricted to 1,000 rupees (around $15). This permissible value for a giveaway is enough to ensure the brand recall, which is often cited by firms as a reason for distributing gifts, according to ministry officials.

Also, with respect to  “physician’s sample” as per the new rules, companies can offer a doctor only the medicine required for full treatment courses for three patients for free.

Companies are allowed to conduct awareness campaigns and disease screening camps at public health centers but the rules forbid stealth promotion of products. Likewise, drug companies are barred from making any claims on the efficacy of the product without solid scientific evidence.

Violators will face harsh penalties as the government mandates the rules to be followed in “letter and spirit” once it comes into force.

Penal provisions of the current draft are ranging from a warning to suspension on the sale of the company’s products for up to a year or confiscation of all packs, depending upon the severity of the breach. Drug makers may also have to deal with a provision that would see them face a marketing ban on top of having to pay hefty penalties if the don’t comply with the new rules.

The new rules also propose the position of an Ethics Compliance Officer to keep track of violations and ensure compliance.

The code will cover the entire supply chain of pharmaceuticals and medical devices including retailers, distributors, wholesalers and doctors across the country.

Industry groups welcome the move viewing the mandatory rules, when implemented, as a way to reign in controversial practices employed by certain companies to promote sales. Early enforcement of the code with better transparency can remove the ongoing uncertainty. At the same time, they argue that the rules should not interfere with the doctors’ need to learn about new medical advances in the field through continuing medical education.

Meanwhile, certain firms have already initiated their own marketing codes to allay public mistrust. GSK Pharmaceuticals India, which started new healthcare marketing code to cover its field staff and doctors last year, is an example. The company stopped target-linked incentives for its 3,000-strong sales force as part of its Patient Focused Selling program. GSK also decided to withdraw direct payments made to doctors for speaking engagements.