The Uniform Code for Pharmaceutical Marketing Practices (UCPMP), released last week by the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers, would replace the code in force since 2015. It spells out the rights and wrongs in terms of promotional activities by pharma companies and their representatives. Over-the-top promotional activities raise prices for the consumer as well as expose her to medicines that could be ineffective or harmful.

The code remains ‘voluntary’ in the sense that its provisions are not directly enforceable under any law. Complaints are addressed by the ethics committees of pharma associations. This could raise doubts about implementation of the code, in the absence of members from government and civil society. But the experience of UCPMP 2015 suggests that it has had a subtle restraining influence on gifts and promotional inducements given to the medical community. The key is to get the regulation just right — where the rap works as a deterrent without shackling legitimate promotional activity that must accompany a new drug. Any attempt to make the entire code ‘mandatory’ (actionable in punitive terms under a law) could lead to inspector and raid raj.

As for the salient features of the new UCPMP, it says that the promotional literature cannot claim that a medicine is ‘safe’ without any side effects; nor can the term ‘new’ be used loosely. Audio visual presentation must be accompanied by printed material, which is welcome in an age of influencers. Educational meets cannot be conducted overseas; they should be held in medical establishments and universities, with the expenses incurred being clearly spelt out. Gifts, travel, hospitality and monetary grants to health professionals have been disallowed. These injunctions could have a bearing on Section 37(1) of the Income Tax Act which does not allow certain promotional expenses to be deductible for tax purposes. The negative list for Section 37 (1) is pegged to the ethics code for doctors, the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. Discrepancies, if any, between the two ‘codes’ — one for pharma companies and doctors — should be ironed out.

The key lies in effective enforcement. The UCPMP, on the face of it, does not promise stern action against the errant producer. It could suspend or ‘expel’ the entity from the Association and “reprimand the entity and publish full details of such reprimand”. In the age of social media, the reputational harm could be immense. Yet, in cases of extreme violations, such as deliberate misinformation or bribery, there should be scope for punitive steps, just as there are for medical professionals. The identity of the complainant or whistleblower should be protected, whereas the code demands full disclosure. As for marketing literature, it is worth considering whether the Union Health Ministry should create a separate wing to certify it, just as they approve a new drug. This may resolve many concerns raised by the UCPMP.

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