Marketing of medicines in India

Informing, influencing, or inducing?

India has a large pharmaceutical industry. A major expansion started in the early 1970s when the Indian government took two fateful decisions. Firstly, it decided to permit domestic manufacturers to produce generic versions of patented molecules without permission from overseas innovators—provided a different manufacturing process was employed. Secondly, small scale pharmaceutical units were eligible for huge fiscal incentives and state subsidies. The new policy led to an unprecedented growth of medicine makers. Today an estimated 17 000 pharmaceutical companies produce over 40 000 branded formulations, many times more than the rest of the world.

Since the industry has free access to medicines discovered abroad, there is little incentive to undertake research to make new drugs. Consequently, nearly all companies are engaged in vicious competition to sell the same molecules under different brand names. Over 140 brands of omeprazole and over 120 brands of cefadroxil exist in India. As companies resort to unconventional methods to sell their brands, ethics take a back seat. Expanding indications, exaggerating efficacy, ignoring contraindications, and underplaying adverse effects have become routine practice.

Some recent examples illustrate these questionable marketing methods. Nimesulide, a non-steroidal anti-inflammatory drug, is being recommended for use in neonates and infants for undiagnosed fever. The European Medicine Evaluation Agency has contraindicated its use in children below 12 years due to its hepatotoxic potential.1 Metoclopramide is marketed for nausea and vomiting in all age groups including low birthweight neonates,2 though its use was restricted in the West in the mid-1990s to people aged over 18 years. The Nootropil brand of piracetam is indicated for cortical myoclonus in people older than 16 years.3 In India, it is recommended for social maladjustment, lack of alertness, loss of memory, and learning disabilities in children. Known side effects are conveniently side stepped.

Companies find it hard to generate prescriptions based solely on science. Relying on published datasheets issued by the inventing companies reduces the scope of a drug because of the inconvenience of contraindications, precautions, drug interactions, and adverse effects. Sometimes, for purely promotional purposes local data are generated, as happened with letrozole, which was given to over 430 young women to test its efficacy in inducing ovulation.4

Without new molecules, companies create “novel” products by mixing two or more medicines in a fixed dose combination. Such combinations are often irrational, and some pose danger. Short term use of combinations of quinolones with imidazoles for undiagnosed diarrhoea is encouraging Salmonella typhi resistance to quinolones.5

Just as elsewhere, gifts and other incentives to prescribers are used by manufacturers to promote their products—and the methods are often ingenious. There is little consumer resistance to these practices for two reasons: faith in the perceived integrity of the medical profession, and lack of information. An examination of 1200 randomly selected formulations showed that only 316 had package inserts, and none had patient information leaflets.6 Many poor, illiterate people in India ask pharmacists for medicines for common problems such as colds, cough, aches, and pains. In order to tap this lucrative market, companies produce “branded generics.” These are not promoted to the medical profession, but to pharmacies, which are offered huge discounts. In the process it is conveniently forgotten that inducing pharmacies to sell prescription drugs without prescriptions is unethical and illegal.

The commercial needs of countless, fiercely competing pharmaceutical companies have led them to depend on the tried and tested 3Cs: convince if possible, confuse if necessary, and corrupt if nothing else works. It is easy to find fault with policies adopted decades ago, and the fault may lie in the regulatory system failing to keep pace with innovations in the pharmaceutical industry. Nevertheless, the government has failed in its duty of preventing unethical promotion that has already resulted in misery, illness, and death.