For doctors, pain of handling narcotic drugs

PT Jyothi Datta | Updated on January 20, 2018 Published on June 24, 2016

At a de-addiction centre... doctors fear draconian laws over slightest error in use of psychotropic drugs to treat addicts or in pain management

A strong case is being made for a single agency to handle all aspects of controlled substances used in medical conditions

In December 2014, two psychiatrists were arrested in Punjab for prescribing buprenorphine, an approved psychotropic drug used in pain management and to treat opium addicts.

More recently, another controlled substance, ephedrine, hit the headlines, as an international story of alleged drug smuggling unravelled out of Thane reportedly involving a listed company and a Bollywood actress.

As such extreme incidents get reported around narcotic, psychotropic and controlled substances, fear stalks drugmakers and doctors involved with the production and prescription of these drugs for medical purposes.

Fear is palpable among doctors using such medicines for pain management or in de-addiction programmes, says Atul Ambekar with the All India Institute of Medical Sciences’ National Drug Dependence Treatment Centre and Department of Psychiatry.

“Doctors and drug peddlers should not be treated in the same manner,” he says, calling for a system that differentiates legitimate people handling these drugs (doctors, chemists, manufacturers) from peddlers.

The heavy hand of enforcement has resulted in many doctors shying away from these medicines for fear of landing in prison on the smallest, inadvertent technical lapse, he explains. The real “sufferer” here, he adds, is the patient who is unable to access the medicine, as the doctor is unwilling to prescribe it.

Seeking a safer pathway for those handling narcotic, controlled and psychotropic substances for medical use, doctors and pharma industry professionals have approached the Government seeking a single agency to handle all issues around these substances.

The Narcotic Drugs and Psychotropic Substances Act,1985 set out to prevent illegal trafficking and only recently (2014) did medicinal and scientific uses get incorporated into it.

Policing worries

But there seems to be a “perennial confusion” when it comes to “policing” under the Act, says Nagesh Simha, Medical Director, Karunashraya and former president of the Indian Association of Palliative Care.

Presently, multiple Central and State agencies are involved in the licensing and surveillance of narcotic, psychotropic and controlled substances. They include the State Food and Drug Administrations, the Drug Controller General’s offices in different States, the State police and the Narcotics Control Bureau (NCB), says an industry-hand, preferring to remain unnamed. These enforcement agencies come under different Ministries — Health, Finance or Home — and often there is little coordination between them, the representative alleges.

A single agency should handle all aspects — from licensing to enforcement — of these substances used for medical purposes, says Daara Patel with the Indian Drug Manufacturers’ Association, citing the USDEA (United States Drug Enforcement Agency) example.

Ephedrine and pseudoephidrine are bulk drugs used to make decongestant and anti-asthmatic medicine, he says, and are products of choice the world over.

Doctors and industry also worry about the “draconian” penalties over the slightest technical error. Any transgression attracts non-bailable imprisonment for six months, they say. There should be compounding (graded) penalties, where small lapses attract a fine payment and illegal activities are punished by putting those involved behind prison bars, says Simha.

Countering criticism of a heavy hand, a senior police official says that enforcement agencies are “sensible” to not go after doctors using such medicines in de-addiction programmes. Time and again there are ground reports of diversions happening from legal entities and that risk continues, he says, explaining the challenge faced by enforcement agencies.

Industry officials agree that the byproduct from the manufacturing process needs to be destroyed to prevent misuse. But even destroying it involves chasing authorities, they complain.

Handling such medicines is a concern even globally, and earlier this year, US President Barack Obama proposed new funding to ensure access to medically assisted opioid use, even as enforcement agencies continued their crackdown on the abuse of these drugs.

Party drug?

Ephedrine and pseudoephedrine are not party drugs (with hallucinatory effect). But they are classified as precursor chemicals or controlled substances under the NDPS Act as they can be processed to make Meth (methamphitamine), a party drug.

But anyone handling these controlled substances needs to register with the NCB and file sales details regularly with the Department of Revenue Intelligence. There are checks on production, prescription and export that leave a documentary trail for enforcing agencies, explains an industry hand.

The irony is that India supplies this raw material globally when its own people are unable to access it, says Simha, referring to its requirement in managing excruciating pain in cancer and HIV, besides other psychiatric medication.

More reason why the government needs greater clarity in enforcement, ensuring genuine access to patients, even as it cracks downs on illicit drug peddlers.

Published on June 24, 2016
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