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Resource centre on India's rural distress
 
 

Cancer, HIV patients suffer as morphine supplies are hobbled by excessive regulation
-The Economic Times

MUMBAI: India, the world's largest exporter of morphine sulphate, has very little of the drug to offer its terminally ill patients suffering from cancer and HIV. The supply of morphine, a narcotic pain reliever used for treating pain, is severely constrained in local hospitals and retail stores due to stringent laws that prevent and hinder companies from making and transporting the final product.
Morphine sulphate is a byproduct of opium and is the most common and cheapest painkiller for terminally ill patients suffering from cancer or HIV. India is one of the few countries that allow planting of poppy seeds, from which opium is derived.

Ironically, even as patients in the country writhe in pain for lack of the medicine, foreign countries are getting a ready supply of morphine sulphate due to India's booming exports (the figure for 2009 was 390 tonnes).

Due to the short supply at home, patients are either turned down by chemists or given substitutes such as sentanyl, which are more expensive and a poor substitute.

"A pharma company needs a minimum of 10 licences to manufacture morphine tablets, and if you are shipping to different states, separate state licences are required," rues Umesh Kumar Modi, MD of the Delhi-based Modi Mundi Pharma, one of the few makers of narcotic drugs in India.

The process of procurement varies from region to region, and is further hindered by lack of licences at hospitals across the country, Modi adds. Even hospitals that do have a licence can only consume morphine up to the possessional and annual quota fixed by the excise and drug departments. 

SMALL TOWN RESIDENTS WORST-HIT
morphine
Poonam Bagai, a cancer survivor who runs a Delhi-based NGO Cankids, says the worst-hit are people living in small towns. A city resident can at least hope to access the medicine in government hospitals, she says. But for a patient living in a small town, frequent trips to procure the drug become expensive and cumbersome. Due to the stringent laws, even doctors shy away from applying for licences. 

Morphine production in the country is regulated by the Central Bureau of Narcotics and governed by the Narcotic Drugs and Psychotropic Substances Act. The Government Opioids and Alkaloid Works is the nodal agency that distributes opioids to pharma companies. About 70% of the opium produced in India is exported while the rest is used to meet domestic demand.

A health expert says that even after exporting the drug, India can comfortably meet domestic demand, but regulations hinder that. The government, on the other hand, is worried that morphine, an addictive drug, could fall into the wrong hands if the law is relaxed.

The cumbersome laws and regulation cover all aspects of the drug, from transport of the raw material to manufacture and ultimately its sale across the country. Along with central laws, companies also have to comply with state regulations.

The Narcotics Act, enacted in 1986, makes it mandatory for drug manufacturers and even patients to have a valid licence to access morphine tablets. Each tablet has to be accounted for, and licence holders can be charged for drug abuse or illicit trafficking if even one dose is unaccounted for. Fearful of the draconian laws - it is a non-bailable offence with a punishment of 10 years' rigorous imprisonment - pharmacists rarely stock the drug.

For drug companies, there is another problem. Margins are so low in this business that there is no incentive to manufacture. "We sell the drug for anywhere between 90 paise to Rs 2, so this is hardly a business proposition," says a senior official at Modi Mundi. The view is shared by the medical fraternity. "There is no profit in selling these drugs, and with so much paperwork involved, only companies with philanthropic intentions are in the business," says Dr Purna Kurkure of Tata Memorial Cancer Hospital, who is also the president of Indian Cancer Society.

To help cure the situation, Dr MR Rajagopal of the Trivandrum Institute of Palliative Sciences, along with cancer patients, filed a public interest litigation in 2007 calling for an amendment to the Narcotics Act to ensure patients get easy access to the drug.

One of the solutions Rajagopal offers is to have a single licence issued by the Centre. With the Narcotic Drugs and Psychotropic Substances (Amendment) Bill coming up in the monsoon session of Parliament, Rajagopal hopes the government will not put the issue on the back burner. According to the WHO, India has roughly 2.5 million cancer patients.