E-DRUG: Doctors in India defy guidelines on generic drugs
[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
Cite this as: BMJ 2013;347:f4244
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
'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,
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
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
'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.
Cite this as: BMJ 2013;347:f4244
Mitra P. India Pharma 2020: propelling access and acceptance, realising
true potential, McKinsey, 2010.