Fight against pharmaceuticals

With a series of cases against spurious pharmaceuticals, generic drugs with effective quality control must be better promoted

Fight against pharmaceuticals

The issue of cheap drugs and their quality has always been a cause of concern. With more than 40 per cent of our population living below the poverty line, a patient ends spending more than half of her/his earnings on buying medicines. As per the trends of health expenditure in India: 1993 to 2014, published in the Bulletin of WHO 2018, out of pocket expenditure on health in India is catastrophic. The catastrophic health expenditure is defined as 'out-of-pocket payments on health equalling or exceeding 10 per cent of total household expenditure and 40 per cent of the household's capacity to pay'. The proportion of households experiencing catastrophic health expenditure has increased in the last 20 years, and the increase was greater for the poor than the rich.

As per the National Sample Survey on healthcare in 2014, 'medicines emerged as a principal component of total health expenses – 72 per cent in rural areas and 68 per cent in urban areas'. It is, therefore, pertinent that their prices are regulated effectively and quality control ensured.

Drugs in our country are sold in two forms. First, the branded drugs, which are promoted by manufacturers and given a specific trade name by the company. Since their cost involves several promotional expenses, their price is higher. At least 90 per cent of the Indian domestic pharmaceutical market of Rs 1,00,000 crore and more, comprises drugs sold under brand names.

The concept of generic drugs was evolved to cut down this excess cost involved in packaging and other promotional means. The Indian government began encouraging more drug manufacturing by Indian companies in the early 1960s. Public sector pharmaceutical units played a vital role. A generic drug is sold under a pharmaceutical/chemical name with equal efficacy as the branded drugs. These are marketed under the chemical/pharmacological name without advertising. However, here too, companies started manufacturing them under brand names. These are termed branded generic drugs, which are being sold not under a pharmacological name but under a different brand name even though produced by a company which is involved in manufacturing and promoting branded drugs.

To facilitate the use of generic drugs, the Government of India has set up Jan Aushadhis, which sell only generic name medicines. However, there are not enough Jan Aushadhis, possibly less than 3,000 against more than eight lakh retail outlets selling branded drugs.

Through the Indian pharma's field force numbering nearly one million, medical representatives, doctors and patients have begun to trust specific companies and their brands. For a similar trust to develop in generic drugs, there is a need for perceptible quality assurance. Otherwise, the use of generic drugs is unlikely to increase.

With a value of USD 20 billion, the pharma sector in India is doing better than many other sectors and still continues to be a major source for the supply of cheap bulk drugs globally, even to some developed countries.

But there are also reports of low-quality medicines. Spurious/falsely-labelled/falsified/counterfeit (SFFC) drugs can cause treatment failure or even death. This is unacceptable. A working paper published through the US National Bureau of Economic Research gave details of the results of an extensive investigation into Indian pharmaceutical quality. Around 1,500 India-made drug samples were collected from 22 cities throughout Africa and it was found that '10 per cent of the antibiotic and anti-tuberculosis samples contained insufficient levels of the key active ingredients'. Most of those drugs were not counterfeit; they are legally made by legitimate companies. They contain some therapeutic elements, but probably not enough active ingredients to actually treat disease'.

There have been cases of default by some of the leading companies. 'Ranbaxy was found guilty in a US court in May 2013 and had to pay over half a billion dollars in fines and settlements. In 2012, Ranbaxy was forced to recall millions worth of drugs after glass particles were found mixed with the raw ingredients used for its generic version of Lipitor. Dr Reddy's Laboratories had to recall about 58,000 bottles of an ulcer medication because some of the pills were found to be contaminated'. According to the Central Drugs Standard Control Organization (CDSCO) estimation, during 2003-2008, 6.3-7.5 per cent of the samples were of substandard quality and 0.16-0.35 per cent were encountered as spurious.

Such reports reduce the confidence among health providers and patients on the efficacy of drugs, more so on generic drugs. It may be noted that there is powerful propaganda against generic drugs by companies selling branded drugs. This propaganda also impacts patients who invariably ask for branded drugs from multinational companies. This can be countered through strict quality control on all drugs, particularly the generic drugs. Their trade margins have to be regulated. To enforce the regulations, there should be a surprise check of samples collected from the market. The CDSCO has to play a vital role in this. People's confidence has to be built through public awareness and effective standardisation of drug quality. More public sector pharmaceutical units should be opened as it is easier to exercise quality control over them.

(The author is Senior Vice President, Indian Doctors for Peace and Development. The views expressed are strictly personal)

Arun Mitra

Arun Mitra

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