New Cancer Pain Research Underscores Urgency to Reform Drug Act
December 4, 2013

(New Delhi) – India [2]’s parliament should approve changes to the country’s drug law to improve availability of strong pain medicines, Human Rights Watch and Pallium India said today. The winter session of the Indian parliament opens on December 5, 2013.

Millions of patients in India unnecessarily experience excruciating pain because restrictive drug regulations prevent them from getting inexpensive and effective pain medications, the organizations said. The government introduced amendments to the Narcotic Drugs and Psychotropic Substances Act (the Drug Act) in 2012. However, during its past two sessions, parliament did not consider the government’s proposal.

“Amending the Drug Act could help spare millions of Indians unnecessary suffering from pain,” said Dr. MR Rajagopal, chairman of Pallium India [3], a leading Indian palliative care organization. “Parliament should not pass up this opportunity to perform a great service.”

The proposed amendments to the Drug Act would give the central government authority to regulate so-called “narcotic drugs,” require a single license for the procurement of morphine and other strong opioid medications, and charge one government agency, the state drug controller, with enforcement.

Preliminary findings of a recent study of pain prevalence at four major cancer hospitals in India underscored the importance of the amendments, the organizations said. The study was conducted by Pallium India, Hyderabad Pain Relief and Palliative Care Society, and Human Rights Watch, in collaboration with the Regional Cancer Centers in Hyderabad, Kolkata, Cuttack, and Ahmedabad. It found that almost 90 percent of cancer patients suffered from pain when they arrived at these institutions, almost 60 percent from moderate to severe pain. More than 90 percent of patients with moderate to severe pain were not receiving adequate pain medicines.

The World Health Organization and the Indian government consider morphine an essential medicine for the treatment of strong pain from cancer and other illnesses. Yet, as Human Rights Watch documented in a 2009 report, “Unbearable Pain: India’s Obligation to Ensure Palliative Care [4],” under the Drug Act, the process for procuring the medication is so complex that many hospitals, including major cancer institutions, refuse to stock it.

Since the Drug Act was introduced in 1985, most Indian states and territories have enacted regulations that require hospitals and pharmacies to obtain four or five different licenses from several government agencies to be allowed to purchase morphine. Some licenses have a limited validity period, but all must be valid at the same time. In the seven years following the introduction of the Drug Act, morphine use in India plummeted by 97 percent.

Human Rights Watch estimated that the amount of morphine India used in 2008 was sufficient for just four percent of patients with advanced cancer who required it.

Patients who experienced severe pain without access to adequate treatment face enormous suffering. Like victims of torture, these patients often told Human Rights Watch that the pain was intolerable and that they would do anything to make it stop. Many said that they saw death as the only way out and some said they had become suicidal.

Over the last 15 years, India’s central government has taken several steps to counter the Drug Act’s detrimental effects on availability of pain medicines. In 1998, it recognized that the law had caused “undue sufferings and harassment” to cancer patients and recommended simplified regulations for morphine tablets. However, because the law leaves regulation of narcotic drugs to India’s states and territories, the central government could not force them to carry out the recommendation. Only 17 of India’s 35 states and territories have introduced the simplified procedure.

The new cancer pain study was conducted at major cancer centers in the states of Andhra Pradesh, Gujarat, Orissa, and West Bengal. All four hospitals belong to a group of 29 comprehensive cancer institutions that the central government has recognized as Regional Cancer Centers, and are public or charitable hospitals.

Researchers surveyed a total of 1,707 patients at the four institutions, including 848 new patients, between October 2012 and January 2013. Of the new patients, 329 reported suffering from severe pain in the previous week. Under WHO recommendations for treatment of cancer pain, they should have received morphine or another strong opioid medication. Yet, the study found that only 3 of them had received such medications. The vast majority had not received any pain medication.

The findings of the pain study are undergoing full analysis in preparation for publication. It was the first study of pain prevalence among cancer patients in India since 1998.

“It is inconceivable in most countries that specialized cancer hospitals would not have morphine available for pain treatment,” said Diederik Lohman [5], senior health researcher at Human Rights Watch. “The amendments pending in parliament are a major step toward ending this tragic reality.”

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