Pharma needs a dose of regulation

Code for pharmaceutical marketing must be implemented

The recent income tax raids on Bengaluru-based Micro Labs, makers of an over-the-counter paracetamol tablet widely used in the treatment of Covid-19, have re-focused attention on the code of conduct governing ethical practices for pharmaceutical companies and medical practitioners. Apart from tax evasion, Micro Labs has been accused of paying doctors Rs 1,000 crore as bribe to prescribe Dolo-650 for Covid-19 patients, registering sales that were significantly higher than those of competing products in the market. The company has denied the charge and said that the promotion cost of  Rs 1,000 crore was for all its drugs over several years, not just for Dolo. Ironically, this latest controversy has occurred in spite of the existence of a code restricting the practice of “excessive marketing”, such as offering doctors inducements to prescribe their brand. That was adopted as far back as 2015. This code, however, has been vastly undermined by the fact that it is voluntary in nature.

The Supreme Court is currently hearing a plea to make the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) a statutory requirement. This is an unexceptionable case in as much as the nexus between doctors and pharma companies is a well-known secret. In its most common and harmless form it consists of sending doctors and practitioners branded stationery, calendars, or desk knick-knacks to keep their products on top of the mind in a crowded market. This is especially important in a market such as India, where many essential drugs are placed under price control. The more serious examples of this nexus are when doctors are offered paid-for junkets to attend medical conferences, or given fees to act as lead investigators on clinical trials or in endorsing key research papers.

It has been suggested that under the statutory code, all pharma companies disclose payments made to doctors or their associations, directly or indirectly. This is a sensible suggestion on the face of it but it is an open question whether the conversion of a voluntary code into a statutory one will change the situation appreciably, even if the penalties imposed are severe. For a code to be effective, several conditions have to be met. These egregious practices occur all over the world, not just in India. But a combination of stronger regulation and robust whistleblower policies in developed nations has ensured that these practices come to light from time to time. In India, whistleblower protections remain weak on account of the inefficiencies of the judicial system. But another uniquely Indian administrative problem of overlapping jurisdictions is also likely to hamper the effectiveness of a UCPMP.

The ambit of the UCPMP is currently the focus of a tussle between the Department of Pharmaceuticals, which comes within the purview of the Ministry of Chemicals and Fertilisers, and the Ministry of Health. The latter, predictably, has been pushing for the UCPMP to be brought under the impending Drugs, Medical Devices and Cosmetics Act, but the Department of Pharmaceuticals is unwilling to forfeit its control of this large and fast-growing industry. Whichever institution ultimately gains control of this vital regulatory function, however, will need to be armed with the organisational heft to keep track of transgressions of this massive industry with over 3,000 companies and 10,500 manufacturing facilities. In that context, the inability to staunch the proliferation of fake drugs does not raise much confidence for enforcing the UCPMP.