Thursday, August 02, 2007

 

Morphine and narcotics control laws

Businessworld

GAURI KAMATH




Last summer, L. Jaichand Singh ordered 10,000 morphine tablets — about six months’ worth for cancer patients at Imphal’s Regional Institute of Medical Sciences (RIMS). What should have been a straightforward process, has now taken over a year. Singh, a professor in RIMS’ department of radiotherapy, has chased multiple government departments for licences that will permit him to receive the drug. Rigorous laws govern the stocking, transport and supply of morphine and all other opiates (drugs derived from opium) in India.

“By the time I got the licences, the company’s godown ran out of stock,” says Singh. He now hopes the morphine will arrive by mid-August. What shocks is that Singh’s hospital faces these problems despite being designated a regional cancer treatment centre and receiving funds from the government.

Morphine is endorsed by the World Health Organisation and other international agencies as a safe and effective treatment for severe pain. The International Narcotics Control Board (INCB) accepts that “opiates, and above all, morphine, are indispensable for the treatment of severe pain related to cancer”. It is definitely the cheapest.

Yet, according to the INCB, in 2004, heavily-populated, developing countries like India obtained a mere 6 per cent of the world’s supply of legal morphine. Paradoxically, India is among the world’s top producers of legal opium, which gives morphine. “We export poppy by the truck loads, yet our people are denied it,” says M.R. Rajagopal, a palliative care physician in Thiruvananthapuram, who has co-authored an article about morphine in the British medical journal The Lancet. The INCB attributes this paradox to “unnecessarily strict rules and regulations”, among other things. In a country where rash driving kills nearly 100,000 people annually, many would baulk at a law restricting fast cars or hard liquor. So, why can’t 2.5 million Indian cancer patients get access to an internationally endorsed drug?

All these restrictions seem to be in the wrong places. The United States’ 2007 International Narcotics Control Strategy observes that 20-30 per cent of India’s opium crop is diverted to illicit use. Even Indian brown sugar — based on morphine — is now available in neighbouring countries, it says.

Opium, it so happens, has had mankind on a high as far back as 3,400 B.C. The Mesopotamians cultivated the plant, and called it ‘Hul Gil’ or the Joy Plant. Presumably, they had their share of fun. But the plant is infamous for its debilitating effect on China in the 18th and 19th centuries, when opium dens turned millions of Chinese peasants into unproductive drifters.

Ancient Greek physician Hippocrates first realised there was more to opium than a ‘high’, but it was German chemist Friedrich Sertürner who, in 1804, extracted opium’s active ingredient and called it morphine — after Morpheus, the Greek god of dreams. Physicians then began to prescribe the drug as a pain-killer.

Later that century, on battlefields across the world, millions of soldiers were given morphine to relieve them from the pain of war wounds. When these soldiers traded their battle fatigues for workmen’s overalls, their addiction went with them — a phenomenon called ‘soldier’s disease’ — and slowed down the economy. In 1914, the US enforced the Harrison Narcotics Tax Act, to restrict the distribution of narcotic substances. Opiates such as morphine and heroin fell under these restrictions.

Today, although several countries allow the liberal prescription of morphine to alleviate pain, access is still strictly controlled, including in India.

“Why is it that the junkies get the drugs, but the patients who need it don’t?” he asks. Ghooi filed a public interest litigation (PIL) in the Supreme Court in February this year. It demands that state governments simplify their cumbersome narcotics laws and licensing procedures to obtain morphine and other opiates for medical use. His co-petitioners include Rajagopal, co-author of the Lancet article, and Poonam Bagai, a cancer survivor who runs a Delhi-based NGO, CanKids...KidsCan, for children with the disease.

They have a strong case. Before the judgement, but after his petition, N.K. Singh, the then revenue secretary in the union government, wrote to states advising them to simplify their laws and establish procedures that allowed recognised institutes to stock and sell morphine. That, theoretically, should have included regional cancer centres such as RIMS.

Every Indian state has its own version of the Narcotic Drugs and Psychotropic Substances Act of 1985, which regulates morphine and other similar drugs. The Act requires extensive paperwork; records must be maintained for several years. It also authorises the government to conduct raids, and put suspected wrongdoers behind bars, without bail. Even clerical errors — bound to occur with such extensive documentation — could be viewed with suspicion. This has dissuaded doctors and chemists from storing the drug. “The procedures involved are often strict and cumbersome, and… this has caused undue suffering and harassment,” Singh wrote in his letter.

Opium production is also state-owned. Drug companies can only formulate the morphine powder bought from government units. This is true of other narcotics as well. Recently, Mumbai’s Nicholas Piramal took a Rs 25 crore hit on sales of cough syrup Phensedyl. The supply of its key ingredient, codeine (another opiate) is controlled by the government. “For nine months, there was no supply from the government factory,” says Ajay Piramal, chairman, Nicholas. And government took its own time importing it. No wonder, then, that only three private formulators of morphine exist in India, according to Ghooi. In states with simpler procedures, supply is a constraint. “There just isn’t enough,” says Shona Nag, a cancer specialist at Pune’s Jehangir Hospital. It is not uncommon for patients to have to rush from hospital to hospital to get their stock, she adds. Nag, who studied in Australia, says doctors there “use morphine liberally”. The developed world, according to the INCB, is the largest consumer of medical morphine produced in developing countries.




But in India, even if the states simplified procedures, this would solve only part of the problem. “Two generations of doctors have grown up not using it (morphine),” says Rajagopal, who founded Kerala’s first palliative care centre. He identifies two reasons for this. First is the law, and second, the stigma associated with morphine use itself. “People see pain as inevitable, and painkillers as dangerous,” he says. Indeed, both Rajagopal and Bagai of CanKids...KidsCan believe that the issue is symptomatic of a larger problem.

According to them, the government does not understand the importance of palliative care or improving the quality of life of chronically ill patients, many of who are about to die. This involves not just helping with the physical pain, but also dealing with the psychological trauma. Bagai, who fought colon cancer, recalls being depressed during the course of her disease. “You are constantly afraid of dying… you need psychosocial support,” she says, adding that the importance of palliative care cannot be overemphasised.

Bagai says government intervention in cancer has to go beyond awareness, prevention and detection to include patient support. Rajagopal recommends training doctors and nurses in the whole discipline of palliative care including the use of morphine — not currently in medical syllabi — and creating more care centres around the country. At present, Kerala is the only state with a critical mass of such centres. The PIL requests that the government be ordered to put in place a National Palliative Care Policy for this purpose.

There is an urgency to the issue that the government appears to have missed. Severe, chronic pain is comes not only with cancer but also with other diseases. The case for making medical morphine easily available has been accepted globally. India’s foot-dragging has caused millions to suffer.


Strange that these laws do not deter the traditional use of opium by local communities in Rajasthan and MP. The local administration turns a blind eye probably because the traditional usage is moderated by community elders and limited to certain occassions.



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