Breaking the nexus

Prime Minister Narendra Modi's bid to bring about a mandatory code of drug marketing practices to ensure doctors prescribe generic drugs rather than expensive branded medicines and make pharmacists follow the rule for the benefit of the common man is a novel one, though not quite a new idea. Since 1975, after the submission of the Hathi Committee report, one government after another tried to discipline the drug industry and its key on ground marketing tool, prescription-writing doctors, and surgeons, with modest success. Over the years, prices of drugs, especially the patented and new generation medicines, have sky-rocketed. This is despite the existence of the drug price control order (DPCO, 1995 and 2013), the National Pharmaceutical Pricing Authority (1997) controlling the prices of essential drugs and the government's attempt to fix post-manufacturing expenses (PME) for prescription drugs. And all through, doctors were constantly induced to prescribe generic medicines to patients with limited success. The drug firms and doctors have remained adamant.

This is despite the existence of the drug price control order (DPCO, 1995 and 2013), the National Pharmaceutical Pricing Authority (1997) controlling the prices of essential drugs and the government's attempt to fix post-manufacturing expenses (PME) for prescription drugs. And all through, doctors were constantly induced to prescribe generic medicines to patients with limited success. The drug firms and doctors have remained adamant.

Over the years, prices of drugs, especially the patented and new generation medicines, have sky-rocketed. This is despite the existence of the drug price control order (DPCO, 1995 and 2013), the National Pharmaceutical Pricing Authority (1997) controlling the prices of essential drugs and the government's attempt to fix post-manufacturing expenses (PME) for prescription drugs. And all through, doctors were constantly induced to prescribe generic medicines to patients with limited success. The drug firms and doctors have remained adamant.

Pharmaceutical companies, with most leading private practitioners firmly behind them, are already questioning the Prime Minister's announcement that there could be a law mandating doctors to prescribe medicines with their generic names instead of brand names. The Union Health Ministry asked the medical community to follow a 2016 notification by the Medical Council of India (MCI) mandating doctors to prescribe medicines by generic names.

A generic medicine is a bioequivalent to a branded drug. Incidentally, there is nothing new about the latest MCI mandate. It has been debated over the years and put in cold storage several times. Even if a law is passed on the subject nothing much is expected to change. It will only promote corruption in the lowest and the most critical level of unregulated chemists, who will push products that give them maximum margins. Who will vouch for the quality and efficacy of such generics? The jobs of drug inspectors and test labs will increase manifold. The system will, at best, promote more dishonest inspectors and test labs. The US system of drug prescription is most unlikely to succeed in India, known to be one of the world's epicentres of business corruption, in the absence of the necessary framework. Ask the US Food and Drug Administration (FDA), which has to regularly conduct inspections and raids on Indian generic drug exporters to that country, including some of the biggest names in the local pharmaceutical industry. The proposed Uniform Code for Pharmaceutical Marketing Practices (UCPMP) may look somewhat perfect on paper, though not actually potent in practice. What looks good for the USA, boasting one of the world's strongest law enforcement authorities especially when it comes to human life and health, may mean little to India. Almost 80 per cent of prescription drugs sold in the USA are generics, helping patients and hospitals save billions of dollars every year. The FDA has ensured that generic medicines can be trusted to have the same quality as brand-name drugs -- but at a lower price.

The US system of drug prescription is most unlikely to succeed in India, known to be one of the world's epicentres of business corruption, in the absence of the necessary framework. Ask the US Food and Drug Administration (FDA), which has to regularly conduct inspections and raids on Indian generic drug exporters to that country, including some of the biggest names in the local pharmaceutical industry.

The proposed Uniform Code for Pharmaceutical Marketing Practices (UCPMP) may look somewhat perfect on paper, though not actually potent in practice. What looks good for the USA, boasting one of the world's strongest law enforcement authorities especially when it comes to human life and health, may mean little to India. Almost 80 per cent of prescription drugs sold in the USA are generics, helping patients and hospitals save billions of dollars every year. The FDA has ensured that generic medicines can be trusted to have the same quality as brand-name drugs -- but at a lower price.

It is important to know that this is despite the fact that no American wants to skimp on health, even if it means saving money. The FDA approves a generic drug only after it is sure that it is the same as the brand-name product in terms of active ingredient; strength; use and effect (for example as a pill, inhaler, liquid, or injectable); ability to reach the required level in the bloodstream at the right time and to the same extent; and, finally, testing standards. The government of India, along with state governments, will have to work hard to change the country's drug industry practices, drug administration system and regulatory mechanism before a new law or executive order such as UCPMP become a success to a reasonable extent.

Few will deny the fact that the government has not achieved much since the report of the Hathi Committee (1975) was made public by the then Prime Minister Indira Gandhi, who came down heavily on foreign drug firms in India such as Pfizer, Glaxo, Abbott, Sandoz, Wyeth, Merck, Roche, Bayer, etc., making big money on manufacturing formulations instead of bulk drugs. The Hathi Committee had emphasised the need for India's achievement of self-sufficiency in medicines and of abundant availability at reasonable prices of essential medicines. One may say India has reasonably progressed in manufacturing formulations as well as basic drugs. It has emerged as a major exporter of generics, under the USFDA hawk eye. The industry has shown a double-digit growth over the last three decades. But, it is still far behind achieving the desired objective.

Sadly, many of the government's own drug companies, manufacturing bulk drugs, and formulations, fell sick over the years in the face of competition from multinational corporations and also administrative apathy.

Hopefully, the Prime Minister is aware that on December 12, 2014, the Department of Pharmaceuticals (DoP) announced the details of the 'Uniform Code of Pharmaceutical Marketing Practices (UCPMP),' which was to be effective across the country from January 1, 2015. Earlier, a draft UCPMP, inviting stakeholders' comments, was issued on March 19, 2012, under Manmohan Singh-led UPA government. Immediately after that, top officials of many concerned departments held several discussions on that draft with the constituents of the pharmaceutical industry, Ministry of Health, Medical Council of India (MCI), besides other stakeholders.

It'd be nice if Prime Minister Narendra Modi finds out why no decision on the subject could be taken for the last five years and if intense lobbying by interested constituents was behind the inaction. Such a backgrounder will save the government of any embarrassment on UCPMP's possible failure, resulting in a chaos in the highly public-sensitive health sector and the process of drug administration before the 2019 Lok Sabha election.