UCPMP, (Uniform Code for Pharmaceuticals Marketing Practices) is a subject that has been around for over one and a half years now. This was issued by Dept of pharmaceuticals in Dec 2014 and is meant to be adopted by Pharma companies voluntarily.
Since Dec 2014, there has been an expectation in the industry that this will transition into an ACT on the lines of two highly powerful acts in the US i.e.
Prescription Drug Marketing Act (PDMA)
Physician Payment Sunshine Act
However, as of now, in India, this is still a voluntary guideline and not an Act. To add to the lack of full clarity, the guideline also mentions that “where there is any item missing, the code of MCI as per Indian Medical Council Regulations 2002 as amended from time to time, will apply”. The problem is that this act applies to physicians, and not pharma companies. So, the onus of following professional conduct, etiquette and ethics is on the physician, not the company dealing with him/her, under this Act.
And so, what do Pharma companies need to do now? This guideline has been extended indefinitely recently by the department. However, sources in the department have told me that it is question of time before this becomes an Act. My gut feeling is that, when UCPMP becomes an Act, all the current “guidelines” will be reworded into very concrete clauses making it necessary for companies to collect and report a lot of data.
Pharma companies should now ensure that their CRM applications have the capability to deal with UCPMP. Many companies have already ensured that, but many have applications that may not address UCPMP in its entirety.
Careful attention must be paid to the following to see if the CRM application can handle the various stated (and unstated!) requirements of UCPMP.
Handling of Samples: It is not long before the essence of PDMA as done in the US will apply to India. Companies must prepare for a very carefully and structured handling of samples.
Text, audio visual and other promotional material: The act (once it comes in), will need very careful processes and monitoring of all content approvals. Extreme caution and ownership –with proofs of review and approval would be needed.
CME: There are various guidelines on CME s. These, once they become an Act, will warrant collecting and keeping a lot of relevant data. Your application must have the means to do that.
It is my recommendation that all pharma companies start paying attention to UCPMP and ensure that the CRM application can cope with it. Companies will need to prepare from now, so, they are not caught unawares! .