Doctors in India defy guidelines on generic drugs

BMJ 2013; 347 doi: (Published 01 July 2013) Cite this as: BMJ 2013;347:f4244
  1. Ganapati Mudur
  1. 1New Delhi

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; €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.


Cite this as: BMJ 2013;347:f4244