To the policy maker and administrator • The people of India are already facing an unbearable burden of infectious and non-communicable diseases that take a heavy toll of health and lives. The government with its low spending on health increases this burden by depriving the people of the means to cope with these. The number of people, who do not seek care for their illnesses, is rising with the rise in healthcare costs. Drugs cannot be compared to ordinary consumer goods and the market for medicines cannot be allowed to become a ‘free’ market. Please see for yourself how this ‘free market’ behaves by inflating drug prices, sometimes to outrageous limits, for the consumer. Health is a fundamental right and access to affordable essential medicines is a prerequisite to realising that right. In the absence of the government’s ability to provide people with essential medicines free of cost, it is the government’s moral obligation to protect the patients from irrational drug prices that are driving people into debt and misery. The very least that the government can do is to ensure that the burden on the patients is the least that is compatible with the profitability of the pharmaceutical sector. The government has to, as it did in the past, balance the commercial interests of the pharmaceutical sector with the interests of public health in India. Please increase spending on health and strengthen the public health system as promised in the National Health Policy 2001. Access to affordable essential medicines has been the main objective of India’s drug policy, but the pronounced pro-industry tilt in the policies of 1994 and 2002 has turned it into almost empty rhetoric. The primacy of this first principle of the drug policy has now to be restored. The drug regulatory system in India suffers from laxity, inefficiency and corruption. This is untenable in a sector that is so vital to people’s lives. The policies from 1979 onwards have all called for strengthening of the drug regulatory apparatus and the creation of a National Drug Authority. The present fragmentation of drug regulated issues between the Ministry of Health, the Ministry of Chemicals and Fertilisers and the Ministry of Science and Technology leads to a lot of avoidable confusion and inefficiency.

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To drug regulatory authorities • There is good evidence from the data presented in this document that the poor patients of India are being taken on a ride by India’s pharmaceutical market, which is nominally regulated but is actually ‘free’ in the negative sense of the term. The National Pharmaceutical Pricing Authority (NPPA) was formed with the express objective of protecting the consumer from violations of the drug price control order (DPCO) and from abnormal behaviour in the prices of those drugs that are outside price control. We plead with the NPPA to implement the DPCO with greater firmness and to respond to the highly abnormal variations in prices of decontrolled drugs while urging the government to add these to the price control regime. The Drug Controller General of India (DCGI) and the state drug control administrations are responsible for ensuring the quality of drugs, approving new drugs and preventing spurious drugs from reaching the consumer. We call upon these authorities to also stem the flood of irrational combinations and unsafe drugs in the market that lack efficacy and / or safety and certainly lead to wasteful expenditure. Should India have the dubious distinction of being the first and the only country to have allowed animal blood to be used as an anaemia preparation or being the last country to not ban unsafe drugs e.g. Analgin.

To consumer groups • The price that consumers pay for their medications, the content of the medications themselves and their scientific rationale, the quality of the medications, the promotional practices of the drug companies, and finally the prescribing practices of doctors have received far less scrutiny from consumer groups than they should have. This has allowed the government to adopt policies which are clearly skewed in favour of the pharmaceutical industry and which encourage them to indulge in unfair trade and promotional practices. • Drugs in India are often overpriced (by a factor of 20 to even 30 times in some cases), sometimes irrational and, not infrequently, of questionable quality. Prescriptions of doctors often violate scientific guidelines and contain drugs of dubious therapeutic (and enormous commercial) value that add nothing to their effect and everything to their cost. • Consumer groups should lobby for heightened regulation and scrutiny of drug prices, drug contents, and quality by exerting pressure on the NPPA and the Drug Controller General of India. There should be a curb on unfair trade practices, including the unethical promotion of drugs and vaccines to doctors and the public. One should push for the use of essential drugs in generic form and for adherence to appropriately framed standard treatment guidelines while prescribing. To academia and the public health professional • • The concept of essential drugs and the use of evidence-based standard treatment guidelines should form the core of the pharmacology-teaching curriculum in our colleges. In a country, where the majority of people are poor, the cost-effectiveness of drugs is an overriding factor in the framing of our prescriptions. The Essential Drugs List can be a guide to the most costeffective, safe and efficacious drugs. Prescribing the latest congeners of existing drugs at three times the cost, merely on a hunch about their increased efficacy, to a patient, who cannot afford them is not only irrational but also unethical. Academia should take the lead in pointing out the irrational preparations for pain, infections, anaemia, undernutrition, diabetes and hypertension to the drug regulatory authorities.

To the practising doctor • Your pen is very mighty. The bottomline of drug companies and the size of the hole in the patient’s pocket depend on the way you wield it. If we critically evaluate the drug industry’s claims on a new drug and hold back on prescribing it until the frothy hype of promotion has settled and the drug has made its way into standard textbooks, we stand to provide better, safer and more cost-effective care to our patients.

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