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[e-drug] BMJ - Doctors in India defy guidelines on generic drugs

E-DRUG: Doctors in India defy guidelines on generic drugs
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[A balanced article on the problems of influencing prescribing of 
generic medicines in India. Certain generic companies are thought to 
produce better quality products than others resulting in certain 
'branded generics' being preferred over other generics. Strengthening 
the regulatory approval and monitoring process to ensure quality is 
important. However, even then, simple advice to prescribe by generic 
name is not likely to change mainstream prescribing without some 
administrative or legal sanction. And the concern raised about which 
generic a pharmacist might dispense also needs to be considered - if the 
public were assured of generic quality and were informed of the prices 
that could drive change at that level if supported by suitable 
legislation and enforcement measures. Copied as Fair Use. DB]

Doctors in India defy guidelines on generic drugs
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f4244 (Published 1 July 
2013)
Cite this as: BMJ 2013;347:f4244

Ganapati Mudur

Doctors across India seem unwilling to write prescriptions containing 
only the generic or unbranded chemical names of drugs, despite two 
recent advisories from the Medical Council of India urging them to do so.

The advisories, issued in November 2012 and January 2013 asking 
physicians to 'as far as possible prescribe generic drugs,'� are unlikely 
to change prescription practices in the country, private and government 
doctors have said.

Some doctors have described the advisories as a fresh reminder of a code 
of ethics that doctors are expected to follow. In 2002, the Medical 
Council of India told doctors to prescribe generically to protect 
patients from the effect of promotional campaigns by drug companies. But 
many doctors say that the suggestion to prescribe drugs without brand 
names is impractical given the diversity of chemical formulations and 
the stark differences in the prices of drugs from different 
manufacturers in India.

Generic drugs sold under different brand names dominate the Indian 
pharmaceuticals market. A McKinsey report had predicted three years ago 
that patented products will probably make up less than 5% of the 
projected $55bn pharmaceutical market in India by 2020.1

Krishan Kumar Aggarwal, a senior cardiologist in New Delhi who is also 
head of the ethics committee of the Delhi Medical Council, a state body, 
told the BMJ: 'Doctors in India are already prescribing generic drugs, 
but through their brand names. If the authorities want us to prescribe 
drugs through chemical names, why do they allow so many brand names and 
why are there such wide price variations?'

Figures from the Monthly Index of Medical Specialities (MIMS), India, 
suggest that 10 tablets of unbranded cetirizine were available in 2012 
for about 1.50 rupees (�0.017; Euro��0.019; $0.025), while a branded generic 
product was sold at 27 rupees, and a branded version cost 39 rupees.

'We don't see such price variations in the United Kingdom,' � said Chandra 
Gulhati, editor of MIMS India. For example, Panadol, a branded version 
of 1000 mg paracetamol, costs �3.30 for 100 tablets, he said, while 
unbranded 500 mg paracetamol costs �2.88.

Doctors say that the differences in prices of the same drugs and the 
promotional campaigns by medical representatives of pharmaceutical 
companies have given rise to perceptions about the quality of specific 
brands.

'Perceptions of quality of drugs are not unfounded and cannot just be 
wished away,' said Vinay Kapoor, a professor and gastrointestinal 
surgeon at the Sanjay Gandhi Postgraduate Institute of Medical Sciences, 
in Lucknow.

Earlier this year, India's health ministry told the Indian parliament 
that of 48,082 samples of drugs tested in 2011 by government drug 
regulators, 2186 (4.5%) had been found to be of substandard quality. In 
each of the three preceding years, the proportion of substandard drugs 
among samples tested ranged from 5.7% to 4.9%.

'The first step should be to ensure quality standards, quality 
monitoring, and quality assurance' unless doctors become convinced [that] 
there is uniform quality, independent of the source of the compound, I 
don't expect doctors in India will routinely write out prescriptions 
with chemical names of drugs,'� Kapoor told the BMJ.

Doctors also point out that writing prescriptions with unbranded generic 
names would be tantamount to handing over the choice of drug to chemists 
in retail pharmacies, who are likely to hand over the products that 
provide them the highest margins.

'We're not comfortable with leaving the choice of the drug to chemists,'
said Harivallabh Pai, a paediatrician in Vasco, a town in the western 
coastal state of Goa, and president of the state branch of the Indian 
Medical Association.

But not everyone is opposed to the idea. Amar Jesani, a physician and 
editor of the Indian Journal of Medical Ethics, said that the quality 
argument was a 'hoax'  at times conveniently used to prescribe specific 
brands.

'Doctors in India rarely think about price considerations,'  Jesani told 
the BMJ. 'With generic prescriptions, at least consumers can demand 
cheaper drugs -  let consumers decide and fight it out with chemists.'

'This debate on generics and unbranded medicines is taking the focus 
away from the real issue: price control,' said Gulhati. 'The cost of 
producing 10 tablets of paracetamol remains the same for branded or 
unbranded products: profit margins vary - not cost of production.'

A government initiative to expand the distribution of generic drugs free 
through primary health centres and other government healthcare centres 
is likely to turn state governments into the biggest bulk buyers of 
unbranded generic drugs.

Health ministry officials point out that the government has earmarked 
120bn rupees for this initiative to cover the period between 2012 and 
2017. Government procurement agencies will be expected to buy generic 
drugs in bulk and distribute them to healthcare centres.

'Some states are already doing this, and we're now waiting for feedback 
from other states to understand requirements,' a senior health official 
told the BMJ. But public health experts estimate that drugs distributed 
in government clinics make up less than 20% of drugs consumed in India.

Notes
Cite this as: BMJ 2013;347:f4244

References
Mitra P. India Pharma 2020: propelling access and acceptance, realising 
true potential, McKinsey, 2010. 
www.mckinsey.com/locations/india/mckinseyonindia/pdf/India_Pharma_2020.pdf.
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