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Ramesh Shankar
Wednesday, March 20, 2024, 08:00 Hrs  [IST]

The Department of Pharmaceuticals has recently come out with a new Uniform Code for Pharmaceutical Marketing Practices (UCPMP) to put an end to the unethical marketing practices by the pharmaceutical companies to promote their brands. The new code permits the companies to offer brand reminders to the doctors in informational and education items like books, calendars, diaries, journals including e-journals, dummy device model and clinical treatment guidelines for professional use in healthcare settings. However, value of these items should not exceed Rs. 1000 per item and such items should not have an independent commercial value for the doctors. On the controversial issue of giving free samples to doctors, the new code states that free samples should not be supplied to any person who is not qualified to prescribe such a product. Apart from limiting the sample packs to prescribed dosage to not more than three patients for the required course of treatment, no company should offer more than 12 such sample packs per drug to any healthcare practitioner per year. The new code has dealt with yet another controversial issue of engagement of pharmaceutical industry with doctors for Continuing Medical Education, Continuing Professional Development, or otherwise for conference, seminar, workshop, etc and research activities in collaboration with educational institutions. In a right step, the new code has put a blanket ban on conducting such activities in foreign locations.  However, CME and CPD meetings can be conducted by medical colleges, teaching institutions, universities, hospitals, professional associations of doctors and specialists, NIPERs, laboratories of ICMR, DBT and CSIR, pharma colleges and other academic and research institutions. However, all the expenditures incurred for these purposes are subject to independent, random, or risk-based auditing by the government.

Unethical marketing practices by the pharmaceutical companies have been a major issue the country has been facing for a long time now. Accusations have periodically been flying thick and fast that several pharmaceutical companies spend crores of rupees on marketing of their products. It was under this background, the DoP came out with the first UCPMP in 2011 to arrest the unethical marketing practice of bribing of doctors by the pharma companies. Unfortunately, it remained largely on paper as it was a voluntary code. In a country like India where even the mandatory laws are very often violated rather than complying, the less said the better about the implementation of a voluntary code like UCPMP. After releasing the code, the DoP had then stated that its implementation will be reviewed after six months and if it is found that it has not been implemented effectively by the pharma companies, the government would consider making it a statutory code. But, instead of making it mandatory after six months, the government dragged its feet on the issue. Finally, the DoP came out with a revised UCPMP in 2015, which was also voluntary. As the code lacked penal provisions to deter the wrongdoers, a large section of the pharma companies continued to indulge in bribing the doctors. As voluntary compliance failed, the DoP finally decided to make code mandatory with legal backing and penal provisions by introducing it under the Essential Commodities (EC) Act, 1955. But, due to stiff resistance from the industry, the government backed off.  As the issue lingered on, the government in 2022 constituted a five-member high-level committee headed by Indian government's policy think-tank NITI Aayog's member (Health) V K Paul to study a legal mechanism to regulate the marketing and promotional activities of the pharmaceutical companies in the country. This committee has now come out with the new code with some legal provisions as all the promotional expenditures have now come under the relevant provisions of the Income Tax Act, 1961 with respect to deductions and reporting of income. At last, the government has given the UCPMP some teeth. The government should now implement it in letter and spirit.

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